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Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for Shoulder PacemakerTM are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults only.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

• conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
• saver protection, interposed between the stimulator and the patient's arm.

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The provided text describes a 510(k) summary for a medical device called "Shoulder Pacemaker™," an electrotherapy device for neuromuscular electrical stimulation (NMES). It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance data to support its substantial equivalence.

However, the document does not contain the level of detail typically found in a clinical study report or a formal acceptance criteria document for an AI/ML medical device. Specifically, it lacks information regarding:

• Quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on electrical safety, EMC, and compliance with standards rather than clinical performance metrics for a specific diagnostic or therapeutic outcome.
• A "study" that proves the device meets acceptance criteria in the context of clinical effectiveness with quantitative results. The performance data section refers to non-clinical testing (electrical safety, EMC, software validation) and compliance with standards, not a clinical trial or performance study involving a test set, ground truth, or expert readers.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods as these pertain to clinical performance studies.
• MRMC studies or standalone algorithm performance as these are relevant for AI/ML devices analyzing complex data like images, which is not the primary function described for this NMES device.

Given that the device is a Powered Muscle Stimulator (Product Code IPF) intended for NMES, its performance evaluation focuses on electrical parameters, safety, and functional equivalence to predicate stimulators, rather than diagnostic accuracy as one might expect from an AI/ML imaging device.

Therefore, I cannot populate all sections of your requested outline based on the provided text. I will, however, extract the relevant information regarding acceptance criteria (as implied by the testing performed) and the "study" (non-clinical testing) that demonstrates compliance.

Acceptance Criteria and Device Performance for Shoulder Pacemaker™

Based on the provided 510(k) Summary, the acceptance criteria and performance are primarily related to electrical safety, electromagnetic compatibility (EMC), software validation, and general functional equivalence to predicate devices. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity, or accuracy scores) for a clinical outcome mentioned for the Shoulder Pacemaker™, as it is a muscle stimulator focused on electrical stimulation parameters rather than a diagnostic AI/ML device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document describes non-clinical testing (e.g., electrical safety, EMC, software validation) performed on the device itself. It does not refer to a "test set" in the context of a clinical performance study with human data. Therefore, details like data provenance (country of origin, retrospective/prospective) are not applicable or provided for a clinical test set. The testing was conducted on samples of the Shoulder Pacemaker™ device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for this device's evaluation is primarily established by regulatory standards (e.g., IEC 60601 series, ISO 14971) and engineering specifications, tested by qualified laboratory personnel. There is no mention of experts establishing ground truth for a clinical test set.

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

Not applicable, as there is no mention of a human-reviewed clinical test set requiring adjudication.

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 an NMES stimulator, not an AI/ML-driven diagnostic imaging device that assists human readers.

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

Not applicable in the context of an AI/ML algorithm's standalone performance. The device itself operates independently to deliver electrical stimulation. Its "standalone" performance relates to its ability to meet electrical output specifications, which were assessed through non-clinical bench testing.

7. The type of ground truth used

The "ground truth" for the device's safety and effectiveness determination is based on:

• International Consensus Standards: e.g., IEC 60601 series for electrical safety, EMC, usability; ISO 14971 for risk management.
• Regulatory Guidance: e.g., FDA guidance for software, FDA Final Guidance Document for Powered Muscle Stimulators.
• Engineering Specifications: Internal design parameters and output characteristics (e.g., voltage, current, waveform) that are tested against pre-defined safe and effective ranges.

This is not a clinical "ground truth" like pathology, expert consensus on images, or outcomes data.

8. The sample size for the training set

Not applicable. The device is a hardware and software system, not a machine learning model developed with a "training set" of data in the AI/ML sense.

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

Not applicable, as there is no "training set" for an AI/ML model for this device.

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