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Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.

The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.

The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).

The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. The compatible generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas passes over the energized electrode, a helium plasma is generated for soft tissue cutting, coaqulation or ablation.

The Renuvion® APR Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).

The provided document describes the K220970 Premarket Notification for the Renuvion APR Handpiece. The focus of this submission is not on a new device but on an expanded indication for use for an existing, previously cleared device (Renuvion APR Handpiece, cleared under K191542). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are specifically related to proving the safety and effectiveness of the device for this new indication, rather than the core functionality of the electrosurgical device itself, as no modifications were made to the hardware.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are effectively the primary and safety endpoints defined for the clinical study.

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

• Sample Size: 65 adults. The effectiveness endpoint was assessed on 63 subjects, and the safety endpoint on 64 subjects.
• Data Provenance: The study was a "prospective, multi-center, evaluator-blinded study." The document does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data from a US-based or FDA-compliant clinical trial.

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

• Number of Experts: 3 blinded Independent Photographic Reviewers.
• Qualifications of Experts: The document does not explicitly state the qualifications of these reviewers (e.g., radiologist with X years of experience). They are referred to as "Independent Photographic Reviewers," implying expertise in assessing aesthetic outcomes from photographs.

4. Adjudication Method for the Test Set

• Adjudication Method: "Correct identification of the 'after' images by at least 2 of 3 blinded Independent Photographic Reviewers." This is a 2-out-of-3 majority consensus method.

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

• Was an MRMC study done? No, this was not an MRMC study comparing human readers with and without AI assistance. The study assessed the clinical effectiveness of the device itself by human evaluators of photographic outcomes. The device is not an AI algorithm.

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

• This is not applicable as the Renuvion APR Handpiece is a physical medical device that delivers energy and plasma for treatment, not an AI algorithm. Its performance is directly observed in patient outcomes or through human assessment of those outcomes. The "performance data" sections (Bench Testing, Electrical Safety, Biocompatibility, Pre-Clinical & Ex-Vivo) were all "N/A" for new testing because no modifications were made to the commercially available Handpiece cleared under K191542, indicating that these aspects were previously evaluated for the predicate device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for effectiveness was established by expert consensus based on the visual assessment of 2D photography images by 3 blinded Independent photographic reviewers. For safety, the ground truth was patient-reported outcomes (pain levels via Numeric Rating Scale).

8. The Sample Size for the Training Set

• Training Set Sample Size: This information is not applicable and not provided. The device isn't an AI model that requires a "training set" in the conventional sense. The entire clinical study (n=65) serves as the "test set" to prove the device's performance for its expanded indication.

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

• This is not applicable, as there is no "training set" for this device in the context of an algorithm or AI. The clinical trial data is the performance data used to support the claim.

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