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

The Indications for Use for the Shoulder PacemakerTM device are:

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

The device is intended for adults and adolescents age 14 and older.

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) submission for the Shoulder PacemakerTM device, focusing on expanding its indications for use to include adolescents aged 14 and older. The submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (K210674), which is also the "Shoulder PacemakerTM" from the same manufacturer, NCS Lab Srl.

The core of the submission addresses the device's safety and effectiveness through non-clinical testing and leveraging existing clinical data through pediatric extrapolation, rather than conducting a new clinical study.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense for a new clinical study comparing the device to a threshold or another device. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (K210674) and compliance with relevant medical device standards. The "reported device performance" is primarily the affirmation that the device meets these standards and is functionally identical to the predicate for all characteristics except the expanded age range.

The "performance data" section states: "All non-clinical, BLE module, battery, electrical safety, EMC and software testing was reviewed in K210674. No substantial changes have been made to the device since it was cleared by the FDA on August 24, 2021 that would affect prior testing results."

This implies that the device's performance aligns with the predicate device, which had already met the necessary performance criteria for its original clearance.

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

There was no new clinical "test set" or study conducted for this specific 510(k) submission in the traditional sense of prospectively enrolling patients for direct device performance testing. The clinical evaluation for the expanded age indication was based on pediatric extrapolation as per FDA guidance. This means:

• Sample Size: Not applicable for a new clinical test set. The submission relies on existing clinical literature and real-world use data.
• Data Provenance: The text mentions "Published literature and real-world use data." The specific countries or whether this data was retrospective or prospective from the original studies are not detailed within this summary, but it generally refers to existing, previously collected 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)

Not applicable. No new clinical test set was created, and thus no new ground truth was established by experts for this specific submission. The clinical evidence for pediatric extrapolation relied on published literature.

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

Not applicable. No new clinical test set requiring adjudication was conducted.

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-powered diagnostic or assistive tool for human readers, so an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device (muscle stimulator), not an algorithm in the context of standalone diagnostic performance. The device does operate in a "stand-alone mode" (uncontrolled by a wireless tablet) but this refers to its operational mode, not a standalone algorithm performance test.

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

For the pediatric extrapolation, the "ground truth" would be considered the established clinical outcomes data from published literature and real-world use for NMES devices in both adult and pediatric populations, as well as the comparison of patient, disease, and device characteristics. This is a form of outcomes data and literature-based evidence analyzed to support equivalence in a younger population.

8. The sample size for the training set

Not applicable. This submission concerns a hardware device with an expanded indication for use, not an AI/ML algorithm requiring a training set in the typical sense. The software validation mentioned (IEC 62304) involves testing against design requirements, not training on a dataset.

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

Not applicable. There was no training set for an AI/ML algorithm.

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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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