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510(k) Data Aggregation
(284 days)
The BTL-785W device has the following indications for use:
The BTL-785W with BTL-785-1 applicator 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 BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-785W with BTL-785-2 applicator is indicated 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 BTL-785W with BTL-785-3 applicator 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 Applicator BTL-785-4 of BTL-785W device used with tips BTL-785-4-1, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostass. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.
The BTL-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3 and BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 single use electrodes 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 BTL-785W is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field. The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785W device comes with five different types of applicators. The BTL-785W device consists of the following main components: microprocessor-driven control unit, radiofrequency generator, user interface with 15.6" color touch screen, applicators for an application of radiofrequency, exchangeable applicator tips.
The provided document is a 510(k) summary for the BTL-785W device, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data related to electrical safety and the ability to achieve and maintain superficial skin temperature.
Therefore, the document DOES NOT describe a study that involves ground truth establishment by experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance for AI/ML-based medical devices.
Instead, the "Performance Data" section (page 7) details a series of compliance tests against various IEC and ISO standards related to electrical safety, electromagnetic disturbances, biological evaluation, and sterility, and non-clinical performance for the new applicator.
Given the information in the document, it's impossible to fill out the requested table and answer the questions related to AI/ML device testing criteria (sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone performance), as these types of studies were not conducted or reported for this device.
Here's what can be extracted and inferred from the document based on the prompt's categories, with significant portions marked as 'N/A' due to the nature of the device and testing described:
Acceptance Criteria and Device Performance (Based on provided information)
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | IEC 60601-1 (General requirements for basic safety and essential performance) | Device complied with applicable medical device safety standards. |
| IEC 60601-1-2 (Electromagnetic disturbances) | Device complied with applicable medical device safety standards. | |
| IEC 60601-2-2 (HF surgery equipment) | Device complied with applicable medical device safety standards. | |
| IEC 60601-2-5 (Ultrasonic physiotherapy equipment) | Device complied with applicable medical device safety standards. | |
| Usability | IEC 60601-1-6 (Usability) | Device complied with applicable medical device safety standards. |
| Software Life Cycle | IEC 62304 (Medical device software) | Device complied with applicable medical device safety standards. |
| Risk Management | ISO 14971 (Application of risk management to medical devices) | Device complied with applicable medical device safety standards. |
| Biological Evaluation | ISO 10993-1, -5, -7, -10, -11 (Biocompatibility tests) | Device complied with applicable medical device safety standards. |
| Sterilization | ISO 11135 (Ethylene oxide sterilization) | Device complied with applicable medical device safety standards. |
| Packaging | ISO 11607-1, -2 (Packaging for sterilized medical devices) | Device complied with applicable medical device safety standards. |
| Functional Performance (BTL-785-7 applicator) | Achieve and maintain superficial skin temperature (40 - 45°C) for required therapy time. | Testing data demonstrated that the device is capable of achieving therapeutic parameters substantially equivalent to the cleared predicate device. |
| Maximum RF and Output Power (compared to predicate) | The maximum RF power and output power of the BTL-785-7 is lower than the predicate, but internal tests demonstrated equivalent treatment temperature. | |
| Technological Equivalence | Same technological characteristics as predicate (RF generator, computer, touch-screen, applicators, monopolar mode, waveform, frequency, RF tip properties). | The BTL-785W device has the same technological characteristics as its predicate device. No technological modifications to the device and its applicators. |
Detailed Answers to Specific Questions:
1. A table of acceptance criteria and the reported device performance
- (Provided above)
2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test set/Study Type: The performance data primarily refers to compliance with safety standards (IEC, ISO) and internal non-clinical testing for the new applicator's ability to achieve and maintain target temperature. This is not a typical "test set" in the context of AI/ML or clinical efficacy studies with human subjects.
- Sample Size: Not specified for any particular test. Compliance with standards typically involves engineering tests, material tests, and functional tests on device prototypes or production units, not a "sample size" of patient data. For the BTL-785-7 applicator, it states "internal tests" were done, but no number of subjects or runs is provided.
- Data Provenance: Not specified. "Internal tests" suggests in-house testing by the manufacturer. Retrospective/prospective is not applicable as this is not a clinical data collection study for performance.
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)
- N/A. This device and its testing do not involve establishing ground truth from expert interpretations of medical images or conditions. The "ground truth" for the performance claims would be objective measurements (e.g., temperature readings, power output, compliance with standard specifications) in a laboratory or bench testing environment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for subjective human interpretations (e.g., reading medical images) where discrepancies might arise. This is not applicable to the engineering and bench tests described.
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
- N/A. An MRMC study is relevant for AI-assisted diagnostic or interpretative devices. This document describes a radiofrequency device for therapeutic purposes, and no AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device is hardware for energy delivery, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective Measurements/Standards Compliance. For electrical safety and performance, the "ground truth" is adherence to predefined engineering specifications and regulatory standards (IEC, ISO) and the ability to physically achieve and maintain a certain temperature. This is not a disease diagnosis or outcome that would require expert consensus or pathology.
8. The sample size for the training set
- N/A. The device is not an AI/ML model and therefore does not have a "training set."
9. How the ground truth for the training set was established
- N/A. This question is not applicable as there is no training set mentioned or implied for this device.
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(195 days)
The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids.
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.
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.
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