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The Portrait® PSR is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based dermatological surgical and skin resurfacing technologies.

The system includes:

Portrait® PSR3 Generator
Footswitch
Handpiece and Cable Assembly
Treatment Pack comprising a disposable Nozzle and an electronic "treatment pack key"
Nitrogen Gas Cylinder

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) Summary) does not explicitly define specific "acceptance criteria" in terms of quantitative performance metrics (e.g., a specific percentage of improvement, a reduction in lesion size by X%). Instead, the acceptance is based on the demonstration of substantial equivalence to predicate devices and the safety and effectiveness for its stated indications for use.

Therefore, the "acceptance criteria" are implied by the regulatory standard for a 510(k) submission:

Substantial Equivalence: The device must be as safe and effective as a legally marketed predicate device.
Indications for Use: The device must be shown to be safe and effective for its stated indications.

The reported device performance is described qualitatively:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to predicate devices (K071786, K963339, K030453, K053047)	"Portrait® PSR3 utilizes the same technology as previously cleared for Portrait® PSR3. There have been no changes to the device design. The substantial equivalence of this device is supported by the prior approval of this device and the clinical data submitted."
Safety and Effectiveness for labeled Indications for Use:	"Clinical studies to support clinical performance of the Portrait® PSR3 to improve acne scarring were conducted... These studies conclude that the Portrait® PSR³ is safe and effective for treating acne scars."
"Clinical studies demonstrated that the Portrait® PSR3 is capable of producing tissue effects similar to that seen with carbon dioxide laser treatment."
Treatment of wrinkles and rhytides	Implied by general safety and effectiveness claims. (No specific study details for this indication provided in the summary)
Superficial skin lesions	Implied by general safety and effectiveness claims. (No specific study details for this indication provided in the summary)
Actinic Keratosis	Implied by general safety and effectiveness claims. (No specific study details for this indication provided in the summary)
Viral Papillomata	Implied by general safety and effectiveness claims. (No specific study details for this indication provided in the summary)
Seborrhoeic Keratosis	Implied by general safety and effectiveness claims. (No specific study details for this indication provided in the summary)

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

Sample Size: The 510(k) Summary does not specify the sample size for the clinical studies. It mentions "Clinical studies... to improve acne scarring," but the number of subjects or cases is not provided.
Data Provenance: Not explicitly stated. The studies were conducted "in compliance with the Code of Federal Regulations, as specified in 21 CFR 812," which governs investigational device exemptions in the US. This implies the studies were likely conducted in the United States and were prospective clinical studies.

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

The 510(k) Summary does not provide any information on the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The 510(k) Summary does not provide any information on the adjudication method used for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The 510(k) Summary does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies mentioned focus on evaluating the device itself, not comparing human readers with or without AI assistance. The device is a direct treatment device, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the Portrait® PSR3 System is an electrosurgical device for dermatological treatment, not an algorithm or AI-based diagnostic tool. It requires human operation.

7. The Type of Ground Truth Used

The ground truth for the clinical studies evaluating "acne scarring" would typically be based on clinical assessment/outcomes data by clinicians (e.g., visual grading scales, objective measurements of scar reduction, patient satisfaction). The summary states "Clinical studies... conclude that the Portrait® PSR³ is safe and effective for treating acne scars," implying clinical endpoints were used.
For the claim of "producing tissue effects similar to that seen with carbon dioxide laser treatment," the ground truth would likely involve histopathological analysis (biopsies) of treated tissue, potentially compared to tissue treated with CO2 lasers.

8. The Sample Size for the Training Set

The 510(k) Summary does not mention a "training set" in the context of machine learning or AI algorithms. The device described is a physical medical device, not an AI model requiring a training set.

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

This question is not applicable as the device is not an AI model that would require a training set and associated ground truth establishment.

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