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The SLENDERTONE® Connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

The SLENDERTONE® Connect Abs, Type 570 is a portable, neuromuscular, electrical stimulation system intended to deliver electrical stimulation to the abdominal muscles. The system includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable, pouch and instructions for use. One toning program is pre-installed in the unit. Wireless communication is enabled by a Bluegiga BLE113 Bluetooth module. The modified Slendertone Connect Abs device supports a range of mobile devices via both iOS and android mobile applications.

This document is a 510(k) premarket notification for a medical device, the SLENDERTONE® Connect Abs, Type 570. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.

Therefore, the information requested regarding a study for acceptance criteria (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set) is not present in this document. This typically means such a study was not required or was deemed unnecessary for a 510(k) submission based on substantial equivalence.

However, the document does list various performance testing conducted in accordance with international safety standards. These tests are the "acceptance criteria" in the context of this submission, demonstrating the device's adherence to safety and essential performance requirements.

Here's the breakdown of what is available and what is not:

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

Regarding the study that proves the device meets the acceptance criteria, the following information is NOT available in the provided text:

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

• Not provided. The document states "Performance testing was conducted," but does not detail the methodology, sample sizes of devices or participants, or data provenance for these engineering and safety tests.

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):

• Not applicable for this type of testing. The "acceptance criteria" here relate to engineering safety and performance standards for a powered muscle stimulator, not diagnostic accuracy requiring expert panel review or ground truth establishment in a clinical imaging or diagnostic context.

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

• Not applicable for this type of testing. Adjudication methods are typically used in clinical studies involving interpretation of results, which is not the nature of these engineering and safety compliance tests.

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 powered muscle stimulator, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is hardware with firmware/software, not an algorithm in the sense of a diagnostic AI. The "standalone" performance here refers to the device's electrical and mechanical safety compliance.

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

• Not applicable/Implicit. For engineering and safety standards, the "ground truth" is defined by the parameters and methodologies outlined in the referenced international standards (e.g., electrical safety limits, biocompatibility requirements, electromagnetic compatibility limits). Compliance is measured against these defined benchmarks.

8. The sample size for the training set:

• Not applicable. This device uses pre-programmed functionalities and does not indicate any machine learning or AI components that would require a "training set."

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

• Not applicable. As no training set is mentioned or implied.

In summary, this 510(k) submission successfully demonstrates substantial equivalence through a comparison of technological characteristics to a predicate device and via compliance with relevant safety and performance standards, rather than presenting a clinical study with subjective endpoints that would require the detailed information you requested.

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