(26 days)
Slendertone Gymbody is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen.
Slendertone Gymbody, Type 512-01 is a two-program battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is a variant of Slendertone Flex, Type 512 abdominal training system and was developed to provide a lower cost alternative to the consumer.
It comprises of two main components, an electronic stimulator module, which generates the required stimulation signals, and an abdominal electrode belt, which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt.
The product is supplied with a set of double-sided adhesive electrodes, an instruction manual and a set of batteries. Power is derived from 1 x 9volt battery located in a compartment protected by a removable battery cover.
The 3 pads are attached to the belt covering the 3 metal studs on the inner surface of the belt. The larger pad is placed in the middle, over the umbilicus, and the two side electrodes are located on either side of the body towards the mid axillary line, between the pelvis and the rib cage.
The pulsed stimulation current passes between the side and center electrodes only. There is no current passed from side to side.
This document is a 510(k) premarket notification for the Slendertone Gymbody, Type 512-01, a muscle stimulator. It does not contain acceptance criteria or a study that proves the device meets specific performance criteria through empirical data.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Slendertone Flex, Type 512, K010335) based on technological comparison and the claim that the fundamental scientific technology has not changed.
Here's a breakdown based on your requested information, highlighting what is (and isn't) present in the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The submission focuses on technological equivalence rather than performance metrics against specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. No new clinical study or test set data is described for the Slendertone Gymbody, Type 512-01. The submission references "original clinical trial data submitted for review along with Slendertone Flex, Type 512 (K010335)" for effectivity, implying reliance on the predicate device's data.
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)
This information is not present as no new clinical study or ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present as no new clinical study or test set is 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
This is not applicable to this device. The Slendertone Gymbody is a muscle stimulator, not an AI-powered diagnostic or interpretive device that would be subject to MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. The Slendertone Gymbody is a physical muscle stimulator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated for any studies. The submission mentions "effectivity of which is borne out in the original clinical trial data submitted for review along with Slendertone Flex, Type 512 (K010335)." Without access to the K010335 submission, the specific type of ground truth used in those original trials (e.g., muscle strength measurements, body circumference changes, user reported outcomes) is unknown.
8. The sample size for the training set
This information is not present as no new training set for the Slendertone Gymbody, Type 512-01 is described.
9. How the ground truth for the training set was established
This information is not present as no new training set is described.
Summary of the Device's Claimed "Proof" of Meeting Criteria:
The core of this 510(k) submission for the Slendertone Gymbody, Type 512-01, is to demonstrate substantial equivalence to its predicate device, Slendertone Flex, Type 512 (K010335). The "study" that proves the device meets the (implied) acceptance criteria is essentially the comparison to the predicate device and the assertion that "The same technolgical platform and modus operandi is used for the new variant, effectivity of which is borne out in the original clinical trial data submitted for review along with Slendertone Flex, Type 512 (K010335)."
The acceptance criteria are therefore implicitly the performance and safety demonstrated by the predicate device. The new device is argued to meet these because:
- Its intended use and indications for use are identical to the predicate.
- Its fundamental scientific technology does not differ.
- Changes (e.g., fewer programs, different user interface, different battery type, single amplitude control) are assessed as not impacting on the safety or efficacy of the device.
- Risk analysis conducted on the modified device aligned with ISO 14971 confirmed no new significant risks.
Essentially, the manufacturer is relying on the prior approval and demonstrated effectiveness of the predicate device, claiming all changes in the new device do not alter its safety or effectiveness profile.
§ 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).