(128 days)
The XP300 device is indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids.
The XP300 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 the operator to see the on-screen information from various angles during the procedure. In addition, the brightness of the screen can be set to match the lighting in the room. The on-screen 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. The XP300 device incorporates the ultrasonic feature for added patient comfort. 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 therapy applied, the set power, and other necessary data. The XP300 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic generator and ultrasonic element, user interface with 8.4" colour touch screen, applicator with colour screen and control buttons. The main change between this device and the predicate is the inclusion of the Ultrasonic convenience function which is intended to improve patient's comfort during the procedure.
This document is a FDA 510(k) summary for the BTL Industries XP300 device, an electrosurgical cutting and coagulation device and accessories indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids. The submission is for a modification to the XP200 device, specifically the inclusion of an ultrasonic element to improve patient comfort.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as performance metrics for clinical efficacy in a table format with reported performance. This 510(k) is a submission for a modification to an already cleared device (XP200), and the primary focus is on demonstrating that the modification (ultrasonic element for patient comfort) does not negatively impact the existing safety and effectiveness, and that the device still meets relevant safety and performance standards.
Instead of clinical performance acceptance criteria, the document focuses on compliance with various electrical, mechanical, and biocompatibility safety standards, and confirms that the technical specifications of the XP300 are equivalent to the predicate XP200, with the only notable difference being the addition of the ultrasonic feature.
Here's a table based on the non-clinical performance data and comparison to the predicate:
| Acceptance Criterion (Implicit) | Reported Device Performance (XP300) |
|---|---|
| Safety and Electrical Standards Compliance: | |
| ISO 14971 (Risk Management) | Complies |
| IEC 62304 (Software Life Cycle) | Complies |
| IEC 60601-1 (General Safety) | Complies |
| IEC 60601-1-2 (EMC) | Complies |
| IEC 60601-2-2 (HF Surgical Equipment Safety) | Complies |
| IEC 60601-1-6 (Usability) | Complies |
| IEC 61000-4-2 (EMC) | Complies |
| IEC 61000-4-3 (EMC) | Complies |
| IEC 61000-4-4 (EMC) | Complies |
| IEC 61000-4-5 (EMC) | Complies |
| Electrical Safety Testing | Passed (Class II, BF) |
| Biocompatibility Standards Compliance: | |
| ISO 10993-1, -5, -10 (Biological Evaluation) | Complies (same as predicate XP200, no impact with change) |
| Performance Testing (Non-Clinical): | |
| Frequency Accuracy and Carrier Wave Form | Confirmed |
| Carrier Wave Nominal Output Power | Confirmed |
| Power Fluency | Confirmed |
| Tissue Heating (simultaneous RF and ultrasound energy safety) | Confirmed safety of simultaneous application. The modified applicator demonstrated convenient patient contact surface temperature. |
| Overall design, biocompatibility, and electrical safety | Meets all requirements, output meets design inputs and specifications. Complies with applicable voluntary standards. |
| Patient Contact Materials | No change to patient contact materials from predicate. |
| Technology/Principle of Operation | No change in principle of operation (high-frequency field for RF energy). The ultrasonic feature is for comfort and does not change the therapeutic principle. |
| Patient Comfort (with ultrasonic feature) | Improved (intended purpose of the ultrasonic convenience function, though no direct quantitative measurement of comfort is provided in this summary, it's stated as the objective of the change). The modified applicator testing ensures convenient patient contact surface temperature. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "There was no clinical testing required to support the XP 300 medical device as the indications for use are equivalent to the predicate device." Therefore, there is no clinical test set, sample size, or clinical data provenance discussed for the XP300's primary indication.
The "testing" mentioned refers to non-clinical performance and safety testing (electrical, EMC, biocompatibility, software validation, and tissue heating related to the combined RF and ultrasound). These tests are typically conducted in a laboratory setting, not with human subjects, and thus terms like "sample size" for a test set in the clinical sense are not applicable. The document does not specify the number of units or test configurations used for these non-clinical tests.
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. As no clinical test set was required or performed, there was no need for experts to establish ground truth in a clinical context. The "ground truth" for non-clinical testing is established by compliance with international standards and engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as 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. The XP300 is an electrosurgical device for dermatological procedures, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The XP300 is a hardware device with software controls, not an algorithm for standalone performance evaluation in the context of diagnostics or AI. Its performance is evaluated through compliance with electrical, mechanical, and safety standards, and its ability to deliver specified energy (RF and ultrasound) safely.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this submission, the "ground truth" is primarily based on:
- Compliance with international and national safety standards: IEC 60601 series, ISO 14971, ISO 10993 series, etc.
- Engineering specifications and design inputs: The device's electrical, mechanical, and software parameters conforming to its intended design.
- Performance confirmation of the physical outputs: E.g., accurate frequency, nominal output power, power fluency, and safe tissue heating.
8. The sample size for the training set
Not applicable. This is a hardware device; "training set" typically refers to data used to train machine learning models, which is not relevant here.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for this 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.