PRIMAEVA MEDICAL SYSTEM

• K Number: K080145
• Device Name: PRIMAEVA MEDICAL SYSTEM
• Manufacturer: PRIMAEVA MEDICAL, INC.
• Date Cleared: 2008-02-28 ( 37 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Special
• Panel: SU
• Reference & Predicate Devices: K072261

Intended Use

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

Device Description

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:

1. 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.

2. 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.

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)

   • 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.

4. 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.

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

   • No. This is not an AI device. The document is for an electrosurgical system. Therefore, no MRMC study or AI-related effectiveness is discussed.

6. 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).

7. 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."

8. The sample size for the training set

   • Not applicable/Not provided. This information is for AI/machine learning models, which this device is not.

9. 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.

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.