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The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Shaser Skin Beauty Intense Pulsed Light System Family For Acne is an Over-The-Counter, Light-Based Acne Clearing Device. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger/AC cord. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. The Principle of Operation is both photochemical and photothermal. The Mechanism of Action is to stimulate oxygen production which attacks p.acne and to reduce inflammation due to acne.

The Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282) is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific reduction percentage in acne). Instead, the clinical performance data focuses on label comprehension and usability to ensure safe and appropriate use of the device by consumers in a home setting.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 84 study subjects were tested for label comprehension and usability.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "simulated home-use environment," implying a prospective study design for the usability and comprehension aspects.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or disease diagnosis. The assessments were focused on consumer understanding and ability to use the device, rather than expert diagnostic accuracy. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method (Test Set)

No adjudication method is described, as the studies conducted focused on label comprehension and usability by the subjects themselves, rather than expert assessment of an outcome requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned. The study focused on consumer (user) performance in understanding and operating the device, not on diagnostic accuracy or comparison of human readers with and without AI assistance for acne diagnosis.

6. Standalone Performance (Algorithm Only)

The device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its physical operation and user interaction.

7. Type of Ground Truth Used (Test Set)

For the clinical performance data presented (label comprehension and usability), the "ground truth" was established by observing and evaluating the subjects' ability to understand the instructions and use the device correctly and safely. This is an assessment of human behavior and understanding in relation to the device, rather than a medical ground truth (e.g., pathology, clinical outcomes, expert consensus on disease state).

8. Sample Size for Training Set

The document describes a medical device study for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device and verifying safety and effectiveness through non-clinical and clinical performance testing. This is not a machine learning or AI algorithm submission that would have a distinct "training set." Therefore, information on the sample size for a training set is not applicable.

9. How Ground Truth for Training Set was Established

As there is no "training set" in the context of an AI algorithm, this question is not applicable.

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The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. 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 regimen.

Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

This 510(k) summary describes a new version of an Intense Pulsed Light (IPL) system for hair removal, claiming substantial equivalence to previously cleared devices. It relies on the predicate devices' performance and does not present new acceptance criteria or device performance data for hair reduction efficacy. Instead, the study focuses on user comprehension and usability for safe operation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria for hair reduction or phototherapeutic effect are provided in this submission for the new device. The submission references the predicate devices (Shaser V-MINI 2 and Shaser Lumena FH) as having "identical performance specifications" and "the same basic design and performance characteristics related to device safety and effectiveness."

The only "performance data" presented for the new device relates to user-friendliness:

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

• Label Comprehension: 150 study subjects.
• Usability Test: 123 study subjects.
• Data Provenance: Not explicitly stated, but the context of an OTC home-use device and consumer testing suggests the data is likely prospective and collected within the United States. The inclusion of "low literacy subjects" is noted.

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

There is no mention of "experts" establishing ground truth in the traditional sense (e.g., medical experts diagnosing conditions). For a label comprehension and usability study, the "ground truth" is typically established by:

• The instructions for use (IFU): This document defines the correct understanding and safe usage of the device.
• Study facilitators/observers: These individuals (whose qualifications are not specified) would assess whether subjects understood the label correctly and used the device safely according to predetermined criteria derived from the IFU.

4. Adjudication Method for the Test Set

Not applicable. This was not a study requiring adjudication of medical outcomes or interpretations. The assessment was based on direct observation of user interaction and responses to questions about the instructions.

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 an IPL hair removal system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This is a physical consumer-use device, not an algorithm. The "standalone performance" of the device itself (hair removal efficacy) is presumably based on the predicate devices, but no new standalone efficacy study was presented for this specific submission. The study described focuses on the human user's interaction with the device.

7. The Type of Ground Truth Used

• For label comprehension: The correct interpretation of the instructions for use (IFU) provided with the device.
• For usability: Safe and appropriate operation of the device according to the IFU, as observed by trained study personnel.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The clinical performance data described for this submission relates to human user comprehension and usability testing, not to training an algorithm.

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

Not applicable, as there was no training set for an algorithm.

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