(105 days)
The Finiff System is intended for use in Dermatologic and General Surgery procedures that require electrocoagulation and hemostatis.
The Finiff System is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The Finiff System consists of a console that houses an RF generator as well as the electronics. The user interface is a touchscreen that is located on the console. There are two handpieces that attach to the console:
• The VertoRF Handpiece is a microneedling handpiece that delivers energy in 2 frequencies: 1mHz and 2mHz. The VertoRF has one disposable tip configuration that consists of 25 needles and penetrates the tissue up to 4mm in depth.
• Ther VitaRF Handpiece delivers noninvasive RF energy at a frequency of 6.78 MHz. The VitaRF handpice has 2 Treatment Tips: the VitaRF F-Tip and the VitaRF E-Tip
In addition to the console and the 2 handpieces, there are accessories as follows:
• Power Cord
• Footswitch (optional)
• Cryogen canister
• Return Pad
• Coupling fluid
The provided text is a 510(k) summary for the Finiff System, an electrosurgical device. It outlines the device's description, intended use, and comparison to predicate devices, but it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: Not detailed. The summary mentions "Bench Testing and histology testing was conducted to show the performance of the Finiff System and its applicators," but it does not provide specific results (e.g., in terms of coagulation depth, impedance, power output ranges, etc.) or comparative data against the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document only states that "Bench Testing and histology testing was conducted." It doesn't mention sample sizes for these tests or the data provenance.
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)
- Not applicable/Not provided. Since the studies mentioned are "Bench Testing and histology testing" (likely referring to ex vivo or animal studies for device performance), the concept of "experts establishing ground truth" in the diagnostic sense (e.g., for image interpretation) does not apply or is not detailed in terms of human reviewers for classification tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically relevant for human review of diagnostic results. This document describes performance testing of an electrosurgical device, not a diagnostic algorithm.
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, an MRMC study was not done. This type of study is for evaluating the impact of AI on human diagnostic performance. The Finiff System is an electrosurgical device, not an AI-powered diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The Finiff System is an electrosurgical unit, not a standalone algorithm. Its performance is inherent to its physical operation and energy delivery.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the "histology testing" mentioned, the ground truth would typically be histopathological analysis, which is a direct observation of tissue changes at a microscopic level. However, the details of how this was performed (e.g., by whom, what criteria) are not provided. For "Bench Testing," the ground truth would be based on physical measurements and technical specifications.
8. The sample size for the training set
- Not applicable. The Finiff System is a hardware medical device; it does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
Summary of what the document does indicate about performance:
The document primarily states that the Finiff System is "substantially equivalent" to predicate devices (Potenza K201685 and Thermage FLX System K170758). This means that its safety and effectiveness profiles are considered comparable based on the provided information.
- Technological Comparison: The FINIFF shares the same indications for use, mode of operation, and overall design as the predicate device.
- Differences: Slight differences noted are: predicate has three electrode sizes, FINIFF has two; predicate functions in bipolar modes, FINIFF has monopolar; slight differences in RF duration. The document asserts these differences "do not have any impact on safety or efficacy."
- Testing: "Bench Testing and histology testing was conducted to show the performance of the Finiff System and its applicators. There are no new concerns for safety or efficacy raised."
In conclusion, this regulatory document focuses on establishing substantial equivalence for a physical medical device. It does not provide the in-depth performance metrics or study details typical for AI/diagnostic submissions that your request is tailored for.
§ 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.