(87 days)
The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow.
The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.
The ODFS Dropped Foot Stimulator (ODFSIII Version 6.2) is an external functional neuromuscular stimulator. The ODFS Dropped Foot Stimulator electrically stimulates the common peroneal nerve which may produce contraction of the appropriate muscles that cause dorsiflexion of the ankle in individuals who have lost the ability to do so following neurological injury.
The device is comprised of a small belt-worn, single-channel, foot-switch controlled stimulator used with skin-surface stimulating electrodes. The surface electrodes are typically placed over the common peroneal nerve as it passes near the head of the fibula and the motor point of the tibialis anterior in the lower leg. The heel switch allows the delivery of stimulation to be triggered according to the gait of the user.
The provided 510(k) summary for the ODFS Dropped Foot Stimulator does not contain sufficient information to comprehensively describe acceptance criteria and the study that proves the device meets those criteria, as it primarily focuses on substantial equivalence to predicate devices and general performance testing.
Here's an attempt to extract and describe the available information based on your request, highlighting what is not explicitly stated in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Not explicitly stated as such, inferred from testing) | Reported Device Performance |
|---|---|---|
| Output and operational characteristics | Meet product specifications (inferred) | All units tested met product specifications. |
| Electrical Safety (IEC 60601-1) | Compliance with standard | Testing included IEC 60601-1 (with amendments). |
| Electrical Safety (IEC 60601-2-10) | Compliance with standard (if applicable) | Testing included IEC 60601-2-10 (as applicable). |
| Electromagnetic Compatibility (ISO 60601-1-2) | Compliance with standard (if applicable) | Testing included ISO 60601-1-2 (as applicable). |
| Waveform | Biphasic (Symmetrical and Balanced Asymmetrical) | Biphasic (Symmetrical and Balanced Asymmetrical) |
| Pulse Width | 7 (±4) to 365 (±20) µsec (patient selectable) | 7 (±4) to 365 (±20) µsec (patient selectable) |
| Frequency | 40 (±4) Hz | 40 (±4) Hz |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "All units tested met product specifications," implying a smaller, internal testing sample rather than a clinical trial test set.
- Data Provenance: Not specified. The device sponsor is based in the United Kingdom, so the testing likely occurred there, but this is not explicitly stated. The document does not indicate if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as the submission describes device performance testing against specifications, not a clinical study involving experts establishing ground truth for clinical outcomes.
4. Adjudication Method for the Test Set
This information is not provided as the submission does not detail a clinical study with a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The document does not mention an MRMC study or any clinical study comparing human readers with and without AI assistance. The device is a stimulator, not an imaging analysis tool.
- Effect size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an external functional neuromuscular stimulator, not an algorithm for diagnostic purposes. The performance assessment describes the device's ability to meet its technical specifications. There is no "algorithm only" performance reported in the context of diagnostic accuracy. The performance described relates to the device's physical outputs (waveform, pulse width, frequency).
7. Type of Ground Truth Used
- For the reported performance ("All units tested met product specifications"), the "ground truth" was the pre-defined product specifications for electrical output and operational characteristics. This is a technical ground truth, not a clinical one.
8. Sample Size for the Training Set
This information is not applicable/provided. The device is a hardware product with electrical specifications, not an AI or machine learning algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above. The "ground truth" for the device's technical specifications would have been established during the design and engineering phases, based on established physiological needs for functional electrical stimulation and electrical engineering principles.
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).