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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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Single Use CO2 Laser Fiber is indicated for the ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.

Single Use CO2 laser fiber is a single use hollow fiber compatible to CO2 laser systems with the following specifications:

• equipped with F-SMA receptacle connector; ●
• equipped with a CO2 laser source, emitting radiation at 10.6 µm wavelength with pulsed and continuous wave (CW) emission mode;
• . able to produce a beam of maximum 300 µm diameter with maximum 30 mrad divergence at the fiber input plane;
• . with a maximum power of 40 W;
• equipped with an internal compressed air delivery system capable to generate a positive air flow ● inside the fiber tube;

The fiber structure is reported in Figure 1. It is composed of two layers: a capillary tube made of fused silica and a jacket made of ETFE. The cavity is covered by two films: the outer one is made of silver and the inner one is made of silver iodide. Silver, due to its high reflectivity, allows laser beam reflection and, thus, propagation inside the cavity. The addition of a silver iodide film from oxidation. A summary of fiber materials is reported in Table 2. Such materials represent patient contacting materials. D1, the lumen diameter, also corresponds to the laser beam diameter.

Optical fiber main components are shown in Figure 2. It is equipped with a SMA905 connector to be coupled to the laser system and a code plug that, for laser systems equipped with a code plug connector, allows the laser device to detect the fiber presence. A protective cap, to be removed before use, is placed on the fiber tip. Strain relief protects the fiber from mechanical stress at the connector side.

This kind of fiber needs to be connected to a laser system with an internal compressed air system. An air flow inside the fiber lumen is necessary to both cool the fiber and keep it free from debris.

This document describes the 510(k) summary for the Single Use CO2 Laser Fiber (HAF005001). It does not contain information about an AI/ML device or its acceptance criteria and study data. The document focuses on demonstrating substantial equivalence to a predicate laser fiber through technical specifications, indications for use, and non-clinical bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI/ML device meets them, as the provided text pertains to a laser medical device, not an AI/ML product.

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Litho laser system and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectorny, Gynaecology, ENT and General Surgery.

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Urethral Strictures
• · Bladder Neck Incisions (BNI)
• · Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors
• · Ablation of Benign Prostatic Hypertrophy (BPH)
• · Transurethral incision of the prostate (TUIP)
• · Holmium Laser Resection of the Prostrate (HoLRP)
• · Holmium Laser Enucleation of the Prostate (HoLEP)
• · Holmium laser Ablation of the Prostate (HoLAP)
• · Condylomas
• · Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate,

• monohydrate and calcium oxalate
• · Dehydrate stones
• · Endoscopic fragmentation of kidney calculi
• · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Gastroenterology
Open and endoscopic Gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Polyps
• Biopsy
• · Gall Bladder calculi
• Biliary/Bile duct calculi
• · Ulcers
• · Gastric ulcers
• · Duodenal ulcers
• · Non Bleeding Ulcers
• · Pancreatitas
• Haemorrhoids
• · Cholecystectomy
• · Benign and Malignant Neoplasm
• · Angiodysplasia
• Colorectal cancer
• · Telangiectasias
• · Telangiectasias of the Osler-Weber-Renu disease
• Vascular Malformation
• Gastritis
• · Esophagitis
• · Esophageal ulcers
• · Varices
• Colitis
• · Mallory-Weiss tear
• · Gastric Erosions

Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

• · Ligament and tendon Release
• · Contouring and sculpting of articular surfaces
• · Capsulectomy in the Knee
• · Chondreplasty in the Knee
• Debridement of inflamed synovial tissue
• Chondromalacia Ablation
• · Chondromalacia and tears
• Plica Removal
• · Meniscectomy
• Loose Body Debridement
• Lateral retinecular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

• · Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty
• · Percutaneous Cervical Disc Decompression/Discectomy
• · Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, and haemostasis of soft tissue and cartilage) including:

• · Endonasal/sinus Surgery
• · Partial turbinectomy
• · Polypectomy
• Dacryocystorhinostomy
• · Frontal Sinusotomy
• · Ethmoidectomy
• Maxillary antrostomy
• Functional endoscopic sinus surgery

General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Skin incision
• · Excision of external and internal lesions
• · Complete or partial resection of internal organs, tumors and lesions
• • Biopsy

Litho family includes surgical laser devices that are used by health care professionals in professional healthcare environments. Litho family includes the following models: Litho 60, Litho 100 and Litho 150. They differ only for the maximum power: 60, 105 and 152, respectively.

Litho devices are connected to optical fibers accessories (separately FDA cleared: K131473, K160513, K200234).

The device is equipped with a graphical user interface through which the user can set energy, frequency and pulse duration level. Different pre-sets are available among which the so called "special effects": Virtual Basket and Magneto. Virtual basket and Magneto are optional configurations.

Virtual basket had been introduced with K192600 (for Litho 100) and already included in Litho 150 510K (K201455). While, Magneto is the object of the present 510K.

Virtual basket consists of two sub-pulses separated by a certain delay. The first pulse generates a cavitation bubble and the second one is emitted when the first bubble reaches its maximum expansion. This allows the stone to be "caught" to be fragmentated. The set energy is the sum of the two sub-pulses. While Magneto consists of a pulse with a duration higher than standard one (2000 μs vs 1100 μs). Devices with Magneto configuration installed are characterized by black covers and Magneto logos.

The device can be divided into four main sections:

• . Power electronics: they manage power supplied to all device compartments;
• . Control electronics: they mainly consist of a microcontroller board where device main firmware (FW) is resident and a PC embedded with graphical user interface where device software (SW) runs;
• Cooling system: it cools the laser source pumping chamber;
• . Optical bench.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving device performance.

It's important to note that the provided text is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical laser device. This type of document primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than outlining a detailed clinical or performance study with acceptance criteria in the way one might for a novel AI/ML device.

Therefore, many of the typical questions asked about acceptance criteria and proving device performance for AI/ML devices (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies) are not directly applicable or explicitly detailed in this type of submission.

The "performance" described here is primarily in terms of technical specifications and demonstrating that the device's optical and safety characteristics are similar to or within acceptable limits compared to predicates.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Overview: The submission describes the "Litho 60; Litho 100; Litho 150" laser systems. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Litho 60, Litho 100 (K192600), Litho 150 (K201455)) and a reference device (MultiPulse HoPlus (K161257)). The change addressed in this submission is the introduction of a new "Magneto" configuration, which alters the pulse duration.

The "acceptance criteria" in this context are not performance metrics for an AI/ML algorithm (like sensitivity/specificity), but rather the demonstration that the modified device's technical specifications (e.g., laser wavelength, power, pulse width) and safety profiles remain substantially equivalent to, or are a sub-set of, the predicate/reference devices, and that it continues to meet relevant medical device safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This document does not describe a "test set" in the context of an AI/ML model's performance on patient data.
• The "testing" mentioned refers to non-clinical bench testing to confirm the device's technical specifications and compliance with safety standards (e.g., electrical safety, electromagnetic compatibility, laser safety).
• Data provenance for such bench tests is typically internal laboratory data, not patient data from specific countries or retrospective/prospective studies.

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

• Not applicable. There is no "ground truth" derived from expert review in this type of submission. Performance is measured against engineering specifications and international standards.

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

• Not applicable. No expert adjudication process foreseen for this type of device and 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 is not an AI/ML device, and no MRMC study was performed.

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

• Not applicable. This is a laser surgical instrument, not an algorithm.

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

• Not applicable in the AI/ML sense. The "ground truth" here is the adherence to engineering specifications, validated physical measurements (e.g., laser power, pulse width), and compliance with the requirements of recognized safety and performance standards (e.g., IEC 60601 series).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

In summary, this 510(k) demonstrates substantial equivalence for a medical laser device based on engineering specifications, compliance with international safety standards, and comparison of its performance characteristics (like laser parameters) and indications for use to previously cleared devices. It does not involve AI/ML performance testing or studies with human readers/cases.

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The device is intended to be used in surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology, including:

• Treatment of benign vascular lesions

• Hair removal

• Permanent* hair reduction

• permanent hair reduction defined as reduced hair growth without maintenance when measured at 6, 9 and 12 months.

The laser device Echo is a 160 W diode laser emitting at 808 nm laser wavelength. The device is a therapeutic and aesthetic medical laser system for professional use only.

For the release of laser radiation to the patient, the device uses, as delivery system, a fiber with a handpiece plugged on its end.

Echo is a transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction.

Laser radiation is delivered through optical fibers connected to handpieces having fix spot dimension.

The device is equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling and housing the laser handpiece at the same time.

Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler handpieces.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample size, ground truth establishment, or multi-reader multi-case studies. The document is an FDA 510(k) clearance letter and summary for a laser device, primarily focusing on its equivalence to predicate devices based on technical specifications and non-clinical testing for safety and effectiveness according to established standards. It does not include the detailed clinical study information you requested.

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Fiber Dust PRO is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

• · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• · Laser Resection of the Prostrate (LRP)
• · Laser Enucleation of the Prostate (LEP)
• · Laser Ablation of the Prostate (LAP)
• · Transurethral Incision of the Prostate (TUIP)
• Condylomas
• · Urethral strictures
• Lesions of external genitalia
• · Bladder neck incisions (BNI)
• · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• · Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
• monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Angiodysplasia
• · Polyps
• · Colorectal cancer
• · Biopsy
• · Telangiectasias
• Gall Bladder calculi
• · Telangiectasias of the Osler-Weber-Renu disease
• Biliary/Bile duct calculi
• Vascular Malformation
• Ulcers
• · Gastritis
• · Gastric ulcers
• · Esophagitis
• · Duodenal ulcers
• · Esophageal ulcers
• Non Bleeding Ulcers
• · Varices
• Pancreatitis
• Colitis
• Haemorrhoids
• Mallory-Weiss tear
• ·Cholecystectomy
• · Gastric Erosions
• ·Benign and Malignant Neoplasm

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue.

Fiber Dust PRO is a laser system that emits a wavelength of 1940 nm with a laser output power up to 60W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 um. The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical format of a clinical trial or performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, this is a 510(k) summary for the device "Fiber Dust PRO," indicating it's a premarket notification to the FDA. The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device (FiberDust - Quanta System S.p.A. (K210142)).

Here's a breakdown of the information available, addressing your questions where possible:

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

The document does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or other quantitative measures typically associated with device performance in clinical studies for diagnostic or AI-driven devices.

Instead, the "Performance data" section (page 7) states:

• "Based on the nature of the modified device was subjected to performance testing in accordance with the following recognized consensus standards:
  • IEC 60601-1:2005 MOD Medical Electrical equipment Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests"
• "The modified device passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

This indicates that the "acceptance criteria" were compliance with these safety and performance standards for medical electrical equipment, which the device reportedly met. These standards typically cover aspects like electrical safety, electromagnetic compatibility, mechanical safety, and basic operational performance, not clinical efficacy or diagnostic accuracy.

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

Not applicable. This submission relies on compliance with engineering standards and comparison to a predicate device, not on a clinical trial with a test set of 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 clinical test set or ground truth established by experts is described for this type of submission.

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

Not applicable.

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-driven or diagnostic device undergoing an MRMC study.

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

Not applicable. This is a laser surgical instrument, not an algorithm.

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

Not applicable. The performance reported is adherence to electrical and electromagnetic compatibility standards, not clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of the Study and Device Claim:

The "study" presented here is a premarket notification (510(k)) aimed at demonstrating substantial equivalence to a previously cleared predicate device (FiberDust, K210142). The Fiber Dust PRO is a powered laser surgical instrument.

The key aspects of the "study" are:

• Device Comparison: The Fiber Dust PRO is described as a modified version of the predicate device, primarily differing in its configuration (mobile vs. desktop). Key technical specifications (laser source, wavelength, emission, pulse duration, frequency, max average power, delivery system, aiming beam) are stated to be "Same or similar" to the predicate.
• Intended Use: The intended use and indications for use are "exactly the same" as the predicate device.
• Performance Data: The device underwent testing to ensure compliance with recognized international safety and performance standards for medical electrical equipment (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that the device "passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."
• Software Verification and Validation: Software testing was conducted according to FDA guidance for medical device software.
• Biocompatibility: No new patient-contacting materials were introduced that would adversely affect biocompatibility, implying reliance on the predicate's biocompatibility assessment.
• Conclusion: The submission concludes that the modifications "do not raise new types of questions regarding the safety and effectiveness" and that the performance testing supports its safe and effective use, thus establishing substantial equivalence to the predicate.

In essence, the "acceptance criteria" here are compliance with established safety and general performance standards for medical devices and demonstration that the changes from the predicate do not alter its safety or effectiveness profile. This is typical for a 510(k) submission for a non-diagnostic, non-AI device where engineering and safety standards are the primary focus of performance evaluation, rather than clinical efficacy studies with patient data.

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694 nm nanosecond (QS mode)
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 picosecond (PS mode)
Indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

Not Found

Based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established for the Rosso device.

The document is an FDA 510(k) clearance letter for the Rosso laser surgical instrument. It states that the device is substantially equivalent to legally marketed predicate devices and lists its "Indications for Use." This type of document confirms regulatory clearance but does not typically include the detailed technical study information that would be found in a clinical study report or a more comprehensive technical submission.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study, as this information is not present in the provided text.

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Fiber Dust is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

• · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• · Laser Resection of the Prostrate (LRP)
• · Laser Enucleation of the Prostate (LEP)
• · Laser Ablation of the Prostate (LAP)
• · Transurethral Incision of the Prostate (TUIP)
• Condylomas
• · Urethral strictures
• Lesions of external genitalia
• · Bladder neck incisions (BNI)
• · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• · Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
• monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Angiodysplasia
• · Polyps
• · Colorectal cancer
• · Biopsy
• · Telangiectasias
• Gall Bladder calculi
• · Telangiectasias of the Osler-Weber-Renu disease
• Biliary/Bile duct calculi
• Vascular Malformation
• Ulcers
• · Gastritis
• · Gastric ulcers
• · Esophagitis
• · Duodenal ulcers
• · Esophageal ulcers
• Non Bleeding Ulcers
• · Varices
• Pancreatitis
• Colitis
• Haemorrhoids
• Mallory-Weiss tear
• ·Cholecystectomy
• · Gastric Erosions
• ·Benign and Malignant Neoplasm

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue.

The Fiber Dust laser device includes a diode laser that emits a wavelength of 1940 nm with a laser output power up to 60W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 μm.

The main subsystems of the device are the diode laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

The provided text is a 510(k) summary for the "Fiber Dust" laser device, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing against recognized consensus standards. It does not contain information about the use of AI/ML or a study that establishes acceptance criteria for an AI-powered device's performance metrics like sensitivity, specificity, or AUC, as typically seen in submissions for AI/ML medical devices.

Therefore, the requested information cannot be fully extracted based on the provided text. Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided in a format relevant to AI/ML device performance (e.g., no metrics like sensitivity, specificity, or accuracy based on a clinical ground truth). The document states that "non-clinical performance standards testing support that the device can be used safely and effectively," but these refer to engineering and safety standards, not AI performance metrics.

2. Sample size used for the test set and the data provenance: Not applicable, as no AI/ML test set is described. Performance testing primarily refers to engineering and safety standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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. The device is a surgical laser, not an AI-assisted diagnostic or decision-support tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the purposes of this submission, the ground truth relates to the device meeting engineering and safety standards (e.g., electrical safety, electromagnetic compatibility, laser safety). There is no "ground truth" as it would be defined for an AI/ML diagnostic or predictive model.

8. The sample size for the training set: Not applicable, as there is no mention of an AI model being trained.

9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to "acceptance criteria" and "study":

The acceptance criteria for the Fiber Dust device are based on compliance with recognized consensus standards for medical electrical equipment and laser safety.

• IEC 60601-1:2012, ed 3.1 (General Requirements for Basic Safety And Essential Performance)
• IEC 60601-1-2:2014, ed 4 (Electromagnetic Disturbances - Requirements And Tests)
• IEC 60601-2-22: 2012, ed 3.1 (Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment)
• IEC 60825-1:2014, ed 3.0 (Safety of laser products – Part 1: Equipment classification and requirements)
• IEC60601-1-6:2013, ed 3.1 (Usability)

Additionally, "Software Verification and Validation Testing" was conducted following FDA guidance for software in medical devices.

The "study" or testing that proves the device meets these criteria refers to the performance testing against these standards, the results of which "support that the device can be used safely and effectively." These are non-clinical tests typically conducted in a laboratory or engineering environment. The document states: "The results of the non-clinical performance standards testing support that the device can be used safely and effectively."

In conclusion, the provided text describes the clearance of a traditional medical device (a surgical laser) based on engineering and safety standards compliance, not an AI/ML-driven device with performance metrics based on clinical data or expert ground truth.

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Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, 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)

Chrome is intended for treatment of benign vascular lesions, benign pigmented 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), 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-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 (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lessons such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for benign pigmented lesion size, for patients with benign lesions that would potentiallybenefit from aggressive treatment, and for patients with benign that have not responded to other laser treatments.

It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

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 lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

Chrome is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at 532 nm and 1064 nm (Nd:YAG laser).

Chrome, 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.

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

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

Chrome is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not contain information about acceptance criteria for performance, device performance metrics, or any clinical study details (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, or training set details).

The document focuses on regulatory approval (510(k) premarket notification) for a laser device called "Chrome." It establishes "substantial equivalence" to predicate devices, primarily based on technological characteristics and safety standards.

The sections that might typically contain such information (like "Performance data" and "Technological Characteristics Comparison") focus on:

• Performance data: Lists recognized consensus safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and states that "Software Verification and Validation Testing" was conducted. It also mentions biocompatibility was established by comparison to a predicate. This refers to safety and electrical performance standards, not clinical efficacy or diagnostic accuracy.
• Technological Characteristics Comparison: Compares specific technical parameters (laser wavelengths, pulse width, max fluence, spot size, repetition rate, microbeam handpiece details, IPL wavelengths) of the Chrome device to two predicate devices. This demonstrates that the device operates within similar technical specifications as already approved devices, not that it has met specific clinical performance criteria.

Therefore, I cannot populate the requested table and answer the detailed questions about the study that proves the device meets acceptance criteria, as that information is not present in the provided document.

The document primarily demonstrates:

1. Indications for Use: What conditions the device is intended to treat (various dermatological conditions, tattoo removal, hair reduction, etc.).
2. Technological Equivalence: That its technical specifications (laser types, wavelengths, power, etc.) are comparable to previously cleared devices.
3. Safety & Standards Compliance: That it complies with general safety and electrical standards for medical devices and lasers.

This type of 510(k) submission often does not require new clinical studies if substantial equivalence can be established based on technological characteristics and intended use compared to legally marketed predicate devices.

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Opera Evo laser device and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical Traditionalties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery and Arthroscopy.

The Opera Evo laser device includes a diode laser that emits a wavelength of 1940 nm and includes a diode laser that emits a wavelength of 1470 nm, with a combined cumulated laser output power up to 40W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 um. The main subsystems of the device are the two diode lasers, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch

This document is a 510(k) premarket notification for the Opera Evo laser device. It outlines the device's indications for use, technological characteristics, and compares it to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly state quantitative acceptance criteria or a direct table of reported device performance values against those criteria. Instead, it relies on demonstrating compliance with recognized consensus standards. The "performance" assessment is qualitative, asserting that the device meets safety and effectiveness standards.

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

The document describes non-clinical performance testing only. It does not refer to a "test set" in the context of patient data or clinical samples. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary. The testing was likely conducted in a laboratory setting.

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

This information is not applicable as the document describes non-clinical performance testing against engineering and safety standards, not a study involving human experts establishing ground truth on clinical data.

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

This information is not applicable for the reasons stated above.

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 such study was conducted or is referenced in this document. The Opera Evo is a surgical laser device, not an AI-assisted diagnostic or interpretive device.

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

This information is not applicable as the device is a medical laser and doesn't involve an algorithm operating independently in a diagnostic or interpretive capacity. Its "performance" is about its physical characteristics and adherence to safety standards.

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

For the non-clinical performance testing, the "ground truth" refers to the established requirements and limits defined within the specified IEC and other consensus standards. For instance, ground truth for electrical safety would be adherence to specific voltage/current limits, or for laser safety, compliance with defined emission levels.

8. The sample size for the training set

This information is not applicable. The document describes a medical device, not a machine learning model that requires a training set. The "Software Verification and Validation Testing" refers to standard software development and testing practices, not the training of an AI algorithm.

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

This information is not applicable as there is no training set for an AI/machine learning model mentioned.

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The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

The devices belonging to Multicavity Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

The provided document is a 510(k) premarket notification for a medical device called "Litho 150, Cyber Ho 150" (Multicavity Holmium laser). It describes device modifications and asserts substantial equivalence to a predicate device (Litho 100/60, K192600).

However, this document does not contain the detailed information necessary to complete the requested table and answer questions 2-9.

Here's why and what information is missing:

• Acceptance Criteria and Reported Performance: The document states that the device "underwent and successfully passed electrical safety, EMC and performance testing" according to specific standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and "Software Verification and Validation Testing". However, it does not provide specific numerical acceptance criteria (e.g., "power output must be within +/- 5%") or the actual numerical performance results of these tests (e.g., "power output was 150W +/- 2W"). It only confirms successful passing of these tests.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These questions are typically relevant for studies evaluating the clinical effectiveness or diagnostic accuracy of a device, especially those involving AI/ML models, image analysis, or outcomes assessment. This 510(k) is for a surgical laser, and the "performance testing" mentioned refers to engineering and safety standards, not a clinical study to establish diagnostic or treatment efficacy performance metrics in terms of sensitivity, specificity, accuracy, or similar measures against a clinical ground truth.

Therefore, I cannot populate the table or answer questions 2-9 based on the provided text.

However, I can extract the available information regarding the device's technical specifications and the standards it met:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions (2-9):

The document provides no information on these points because the submission is a "Special 510(k)" for device modifications based on hardware changes (increased power and frequency) to an already cleared device (K192600). The basis for this type of submission relies on demonstrating that the modified device remains substantially equivalent to the predicate through engineering and safety testing, not typically through new clinical studies involving human subjects or extensive ground truth establishment in the manner described by these questions. Such detailed clinical study methodology would be expected for novel devices or significant changes impacting clinical performance but is not provided for this specific submission type.

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