(77 days)
BTL 799-2 is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks and thighs.
The BTL 799-2 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the BTL 799-2 helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The BTL 799-2 is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information quides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided document is a 510(k) premarket notification for a medical device called BTL 799-2, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (AM-100) rather than presenting a clinical study with detailed acceptance criteria and performance metrics for the BTL 799-2 itself.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the context of clinical performance (e.g., accuracy, sensitivity, specificity).
Instead, the document details non-clinical testing to ensure safety and compliance with medical device standards. The "acceptance criteria" in this context are compliance with these standards, not clinical performance metrics.
Here's a breakdown of why the requested information cannot be fully provided from this document:
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Table of acceptance criteria and reported device performance: This document does not establish clinical performance acceptance criteria (e.g., specific percentages for improvement in abdominal tone) or report device performance against such criteria. Its entire purpose is to show technological and intended use equivalency to a previously cleared device.
- Acceptance Criteria (as implied by the document for regulatory clearance): Compliance with relevant electrical safety and biocompatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62366, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10).
- Reported Device Performance: The document states the BTL 799-2 "has been found to comply" with these standards. No specific performance metrics (e.g., current output, magnetic field intensity) are presented as "reported device performance" against explicit "acceptance criteria" related to a clinical outcome. The technical specifications (Magnetic Field Intensity, Pulse Repetition Rate, Pulse Duration, Induced Current in the Tissue) are listed as characteristics, but not as performance against a target.
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Sample size used for the test set and data provenance: Not applicable. No clinical test set data is presented. The "test set" for this submission was the device itself, tested against engineering and safety standards.
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Number of experts used to establish the ground truth and their qualifications: Not applicable. No clinical ground truth was established from patient data.
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Adjudication method for the test set: Not applicable. No clinical test set required adjudication.
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Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating observer performance, usually with imaging or diagnostic devices. The BTL 799-2 is a therapeutic muscle stimulator.
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Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is a therapeutic device, not an AI or diagnostic algorithm.
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Type of ground truth used: Not applicable for clinical performance. For safety and substantial equivalence, the "ground truth" refers to recognized medical device standards and the characteristics of the predicate device.
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Sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires training data.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The BTL 799-2 device's "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to an already cleared predicate device (AM-100) and compliance with relevant electrical safety and biocompatibility standards.
Acceptance Criteria (Implicit for Substantial Equivalence and Safety):
- Same Intended Use: The device must have the same indications for use as the predicate (improvement of abdominal tone, strengthening of abdominal muscles, firmer abdomen; strengthening, toning, and firming of buttocks and thighs).
- Similar Technological Characteristics: The device must operate on similar principles (magnetic field, muscle stimulation) and have comparable technical specifications, or any differences must not raise new safety or effectiveness concerns.
- Compliance with Safety Standards: The device must pass non-clinical testing against a suite of recognized international safety and biocompatibility standards.
Study/Evidence that Proves Meeting Acceptance Criteria:
The "study" in this context is the 510(k) submission itself, which provides a comparative analysis of the BTL 799-2 with the predicate device (AM-100) and documentation of non-clinical testing results.
| Acceptance Criterion | Reported Device Performance/Evidence from Document |
|---|---|
| Intended Use Equivalence | - BTL 799-2 Indications: "Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs." |
- AM-100 Indications: "Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs."
- Conclusion: "The BTL 799-2 device has the same intended use as its predicate devices." |
| Technological Equivalence & Safety | - Principle of Action: Both BTL 799-2 and AM-100 state "Initiating action potential of nerves results in muscle contraction." - Type of Energy: Both utilize "Magnetic field."
- Pulse Repetition Rate: Both 1 - 150 Hz.
- Pulse Duration: Both 280 ± 20% µs.
- Induced Current in the Tissue: Both 28-30 mA.
- Differences Addressed: BTL 799-2 has a larger touch screen (15.6" vs 8.4") and two outputs (vs one for AM-100). The document states: "The technological differences between the BTL 799-2 device and the predicate device do not raise any new types of safety or effectiveness questions." |
| Compliance with Safety and EMC Standards | - Standards Listed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62366, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10. - Reported Performance: "The BTL 799-2 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards." (No specific test results or failure rates are provided in this summary, just a statement of compliance). |
| Biocompatibility | - Standards Listed: ISO 10993-1, ISO 10993-5, ISO 10993-10. - Reported Performance: Implicitly "found to comply" as part of the non-clinical testing section. |
This document serves as regulatory submission for substantial equivalence based on technical comparisons and adherence to relevant standards, not a clinical trial evaluating specific performance metrics against a predefined acceptance threshold.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).