FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Portrait® PSR3 System 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 and RF-based dermatological surgical and skin resurfacing technologies.
The system includes:

Portrait PSR3 Generator a mobile unit comprising a trolley and lift-out section referenced to as a "generator section". Treatment parameters are displayed on the control panel. The unit is powered by a 110/230 VAC standard wall socket.
Footswitch - single pedal unit for activation
Handpiece and Cable Assembly carries RF power and Nitrogen gas to the Nozzle.
Treatment Pack comprising a disposable Nozzle that is connected to the Handpiece and an electronic "treatment pack key" that is used by the generator to ensure the Nozzle is not used beyond its validated operational life. The instrument does not touch the skin during treatment.
Nitrogen Gas Cylinder -- the gas is provided in a cylinder housed in the generator enclosure. Refill cylinders containing the required purity of Nitrogen are obtained by the user from a commercial gas supplier.

AI/ML Overview

The document provided is a 510(k) summary for the Portrait® PSR3 System. It details a modification to an already cleared device (K073111). The primary goal of this submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish new clinical efficacy or safety from scratch. Therefore, the study described is a non-clinical test focused on the specific modification.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Deliver 4 Joules within product specification (Modified Mode)	"The modified mode provides 4 Joules within the product specification."
No change in indications for use	"The indications have not been changed from the cleared submission, K073111."
No change in technological characteristics	"The technology involved in the Portrait® PSR3 System has not been changed."
Achieve predictable tissue effects (overall system)	Covered by previous clearances, and the modification maintains this characteristic by delivering specified energy.

Note: The acceptance criteria are implicit as the submission focuses on demonstrating substantial equivalence of a modification to a previously cleared device. The "product specification" for 4 Joules is not explicitly defined in the provided text (e.g., a specific tolerance range), but the reported performance states it was met.

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

Sample Size: Not explicitly stated as a number of cycles or measurements, but it was a "Tests" (plural) conducted.
Data Provenance: Not specified, but likely an in-house laboratory test conducted by Rhytec, Inc. ("Tests were conducted using a calorimeter..."). It is a non-clinical test, not involving human subjects or patient data.

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

Not applicable. The ground truth for this non-clinical test (energy delivery) was established by direct measurement using a calorimeter, a standard scientific instrument for measuring energy. No human experts were required to establish "ground truth" for the energy output.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, objective measurement using a calorimeter. There was no need for adjudication as the outcome was directly measured by an instrument.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a modification to an existing device and focuses on non-clinical performance (energy delivery).

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

Yes, a standalone test was done, but it was a non-clinical test of the device itself, specifically its ability to deliver the specified energy output. The device (the Portrait® PSR3 System with the modified software/hardware) was tested in isolation using a calorimeter. There is no AI component or algorithm being evaluated for human-in-the-loop performance in this submission.

7. The Type of Ground Truth Used

The ground truth used was objective physical measurement of energy delivery by a calorimeter.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of this 510(k) submission. This is a modification to a medical device's functionality (delivery of 4 Joules as two consecutive pulses), not an AI/ML algorithm that requires training data.

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

Not applicable, as there was no training set.

Summary

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.