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The Portrait PSR3 is indicated for treatment of the following dermatological conditions:

• Treatment of wrinkles and rhytides .
• . Superficial skin lesions
• . Actinic Keratosis
• . Viral Papillomata
• . Seborrhoeic Keratosis

The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects.

Here's an analysis of the provided text regarding the Rhytec, Inc. Portrait PSR3 device, focusing on acceptance criteria and the supporting study:

The provided document, K060948, is a 510(k) summary for the Rhytec, Inc. Portrait PSR3 device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a full Premarket Approval (PMA) process. As such, the information on "acceptance criteria" and a detailed "study that proves the device meets the acceptance criteria" is less comprehensive than what would be found for a novel device or a PMA submission.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria (e.g., "90% sensitivity" or "reduction of X points on a scale") are not explicitly stated or defined in the manner commonly seen for diagnostic or AI-driven devices.

Instead, the "acceptance criteria" appear to be implicit in the demonstrated "significant improvement" in dermatological conditions, which aligns with the device's stated indications for use.

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

• Sample Size (Test Set): 10 subjects, treated in 30 anatomical sites.
• Data Provenance: Not explicitly stated (e.g., country of origin). No mention of retrospective or prospective nature; however, a "clinical study was conducted," implying a prospective design.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method:

• Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No, an MRMC comparative effectiveness study is not mentioned in the provided text. The study described focuses on the device's performance alone, not in comparison to or with assistance from human readers.

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

• This device is an electro-surgical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device. The clinical study described evaluates the direct physical effect of the device on the human body.

7. Type of Ground Truth Used:

• The ground truth appears to be based on clinical observation of "significant improvement," "reduction in skin dyspigmentation," and "reduction in wrinkle severity." The specific methods for quantifying these improvements (e.g., grading scales, photographic analysis, physician assessment scores) are not detailed in this summary. It is likely direct clinical assessment by a qualified physician.

8. Sample Size for the Training Set:

• This device is an electro-surgical device; it does not involve a "training set" in the context of machine learning or algorithms. The clinical study with 10 subjects and 30 anatomical sites serves as the primary performance evaluation.

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

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

Summary of Limitations Based on Provided Text:

The 510(k) summary is designed to establish substantial equivalence, not to provide exhaustive detail on clinical trial methodology as would be required for a PMA. Therefore, many standard details regarding study design, ground truth establishment, reader qualifications, and statistical methodologies are not provided in this document. The "Performance Data" section is very brief, indicating a clinical study showed "significant improvement" but lacking specific metrics or detailed methodology.

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