(193 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated or implied) |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | Complies with CEI EN 60601-1, IEC 60601-1:2005+AMD1:2012 |
| Compliance with IEC 60601-1-2 (EMC) | Complies with CEI EN 60601-1-2, IEC 60601-1-2:2014 |
| Compliance with IEC 60601-2-10 (Nerve/Muscle Stimulators) | Complies with CEI EN 60601-2-10, IEC 60601-2-10:2016 |
| Compliance with IEC 60601-1-11 (Home Healthcare) | Complies with CEI EN 60601-1-11, IEC 60601-1-11:2015 |
| Compliance with IEC 60601-1-6 (Usability) | Complies with IEC 60601-1-6 |
| Compliance with IEC 62366-1 (Usability) | Complies with CEI EN 62366-1 |
| Compliance with IEC 62304 (Software Life Cycle) | Complies with CEI EN 62304; Software validation tests demonstrated it meets design requirements. |
| Compliance with ISO 14971 (Risk Management) | Complies with ISO 14971 |
| Compliance with FCC 47 CFR PT 15 SPT B (BLE module) | Complies with FCC 47 CFR PT 15 SPT B |
| Compliance with FCC 47 CFR PT 15 SPT C (BLE module) | Complies with FCC 47 CFR PT 15 SPT C |
| Compliance with IEC 62133-1 (Battery Safety - Nickel) | Complies with IEC 62133-1:2017 (for relevant battery types) |
| Compliance with IEC 62133-2 (Battery Safety - Lithium) | Complies with IEC 62133-2:2017 (for relevant battery types) |
| Substantial equivalence in technological characteristics to predicate device | Stated as "substantially equivalent" with only differences in IFU age range. |
| Supported by pediatric extrapolation for expanded age range | Discussion provided based on FDA guidance and published literature. |
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.
§ 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).