(279 days)
The Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Fractora is composed of a console, hand held applicator, and disposable tip, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins.
The provided 510(k) summary for the Invasix Ltd. Fractora device does not contain the detailed information requested regarding specific acceptance criteria, a study proving the device meets those criteria, or most of the other parameters you've asked for.
The document is a typical 510(k) submission which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance study results against pre-defined acceptance criteria.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., specific thresholds for ablation depth, resurfacing percentage, or safety outcomes). The acceptance criterion implicitly seems to be "similar output and intended use as the predicate device" and raising "no new issues of safety or effectiveness."
- Reported Device Performance:
- Bench Testing Performance Data: The submission states "bench testing performance data" was presented, but the specifics and their outcomes are not included in the summary.
- Histology Data: The submission states "histology data" was presented, but the specifics and their outcomes are not included in the summary.
- Substantial Equivalence Claims:
- Intended use is identical to the predicate device (Matrix RF applicator).
- Technological characteristics are similar (delivers bipolar RF energy through multi-electrode pins).
- Main output parameter (energy per pin) is identical to the predicate.
- Minor differences in number of pins and array dimensions may slightly affect the number of pulses required.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Identical intended use to predicate device | Fractora's intended use ("for dermatological procedures requiring ablation and resurfacing of the skin") is identical to the predicate device, Matrix RF applicator. |
| Similar technological characteristics to predicate device | Fractora delivers bipolar RF energy to the skin via an array of multi-electrode pins, resulting in heating for ablation and resurfacing. The predicate device uses similar technological characteristics. |
| Identical main output parameter (energy per pin) to predicate device | The main output parameter (energy per pin) is identical for Fractora and the predicate device. |
| No new issues of safety or effectiveness compared to predicate | Based on analysis, Invasix Ltd. believes no significant differences exist and Fractora should raise no new issues of safety or effectiveness. (This is a conclusion made by the submitter, not a performance metric from a study explicitly comparing safety/effectiveness outcomes). Specific bench testing and histology data were presented but not detailed in this summary document. |
2. Sample sized used for the test set and the data provenance:
- Not provided. The document refers to "bench testing performance data" and "histology data" but does not specify the sample sizes used for these tests or whether they were conducted on humans, animals, or ex-vivo tissue, nor their provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The summary does not describe any study involving expert ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided.
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/Not done (based on provided text). This device is a medical device for dermatological procedures, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not done (based on provided text). This device is not an algorithm, but a physical device (console, hand-held applicator, disposable tip). Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Partially inferred: The document mentions "histology data," which implies some form of pathological or microscopic examination was used as a basis for evaluating the device's effects on tissue. However, the specific type of ground truth (e.g., expert interpretation of histology, specific measurements) is not detailed.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device, so a "training set" in that context does not apply. If "training set" refers to data used for device design and optimization, it's not specified.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set for an AI model is mentioned.
In summary, the provided 510(k) summary primarily focuses on demonstrating substantial equivalence based on intended use and technological characteristics, along with a general statement about bench testing and histology data. It does not provide the detailed performance study information, acceptance criteria, or ground truth establishment methods typically associated with clinical trials or AI/diagnostic device evaluations.
§ 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.