The Primaeva Medical System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface, a reusable cooler controller, a reusable cooling system handpiece, a reusable electrode insertion device and a disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.

AI/ML Overview

The provided text is a 510(k) summary for the Primaeva Medical System. It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain the type of detailed acceptance criteria or a specific study proving the device meets those criteria in human-centered performance metrics that your request is looking for (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, or ground truth details).

This document focuses on regulatory approval based on substantial equivalence to a legally marketed predicate device (Primaeva Medical Finesse System, K072261) through non-clinical testing.

Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:

A table of acceptance criteria and the reported device performance
- Not provided. The document states that non-clinical testing (visual, mechanical inspection, electrical and mechanical safety testing, functional performance testing) was conducted and that the device "meet established design specifications; function as intended; and are considered to be substantially equivalent to the above noted predicate device." It does not list specific numerical acceptance criteria or performance metrics for this device.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "bench and/or animal testing" for non-clinical tests but does not specify sample sizes or data provenance.
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)
- Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation or clinical outcomes. The provided document describes non-clinical (bench and animal) testing for an electrosurgical unit, not a diagnostic or AI device requiring expert ground truth establishment for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Similar to point 3, this is not relevant for the type of non-clinical testing described.
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
- No. This is not an AI device. The document is for an electrosurgical system. Therefore, no MRMC study or AI-related effectiveness is discussed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm. It's a physical medical device (electrosurgical unit).
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in detail. For the non-clinical tests, the "ground truth" would be engineering specifications, established safety standards, and the functional performance of the predicate device. The document states the tests "meet established design specifications; function as intended."
The sample size for the training set
- Not applicable/Not provided. This information is for AI/machine learning models, which this device is not.
How the ground truth for the training set was established
- Not applicable/Not provided. This information is for AI/machine learning models, which this device is not.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical bench and/or animal testing for an electrosurgical unit. It does not contain the detailed human-centric performance metrics, AI study methodologies, or extensive ground truth establishment details that your request outlines. The "study" referenced in the document is the "Non-Clinical Test Summary" which includes "visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench and/or animal testing." The acceptance criteria are broadly stated as meeting "established design specifications" and functioning "as intended," demonstrating substantial equivalence to the predicate device.

Summary

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510(k) Summary - K080145

This 510(k) summary of substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92.

A. Name, Address, Phone and Fax Number of Applicant

Primaeva Medical, Inc. 42840 Christy Street, Suite 101 Fremont, CA 94538, USA (510) 933-6000 Telephone: Fax: (510) 933-6001

B. Contact Person

Brian Grigsby Vice President. QA & RA Telephone: (510) 933-6090

C. Date Prepared

February 14, 2007

D. Device Name

Trade Name: Common Name: Classification Name: Primaeva Medical System Electrosurgical Unit and Accessories Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code GEI)

E. Predicate Device

The Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge is substantially equivalent to the Primaeva Medical Finesse System, a legally marketed device (K072261).

F. Device Description

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KO80145

G. Intended Use

rimāeva

The Primaeva Medical System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

H. Technological Characteristics Comparison

The Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge is substantially equivalent in terms of intended use, target population, energy source, principles of operation, etc., to the above noted predicate device.

1. Non-Clinical Test Summary

Non-clinical testing of the Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench and/or animal testing.

J. Summary

In summary, the results of non-clinical mechanical, electrical and functional bench and/or animal testing have demonstrated that the Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge meet established design specifications; function as intended; and are considered to be substantially equivalent to the above noted predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three lines forming the staff and snakes, giving it a modern and abstract appearance. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2000

Primaeva Medical, Inc. % Mr. Brian Grigsby Vice President, QA & RA 42840 Christy Street, Suite 101 Fremont, California 94538

Re: K080145

Trade/Device Name: Primaeva Medical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 18, 2008 Received: January 30, 2008

Dear Mr. Grigsby:

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.

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Page 2 - Mr. Brian Grigsby

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Mark M. Wilkerson

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

Enclosure

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Indications for Use

KO80145 510(k) Number (if known):

Device Name: Primaeva Medical System

Indications for Use:

The Primaeva Medical Finesse System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Much A. Millen

(Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number K080145

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.