(204 days)
The Pioneer Nerve Monitoring Cable, in conjunction with Pioneer pedicle probes, taps, awls or screw drivers, is intended to stimulate peripheral motor nerves during surgery for the purpose of locating and identifying these nerves, including spinal nerve roots during the incision and removal of soft and hard tissue or bone.
This device is intended for use as an intra-operative motor nerve stimulator with common EMG monitors. Construction of the device allows nerve stimulation with general manual orthopedic surgical instruments, e.g. taps, awls, probes, etc. The terminal end of the cable is a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating.
The provided 510(k) summary for the Pioneer Nerve Monitoring Cable describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics in the way that would typically be presented for an AI/ML medical device.
The basis for substantial equivalence is primarily focused on comparisons of device performance data, materials, indications, and design/function to predicate devices. This suggests that the "study" demonstrating the device meets acceptance criteria is a comparison to already approved devices, rather than a novel clinical trial or performance evaluation with quantifiable metrics.
Therefore, many of the requested fields cannot be directly extracted from the provided text for this specific device. I will fill in what can be inferred or directly stated, and clearly mark where the information is not available in the document.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety | Implied to be equivalent to predicate devices through material conformance (ASTM Standard Specifications) and regulatory comparison. No specific safety endpoints or thresholds are provided. |
| Effectiveness/Functionality | Intended to stimulate peripheral motor nerves for locating and identifying them during surgery. Performance is deemed substantially equivalent to predicate devices (K063729, K063305, K013215, K002677, K062996, K050194). No specific quantitative performance metrics (e.g., stimulation threshold, signal fidelity) are provided. |
| Material Biocompatibility | Materials used are in conformance with ASTM Standard Specifications, implying biocompatibility. No specific acceptance criteria or test results are disclosed. |
| Electrical Safety | Terminal end of the cable is a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating. Implies compliance with electrical safety standards, but no specific criteria or test results are provided. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device test set. The submission relies on comparison to predicate devices, which would have had their own historical performance data (provenance not specified in this document). No specific "test set" in the sense of a data set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a device like this would be established through direct physical testing and compliance with engineering standards, not expert annotation of a data set. No 'test set' requiring expert ground truth is described.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a nerve monitoring cable, not an AI/ML diagnostic tool typically evaluated with MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: For a physical device like this, ground truth would be established through engineering testing, e.g., electrical impedance measurements, current delivery, signal integrity, material properties, and functionality testing. The document states "comparisons of device performance data... to predicate devices" which implies such testing would have been done to demonstrate equivalence, but the specifics are not detailed.
- The sample size for the training set: Not applicable. The device is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable. See above.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).