(245 days)
The ODFS® Pace is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. By detecting the swing phase of gait through a foot switch signal, appropriate electrical stimulation of the leg and ankle muscles may improve gait by flexing the foot of persons who have lost or impaired function. There may be additional benefits from FES such as muscle re-education, prevention/retardation of disuse atrophy, increased or maintained range of joint motion and increase in local blood flow.
The ODFS® Pace is a medical device and should only be used under medical supervision for the treatment of dropped foot following an upper motor neuron injury.
The ODFS® Pace is an external functional neuromuscular stimulator. It consists of a small, body worn, single channel stimulator which is triggered by a wired footswitch worn in the shoe. Electrical pulses are generated by the device in order to stimulate muscles in the lower limb. Triggering with a footswitch permits the stimulation to be varied according to the gait of the user. Stimulation produces contraction of the appropriate muscles to cause dorsiflexion of the ankle in individuals who have impaired or absent ability to pick up their foot during walking as a result of a neurological injury. This partial paralysis affecting the foot is commonly known as 'drop foot' or 'dropped foot'.
The electrical stimulation is delivered via self adhesive skin surface electrodes. The electrodes may be flexibly placed according to the optimum response of the patient but typically are located over the common peroneal nerve as it passes near the head of the fibula.
For individuals presenting with weakness and/or spasticity a muscle stimulation exercise program can be delivered by the ODFS® Pace. In this case the footswitch trigger is not used and the ODFS® Pace functions as a powered muscle stimulator. A clinician would determine the need for this application which can enabled from a setup option in the ODFS® Pace. (Default is to have the exercise disabled)
The provided text describes a 510(k) submission for the ODFS® Pace, an external functional neuromuscular stimulator. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria based on studies and then proving the device meets those criteria.
Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and comparative effectiveness are not applicable or available within this type of regulatory document. This document primarily focuses on technical specifications and regulatory compliance.
Here's the information that can be extracted or deduced, along with explanations for the missing information:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the way a clinical study or performance study would. Instead, it demonstrates compliance with technical specifications and relevant standards. The "device performance" in this context refers to its ability to meet these technical specifications and legal requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional and output specifications met | Production units pass functional testing of stimulator controls, settings and indicators, stimulus output and timing, footswitch operation, and power consumption. Parameters measured under conditions specified in FDA Guidance Document for Powered Muscle Stimulator 510(k)s. |
| Compliance with ISO 60601-1-1:2006 (Basic Safety & Essential Performance) | Passed applicable requirements |
| Compliance with ISO 60601-1-2:2007 (EMC) | Passed applicable requirements |
| Compliance with ISO 60601-2-10:2001 (Safety of Nerve & Muscle Stimulators) | Passed applicable requirements |
| Substantial equivalence to predicate devices for FES indications | ODFS® Pace has identical indications for use as an FES device as ODFS III v6.2 and corresponds to FES functions of EMPI Focus Model 795. |
| Substantial equivalence to predicate devices for NMS/NMES indications | The exercise function of ODFS® Pace corresponds to and is substantially equivalent to the NMS/NMES indications of the EMPI Focus Model 795. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices and technical performance testing, not a clinical trial with a "test set" of patients in the way an AI/diagnostic device might have. The "production units" mentioned for functional testing don't represent a patient-based test set.
- Data Provenance: Not applicable for a typical clinical test set. The technical testing was conducted by Odstock Medical Ltd., which is based in the United Kingdom.
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 "ground truth" established by experts for a test set of patient data is mentioned or required for this type of 510(k) submission for a physical medical device like an FES stimulator. The "truth" is established by compliance with engineering specifications and recognized electrical safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As there is no clinical "test set" of patient cases requiring ground truth establishment, no adjudication method is relevant.
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. The ODFS® Pace is an external functional neuromuscular stimulator, not an AI-powered diagnostic or decision support system that would involve "human readers" or AI assistance in interpretation. It directly delivers electrical stimulation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a hardware stimulator and does not describe a standalone "algorithm" in the context of AI or image analysis. Its function is directly related to hardware performance and user-controlled settings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is primarily defined by the technical specifications for electrical output, waveform properties, frequency, pulse width, and compliance with international safety and performance standards (ISO 60601 series). There is no "patient ground truth" required for this type of submission.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI that would require a "training set" of data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
§ 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).