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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 RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.

The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression.

Here's a breakdown of the acceptance criteria and study information for RetinAI Discovery, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific metrics (e.g., accuracy percentages, Dice scores). Instead, the performance is described through comparison testing demonstrating equivalence with predicate/reference devices for manual segmentation and image measurement of retinal OCT scans.

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

The document does not explicitly state the numerical sample size for the test set (number of OCT scans or patients).

• Test Set: Implied to be the same images used for comparison testing with the reference devices.
• Data Provenance: Not specified. The document states "comparison testing was performed... with the same images segmented in cleared devices," but does not explicitly mention country of origin or whether the data was retrospective or prospective.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The comparison testing relies on the "computed values from the Reference Devices" as the standard, implying that the ground truth is derived from the established and cleared functionalities of those devices when experts perform manual segmentation or measurements within them.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for a test set in the traditional sense of multiple human readers independently assessing and then reaching a consensus. Instead, the "ground truth" for the comparison study appears to be the output of the cleared reference devices when manual segmentation/measurements are performed by users (presumably clinicians or operators) within those systems.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a standalone performance validation comparing RetinAI Discovery's manual segmentation and measurement capabilities with those of existing cleared devices. There is no mention of human readers improving with or without AI assistance, as the device's main specified function (based on the provided text) is for displaying, analyzing, and manual labeling/annotation, not AI-powered automated analysis or decision support for human readers.

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

Yes, a standalone performance validation was done for the manual segmentation and image measurement functionalities of the RetinAI Discovery. The device itself is described as a "standalone, browser-based software application." The comparison testing verified the performance of the Discovery platform's manual segmentation and measurement tools against the established reference devices, essentially testing the accuracy of the tools themselves "without human-in-the-loop performance" improvement claims. The document focuses on the platform's ability to facilitate manual activities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison testing was effectively the "computed values from the Reference Devices" (Heidelberg Engineering Spectralis HRA+OCT and Topcon DRI OCT Triton). This implies that the accepted and pre-cleared outputs of these established ophthalmic imaging and analysis devices, whether derived from their automatic or manual segmentation/measurement tools, served as the benchmark for evaluating RetinAI Discovery.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This is consistent with the nature of the device as described, which is specified for manual labeling and annotation and general image management/display, not for an AI model that requires a large training dataset.

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

As no training set is mentioned for an AI model, the method for establishing ground truth for a training set is not applicable here. The described studies focus on the validation of the manual tools and general software functions.

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The CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures.

Applications and techniques:

• Gastroenterology
• Skeleton
• Thorax and lungs
• Paediatrics
• Urology and gynecology
• Emergency/traumatology
• Digital angiography
• Linear tomography
• Auto Image Paste (Stitching)
• Tomosynthesis

Not Found

The provided text is an FDA 510(k) clearance letter for the CLISIS SYSTEMS, Discovery RF180, a tomographic x-ray system. It states the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, the provided text DOES NOT contain any information regarding acceptance criteria or the study that proves the device meets those criteria. It is a regulatory clearance document, not a detailed technical report or clinical study summary.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

The document focuses on the regulatory approval process and the intended uses of the device, not the technical details of its performance or the studies conducted to validate that performance. To obtain that information, one would typically need to refer to separate study reports, a detailed 510(k) summary (if available publicly with more technical details), or an Instructions for Use (IFU) document if it contains performance specifications.

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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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The AEGIS Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications are:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;
· trauma (i.e., fracture or dislocation);
· deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);

• tumor;
  · pseudarthrosis; and
  · previous failed fusion.

The Anterior Dynamized system is intended for use in anterior decompression instrumentation and fusion for kyphotic deformities, post traumatic kyphotic deformities, degenerative disc discogenic and back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.

The ISOLA Spine System when used as anterior thoracic/lumbar screw fixation system, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The BOWTI Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
The BOWTI Anterior Buttress Staple System is intravertebral body screw fixation/attachment to the T1-S1 spine over one vertebral body extending into the adjacent intervertebral space. Specifically, the device is intended for stabilization and buttressing of bone graft as an aid to spinal fusion. It may be used with other anterolateral or posterior spinal systems.

The DISCOVERY Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods:
Transfacet fixation: The screws are inserted bilaterally through the facet, across the facet joint and into the inferior pedicle.
Translaminar Facet fixation: The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint and into the inferior pedicle.
For both methods this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;
2. Spondylolisthesis;
3. Spondylolysis:
4. Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity;
5. Degenerative diseases which include:
   (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
   (b) degenerative disease of the facets with instability.

The EXPEDIUM Anterior System is intended for anterolateral screw fixation of the T4 to L4 levels of the spine, with metal at least 1 cm from a major vessel. The EXPEDIUM Anterior System may be used in either thoracoscopic procedures or open procedures.
The EXPEDIUM Anterior Spine System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with metal at least 1cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures.
The FRONTIER Anterior Scoliosis System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The KANEDA Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine.
The KANEDA Anterior Scoliosis System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis;
• · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor:
• · pseudarthrosis; and previous failed fusion.

The KANEDA SR Anterior Spinal System is intended for anterolateral screw fixation to the T10 to L3 levels of the spine. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, tumor, fracture and revision of previous surgery.

The intended levels for treatment with the M-2 Anterior Plate System are from T3 to L3. In order to treat levels from T3 to L3, plate attachment is from T2 to L4. The M-2 Anterior Plate System is intended to treat one motion segment per construct.
The M-2 Anterior Plate System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.

The intended levels for treatment with the PROFILE Anterior Thoracolumbar Plate System are from T1-L5 spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The UNIVERSITY PLATE Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for the attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

The VIPER F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:
Transfacet fixation: The screws are inserted bilaterally through the facet, across the facet joint and into the inferior pedicle.
This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;
2. Spondylolisthesis;
3. Spondylolysis;
4. Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity;
5. Degenerative diseases which include:
   (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
   (b) degenerative disease of the facets with instability.

The AEGIS Anterior Plate System consists of an assortment of titanium alloy plates and screws. The plates are uniquely shaped to conform to the anatomy of the anterior spine. They feature screw holes for final fixation to the vertebral bodies.
The ALC Dynamized Fixation System is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The ALC Dynamized Fixation System construct allows continual compression of the bone graft while avoiding hyperextension type forces on the construct.
The Anterior ISOLA Spine System consists of spinal rods, open and closed screws, washers, caps, set screws, and staples.
The BOWTI Anterior Buttress Staple System consists of staples and screws. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation.
The DISCOVERY Facet Screw Fixation System consists of titanium alloy bone screws and washers designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping screws are available in two configurations: fully threaded and partially threaded.
The EXPEDIUM Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The components of the EXPEDIUM Anterior Spine System are designed with anatomic limitations in mind, therefore minimizing the profile of the construct.
The FRONTIER Anterior Scoliosis System is a construct that consists of spinal staples, semi-blunt tip open screws, washers, and 3/16 inch (4.75mm) diameter spinal rods.
The KANEDA Anterior Scoliosis System is a construct that consists of Kass spinal staples, Kass blunt tip open and closed screws, standard Isola open and closed screws and Isola 3/16 inch (4.75mm) diameter spinal rods.
The KANEDA SR Anterior Spinal System is an anterolateral spinal implant system which is used in conjunction with some components of the Isola Spine System. KANEDA SR consists of longitudinal members, spinal anchors and transverse rod couplers. The longitudinal members are 1/4 inch (6.35 mm) diameter smooth spinal rods. The Isola rods can be cut to size during the surgical procedure or Kaneda rods are available in precut lengths. The contoured spiked plates are designed to help the construct anchors resist axial forces and serve as a guide for placement of the screws. The plates are available in three sizes (small, medium and large) and are designed as pairs with specific caudal and rostral components. The screws serve to anchor the vertebral bodies to the longitudinal rods and are available in open and closed screw formats. Caps are available to capture the rod onto the open screws. Set screws are used to tighten the screws to the rods. The transverse couplers add stability, contributing to the construct's ability to resist torsional loads.
The M-2 Anterior Plate System is a construct which consists of one plate attached to the lateral aspect of the vertebrae by either four screws or two screws/two bolts. The components of the M-2 Anterior Plate System have been designed with anatomic limitations in mind.
The MOUNTAINEER Laminoplasty System is an implant system that consists of various sizes of plates and screws. The plates are available in the Inline Side-By-Side, and Offset Side-By-Side configurations. The proposed plate devices come in a preformed shape with holes for bone screws. The plates also contain a slot in the middle portion of the plate for allograft or autograft material attachment. The allograft or autograft material is secured to the plate using bone screws that are inserted through the middle slot on the top portion of the plate.
The PROFILE Anterior Thoracolumbar Plate System consists of various lengths of thoracolumbar and high thoracic plates, cancellous screws, cancellous bolts with locking nuts and screws and bone graft screws. The anterior thoracolumbar plates are implanted using two cancellous bolts placed through the plate's bolt slots and fixed with locking nuts and screws, two cancellous screws placed through the plate's threaded screw holes, and an optional graft screw which can be placed through the plate's center slot to provide fixation between the plate and a strut graft if desired. The high thoracic plates are implanted using four to six cancellous screws, placed through the plate's screw holes.
The UNIVERSITY Plate Anterior System plates are fabricated from implant grade titanium alloy. These plates have a contoured low profile to match the curvature of the lateral aspect of the thoracolumbar vertebral bodies. Three pairs of nested slots allow a wide range of screw and bolt placement, while the spherical countersinks allow up to 15 degrees of screw angulation. The UNIVERSITY Plate Anterior System plates are either rectangular or distally tapered, and come in a variety of lengths. Distally tapered plates are used at the L4 level to avoid contact with the common iliac vessels.
The VIPER F2 Facet Fixation System consists of titanium alloy bone screws designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. Washers are available to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.

This document describes the 510(k) premarket notification for "AEGIS® Anterior Lumbar Plate System" and several other spinal fixation systems. The purpose of this submission is to obtain clearance for magnetic resonance compatibility labeling for these devices.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" of devices used for each test. It refers to "the subject devices" and "the devices listed" in K192281, which includes fourteen different spinal fixation systems. It can be inferred that representative samples of each system (or components thereof) were tested.

The data provenance is from non-clinical testing conducted in alignment with ASTM standards. The country of origin of the data is not specified, but the applicant, Medos International SARL, is located in Switzerland, with the submitter (DePuy Synthes Spine) in Massachusetts, USA. The testing would likely have been conducted in a certified testing facility, potentially in either region or a third-party lab. The studies would be considered prospective in the sense that the testing was designed and conducted specifically to generate data for this regulatory submission.

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

This information is not applicable in this context. The "ground truth" for MR compatibility studies is established by objective measurements based on recognized international standards (ASTM F2213, F2052, F2119, F2182), not by expert consensus on clinical findings or images. These standards define the methodologies and acceptable limits for MR compatibility.

4. Adjudication Method for the Test Set

This information is not applicable. As mentioned above, the data are objective measurements from physical testing, not subjective assessments requiring adjudication by multiple experts.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. The submitted devices are spinal fixation systems, and the submission is for MR compatibility labeling, which involves physical testing, not diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not done. The devices are physical medical implants, not software algorithms or AI systems. The performance studies conducted were physical evaluations of the implants' behavior in an MR environment.

7. Type of Ground Truth Used

The ground truth used for these studies is based on objective physical measurements and adherence to established international standards (ASTM) for magnetic resonance compatibility. These standards define the acceptable physical forces, heating, and artifact levels for a device to be considered safe and compatible in an MR environment.

8. Sample Size for the Training Set

This information is not applicable. The submission concerns traditional medical devices (spinal implants) and their MR compatibility, not an AI or machine learning model that would require a training set.

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

This information is not applicable as there is no training set mentioned in this context.

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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 angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular, diagnostic and interventional procedures.

Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.

The OR table is suitable for interventional and surgical procedures.

GE Healthcare IGS interventional x-ray systems are designed to perform monoplane, biplane fluoroscopic x-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures (standard configuration). Additionally, in the OR configuration (with an OR Table), these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room.
DiscoveryTM IGS 7 OR, DiscoveryTM IGS 7, InnovaTM IGS 6, InnovaTM IGS 5 are the GE Healthcare IGS interventional X-Ray system product models.
Each product model is designed with a set of components that are combined into different configurations for providing specialized interventional x-ray systems. GE Healthcare IGS interventional x-ray system consists of a C-arm positioner (monoplane or biplane), an x-ray imaging table or the interface to the radiologic table, an x-ray tube assembly (per plane), an x-ray power unit with its exposure control unit (per plane), an x-ray imaging chain (including a digital detector and an image processing unit, per plane).
DiscoveryTM IGS 7 is a monoplane system (C-arm with mobile AGV gantry) and is proposed in IGS 740 configuration with a square 41cm digital detector or in IGS 730 configuration with a square 31cm digital detector. These product configurations are declined in sub configurations: Standard or OR configuration. The Innova-IQ table in the OR configuration is the GE OR table
Discovery™ IGS 7 OR is a monoplane system (C-arm positioner with mobile AGV gantry) and is proposed with a square 41cm digital detector or with a square 31cm digital detector configuration. This is the product model compatible with a qualified configuration of the Maquet Magnus OR table system. This product model is provided with a table integration kit. The Magnus OR table configuration compatible with Discovery™ IGS 7 OR includes a flat table top configuration for Interventional X-Ray imaging and surgery procedures, an optional universal table top (table top with articulated joints) to enable expansion to surgical procedures requiring advanced patient positioning and with X-Ray imaging capabilities. A set of Magnus OR table accessories is included in the compatible configuration.
Innova™ IGS 6 is a biplane system (a dual C-arm positioner, LC and LP gantry) and is provided with an Omega V table. Innova™ IGS 6 is proposed in IGS 630 configuration with a square 31cm digital detector per plane or in IGS 620 configuration with a square 20.5cm digital detector per plane. These product configurations are available in Standard configuration.
Innova™ IGS 5 is a monoplane system (C-arm positioner with LC gantry) and is proposed with a square digital detector of 41cm or 31cm or 20.5cm. These product configurations are available in Standard configuration with Innova-IQ or Omega V table or Omega IV table (IGS 520 configuration only); or in OR configuration with GE OR table.
The purpose of this Premarket Notification is for 2 changes:
First, a change of the collision management of Discovery™ IGS 7 OR to enable the use of a Neurosurgical head holder (skull clamp). During trauma neck surgery and stereotactic navigation, a gantry collision with the skull clamp could result in patient harm, delayed or halted surgical procedures. The subject of this submission is to introduce a functionality for adapting the collision avoidance model to the geometrical characteristic of the skull clamp and patient position with a guard volume defined and validated by the operator during the procedure preparation phase. During the procedure, the collision avoidance software will slow down and stop gantry and/or table axis to minimize risk of collision of a motorized moving part with the patient head or the skull clamp. In this configuration, the OR table, the Neurosurgical head holder and its support are from third party Medical device manufacturers. As a consequence, there is no mechanical interfaces between these devices and the Discovery™ 7 OR. Those devices are registered and cleared in the US. The Neurosurgical head holder is from Pro Med Instrument manufacturer (K063494). The OR table is the registered Magnus OR
The second change is for a primary technology change, adding an optional wireless footswitch in the examination room to Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7 and Discovery™ IGS 7 OR. It provides identical functionalities as the wired footswitch for the control of X-ray on and off, and for the control of the table top brake release.
Labelling is updated for the enhanced collision management for the use with Neurosurgical head holder and for the wireless footswitch.

This submission describes modifications to existing GE Healthcare IGS interventional X-ray systems (Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7, Discovery™ IGS 7 OR). The changes are primarily:

1. Enhanced collision management for Discovery™ IGS 7 OR: This modification allows the use of a Neurosurgical head holder (skull clamp) by dynamically adapting the collision avoidance model.
2. Optional wireless footswitch: This change adds a wireless footswitch with identical functionalities to the existing wired footswitch for controlling X-ray on/off and table-top brake release.

The document states that these modifications did not require clinical studies to support substantial equivalence and that the intended use and indications for use remain unchanged from the predicate devices. Therefore, the information typically requested regarding acceptance criteria, device performance, ground truth, and reader studies is not explicitly provided in the context of a new efficacy study. Instead, the study focuses on proving the safety and effectiveness of the modifications through non-clinical means and demonstrating substantial equivalence to the predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since no new clinical efficacy study was conducted for these modifications, a table of specific clinical acceptance criteria and device performance metrics (e.g., sensitivity, specificity, accuracy) is not applicable or provided. The "acceptance criteria" here are aligned with safety and effectiveness demonstrated through non-clinical testing and adherence to standards.

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

• Sample Size for Test Set: Not applicable. No clinical test set data from patients or images is described in this submission for the modifications. The testing was non-clinical (simulated use, usability validation, product verification, safety testing).
• Data Provenance: Not applicable for a clinical test set. Non-clinical testing was performed in-house by GE Healthcare.

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

Not applicable, as no external ground truth establishment for a clinical test set was performed. Usability validation involved "representatives of actual users, with knowledge of the customer needs and clinical applications," but this does not constitute establishing a ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states that the changes "did not require clinical studies to support substantial equivalence."

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

No, a standalone algorithm performance study was not conducted in the context of diagnostic accuracy. The collision avoidance functionality is integrated into the system, and its "performance" was assessed via risk management, simulated use, and verification testing to ensure it functions as intended to prevent collisions. The wireless footswitch is a control mechanism, not an algorithm for image interpretation.

7. The Type of Ground Truth Used

• For Collision Management: The ground truth for collision avoidance was based on engineering specifications, physical constraints, and risk analysis to ensure the system prevents physical contact with the skull clamp and patient. This was verified through simulated use and product verification testing against defined requirements and hazard mitigations.
• For Wireless Footswitch: The ground truth for the wireless footswitch was its functional equivalence to the wired footswitch. This was verified by ensuring identical functionalities and confirming that it did not introduce new safety or performance issues through safety testing (EMC, coexistence) and product verification.

8. The Sample Size for the Training Set

Not applicable. This submission concerns modifications to existing devices and does not describe the development of a new artificial intelligence algorithm that would require a "training set" in the conventional machine learning sense. The collision avoidance logic is likely based on deterministic geometric models and sensor inputs.

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

Not applicable, as there was no "training set" described for a new AI algorithm.

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The MECALL CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.

The device is intended for use in:

• Skeleton
• Chest and lungs
• Pediatrics
• Emergency/traumatology
• Gastroenterology
• Urology and gynecology
• Linear tomography
• Digital angiography
• Stitching

Not Found

The provided document is a 510(k) summary for a fluoroscopic x-ray system, the MECALL CLISIS SYSTEMS, Discovery RF180. It states the indications for use but does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, expert adjudication, or sample sizes for training or testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about any of the other requested study details based on this document. This document is a regulatory clearance letter, not a detailed study report.

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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.

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