(154 days)
The PelleFirm RF device is intended to provide heating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.
The device is a hand-held RF probe with integrated massaging head. The device is activated using a footswitch and is used with the Ellman radiofrequency generators. The radiofrequency generator operates at 4 mHz and is used in the pure sinewave ("CUT") mode to produce heating for the elevation of tissue temperature.
The PelleFirm System consists of the PelleFirm handpiece, RF generator, neutral plate, Gel, Footswitch, and associated cables and cords. The handpiece contains a large monopolar electrode to provide tissue heating. A massaging head surrounds the handpiece electrode and provides mechanical stimulation to the tissue to reduce the appearance of cellulite. A cable connects the handpiece to the RF generator.
The provided text is a 510(k) summary for the PelleFirm System. It details the device's technical characteristics and intended use, and states that performance data demonstrates its safety and effectiveness. However, it does not include specific acceptance criteria, sample sizes for test or training sets, details about ground truth establishment, or any information about multi-reader multi-case (MRMC) studies.
Therefore, much of the requested information cannot be extracted from the given text.
Here's what can be provided based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | - Device heats tissues consistently for an extended period of time. |
- Device functioned as intended.
- Tissue heating was observed as expected.
- Device is in conformity with IEC 60601-1 and IEC 60601-2-2. |
2. Sample size used for the test set and the data provenance
The document states "Clinical performance testing demonstrates the device's ability to heat tissues consistently for an extended period of time." However, it does not specify the sample size used for this testing, the country of origin of the data, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text.
4. Adjudication method for the test set
This information is not available in the provided text.
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
This information is not available in the provided text. The PelleFirm System is a medical device for therapeutic use, not primarily an AI-driven diagnostic or imaging analysis tool, so an MRMC study in the context of human readers and AI assistance would not be directly applicable to its function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The PelleFirm System is a physical device operated by a human user (a hand-held RF probe with integrated massaging head). The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this device as described.
7. The type of ground truth used
The document mentions "tissue heating was observed as expected," implying an objective measurement of temperature increase as a basis for assessing performance. However, it does not explicitly define a "ground truth" in terms of expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-based devices. For the "temporary reduction in the appearance of cellulite," the method of assessing this reduction and what constitutes "ground truth" is not detailed.
8. The sample size for the training set
This information is not available in the provided text.
9. How the ground truth for the training set was established
This information is not available in the provided text.
§ 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.