(307 days)
The Applicator 786-1 of BTL-FR2000 device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
The Applicator 786-2 of BTL-FR2000 device is intended for dermatological procedures requiring fractional treatment of the skin.
The BTL-FR2000 device enables application of therapy by a 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 button, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip.
The BTL-FR2000 device comes with two types of the applicator, depending on the applicator tip attached - Applicator 786-1 and Applicator 786-2.
The BTL-FR2000 device consists of the following main components:
- microprocessor-driven control unit
- radiofrequency generator
- user interface with 8.4" color touch screen
- applicator for an application of radiofrequency
- exchangeable applicator tips
This document is a 510(k) summary for the BTL-FR2000 device, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a novel AI device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment, and MRMC studies is not available in the provided text. The document describes bench testing to verify temperature achievement, but without specific performance metrics or acceptance criteria.
Here's an attempt to answer the questions based only on the provided text, Highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific performance metrics in a quantitative way. It mentions "Bench testing has been performed in order to demonstrate the device is able to achieve required temperature in the treated area," but does not provide details on what constitutes "required temperature," the range achieved, or defined acceptance limits.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided. The document mentions "Bench testing" but doesn't specify a sample size, the type of "data" collected (e.g., human subjects, tissue samples), or if a traditional "test set" was established.
- Data Provenance: Not provided. The document does not specify the origin of any data, or if it was retrospective or prospective. Given the nature of "bench testing," it likely refers to laboratory-based evaluations.
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 there is no indication of human-reviewed "ground truth" establishment in the context of typical AI/diagnostic device studies. The "bench testing" likely refers to physical measurements and engineering evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of adjudication methods, which are typically used when multiple human experts are involved in establishing ground truth for diagnostic or AI-assisted tasks.
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
No, an MRMC comparative effectiveness study was not done or reported. This type of study would be relevant for devices that assist human readers in tasks like image interpretation, which is not the stated purpose of the BTL-FR2000.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not directly applicable in the context of the BTL-FR2000 as described. The device is an electrosurgical unit, not an AI algorithm performing diagnostic or predictive tasks. The "performance data" mentioned refers to compliance with safety standards and the ability to achieve a required temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated in the context of "ground truth" as typically discussed for AI/diagnostic devices. The "bench testing" implies that physical measurements and engineering standards were used to verify performance against design specifications, rather than a "ground truth" derived from clinical outcomes or expert labels.
8. The sample size for the training set
Not applicable/Not provided. The document describes an electrosurgical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided, as there is no mention of a training set or AI algorithm.
Summary of what the document does provide:
- Performance Data (General): The device has been "thoroughly evaluated for electrical safety" and found to comply with several international medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, ISO 14971, ISO 10993-1, ISO 11135).
- Bench Testing: "Bench testing has been performed in order to demonstrate the device is able to achieve required temperature in the treated area." This is the closest the document comes to performance evaluation beyond safety standards, but lacks specific quantitative results or acceptance criteria.
- Substantial Equivalence Basis: The device is deemed substantially equivalent to predicate devices based on similar intended use and technological characteristics. Differences (e.g., monopolar vs. bipolar mode) were addressed by noting that monopolar mode is used by other cleared devices and that bench testing verified the device's ability to achieve the required temperature.
§ 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.