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System Arms (Type 390, X60) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles.

System Arms, Type 390, Model X60 is a two-channel, battery powered, muscle stimulation system. It is supplied with two arms garments (left & right arm), a hand-held rechargeable control unit, a pack of 4 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 (i.e. System-Abs Type 390, Model E10/X10, System-Shorts Type 390, Model E20, System-Mini, Type 390, E30 and also System Arms Type 390, Model E60).

There are three programs available to users of the System Arms, Type 390, X60. 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.

For purposes of hygiene, the garment may be cleaned and instructions for belt care are included in the user manual.

The provided text is a 510(k) summary for a muscle stimulator device and does not contain information about the acceptance criteria or a study proving its performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them based on the provided text.

Here is a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document lists intended uses and technological characteristics but does not define specific acceptance criteria or report performance data against them.
2. Sample sized used for the test set and the data provenance: No new clinical studies were submitted, and no test set or related data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new clinical studies or test sets were used.
4. Adjudication method for the test set: Not applicable as no new clinical studies or test sets were used.
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: Not applicable. This device is a muscle stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a muscle stimulator, not an algorithm, and no standalone performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no new clinical studies or test sets were used to establish ground truth for this submission. The device relies on demonstrating substantial equivalence to a previously cleared device.
8. The sample size for the training set: Not applicable as no algorithm training is discussed.
9. How the ground truth for the training set was established: Not applicable as no algorithm training is discussed.

The core of this 510(k) submission is the statement: "No new clinical studies have been submitted as part of this premarket notification." This indicates that the device's clearance relies on its technological equivalence to predicate devices and compliance with international safety standards, rather than new performance data.

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