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As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:

the symptomatic relief of chronic intractable pain, and

as an adjunctive treatment in the management of post-surgical or post-traumatic pain.

As a Neuromuscular Electrostimulation (NMES) device for:

the relaxation of muscle spasms,

prevention or retardation of disuse atrophy,

increasing local blood circulation,

muscle re-education,

immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis

and

to maintain or increase the range of motion.

Acticare HFT/HFI is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves or muscles. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain or as a NMES device for muscle stimulation.

The provided text describes a 510(k) summary for the Bioinduction Acticare HFT/HFI device, a Transcutaneous Electronic Nerve Stimulator (TENS) and Neuromuscular Electrostimulation (NMES) device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics in terms of clinical effectiveness or accuracy.

The document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety testing, rather than a clinical performance study with defined acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Information that can be extracted related to testing:

The device was tested in accordance with the following non-clinical standards:

• IEC 60601-2-10:2001 (Specific requirements for nerve and muscle stimulators)
• IEC 60601-1:1988 (General requirements for safety of medical electrical equipment), Amendment 1, 1991-11, Amendment 2, 1995
• IEC 60601-1-1:2000 (Safety requirements for medical electrical systems)
• IEC 60601-1-2:2005 (EMC compatibility and additional FCC requirements)
• IEC 60601-1-4:2000 (Software for use in Medical Devices)

The conclusion states that the device has "similar technical characteristics, performances and applications" to predicate devices, and that the "information supplied in the full 510(k) application illustrates that the device does not pose any new questions of safety or effectiveness." This implies that the performance aspects assessed were primarily technical specifications as compared to the predicate devices and adherence to relevant safety standards. There is no mention of a clinical or analytical performance study that would typically define acceptance criteria based on diagnostic accuracy or efficacy.

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Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Indications For Use include:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining or increasing range of motion

BE-550 is a single-channel battery operated muscle stimulation system. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires. The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from three AA cells located in a compartment protected by a removable battery cover. The BE-550 is intended to be used as an electronic muscle stimulator.

BE-660: Is the same as the BE-550 model, but is a two-channel battery operated muscle stimulation system.

The provided text is a 510(k) summary for the Besmed 550 and Besmed 660 electrical muscle stimulation devices. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria.

Typically, 510(k) submissions for devices like muscle stimulators rely heavily on established standards and direct comparisons to predicate devices for assessing performance and safety. They do not usually involve extensive AI-specific validation studies with ground truth establishment or MRMC studies.

Therefore, for the specific questions requested, much of the information is not available in the provided document, as it outlines a different regulatory pathway (substantial equivalence) compared to what would be required for a novel AI/ML device with performance claims.

Here's a breakdown based on the available information and an explanation of why other information is not present:

Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" in the way one would expect for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC). Instead, the performance assessment is based on technological characteristic equivalence to a predicate device and adherence to general device safety and effectiveness principles.

Study Details and Missing Information

1. Sample size 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 describes a 510(k) submission for an electrical muscle stimulator based on substantial equivalence to a predicate device. It does not mention a "test set" of data for performance evaluation in the context of AI/ML. Performance is inferred through comparison of technological characteristics and intended use.

2. 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/Not provided. No "ground truth" establishment process is described, as the device is not an AI/ML diagnostic or screening tool requiring such validation.

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

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

4. 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. This is not an AI-assisted device. Therefore, no MRMC study was conducted.

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

   • Not applicable. This is a hardware device (electrical muscle stimulator), not an algorithm.

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

   • Not applicable/Not provided. No specific "ground truth" is discussed for the device's performance, as it is a physical stimulator. Its effectiveness is based on the known physiological effects of electrical muscle stimulation and the equivalence to a legally marketed predicate.

7. The sample size for the training set

   • Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable/Not provided. There is no "training set" or corresponding ground truth establishment described for this device.

Summary Explanation:

The document describes a traditional 510(k) submission for an electrical muscle stimulator. The core of this submission type is to demonstrate that the new device (Besmed 550 and 660) is "substantially equivalent" to a legally marketed predicate device (BioStim Digital NMS). This means showing that the device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the performance evaluation is generally focused on:

• Comparing technical specifications (e.g., output parameters, waveforms) to the predicate.
• Ensuring compliance with relevant electrical safety and biocompatibility standards (though not explicitly detailed in the provided snippet, these are standard requirements for such devices).
• Reviewing the labeling and indications for use to ensure they align with the predicate and are appropriate for the device type.

The questions regarding "acceptance criteria," "test set," "ground truth," "AI assistance," "MRMC studies," and "training sets" are highly relevant for AI/ML-driven medical devices, but they do not apply to the type of device and regulatory submission described in the provided text.

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