(261 days)
The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin
EndyMed's Fractional Skin Resurfacing (FSR) Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346). The FSR Applicator 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.
The provided text describes the EndyMed Fractional Skin Resurfacing (FSR) Applicator and its 510(k) submission. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a detailed study.
The document states that a "performance testing" was conducted and its results "clearly indicate that the Fractional Skin Resurfacing (FSR) Applicator offers a non-invasive, effective, safe device for skin resurfacing." It also claims the device "is as safe, as effective, and performs at least as safely and effectively as the legally marketed device" (predicate devices).
Here's a breakdown based on the information provided, highlighting what is missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Non-invasive, effective, safe for skin resurfacing. Performs at least as safely and effectively as predicate devices. |
Missing Information: The document does not explicitly state specific quantitative or qualitative acceptance criteria (e.g., minimum percentage improvement in skin texture, reduction in wrinkles, safety endpoint thresholds). It only provides a general statement about the device's performance relative to safety and efficacy.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Missing Information: The document states "a performance testing" was conducted but does not provide any details on:
- The sample size of participants or data points used in the test set.
- The country of origin for the data.
- Whether the study was retrospective or 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):
Missing Information: The document mentions "performance testing" but does not describe how ground truth was established, nor does it refer to any experts involved in this process or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Missing Information: There is no information provided about any adjudication method used for establishing ground truth or evaluating the test results.
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:
Not Applicable (Based on available information): This device is an applicator for dermatological procedures (physical treatment), not an AI-assisted diagnostic device that would involve human readers interpreting results with or without AI. Therefore, an MRMC study related to AI assistance for human readers is not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable (Based on available information): Similar to point 5, this is a physical treatment device, not an algorithm. Standalone performance (algorithm-only) is not applicable here. The device's performance inherently involves a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Missing Information: The document does not specify the type of ground truth used for evaluating the device's performance. Given it's a skin resurfacing device, potential ground truths could include clinical assessment scores (e.g., wrinkle scales, skin texture scores), photographic assessment, or potentially histological changes, but none are mentioned.
8. The sample size for the training set:
Missing Information: As the device is not an AI algorithm, there is no "training set" in the conventional sense. The "performance testing" described is likely a clinical trial or study on human subjects, not an algorithm training process.
9. How the ground truth for the training set was established:
Missing Information: As there is no AI algorithm training set, this question is not applicable.
§ 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.