Search Results

The Slendertone System Ultra is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

System Ultra, Type 390, Model E70/X70 is a two-channel, battery powered, muscle stimulation system. It is supplied with a three-electrode abdominal belt garment, a hand-held rechargeable control unit, a pack of 3 adhesive backed gel based electrodes, instructions for use and a carry pouch. The control unit is interchangeable between all the cleared System models from the Slendertone® range of garments. There are ten programs available to users of the System Ultra, Type 390, E70/X70. Power is derived from a 3.6V NiMH rechargeable battery pack pre-installed in the unit. All the internal connections are over-molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML devices, such as performance metrics (e.g., accuracy, sensitivity, specificity) against a ground truth.

This document is a 510(k) summary for a muscle stimulator (System Ultra, Type 390, Model E70/X70) by Bio-Medical Research Ltd. It primarily focuses on demonstrating substantial equivalence to a predicate device (Slendertone System-Abs, Type 390, E10/X10) based on technological characteristics and compliance with international safety standards, rather than clinical performance metrics of an AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, ground truth, and specific study types (MRMC, standalone) for an AI/ML device is not applicable or not provided in this document.

Here's a breakdown of what can be extracted and what is missing based on the prompt:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in terms of intended use, technological characteristics, and compliance with safety standards. The FDA's approval indicates these implicit criteria were met.
• Reported Device Performance: Not presented as specific performance metrics (e.g., accuracy, precision) as would be for an AI/ML device. The "performance" is implicitly tied to its ability to meet the intended use safely, similar to the predicate. The document states: "System Ultra, Type 390, E70/X70 device complies with the following international safety standards:" followed by a list of IEC standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided: This document does not describe a clinical study with a test set in the context of AI/ML performance evaluation. It states, "No new clinical studies have been submitted as part of this premarket notification." The evaluation was based on demonstrating equivalence and compliance to standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided: No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided: No adjudication method is described as there is no test set in the context of an AI/ML performance study.

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: No MRMC study was done, as this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No: This is not an AI/ML algorithm, so no standalone algorithm performance study was relevant or performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided: The concept of "ground truth" as used in AI/ML performance evaluation is not relevant to this submission, which relies on equivalence and compliance with engineering standards.

8. The sample size for the training set

• Not applicable / Not provided: There is no AI/ML algorithm, so no training set is mentioned.

9. How the ground truth for the training set was established

• Not applicable / Not provided: Not an AI/ML algorithm.

Ask a specific question about this device