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The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

The LightSheer™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The handpiece tip is water-cooled to provide active skin cooling.

The provided text describes the LightSheer™ Pulsed Diode Array Laser, which is intended for hair reduction. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size: The document does not specify the exact number of subjects or hair sites included in the clinical study. It only refers to "any subject."
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that it's a 510(k) submission for a new device claiming effectiveness for its intended use, it would typically be a prospective clinical trial conducted in the country of the applicant (USA, based on the address).

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

This information is not provided in the document. The clinical study describes "Observations of hair and skin responses were recorded," but it does not specify who made these observations or their qualifications.

4. Adjudication method for the test set

This information is not provided in the document.

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

An MRMC study was not done. This device is a laser for hair reduction, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable. The LightSheer™ is a physical medical device (laser system), not a software algorithm. Its performance is inherent in its operation, not in an algorithm that could be run standalone.

7. The type of ground truth used

The ground truth appears to be direct observation of hair regrowth and skin responses by unspecified personnel. The definition of "permanent hair reduction" also serves as a ground truth criterion. There is no mention of pathology or other objective outcome data, beyond visual assessment of hair and skin.

8. The sample size for the training set

This information is not applicable/provided. As a physical device, there is no "training set" in the context of machine learning. The device's parameters (wavelength, pulse duration, energy, fluence, etc.) are designed based on scientific principles and prior research into laser-tissue interaction for hair removal, rather than on a data-driven training process.

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

This information is not applicable/provided. As explained above, there is no "training set" for a physical laser device in the way there is for an AI algorithm. The scientific basis for its design would come from general knowledge of light absorption by melanin and tissue thermal damage, which is established through extensive scientific literature and research, not a specific "training set" with ground truth in the context of the regulatory submission.

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The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.

The StarLight system delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². The corresponding pulse energy delivered through the 9 x 9 mm handpiece tip is 8 – 32 J. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.

Acceptance Criteria and Study Details for StarLight™ Pulsed Diode Array Laser System

The provided document describes the StarLight™ Pulsed Diode Array Laser System, intended for the treatment of leg veins. The submission indicates that clinical studies were conducted to demonstrate safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating substantial equivalence to the legally-marketed predicate device, the PhotoGenica LPIR™ by Cynosure, Inc. Therefore, the "acceptance criteria" revolve around the absence of different performance and no new questions of safety or efficacy compared to the predicate device.

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

• Sample Size: The document does not explicitly state the exact sample size (number of subjects) used in the clinical study. It refers to "clinical studies" and "any subject" in the context of safety.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though the description of "clinical studies were conducted" and "observations... were recorded" typically implies a prospective study design.

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

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the test set. It mentions "Observations of vessel clearing and skin responses," which implies clinical assessment by medical professionals, but specific details are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set. Evaluation appears to have been based on direct clinical observation.

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

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study's purpose was to demonstrate substantial equivalence to a predicate device, focusing on the device's own performance and safety.

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

This device is a physical laser system for medical treatment, not an algorithm or AI. Therefore, the concept of a "standalone (algorithm only)" performance assessment is not applicable. The performance is inherently "human-in-the-loop" as it is operated by a medical professional.

7. The Type of Ground Truth Used

The ground truth appears to be based on expert clinical observation and assessment of the treatment outcomes. This includes:

• Vessel effects: reduction in vessel diameter, vessel coagulation, and vessel disappearance.
• Skin responses: absence of scarring or permanent depigmentation.

8. The Sample Size for the Training Set

This document describes a clinical study for a physical medical device, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.

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

As this is not an AI/ML device, there is no "training set" and thus no ground truth established for such a set.

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The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.

The StarLight™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.

The provided document is a 510(k) summary for the StarLight™ Pulsed Diode Array Laser System, focusing on substantial equivalence to a predicate device. It contains information about clinical studies but does not explicitly state acceptance criteria or provide a detailed breakdown of device performance against such criteria. It also lacks many of the specific details requested regarding the study methodology.

However, I can extract the available information and highlight what is missing based on your request.

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

Note: The document does not explicitly state acceptance criteria in a quantitative or pass/fail manner. The reported performance implies that these qualitative outcomes were deemed acceptable for substantial equivalence.

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

• Sample Size: Not specified in the provided document.
• Data Provenance: The document states "Clinical studies were conducted," implying prospective data collection for the purpose of the submission. The country of origin is not specified, but the applicant and contact information suggest a US-based study if conducted directly by them.

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

• This information is not provided in the document. The "Observations of hair regrowth and skin responses" would likely have been assessed by clinical professionals, but their number and qualifications are not detailed.

4. Adjudication method for the test set

• This information is not provided in the document.

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 comparing human readers with and without AI assistance was not done. This device is a laser system for hair removal, not an imaging or diagnostic device that would typically involve "human readers" interpreting results assisted by AI.

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

• This question is not applicable. The device is a laser system for hair removal, where the "performance" is the direct physiological effect of the laser on hair and skin, not an algorithm's output.

7. The type of ground truth used

• Clinical observation: The ground truth for efficacy was "Observations of hair regrowth and skin responses" at various time points (1, 3, 6, and 9 months after treatment). For safety, it was the absence of adverse events like scarring or permanent depigmentation. This relies on direct clinical assessment.

8. The sample size for the training set

• This information is not applicable. The device is a physical laser system, not an AI/ML algorithm that requires a "training set." The clinical studies mentioned are for validation of the device's performance, not for training an underlying model.

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

• This question is not applicable, as there is no "training set" for this type of device.

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