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.

AI/ML Overview

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.

Acceptance Criteria (Implicit)	Reported Device Performance and Conclusions
Device demonstrates efficacy in treating dermatological conditions as listed in indications for use.	"Significant improvement in each of the three anatomic regions observed."
Device demonstrates efficacy in reducing skin dyspigmentation.	"Reduction in skin dyspigmentation... observed in neck and chest skin and in the skin of the dorsum of the hands."
Device demonstrates efficacy in reducing wrinkle severity.	"Reduction in... wrinkle severity was observed in neck and chest skin and in the skin of the dorsum of the hands."

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.

Summary

{0}------------------------------------------------

K060948

510(k) Summary for the Rhytec, Inc. Portrait PSR3

Page 1 of 2

000006

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:	Rhytec, Inc.1000 Winter StreetWaltham, MA 02451
Contact Person:	Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-207-1246
Summary Preparation Date:	March 31, 2006

Names

Device Name:	Portrait PSR3
Classification Name:	Electrosurgical cutting and coagulation deviceProduct Code: GEI

Predicate Devices

The Portrait PSR3 is substantially equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639).

4. Device Description

{1}------------------------------------------------

K060948

5. Indications for Use

Page 2 of (2)

00007

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

6. Performance Data

A clinical study was conducted which included 10 subjects treated in 30 anatomical sites which showed significant improvement in each of the three anatomic regions observed. Reduction in skin dyspigmentation and wrinkle severity was observed in neck and chest skin and in the skin of the dorsum of the hands.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three horizontal lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2006

Rhytec. Inc % Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 1000 Winter Street Waltham, Massachusetts 02451

Re: K060948

Trade/Device Name: Rhytec, Inc. Portrait PSR3 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting coagulation device and accessories Regulation Class: Class II Product Code: GEI Dated: August 7, 2006 Received: August 9, 2006

Dear Ms. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Maureen O'Connell

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): _ K 060948

Device Name: Rhytec, Inc. Portrait PSR3

Indications for Use:

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

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rob

(Division Sign-Off)

Division of Cenera' Restorative,

and Neurological Devices

Page 1 of 1

510 Number /060928

000005

$
$

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.