(85 days)
The Exilis XP RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain. muscle spasms, and increase in local circulation. The Exilis XP massage device is intended to provide a temporary reduction in the appearance of cellulite.
The Exilis XP is a state-of-the-art radiofrequency device, with integrated massaging heads, that enables the application of therapy by a non-invasive, high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip. Contact quality monitoring system is present for monitoring of the contact quality under the patch electrode. An easy-to-read handpiece display shows the selected treatment parameters. The Exilis XP consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, handpiece for an application of radiofrequency, two massage heads.
The provided document is a 510(k) summary for the Exilis XP device. It states that the substantial equivalence determination for the Exilis XP system is not based upon clinical performance testing.
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data. Instead, the safety and efficacy were demonstrated by comparing the technical characteristics of the Exilis XP to a predicate device (PelleFirm System, K132949).
Here's a breakdown of the information that is available based on your request, and where the document explicitly states information is not available:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The document states: "The substantial equivalence determination for the Exilis XP system is not based upon clinical performance testing." Performance is assessed through comparison of technical characteristics to a predicate device, not against specific pre-defined acceptance criteria for clinical outcomes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set was used for performance validation.
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. No clinical test set or ground truth establishment by experts was conducted for performance validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set was used.
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. This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established for performance validation. The device's safety and efficacy were demonstrated through technical comparison to a predicate device.
8. The sample size for the training set
- Not applicable. The device's safety and efficacy were demonstrated through technical comparison to a predicate device, not by training a model on a dataset.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for a training set was used.
Summary of Device Comparison (from document, relevant to "performance" in a S.E. context):
The Exilis XP device's "performance" in the context of this 510(k) is defined by its technical specifications and intended use being substantially equivalent to a predicate device.
Predicate Device: PelleFirm System (K132949)
| Feature / Characteristic | Exilis XP | PelleFirm |
|---|---|---|
| Indications for Use | The Exilis XP RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Exilis XP massage device is intended to provide a temporary reduction in the appearance of cellulite. | The PelleFirm RF device is intended to provide heating for the purpose of elevating 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. |
| Device Technologies | Application of the heat to the tissue via RF energy. Massaging of body parts with massage device. | Application of the heat to the tissue via RF energy. Massaging of body parts with massage device. |
| Maximum Output Power | 120W | 120W |
| Effective Treatment Temp. | 40 - 45 °C | 40 - 45 °C |
| Modes of Operation | Monopolar | Monopolar |
| Output Frequency | 3.25MHz | 4 MHz |
| Massage Attachment Materials | White Plastic material | White Plastic material |
| Massage Attachment 1 (Dimensions) | Diameter 80 mm, Massage ball diameter 19mm, Massage ball number: 5 | Diameter 80 mm, Massage ball diameter 19, Massage ball number: 5 |
| Massage Attachment 2 (Dimensions) | Diameter 52mm, Massage ball diameter 12mm, Massage ball number: 5 | Diameter 52mm, Massage ball diameter 12mm, Massage ball number: 5 |
Conclusion from the document:
"Based upon the intended use and technical information provided in this pre-market notification, the Exilis XP device has been shown to be substantially equivalent to currently marketed predicate device."
"Based on the aforementioned information, the Exilis XP is safe and effective and substantially equivalent to the identified predicate device."
§ 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.