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The Opus Plasma Tips (Focus and Glide), when used with the unipolar applicator, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

The Opus Colibri Applicator and Tips

The Opus Colibri Tips, when used with the unipolar Opus Collbri applicator, are indicated for dermatological procedures requiring resurfacing of the skin.

Device Description

The new Colibri handpiece with two tips incorporates the unipolar RF-based technology and delivers radiofrequency energy via the designed tips that creates micro-plasma causing controlled ablation micro-perforations and a thermal injury zone in the skin, surrounding the perforations.

The new Colibri RF fractional tips are made of the same material as the existing cleared RF tips. The purpose of the Colibri tips is to treat very small areas of skin.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "The Alma Opus System, Colibri Applicator and Tips." This is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a study evaluating specific acceptance criteria for performance with numerical results against a ground truth for a diagnostic AI device.

Therefore, many of the requested elements for an AI device (like reported device performance against acceptance criteria, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this document.

However, I can extract information related to what was tested and the conclusions drawn for safety and effectiveness.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria with numerical performance targets and reported values for classification or detection tasks, as it's not a diagnostic AI device. Instead, it focuses on demonstrating safety and functionality.

The "acceptance criteria" here are implicitly related to:

Compliance with electrical safety standards.
Demonstration of expected tissue effects through histology.
Absence of unexpected adverse events.

Acceptance Criteria (Implicit from testing)	Reported Device Performance
Compliance with IEC 60601-1-2 (Electromagnetic Compatibility)	Performed and presumably complied (implied by clearance).
Compliance with IEC 60601-2-2 (High-Frequency Surgery Equipment Safety)	Performed and presumably complied (implied by clearance).
Compliance with IEC 60601-1 (General Electrical Safety)	Performed and presumably complied (implied by clearance).
Software Verification and Validation	Performed and presumably successful (implied by clearance).
Histological demonstration of controlled ablation/resurfacing in porcine model	"Testing was performed safely on the test animals, and the histology results complied with the FDA requirements at 0, 3, 7 and 14 days."
"Reepithelialization was observed three days after radiation in all specimens."
"No adverse events or unexpected complications have been detected in the swine."
"The damage was found to be very superficial and limited."
"The Alma Opus System Delivery Devices (Colibri Applicator Tips) and Accessories functioned as intended and the results observed were as expected."
No new questions of safety or effectiveness compared to predicate	"These differences do not raise new questions of safety or effectiveness, as the operation of the device and technological parameters are substantially equivalent to the predicate." (Section VI)
As safe and effective as the predicate device (K121150)	"The Alma Opus System, Colibri Applicator and Tips is as safe and effective as the predicate K121150. The proposed system has the similar indications, similar technological characteristics, and same principle of operation as its predicate device." (Section IX)

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 Non-Clinical Performance Testing (Histology): Three (3) Domestic female (Mixed Landrace & Large White) crossbred swine were used.
Data Provenance: The study was conducted on porcine animals, typically domestic. The document does not specify the country of origin for the animals or if the study was prospective/retrospective, but preclinical animal studies are inherently prospective.

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)

This is not applicable as this is not a diagnostic AI device requiring expert ground truth for classification/detection. The assessment of histology slides (which would typically be performed by a veterinary pathologist) is implied by the "histology results complied with the FDA requirements" statement, but no specific number or qualifications of experts are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a diagnostic AI device involving human interpretation of results requiring adjudication.

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 such study was performed or required, as this is not a diagnostic AI device designed to assist human readers. The submission explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

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

Not applicable, as this is a medical device for skin ablation and resurfacing, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance testing, the "ground truth" was established through histology on porcine tissue. This is a direct pathological assessment of tissue changes post-treatment.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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