(339 days)
THE MED RF 4000 SYSTEM IS INTENDED FOR THE EPILATION AND FOR THE TREATMENT OF LOWER LIMB SPIDER VEIN OR TELANGECTASIA BY THERMOCOAGULATION.
The MedRF4000 consists of the following parts: The generator, The pedal, The output cable, The neutral electrode cable (optional), The needle holder. The following consumables can be used with the MedRF4000: The Ballet needles, The neutral electrode (optional).
The provided text is a 510(k) summary for the MED RF4000 device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (EVRF) based on technological characteristics and performance testing.
However, the document does not contain the level of detail requested for acceptance criteria, study design, or ground truth establishment that would be typical for an AI/ML device or a device requiring specific performance metrics for regulatory clearance. The MED RF4000 is an electrosurgical cutting and coagulation device, and its clearance seems to rely more on demonstrating functional equivalence to a predicate device and compliance with electrical safety standards, rather than clinical performance metrics in the way an AI diagnostic device would.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for "acceptance" in the sense of accuracy, sensitivity, specificity, etc., as one would expect for a diagnostic AI device. Instead, the "acceptance" seems to be based on demonstrating similar effect on tissue and compliance with electrical safety standards.
- Reported Device Performance:
- Comparison of output signal of EVRF (predicate) and MedRF4000 (subject device) on pork tissue.
- Result: "results indicate the EVRF (predicate device) and the MedRF4000 (subject device) with and without neutral electrode have equivalent effect."
- The document implies that the acceptance criterion is "equivalent effect" to the predicate device, especially regarding the neutral electrode connection.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent effect to predicate device (EVRF) on pork tissue. | MEDRF4000 (with and without neutral electrode) shows equivalent effect to EVRF. |
| Compliance with electrical safety standards. | MEDRF4000 complies with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2. |
| Neutral electrode connection does not impose new safety risks. | Neutral electrode connection and its use conform to international standards. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The "test set" appears to be pork tissue, not human patient data.
- Data Provenance: Pork tissue (laboratory setting). This is a pre-clinical, non-human study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's likely assessed by engineers or technicians given the nature of the test (output signal and tissue effect).
- Ground Truth Establishment: The "ground truth" seems to be the observed "effect" on pork tissue, which is compared to the predicate device's effect. It's not a diagnostic "truth" requiring expert consensus.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/specified. The comparison of tissue effects likely involved direct observation or measurement in a laboratory setting, not reviewer adjudication as for diagnostic imaging.
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 device is not an AI-assisted diagnostic tool for human readers. It's an electrosurgical device for treatment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of typical AI/ML standalone performance. The device is a "standalone" electrosurgical generator in that it operates independently, but its performance isn't evaluated as an algorithm's diagnostic accuracy. The performance testing was on its physical output on tissue.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for the performance testing was the observed "effect" of the radiofrequency energy on pork tissue, aiming for equivalence with the predicate device. This is a technical, physical effect, not clinical pathology or outcomes directly.
8. The sample size for the training set
- Not applicable. This device does not use machine learning in a way that requires a "training set" for model development. Its software manages impulse duration, power, and delay, but this is fixed programming, not learned behavior.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the AI/ML sense.
§ 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.