FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The XP200 system is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field. The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the onscreen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the set power, and other necessary data. The XP200 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, applicator with color screen and control buttons.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
RF output frequency within product specification.	The testing supports that the RF output frequency of the XP200 device as compared to the predicate devices are within the accuracy for the product specification.
Deliver transmit carrier wave in a standard sinusoid form.	The performance testing demonstrated that the XP200 device delivers the transmit carrier wave in a standard sinusoid form.
Carrier wave output power mutually comparable to predicate devices.	The measurement of the carrier wave output power produced real-life power output characteristics data that are mutually comparable between the subject device and the predicate devices.
Power fluency difference less than 4.8% at 100Ω and less than 8.8% at 150Ω compared to predicate devices.	The calculation of the difference in power fluency between the XP200 device and the predicate devices are less than 4.8% at 100Ω and less than 8.8% at 150Ω, which is within the acceptance criteria for the change value.
Achieve tissue temperature of 45°C.	Measurements made under experimental conditions showed that all devices (XP200 and predicates) are able to deliver sufficient energy to reach the temperature of 45°C, which is in the acceptance criteria.
Critical thresholds of resistance for CQM shut-off at safe level in Operator's Manual.	Critical thresholds of resistance between two contact areas of a dual dispersive patch electrode when the CQM will shut off the energy delivery reacted at the same level for the XPS200 device and the predicate devices. The value obtained in this test for each device was less than described as a safe level in the Operator's Manual.
No adverse events in clinical use.	There were no adverse events reported with any patient.
Device performs as intended with no reported occurrences.	The XP200 device performed as intended with no reported occurrences with either the patients or the device performance.
Produces consistent, statistically significant reduction in periorbital wrinkles.	The XP200 system at 3.25-MHz RF produces consistent, statistically significant reduction in periorbital wrinkles.

Study Details:

The provided document describes both non-clinical (engineering/performance) testing and a clinical study.

Non-Clinical Testing:

1. Sample sized used for the test set and the data provenance: Not explicitly stated for each specific test, but the tests involved the XP200 device and its predicate devices (EXILIS and Pellevé GlideSafeTM Non-Ablative Wrinkle Treatment System) under experimental conditions. The data provenance is implied to be from laboratory testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for non-clinical, objective performance tests. The ground truth would be based on established engineering principles and measurement standards.
3. Adjudication method for the test set: Not applicable for non-clinical objective performance tests.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was not an MRMC study. These were objective performance tests comparing the device's technical specifications to a set of criteria and predicate devices.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the non-clinical tests assess the device's standalone performance in terms of frequency, power, wave form, tissue heating, and safety shut-off mechanisms.
6. The type of ground truth used: Objective measurements and engineering standards (e.g., standard sinusoid form, specified power levels, documented safe temperature thresholds, established resistance levels for safety shut-off).
7. The sample size for the training set: Not applicable. These are hardware/electrical performance tests.
8. How the ground truth for the training set was established: Not applicable.

Clinical Testing:

1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated, but patients were involved. The document states "the subject going through treatment." While not a specific number, it indicates human participants.
- Data Provenance: Prospective, as it involved patients undergoing treatment and subsequent follow-up ("pre- and 90-days post treatment"). The country of origin is not specified but is implied to be within the scope of the FDA submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three (3) principal investigators.
- Qualifications: "principal investigators" are generally qualified medical professionals (e.g., dermatologists or plastic surgeons) experienced in clinical studies and evaluating dermatologic conditions. Specific experience levels are not detailed.
3. Adjudication method for the test set: Not explicitly stated. However, "grading pre- and 90-days post treatment" by principal investigators suggests a subjective assessment by these experts. It doesn't specify if their gradings were pooled, averaged, or adjudicated in cases of disagreement.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not explicitly an MRMC study. It involved multiple investigators, but the focus was on the performance of the single device (XP200) and its effect, not a comparison of human readers with and without AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this was a clinical study involving human patients and human operators (principal investigators) using the device.
6. The type of ground truth used: Clinical outcome data, specifically "wrinkle-reducing effects" graded by clinical investigators, and the absence of adverse events. The "statistically significant reduction in periorbital wrinkles" indicates a quantifiable outcome derived from these clinical assessments.
7. The sample size for the training set: Not applicable, as this is a clinical trial, not an AI model training process.
8. How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

§ 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.