(217 days)
The Ab Belt device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
The Ab Belt is a single channel battery operated muscle stimulation system specifically designed for improving abdominal muscle tone, for strengthening the abdominal muscles and for developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. The device is supplied with a set of three identical electrodes, a tube of conductive gel, an instruction manual, a set of batteries and a fabric belt extension for fuller figures. Power is derived from three (3) 1.5V AAA batteries located on an external pop-on connector and slid into a pocket on the belt facia. The central umbilical electrode is common to each of the left and right stimulation circuits.
The electrodes connect mechanically to 'press-studs' mounted on the inner face of the abdominal belt. The studs are presented in such a way that each of the outer electrodes may be rotated about a single common stud to accommodate both inner and outer muscle groups. Only these single common studs of the outer electrodes and the central umbilical electrode are electrically connected to the stimulator unit. This prevents stimulation to the user through a stud, which is not covered by an electrode pad.
The user extends the belt and puts it in a wrapping motion from front to back, closing it at the back using Velcro patches. When the belt is in place the central electrode locates over the umbilicus and the two outer electrodes locate on either side of the body towards the mid axillary line, between the pelvis and the rib cage. It is well known in the art that this electrode positioning is particularly useful for stimulating the abdominal muscles.
The pulsed stimulation current passes between the outer and center electrodes only. There is no current passed from outer electrode to outer electrode. The user has no access to the wiring or connectors as they are stored internally within the belt structure. As a result he or she cannot alter the current path and so the possibilities for misuse are greatly reduced.
The provided text describes a muscle stimulator called "Ab Belt" and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on regulatory aspects rather than detailed performance study results.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and performance studies, as this information is not present in the provided text.
Specifically, the following information you requested is missing:
- A table of acceptance criteria and the reported device performance: Not present. The document only states the indications for use and compares the device's characteristics to a predicate device.
- Sample sized used for the test set and the data provenance: Not present. No performance testing data is discussed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not present. The device is a muscle stimulator, not an AI diagnostic tool that would typically involve MRMC studies with human readers.
- Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable, as this is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study is detailed.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
The document states:
- "The Ab Belt device has the same indications for use as the predicate device."
- "The Ab Belt device has equivalent technological characteristics and instructions for use, as compared to the predicate device."
- "The device meets the mandatory performance standard identified in 21 CFR 898."
- "The biocompatibility of the electrodes has been established."
These statements indicate that the device meets regulatory requirements and is considered equivalent to a predicate, but they do not provide specific performance metrics, acceptance criteria, or study details. The "mandatory performance standard identified in 21 CFR 898" would specify certain electrical or safety performance aspects, but the text does not elaborate on these or provide test results against them.
§ 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).