(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.
§ 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.