(16 days)
The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides .
- Superficial skin lesions .
- Actinic Keratosis .
- Viral Papillomata .
- Seborrhoeic Keratosis .
The indications are unchanged from K071886.
The Rhytec, Inc. Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts itrogen 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 predicy able tissue effects. The detachable Nozzle Stand-off (distance gauge) assists the user in maintaining the proper distance between the Nozzle and the skin.
The modification is a reusable/disposable Standoff distance gauge accessory to the Portrait® PSR3 system.
This is a difficult request since the provided text is a 510(k) summary for a medical device modification, not a study report. Therefore, much of the requested information about acceptance criteria, study details, and AI performance is not present in the document.
The document describes a modification to an existing electrosurgical device (Rhytec, Inc. Portrait® PSR3) - specifically, a reusable/disposable Stand-off distance gauge accessory. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed clinical study with acceptance criteria for a novel AI algorithm.
Therefore, many sections of your request cannot be fulfilled from the provided text. However, I will extract what can be found and clearly state what is missing.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) summary does not contain a table of acceptance criteria or a detailed study demonstrating that the device meets those criteria in the context of an AI system.
The "study" mentioned is a "bench test" to assure usability and function of a physical accessory.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for a physical accessory) | Reported Device Performance (Implied from "bench tested") |
|---|---|
| Usability of the Stand-off | Assured |
| Function of the Stand-off | Assured |
| Equivalence to non-contacting optical (LED) targeting system | Equivalent |
| Equivalence to Candela Gentle YAG Laser System distance gauges | Equivalent functional performance |
Explanation: The document does not explicitly state acceptance criteria in a quantitative or pass/fail manner. The "Clinical and Non-Clinical Data" section only states: "The Stand-off was bench tested to assure usability and function." This implies that the bench test served as the "study" to confirm that the accessory met basic functional requirements and usability, likely against internal specifications. The "Substantial Equivalence Comparison" section serves as the primary "performance" metric by comparing the new accessory's function to existing predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. (A "bench test" for an accessory would likely involve a small number of prototypes or production units).
- Data Provenance: Not applicable/not specified for a bench test of a physical accessory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/not specified. The "bench test" would likely be conducted by engineering or quality control personnel.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified.
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
- MRMC Study: No, an MRMC study was not done. This device and its modification are physical electrosurgical tools, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance study as typically understood for an AI algorithm was not done. This device is a physical tool used by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the "bench test," the ground truth would have been the engineered specifications and expected functional behavior of the Stand-off. For the substantial equivalence argument, the "ground truth" is the established function of the predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document does not describe the development of an AI algorithm or a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. This document does not describe the development of an AI algorithm or a training set.
Summary of Device and Evidence Presented in Document K072394:
The K072394 document is a 510(k) summary for a physical accessory (reusable/disposable Stand-off distance gauge) for an existing electrosurgical device (Rhytec, Inc. Portrait® PSR3 System). The primary "study" mentioned is a "bench test" to "assure usability and function" of this accessory. The safety and effectiveness argument relies on demonstrating substantial equivalence to previously cleared predicate devices and systems for maintaining distance during dermatological procedures. It does not involve any AI components, clinical trials with patient outcomes, or multi-reader studies.
§ 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.