(267 days)
The Applicator 3 Fractional (A3F) is intended for dermatological procedures requiring ablation and resurfacing of the skin
Pollogen's Applicator 3 Fractional (A3F) is a treatment handpiece to be attached to the FDA cleared Pollogen's apollo™ system (K111026). The A3F tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
Here's an analysis of the provided text regarding the Pollogen Applicator 3 Fractional (A3F) device, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly state quantitative acceptance criteria or a direct comparison of the device's performance against such criteria. The "Summary of Pre-Clinical performance data" only states a general conclusion about safety and efficacy without numerical benchmarks.
| Acceptance Criteria (Not Explicitly Stated/Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safe for use. | Histological evaluation study on porcine skin showed the device to be "safe." |
| Efficacy: Device is effective for intended use. | Histological evaluation study on porcine skin showed the device to be "effective" for skin resurfacing. |
| Intended Use Fulfillment: Ablation and resurfacing of the skin. | "The results of this study clearly indicate that the Applicator 3 Fractional (A3F) offers an effective, safe device for skin resurfacing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The study was a "histological evaluation study on porcine skin," implying a limited number of animal subjects.
- Data Provenance: Porcine (animal) skin, retrospective (historical data is not mentioned to be used).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's implied that experts in histology and skin biology would have assessed the porcine samples.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study Done: No. The provided document describes a pre-clinical histological study on porcine skin, not a comparative effectiveness study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Done: N/A. The A3F is a physical medical device (applicator/handpiece) that emits RF energy, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable here.
7. The Type of Ground Truth Used
- Type of Ground Truth: Histological evaluation. This means tissue samples were examined under a microscope by experts to determine the effects of the device (ablation, heating, resurfacing).
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. As stated in point 6, this is a physical medical device, not an AI/ML algorithm that requires a training set. The "study" mentioned is a pre-clinical performance evaluation, not an algorithm training process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: N/A. Not applicable for this type of device.
§ 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.