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The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery.

Specific indications by wavelength include:
1064 & 532 nm (Q-Switched, nanosecond mode): Treatment of benign vascular lesions, benign pigmented lesions, hair and tattoo removal, incision, excision, ablation, vaporization of soft tissue for General dermatology.

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos.
• Treatment of benign vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, Cherry angioma, Spider nevi.
• Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, Ephalides, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus, Ota Nevus.
• Treatment of seborrheic keratosis.
• Treatment of post inflammatory hyperpigmentation.
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

• Removal of dark ink (black, blue and brown) tattoos.
• Removal of benign pigmented lesions including: nevus of Ota, Café au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Nevus spilus.
• Treatment of common nevi.
• Removal or lightening of unwanted hair.
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (non Q-Switched – free running mode):

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of wrinkles.
• Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode), also with fractional and microbeam handpieces:

• Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
• Benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, treatment of wrinkles in Fitzpatrick Skin Types I-IV.

1064 nm (picosecond mode), also with fractional and microbeam handpieces:

• Removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
• Benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, treatment of wrinkles in Fitzpatrick Skin Types I-IV.
• Only with fractional handpiece, treatment of acne scars in Fitzpatrick Skin Types II-V.

694 nm (Q-Switched), including microbeam handpieces:

• Tattoo removal: Suggested for blue, sky blue, black, green and violet ink.
• Pigmented lesion removal (benign): Cafe au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Ota and Ito Nevus, Nevus spilus, Mongolian spot.

694 nm (non q-switch – free running mode):

• Remove benign dermal and epidermal pigmented lesions.
• Effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

IPL 590-1200nm; 625-1200nm; 650-1200nm:

• Permanent hair removal.

IPL 550-1200nm; 570-1200nm:

• Photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm:

• Inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler:

• Provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments.

Type of Use: Prescription Use

The Discovery Pico Family includes medical laser devices for dermatology and aesthetic medicine used by healthcare professionals (dermatologists) in professional healthcare environments. The family comprises Discovery Pico, Discovery Pico Plus, and Discovery Pico Derm models, which differ based on installed laser sources and the presence of a Twain connector.

The device is equipped with a graphical user interface (GUI) displayed on a screen for user interaction, allowing for laser parameter settings. It can be used with Twain IPL and Twain 2940 devices (Twain 2940 is separately FDA cleared K173002).

The laser beam is delivered via an articulated arm with a handpiece and activated by a footswitch. Four types of handpieces are available:

• Round (diameter): 2 to 12 mm
• Square (side): 2, 3, 4, 5, 7 mm
• Microbeam/fractional handpieces: 8, 9 mm (9 mm microbeam handpiece is also called "High Coverage")
• Rosso handpiece (separately FDA cleared: K211228)

The device incorporates four main sections:

• Power electronics: Manages power supply to all device components.
• Control electronics: Primarily consists of a microcontroller board housing the device's main firmware (FW).
• Cooling system: Cools the laser source pumping chamber and, for Twain IPL, the IPL flashlamp.
• Optical bench.

Twain IPL is an optional accessory handpiece for intense pulsed light (IPL), intended for hair reduction and treatment of various skin lesions. Twain IPL can be cooled or uncooled and supports fixed or changeable guides with wavelength ranges of 650-1200 nm, 625-1200 nm, 590-1200 nm, 570-1200 nm, 550-1200 nm, and 400-1200 nm. Each guide is available in two sizes: small (25x13 mm²) and large (48x13 mm²).

In picosecond (PS) mode, the device offers "VarioPulse" technology, allowing the user to select three pulse levels corresponding to different pulse durations:

• Short (S): 450 ps (1064 nm), 370 ps (532 nm)
• Medium (M): 600 ps (1064 nm), 500 ps (532 nm)
• Long (L): 800 ps (1064 nm), 600 ps (532 nm)

The provided text is an FDA 510(k) clearance letter for the Discovery Pico Family of laser devices. While it outlines the device's indications for use, its technical specifications, and the non-clinical tests performed to demonstrate safety and effectiveness, it explicitly states "Clinical testing: N/A."

This means that the submission for this particular device did not include a clinical study (such as an MRMC study or a standalone algorithm performance study) to prove specific performance criteria against a ground truth in a human-in-the-loop or algorithm-only setting. The clearance relies on non-clinical bench testing and comparison to predicate devices, demonstrating substantial equivalence rather than a direct clinical performance study against quantified acceptance criteria for a specific AI-driven task.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because a clinical study with those elements was not conducted or presented for this 510(k) submission.

Below is a table summarizing the information that is available from the document and indicating where the requested information is "N/A" (Not Applicable) or "Not Provided" due to the nature of this 510(k) submission (bench testing and predicate comparison, not a clinical trial proving AI performance).

Acceptance Criteria and Device Performance (Based on available information)

Study Details (Based on available information)

In summary: The FDA 510(k) clearance for the Discovery Pico Family is based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing, adherence to recognized standards for safety and performance (electrical, software, biocompatibility, reprocessing), and comparison of technical specifications. It does not involve a clinical study to evaluate AI performance against specific clinical acceptance criteria or a ground truth derived from expert consensus or outcomes data. Therefore, the detailed questions related to such clinical studies are not applicable to this specific clearance document.

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The GE Discovery MI Gen2 is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.

Discovery MI Gen2 is intended to image the whole body, head, heart, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).

When used with radiopharmaceuticals approved by the regulatory in the country of use, the raw and image data is an aid in; detection, localization, evaluation, diagnosis, staging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are:

Cardiology:

• Cardiovascular disease
• Myocardial perfusion
• Myocardial viability
• Cardiac inflammation
• Coronary artery disease

Neurology:

• Epilepsy
• Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia
• Movement disorders, such as Parkinson's and Huntington's disease
• Tumors
• Inflammation
• Cerebrovascular disease such as acute stroke, chronic and acute ischemia
• Traumatic Brain Injury (TBI)

Oncology/Cancer:

• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Breast Cancer
• Prostate Cancer
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Colorectal Cancer
• Melanoma

Discovery MI Gen2 is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.

GE's Discovery MI (DMI) Gen2, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GE Positron Emission Tomography (PET) System and a GE Computed Tomography (CT) System. The DMI Gen2 is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. lt is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging.

GE has modified the cleared Discovery MI (K161574) within our design controls to include a 6ring configuration that provides 30 cm Axial Field of View (AFOV) coverage. DMI Gen2 employs the same detector design architecture and manufacturing process as in the predicate to offer scalable ring configurations (3-ring, 4-ring, 5-ring and 6-ring) to have scalable AFOV coverage (15cm, 20cm, 25cm and 30cm) and corresponding imaging performances.

The provided text is a 510(k) Summary of Safety and Effectiveness for the GE Discovery MI Gen2 PET/CT system. It does not include a description of acceptance criteria or a detailed study proving the device meets specific performance metrics in a clinical setting. Instead, it states that clinical testing was not required due to the nature of the changes to the device and the use of established engineering and physics-based performance testing.

Therefore, many of the requested items related to clinical study design and ground truth are explicitly stated as not applicable or not performed in this submission.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

• Absent. The document does not provide specific acceptance criteria or reported performance metrics in a tabular format for clinical outcomes. It focuses on engineering and image performance evaluation testing, but no specific values or acceptance thresholds are given. The mention of "better detectability of small lesions" and "higher AFOV coverage... allows a patient to be scanned using fewer field of views" are general claims of improvement, not specific performance metrics against an acceptance criterion.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This was a non-clinical study. The summary states: "Clinical Testing: Discovery MI Gen2 is designed and built entirely from existing and cleared systems, subsystems, components, and technologies of its Predicate Device (Discovery MI). This type of change in Discovery MI Gen 2 is supported using scientific, established/standardized, engineering/physics-based performance testing, without inclusion of clinical images, to demonstrate that the device is as safe and as effective as the predicate devices. Given the above information and the type and scope of the changes, particularly the addition of the 30 cm, 6-ring, AFOV configuration, clinical testing is not required to demonstrate that the Discovery MI Gen 2 is as safe and as effective as the legally marketed predicate device."
• "Image Performance evaluation testing used a variety of test methods and phantoms covering a broad base of relevant imaging performance and image quality test cases..." This indicates the test set consisted of phantoms, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No human experts were used for ground truth because the testing was non-clinical, using phantoms, and relied on "mathematical and physics analysis" and "scientific methods that are standardized (e.g. NEMA, FDA Guidance), well established, and/or reviewed in previous GE's PETCT or Nuclear Medicine clearances."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No human review or adjudication was performed as it was a non-clinical performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study was not performed as clinical testing with human readers was not part of this 510(k) submission. No AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Partially applicable, but not for a clinical algorithm. The testing was "algorithm only" in the sense that it assessed the device's performance using phantoms and engineering methods, independent of human interpretation in a clinical setting. However, it's a PET/CT system, not an AI algorithm in the context of diagnostic assistance. The document refers to "Deep Learning Image Reconstruction (DLIR) K193170" for the CT System component, suggesting an AI component is involved in image generation, but this submission focuses on the full PET/CT system and does not detail performance data specific to DLIR.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Engineering/Physics-based Standards and Phantoms. The ground truth was established through "scientific methods that are standardized (e.g. NEMA, FDA Guidance)" and "phandoms" [sic] with known properties, along with "mathematical and physics analysis."

8. The sample size for the training set

• Not applicable / Not explicitly stated. This document describes the clearance of a medical imaging device (PET/CT system), not a new AI algorithm that requires a separate training set. While the CT component mentions "Deep Learning Image Reconstruction (DLIR)," the training data and methods for DLIR (K193170) are outside the scope of this specific 510(k) summary. For the overall PET/CT system, there isn't a "training set" in the sense of a machine learning model, but rather a design and development process based on existing technologies.

9. How the ground truth for the training set was established

• Not applicable / Not explicitly stated. As above, no training set for a new AI algorithm specific to this 510(k) is discussed. For the DLIR component (from K193170, mentioned as part of the CT system), the ground truth for its training would have been established in its own separate clearance, likely through high-quality, low-noise CT scans.

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General intended use

The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

Removal of light ink (red. sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angiomaa
• Cherry angioma
• Spider nevi
• Treatment of benign pigmented lesions including, but not limited to:
• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus
• Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus
• Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (non Q-Switched - free running mode)

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.

Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode), also with fractional and microbeam handpieces:

Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

1064 nm (picosecond mode), also with fractional and microbeam handpieces:

Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V

694 nm (O-Switched), including microbeam handpieces

Indicated for:

Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign):

• Cafe au lait spot
• Ephalides, solar lentigo lentigines)
• Becker Nevus
• Ota and Ito Nevus
• Nevus spilus
• Mongolian spot

694 nm (non q-switch - free running mode)

Intended to remove benign dermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesson, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser)

The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

lt can also be connected to Er:YAG handpieces cleared under K173002.

The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

All the models belonging to the Discovery Pico Family have the same components and the same controlling software. The only difference between different models is the optical bench that depends on the sources installed.

The Discovery Pico Family is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

The provided text is a 510(k) summary for the Discovery Pico Family laser device, submitted to the FDA. It details a modification to an already cleared device, primarily the addition of microbeam handpieces. As such, the acceptance criteria and performance data presented are focused on engineering and safety performance, rather than clinical efficacy or diagnostic accuracy as would be the case for an AI/ML-driven diagnostic device.

Therefore, many of the requested fields related to clinical studies, human reader performance, ground truth establishment for clinical data, and training set information are not applicable to this type of device submission.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable / Not specified. The performance data described are related to engineering and safety bench tests (e.g., electrical safety, EMC, output measurements on microbeam handpieces) and software validation. These do not typically involve patient-specific test sets in the same way clinical diagnostic studies do. The phrase "Bench testing measurements were done" implies testing on physical units/components, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. For engineering and safety tests, the "ground truth" is typically established by objective measurements against predefined specifications and recognized standards, not by expert human interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a clinical study. This device's testing involves objective measurements against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic device, but a physical laser device for surgical and aesthetic applications. Therefore, an MRMC study and AI assistance effect size are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is a physical laser device, not an algorithm. The software verification and validation are for controlling the device, not for making independent diagnostic or therapeutic decisions.

7. The type of ground truth used:

• For electrical safety, EMC, and laser safety: Compliance with recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1).
• For microbeam handpiece output: Physical bench measurements to confirm output against design specifications.
• For software: Verification and validation against software requirements as per FDA guidance.
• For biocompatibility: Reference to the predicate device.

8. The sample size for the training set:

• Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not applicable. No training set was used for an AI/ML algorithm.

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The Discovery XR656 HD is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen. extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing. or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.

The Discovery XR656 HD incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

When the VolumeRAD option is included on the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages.

When the VolumeRAD option is used for patients undergoing thoracic imaging, it is indicated for the detection of lung nodules. VolumeRad generates diagnostic images of the radiologist in achieving superior detectability of lung nodules versus posterior and left lateral views of the chest, at a comparable radiation level.

The device is not intended for mammographic applications.

The Discovery XR656 HD Radiography X-ray System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage.
The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices.
The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any Helix™ acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

This document is a 510(k) Premarket Notification submission for the GE Healthcare Discovery XR656 HD with VolumeRad. The submission details the device's technical characteristics, intended use, and a comparison to predicate and reference devices to establish substantial equivalence.

Based on the provided text, the device itself (Discovery XR656 HD with VolumeRad) is an X-ray system, not an AI or algorithm. Therefore, the questions related to AI performance metrics such as reader improvement with AI assistance, standalone algorithm performance, and sample sizes for training/test sets specifically for an AI component are not directly applicable.

However, the document does describe the "Metal Artifact Reduction algorithm for VolumeRad" and mentions its evaluation. This suggests an algorithmic component, though not an AI in the common sense of machine learning for diagnosis. The data provided focuses on demonstrating substantial equivalence to predicate devices for the overall system and its features, including the VolumeRad function with updated detectors and the metal artifact reduction algorithm.

Here's an analysis based on the information available, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence for the Discovery XR656 HD with VolumeRad to predicate devices, rather than defining specific acceptance criteria for a new AI algorithm and reporting its performance against those. The "performance" discussed is related to the overall system's safety and effectiveness, and the ability of the VolumeRad feature to generate diagnostic images comparable to or better than traditional views for lung nodule detection.

The statement regarding VolumeRad: "VolumeRad generates diagnostic images of the radiologist in achieving superior detectability of lung nodules versus posterior and left lateral views of the chest, at a comparable radiation level." acts as a performance claim for the VolumeRad feature itself, which is part of the device.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set for VolumeRad feature and Metal Artifact Reduction Algorithm: The document states that "bench testing using anthropomorphic phantoms was sufficient" for evaluating the Metal Artifact Reduction algorithm and for showing the equivalence of the VolumeRad feature with updated resolution detectors.
  • Sample Size: Not explicitly stated as a number of cases or patients from a clinical study for the test set. It refers to "anthropomorphic phantoms."
  • Data Provenance: Not human clinical data. The data originates from "anthropomorphic phantoms" used in bench testing. Given it's a GE Healthcare product, typically such testing occurs internally or at partner facilities. The location of the manufacturer is China.
  • Retrospective/Prospective: Not applicable as it's bench testing with phantoms.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Since the testing was primarily bench testing with anthropomorphic phantoms, there is no mention of human experts establishing ground truth in the context of reading images from a test set. Evaluation would likely involve technical measurements and visual assessment by product development engineers or possibly consulting radiologists for image quality, but this isn't described as a formal ground truth process for a clinical test set.

4. Adjudication Method for the Test Set:

• Not applicable, as the evaluation was primarily bench testing with phantoms.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The submission explicitly states: "The subject of this premarket submission, Discovery XR656 HD with VolumeRad, did not require clinical studies to support substantial equivalence for the changes identified."
• Effect Size: Not determined, as no such study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• The document implies that the fundamental algorithm to create the VolumeRad image set is identical to the algorithm cleared under K132261. The Metal Artifact Reduction algorithm was evaluated via bench testing. While these are algorithmic components, the overall "device" is an X-ray system. The performance claims for VolumeRad are implicitly related to its ability to present images that aid the radiologist (human-in-the-loop). Bench testing of the algorithms was done, but not as a standalone diagnostic AI performance study in the typical sense for clinical claims.

7. Type of Ground Truth Used:

• For the technical evaluation of the VolumeRad feature and the Metal Artifact Reduction algorithm, the "ground truth" was established through bench testing using anthropomorphic phantoms. This means known conditions (e.g., presence/absence of nodules, specific metal artifacts) were simulated in the phantoms to assess the system's output.

8. Sample Size for the Training Set:

• The document does not describe the development of a new AI algorithm that would typically involve a "training set." The VolumeRad algorithm is stated to be "identical" to a previously cleared algorithm. The Metal Artifact Reduction algorithm is new, but its development process (including any training data if it were a machine learning algorithm) is not detailed. Therefore, the sample size for a training set is not provided.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as no specific "training set" for a new AI algorithm is described. For the general development of the overall system and its included algorithms, ground truth would be established through engineering specifications, phantom studies for image quality, and comparison against known physical properties.

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The Discovery XR656 HD is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
The device is not intended for mammographic applications.

The Discovery XR656 HD Radiography X-ray System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and wireless digital detectors. The System generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.

The provided text describes a 510(k) premarket notification for the GE HUALUN MEDICAL SYSTEMS CO. Ltd. Discovery XR656 HD (K172869), a digital radiographic X-ray system. The document focuses on demonstrating substantial equivalence to a predicate device (Optima XR646, K143270) rather than presenting a performance study with detailed acceptance criteria and clinical efficacy results for the entire system.

The core of the submission revolves around the change in detector technology from Ultra Wideband (UWB) to WiFi (802.11) for image transfer, utilizing cleared detectors (PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector, K161942, and PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector, K161966).

Here's an breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., sensitivity, specificity, accuracy) for the Discovery XR656 HD as a standalone diagnostic tool. Instead, it relies on demonstrating compliance with recognized standards and successful design verification and validation testing to ensure that the modifications (primarily the change to WiFi-enabled detectors) do not negatively impact the device's safety and effectiveness compared to the predicate.

The "Summary of Non-Clinical Tests" section mentions compliance with several voluntary standards. While these standards implicitly contain performance requirements, the specific numerical acceptance criteria for those requirements and the actual measured performance of the Discovery XR656 HD are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "The subject of this premarket submission, Discovery XR656 HD, did not require clinical studies to support substantial equivalence for the incorporation WiFi (802.11) enabled detectors due to these detectors having their own 510(k) clearance."

Therefore, for the Discovery XR656 HD itself, there was no specific clinical "test set" and corresponding sample size for demonstrating diagnostic performance beyond its cleared components. The evaluation focused on non-clinical design verification and validation. The "testing/documentation" mentioned was "according to... FDA guidance documents" (for software and cybersecurity), and these were "bench" tests.

The cleared detectors (PerkinElmer XRpad2 3025 HWC-M and 4336 HWC-M) would have had their own clinical data for their respective 510(k) clearances (K161942 and K161966), but that data is not provided here for the Discovery XR656 HD system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were performed for the Discovery XR656 HD's diagnostic performance, there was no test set requiring expert-established ground truth in the context of diagnostic accuracy. The ground truth for the training of the system's image processing (if applicable, which falls under "image processing algorithms to accommodate multiple image matrix sizes") is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical test set for diagnostic performance was conducted for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a digital radiographic X-ray system, not an AI-assisted diagnostic tool in the sense of providing automated readings or decision support. The "image processing algorithms" mentioned are for accommodating different image matrix sizes and are not described as AI for diagnostic assistance. There is no mention of an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical imaging system, not a standalone algorithm. The "image processing algorithms" are integrated into the system, and their performance is evaluated as part of the overall system's technical validity, not as a standalone diagnostic algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

As no clinical study for diagnostic performance was required or conducted for this 510(k) submission, the concept of "ground truth" (in the diagnostic sense) for this specific submission is not present. The "ground truth" for the system's functionality was established through design verification and validation testing against engineering specifications and industry standards.

8. The sample size for the training set

The document does not specify a training set sample size. While "image processing algorithms" are mentioned, implying potential machine learning components, no details on their training are provided. The focus of the submission is on hardware and communication changes, and the safety and effectiveness of the system with these changes.

9. How the ground truth for the training set was established

Not applicable. No information is provided about a training set or its ground truth establishment.

Ask a specific question about this device

The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery. Specific indications include treatment of benign vascular lesions, benign pigmented lesions, hair removal, tattoo removal, skin resurfacing for acne scars and wrinkles, photocoagulation and hemostasis of benign pigmented and benign vascular lesions, coagulation and hemostasis of soft tissue, treatment of wrinkles, and treatment of mild to moderate inflammatory acne vulgaris.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The systems can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces or a handpiece (Twain IPL) with fixed or interchangeable light filters. All models have the same components and control software, differing only in the installed optical bench. The device is controlled via a touch screen display and emission is triggered by a footswitch.

The provided FDA 510(k) summary for the Discovery Pico Family laser system focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for clinical efficacy through a standalone study.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not present in this document. The document primarily relies on engineering performance standards and a comparative analysis with predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria for clinical performance (e.g., specific percentages of tattoo clearance or lesion removal). Instead, it states compliance with recognized engineering performance standards and "thermal-histology performance data for fractional handpieces." It also asserts that "the device performs as intended" and is "substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical test set with human subjects for efficacy evaluation beyond what might be implied by "thermal-histology performance data."
• Data Provenance: Not applicable/Not provided for clinical efficacy. The engineering standards compliance refers to internal company testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no mention of a ground truth established by experts for clinical performance, as the submission focuses on substantial equivalence based on technical characteristics and predicate devices, rather than a clinical trial with a defined ground truth.

4. Adjudication Method

• Not applicable. No clinical study with a read-out or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study was not done, as this is a laser device and not an imaging AI diagnostic tool that would typically involve multiple readers. The document implicitly compares the new device's capabilities to predicate devices, but not in a formal MRMC study format.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This is a physical laser device, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms doesn't directly apply. The device's standalone performance is assessed through its compliance with engineering standards.

7. The Type of Ground Truth Used

• The ground truth used for relevant aspects where data is mentioned would be:
  • Engineering Standards: Compliance with established safety and performance requirements set by IEC standards.
  • Thermal-histology data: This would typically involve histological analysis of treated tissue in an experimental setting (e.g., animal or ex vivo human tissue) to assess the thermal impact, which serves as a form of ground truth for tissue response. Details are not provided.
  • Biocompatibility: Established by reference to predicate device characteristics.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set was Established

• Not applicable. No training set is used for this type of medical device submission.

Ask a specific question about this device

The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

The Discovery Pico Family is intended for treatment of vascular lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode)

Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angiomaa
• Cherry angioma
• Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode)

Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus
• Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (non Q-Switched - free running mode)

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.

Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to port wine stains,

hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode) . also with fractional handpiece

Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

1064 nm (picosecond mode), also with fractional handpiece

Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

694 nm (Q-Switched)

Indicated for:

Tattoo removal: Suggested for blue, sky blue, black, green and violet ink

Pigmented lesion removal (benign):

• Cafe au lait spot
• Ephalides, solar lentigo lentigines)
• Becker Nevus
• Ota and Ito Nevus
• Nevus spilus
• Mongolian spot

694 nm (non q-switch - free running mode)

Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths. All the models belonging to the Discovery Pico Family have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed. The Discovery Pico Family is controlled via a touch screen display housed in the front of the device. Emission is triggered by means of a footswitch.

The provided document is a 510(k) summary for the Discovery Pico Family laser system, which describes its modifications and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific device performance metrics, or a study design in the way typically expected for a clinical validation or AI-based device. Instead, it focuses on regulatory compliance and the safety/effectiveness of a modified laser device.

However, I can extract the relevant information that is present in the document which aligns with some of your requested categories, and indicate where the requested information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "There are no mandatory performance standards for this device." Instead of specific numerical acceptance criteria for clinical performance, the approval is based on compliance with electrical and safety standards, and equivalence to predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable. This document describes a medical device clearance based on substantial equivalence and compliance with engineering standards, not a clinical study involving a test set of data. The "test set" in this context refers to engineering and safety performance tests of the device itself, not a dataset for evaluating an algorithm's diagnostic or predictive performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. (See explanation for point 2).

4. Adjudication method for the test set

Not applicable. (See explanation for point 2).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-based diagnostic or imaging device. It is a laser surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used

For the engineering and safety performance tests mentioned, the "ground truth" would be established by validated test methods and measurements against established engineering and safety standards. For example, laser power output would be measured with calibrated equipment, and electrical safety would be verified according to IEC standards.

8. The sample size for the training set

Not applicable. (See explanation for point 2).

9. How the ground truth for the training set was established

Not applicable. (See explanation for point 2).

Summary of Study (Based on the provided document):

The "study" described in this 510(k) summary is a regulatory submission demonstrating the substantial equivalence of the modified Discovery Pico Family laser system to previously cleared predicate devices. The primary focus is on proving that the modified device (with added fractional handpieces) maintains the same intended use, indications for use, and fundamental scientific technology as its unmodified predecessor (K163222), and that any differences do not raise new questions of safety or effectiveness.

The document highlights compliance with several recognized consensus standards (IEC 60601-2-22, IEC 60825-1, IEC 60601-1, IEC 60601-1-2) which cover general safety, laser safety, and electromagnetic compatibility for medical electrical equipment. It also mentions "Thermal-histology performance data for fractional handpieces" as being provided, which would involve laboratory/bench testing. Software verification and validation testing were also conducted.

There is no mention of clinical trials, human reader studies, or AI algorithm performance evaluations because the device is a laser system whose safety and effectiveness are established through compliance with existing standards and comparison to legally marketed predicate devices, rather than through novel diagnostic performance.

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The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal. coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect and SIGNA Artist systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems each feature a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each system uses a combination of time varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect. SIGNA Artist systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The original description hasn't changed from predicate devices (K160618), other than reflecting the additional receive channels available.

The modifications to these systems include the MAGIC DWI and CardioMaps software features, delivered via the DV26 program. The proposed software features will be ported over to other GE Healthcare MR systems based on appropriate design controls and evaluation of the change in accordance with FDA's Guidance—Deciding When to Submit a 510(k) for a Change to an Existing Device.

This document describes the premarket notification (510(k)) for GE Medical Systems' SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Magnetic Resonance (MR) diagnostic devices. The submission focuses on the addition of MAGIC DWI (Diffusion-Weighted Imaging) and CardioMaps software features.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or performance metrics for the MAGIC DWI and CardioMaps software features in a table format. Instead, it indicates that testing was completed with "passing results per the pass/fail criteria defined in the test cases."

Implicit Acceptance Criteria (inferred from the document):

• Safety and Effectiveness: The primary acceptance criterion is that the modified software features (MAGIC DWI and CardioMaps) are "as safe and effective as the predicate" devices and do "not raise different questions of safety and effectiveness."
• Compliance with Standards: The software features must comply with voluntary standards: AAMI/ANSI 62304, AAMI/ANSI ES60601-1, and IEC 60601-2-33.
• Acceptable Performance: Phantom testing for both software features must demonstrate "acceptable performance."

Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for either the phantom testing or the clinical images. It generically refers to "phantom testing" and "sample clinical images."
• Data Provenance: Not explicitly stated. For phantom testing, it's typically controlled laboratory conditions. For clinical images, it's not mentioned whether they are retrospective or prospective, nor their country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide this information.
The summary states that images and/or spectra are interpreted by a "trained physician," but it doesn't detail the number or qualifications of experts involved in establishing ground truth for the specific performance evaluation of the new software features.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.
It states that "passing results per the pass/fail criteria defined in the test cases" were achieved for phantom testing. For clinical images, it mentions they are "interpreted by a trained physician," implying clinical judgment, but no formal adjudication process (like 2+1 or 3+1) is described for the evaluation presented in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that an MRMC comparative effectiveness study was performed.
The evaluation relies on compliance with standards, phantom testing, and presentation of sample clinical images to demonstrate "substantial equivalence" rather than a comparative effectiveness study measuring human reader improvement with AI assistance. The software features are enhancements to image acquisition and processing, not explicitly AI-assisted diagnostic tools in the context of comparative reading studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the software features (MAGIC DWI and CardioMaps) represent algorithm-only additions, the document emphasizes that the "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis."
The "phantom testing" and quality assurance measures (e.g., unit-level, integration, performance, safety testing) can be considered standalone evaluations of the algorithms' output quality and adherence to specifications. However, the ultimate "performance" in the diagnostic context is tied to physician interpretation. The regulatory focus here is on the system producing diagnostically useful images, not on an algorithm making a standalone diagnosis.

7. The Type of Ground Truth Used

• For Phantom Testing: The ground truth would typically be established by known physical properties or measurements of the phantom itself. The "pass/fail criteria" would be based on expected quantitative accuracy, image quality, or signal properties against these known values.
• For Clinical Images: The document mentions "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." This implies that the effectiveness in a clinical setting is ultimately judged by expert clinical interpretation, but it does not specify a formal "ground truth" (e.g., pathology, surgical findings, long-term outcomes) used to validate the clinical utility of the specific new software features. It's more about demonstrating that the images produced can be interpreted by a physician to assist diagnosis.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is likely because the referenced software features are defined as modifications to existing MR systems, and while they involve algorithms, the summary doesn't describe them as machine learning models that require distinct "training sets" in the typical sense. The development process described (risk analysis, requirements reviews, design reviews, various levels of testing) is a standard software engineering approach.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for machine learning, information on how its ground truth was established is not applicable or provided in this document.

Ask a specific question about this device

General intended use: The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgerv as follows.

Indications for use:
1064 & 532 nm (Q-Switched, nanosecond mode): The Discovery Pico Family is intended for treatment of vascular lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode): Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos, Treatment of vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angiomaa, Cherry angioma, Spider nevi, Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, Ephalides, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus, Ota Nevus, Treatment of seborrheic keratosis, Treatment of post inflammatory hyperpigmentation, Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode): Removal of dark ink (black, blue and brown) tattoos, Removal of benign pigmented lesions including; nevus of Ota, Café au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Nevus spilus, Treatment of common nevi, Removal or lightening of unwanted hair, Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (non Q-Switched - free running mode): Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Treatment of wrinkles. Treatment of mild to moderate inflammatory acne vulgaris.
532 nm (picosecond mode): Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
1064 nm (picosecond mode): Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
694 nm (Q-Switched): Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink, Pigmented lesion removal (benign): Cafe au lait spot, Ephalides, solar lentigo lentigines), Becker Nevus, Ota and Ito Nevus, Nevus spilus, Mongolian spot.
694 nm (non q-switch - free running mode): Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
IPL 590-1200nm; 625-1200nm; 650-1200nm: Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm: Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm: Indicated for inflammatory acne (acne vulgaris).
Integrated Skin Cooler: The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths. All the models belonging to the Discovery Pico Family have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed. The Discovery Pico Family is controlled via a touch screen display housed in the front of the device. Emission is triggered by means of a footswitch.

The provided text describes modifications to the "Discovery Pico Family" device and its substantial equivalence to the "EVO Platform (K160368)" predicate device. The information focuses on regulatory compliance and technical specifications rather than a clinical study with detailed performance metrics against acceptance criteria for a specific AI-driven diagnostic task.

Therefore, it's not possible to extract the requested information regarding acceptance criteria, reported device performance for a specific task, sample sizes for test/training sets, expert qualifications, ground truth methods, or MRMC study results because this document describes a laser surgical instrument, not an AI diagnostic device. The performance data mentioned refers to engineering and safety standards, not clinical efficacy or diagnostic accuracy.

The document indicates that:

• No specific acceptance criteria for a diagnostic task are listed. The submission is about changes to performance specifications of a laser device, not about a diagnostic algorithm's accuracy.
• No "reported device performance" in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) is provided. The performance data relates to compliance with laser safety and electrical equipment standards.
• No sample sizes for test sets or training sets are mentioned. This type of data is relevant for AI/diagnostic algorithms, not for the laser device in question.
• No information on experts for ground truth or adjudication methods is available. Again, this is not relevant for the regulatory aspects described in this document for a laser device.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported.
• No standalone (algorithm only) performance was done or reported.
• No type of ground truth (e.g., pathology, outcomes data) is mentioned as this is not a diagnostic device.
• No sample size for the training set or how ground truth was established for a training set is provided.

Summary of available information related to performance and testing:

1. Acceptance Criteria & Reported Device Performance: Not applicable for a diagnostic AI. The device was subjected to performance testing in accordance with IEC 60601-2-22 (Medical Electrical Equipment - Laser Equipment) and IEC 60825-1 (Safety of Laser Products). The modified device passed all required testing and is in compliance with these standards. It also complies with IEC 60601-1 (General Requirements For Basic Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
2. Sample sizes for test set and data provenance: Not applicable. The testing described is for laser safety and electrical performance, not clinical diagnostic data.
3. Number of experts and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: No such study is mentioned.
6. Standalone performance: Not applicable as it's not an algorithm.
7. Type of ground truth: Not applicable. Ground truth typically refers to accurate labels for diagnostic tasks; here, device performance relates to meeting engineering standards.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document primarily focuses on demonstrating that the modified device maintains the same safety and effectiveness as the predicate device by meeting established international performance standards for medical electrical equipment and laser products. The key statement for equivalence is that "the maximum fluence is not changed."

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The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200ke V for the detection and display of radioisotope tracer uptake in patients of all ages.

When used with the optional Discovery NM 750b Biopsy system, the Discovery NM 750b is designed to accurately locate, in three dimensions, lesions in the breast using information derived from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes such as biopsy and pre-surgical localization.

The Discovery NM 750b Biopsy system is an optional accessory for the Discovery NM 750b gamma camera (K102231) that utilizes stereotactic imaging to help guide invasive procedures. It is intended for 3D lesion localization to provide the physician image guidance for vacuum assisted needle biopsy of breast lesions determined to be suspicious through molecular breast imagine or other imaging.

The Biopsy system uses a pair of CZT "biopsy" detectors with fixed stereotactic positions. These two detectors acquire pair of anqulated two-dimensional images that are used in determining the 3D localization of the pre-identified suspicious lesion.

The Discovery NM750b Biopsy system includes hardware and software components, which auides the user throughout the biopsv work-flow. The hardware components enable the use of a variety of off-the-shelf biopsy vacuum needles.

In addition to the hardware components, the biopsy system accessory includes software components which, in part, through the user interface help quide the user stepwise through the biopsy workflow. The Discovery NM 750b Biopsy system is designed to support a variety of commercially available vacuum assisted biopsy devices and needles.

The provided text lacks specific acceptance criteria and detailed study results for the Discovery NM 750b Biopsy system. While it mentions various tests performed, it does not present quantifiable metrics or a clear study that "proves" the device meets specific acceptance criteria in a structured manner.

However, based on the information provided, here's an attempt to answer your request by extracting what is available and noting what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes general successful completion of various tests.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "additional engineering bench performance testing using phantoms" and "simulated clinical use testing performed by physicians using a commercially available breast biopsy phantom and a supporting phantom." It specifies "This phantom setup had radiotracer-injected simulated lesions against a uniform radioactive background. The activities of the lesions and background were set to be representative of actual clinical use."

• Sample Size for Test Set: Not explicitly stated as a number of cases or lesions. It refers to "cases that represent a broad range of clinically relevant scenarios."
• Data Provenance: The data appears to be prospective from simulated clinical scenarios using phantoms. There is no mention of human subject data or country of origin for such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Experts used: "physicians" performed the simulated clinical use testing.
• Qualifications of experts: Not specified beyond "physicians."

4. Adjudication Method for the Test Set

Not mentioned. The testing was described as "physician-performed clinical simulation testing." It's unclear if multiple physicians reviewed the same cases or if there was any adjudication process if different outcomes were observed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned. The study described focused on the device's performance in simulated clinical scenarios, not on comparing human reader performance with and without AI assistance from this specific device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes the "Discovery NM750b Biopsy system" as including both hardware and software components that "guides the user throughout the biopsv work-flow." The testing involved "simulated clinical use testing performed by physicians." This suggests the evaluation was for the system as a whole, with human involvement, rather than a standalone algorithm performance without human interaction.

7. The Type of Ground Truth Used

The ground truth for the "simulated clinical use testing" was based on a phantom setup with "radiotracer-injected simulated lesions" where their "activities of the lesions and background were set to be representative of actual clinical use." This is an artificial, controlled ground truth rather than expert consensus, pathology, or outcomes data from human patients.

8. The Sample Size for the Training Set

The document describes the device as an optional accessory using "stereotactic imaging and optics principles" that are "well established." It states the "technological characteristics and corresponding fundamental principles of operation of the Biopsy System are identical or equivalent to that of the GammaLoc system and Senoegraphe Stereo." This suggests the device leverages existing, established technology rather than a machine learning model that would require a distinct training set. Therefore, a training set size is not applicable as described in the context of typical AI/ML-based devices.

9. How the Ground Truth for the Training Set was Established

As no training set (in the AI/ML sense) is mentioned or implied for this device's core functionality, this question is not applicable. The device relies on physical principles and established imaging techniques.

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