(172 days)
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
| Acceptance Criteria Category (Implied by Testing) | Specific Criteria (Based on Standards and Comparisons) | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (General Requirements for Basic Safety and Essential Performance) | Complies with CEI EN 60601-1. |
| Compliance with IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators) | Complies with CEI EN 60601-2-10. | |
| Compliance with IEC 60601-1-11 (Requirements for ME equipment and systems used in the home healthcare environment) | Complies with CEI EN 60601-1-11. | |
| Patient Leakage Current within specified limits (comparison to SP) | Normal condition (μA): Not specified, assumed within limits; Single fault condition (μA): Not specified, assumed within limits. (Stated as "Same to SP Note 1", indicating compliance with similar safe levels as the Secondary Predicate which has 4.88 μA normal, 8.00 μA single fault). | |
| Average DC current through electrodes (when no pulses applied) - negligible | ** |
§ 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).