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The Synchrony (20-3000) is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES).

• Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES).

• Maintenance and/or increase of hand range of motion.
• Prevention and/or retardation of disuse atrophy.
• Increase in local blood circulation.
• Reduction of muscle spasm.
• Re-education of muscles.

The Synchrony (20-3000) system is a functional electrical stimulation (FES) device and a powered muscle stimulator. It is specifically designed to enhance hand functionality in patients with arm paresis through a range of customizable therapies. The system integrates five major components: the Stimulator, Sensor, Patient Interface (electrodes), Motor Point Probe, and Clinician App. The therapies are directed and programmed by a clinician through an iOS based application and then the patient may apply the therapy at their home with the Stimulator and Sensor.

The Synchrony system supports three primary therapeutic modes: Contralaterally Controlled Electrical Stimulation (CCFES), cyclical Neuromuscular Electrical Stimulation (CNMES), and Functional Task Practice (FTP). The CCFES mode uses sensor data from the patient's unimpaired side to control the timing, intensity, and movement of the paretic hand/arm, synchronizing stimulation with natural motor patterns. The cyclical NMES mode delivers repetitive stimulation to targeted muscles, aiding in muscle re-training, as described in the systematic review of research studies using cyclic NMES. The FTP mode allows for direct control of hand movements during task-oriented exercises, using real-time sensor feedback and stimulator output.

Stimulation is delivered through up to four electrodes placed on identified motor points, using symmetric balanced biphasic pulses. The system offers preset stimulation amplitudes of 20mA, 40mA, and 60mA, with a pulse width adjustable between 1-250 µsec, providing high precision with 1 µsec resolution. The device's enclosure is constructed from biocompatible ABS Cycoloy, ensuring durability and patient safety, and is rated IP22 for ingress protection.

The stimulator can operate independently or in conjunction with the Synchrony Sensor, depending on the therapy mode selected. The Sensor, which communicates wirelessly with the Stimulator via Bluetooth Low Energy (BLE), uses a Class I laser that is compliant with 21 CFR 1040.10 and 21 CFR 1040.11 to measure hand opening and closure distances, enabling accurate therapeutic adjustments. Both the Stimulator and Sensor are wirelessly charged using an FCC Part 15 compliant charging pad, enhancing ease of use and handling.

The Synchrony system is engineered for ease of use with user-friendly control interfaces for both patients and clinicians. It incorporates a range of safety mechanisms to ensure effective and safe operation, making it a versatile and reliable tool for improving hand functionality through personalized therapeutic interventions.

The provided FDA 510(k) clearance letter for the Synchrony (20-3000) device does not contain information about acceptance criteria or a specific study proving the device meets those criteria.

The letter primarily focuses on establishing substantial equivalence to predicate devices, referencing adherence to recognized standards, and outlining performance differences between the new device and the predicates without providing specific acceptance criteria or study details.

However, based on the information provided, we can infer some details and highlight the missing information:

Key Takeaways from the document relevant to performance and safety:

• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to predicate devices (K123636 and K960457).
• Standards Compliance: The device claims compliance with numerous IEC, ISO, ASTM, and ANSI standards related to safety, essential performance, usability, electromagnetic compatibility, software lifecycle, risk management, biological evaluation, laser safety, battery testing, shipping, cleaning processes, wireless coexistence, and cybersecurity. These standards inherently contain their own acceptance criteria that the device must meet.
• Performance Differences: The comparison tables highlight differences in technical characteristics and output specifications. The rationale for these differences consistently asserts "No impact on safety and effectiveness."
• Clinical Data: The document explicitly states: "No clinical data were reviewed in this submission in support of the subject device." This is a crucial piece of information indicating that clinical trials were not part of this 510(k) submission for performance validation against specific clinical outcomes or acceptance criteria.

Inferred and Missing Information:

Since dedicated acceptance criteria and a study proving the device meets them are not explicitly detailed in the provided text, the table below will reflect what is implied by the substantial equivalence and standards compliance, and explicitly state where information is missing.

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

2. 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: The document explicitly states: "No clinical data were reviewed in this submission in support of the subject device." Therefore, there is no "test set" of patient data in a clinical sense for this 510(k) submission. Performance testing was primarily based on engineering and bench testing to demonstrate compliance with standards and equivalence.

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 / Not Provided: As no clinical test set was used, no experts were utilized to establish ground truth in this context for this specific submission. The "ground truth" for compliance was adherence to various engineering, electrical, and biocompatibility standards, and demonstrating substantial equivalence to known predicate devices.

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

• Not Applicable / Not Provided: No clinical test set means no adjudication method was employed.

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 / Not Provided: This device is an external functional neuromuscular stimulator, not an AI-assisted diagnostic imaging device. An MRMC study is irrelevant for this type of device and was not conducted.

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

• Partially Applicable / Inferred: The device is a physical medical device that delivers electrical stimulation. Its "standalone" performance is assessed through its compliance with electrical output specifications, safety standards, and functional specifications without a human operator. This is implied by the extensive list of performance testing against standards. For example, the stimulator's ability to deliver a specific pulse width and frequency, or for the sensor to accurately measure hand opening, would be part of its standalone performance. However, there's no "algorithm only" in the sense of a pure software diagnostic or inferential AI system. The "Clinician App" and "Sensor" are components of the system functionality, but their performance tests are part of the overall system validation.

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

• Standards and Predicate Device Specifications: The "ground truth" for this 510(k) submission is derived from:
  • Recognized Consensus Standards: The extensive list of IEC, ISO, ASTM, and ANSI standards (e.g., IEC 60601-1 for basic safety, ISO 10993 for biocompatibility). The acceptance criteria are defined within these standards.
  • Predicate Device Performance: The technical and output specifications of the Bioness H200 and Med Labs EMS-2C served as benchmarks for comparison, implying that the performance of the predicate devices is an established "truth" for safe and effective similar functionality.

8. The sample size for the training set

• Not Applicable: As no clinical data was used and this is not an AI/ML device relying on a training set of patient data, this concept does not apply to this submission. "Training" refers to the engineering development and testing inherent in any device.

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

• Not Applicable: See point 8.

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