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The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows:

1410 nm Indications for Use:

• Fractional skin resurfacing procedures
  1927 nm Indications for Use
• Fractional skin resurfacing procedures
  LPTT (Polytherapy) application of 1410 nm and 1927 nm simultaneously
• Fractional skin resurfacing procedures

The Lumenis YandR Laser System consists of:

• System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts)
• Operator control panel with touch-screen technology (GUI)
• NAFR handpiece and single-use removable tips
• Footswitch and other laser safety accessories

The non-ablative fractional NAFR handpiece emits two wavelengths - 1410nm and 1927nm. The 1410nm and 1927nm laser diode modules are located in the console and are coupled into the single handpiece via fiber optics. Through the GUI screen on the system console, the user can select either fractional wavelength, or a combination of both.

The Lumenis Y&R Laser System is intended for fractional skin resurfacing procedures using 1410 nm, 1927 nm, or a combination of both wavelengths (LPTT mode).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) that a diagnostic or AI device would typically have. Instead, the "acceptance criteria" are implied through the successful demonstration of:

• Safety and effectiveness comparable to predicate devices.
• Expected wound healing responses.
• Compliance with relevant standards and regulatory requirements.

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

• Sample Size: Three (3) female Yorkshire Cross crossbred swine were used for the histology study.
• Data Provenance: The study was conducted by Lumenis Inc. (the manufacturer), and the results were provided to the FDA. The country of origin for the data is not explicitly stated, but as Lumenis Inc. is based in Salt Lake City, UT, USA, and the submission is to the FDA, it is likely the study was conducted in the USA or under protocols recognized by a US-based manufacturer. The study was prospective in the sense that animals were treated and then observed over time.

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

The document does not explicitly state the number or qualifications of experts used for establishing "ground truth" for the histology study. The histopathology analysis was performed, but who specifically read the slides or confirmed the findings (e.g., a board-certified veterinary pathologist) is not detailed.

4. Adjudication method for the test set

The document does not describe an adjudication method for the histopathology findings in the context of multiple readers. The analysis seems to be presented as a single set of conclusions from the study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The study conducted was a histology study on porcine animals to assess wound healing and tissue response, not a human reader performance study.

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

This device is a laser system for medical procedures, not an AI/algorithm-only diagnostic or analytical tool. Therefore, the concept of a "standalone" algorithm performance study (without human-in-the-loop) is not applicable here.

7. The type of ground truth used

The ground truth for the study was based on histopathology analysis of skin tissue samples from the treated porcine animals, examined at different time points post-treatment (0, 1, 7, and 14 days). This involved examining the microscopic structure of the tissue, including re-epithelization, and confirming the non-ablative nature of the device.

8. The sample size for the training set

This device is not an AI/machine learning algorithm requiring a separate training set. The study describes device validation, not algorithm training. Therefore, there is no "training set sample size" in this context.

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

As there is no training set for an AI algorithm, this question is not applicable.

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The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including:

• . Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
  • Proliferative and nonproliferative diabetic retinopathy .
  • Choroidal neovascularization .
  • Branch retinal vein occlusion .
  • . Retinal tears and detachments
  • Retinopathy of prematurity .
• Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma

The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.

The provided document is a 510(k) summary for the Lumenis Vision One Laser System, an ophthalmic surgical laser. It establishes substantial equivalence to a predicate device and details the device's intended use and technical specifications. However, it does not contain the specific information required to answer your request regarding acceptance criteria for a study proving device performance.

Specifically, the document states under "VII. Performance Data:" that "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted." However, it does not provide the detailed results of these tests, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Cannot be answered from the provided text. The document states that performance testing was conducted but does not provide specific acceptance criteria or detailed reported performance metrics.

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

• Cannot be answered from the provided text. The document does not describe a clinical study or a test set, nor does it provide details on sample size or data provenance for any performance testing.

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):

• Cannot be answered from the provided text. There is no mention of a test set, ground truth establishment, or experts involved in performance evaluation.

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

• Cannot be answered from the provided text. There is no information about a test set or adjudication methods.

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:

• Cannot be answered from the provided text. This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable and not mentioned.

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

• Cannot be answered from the provided text. This device is a surgical laser, not an algorithm. Standalone algorithm performance is not applicable.

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

• Cannot be answered from the provided text. There is no information on ground truth establishment for any performance testing.

8. The sample size for the training set:

• Cannot be answered from the provided text. This device is a surgical laser; the concept of a "training set" in the context of machine learning or AI is not applicable here.

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

• Cannot be answered from the provided text. Not applicable for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, patient population, principles of operation, and method of energy delivery. It does not provide the detailed performance study information with acceptance criteria, sample sizes, or ground truth establishment that you are requesting.

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