(249 days)
To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
Disposable pedicle screw probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The disposable pedicle screw probes are supplied sterile and are for single use only. The disposable pedicle screw probes are connected to an electrical stimulator using a flexible lead wire and a "touch-proof" safety connector on the distal end. Disposable pedicle screw probes require a separate stimulator return electrode. Disposable pedicle screw probes are used by the surgeon to locate and identify spinal nerve roots and to assess nerve function. The disposable pedicle screw probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The disposable pedicle screw probes shaft may be bent to allow viewing access under a microscope.
Technomed Europe Disposable pedicle screw probes consist of an insulated probe shaft mounted to plastic handle. The probe shaft is electrically connected to a DIN 42802 "touch-proof" safety connector on the other end. The electrode is supplied in a sterile pouch.
The provided text is a 510(k) summary for the Technomed Europe Needle electrodes (Disposable pedicle screw probe). A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies.
Based on the provided document, the device is considered substantially equivalent to K062996. Therefore, the information requested, which pertains to detailed performance studies with acceptance criteria, expert ground truth, and training sets, is not present in this type of submission.
Here's an explanation based on the available information:
- Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or provide detailed performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device.
- Study That Proves the Device Meets Acceptance Criteria: The document mentions "Non-clinical data: Technomed Europe has been bench testing the Disposable pedicle screw probe for stimulating electrode to confirm performance characteristics of this device." However, it does not provide details of these bench tests, their methodology, sample sizes, or results against specific acceptance criteria.
Therefore, most of the specific questions cannot be answered from the provided text.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Implicit: Substantial equivalence to predicate K062996 in design, materials, chemical composition, packaging, and technological characteristics. | The manufacturer states the device is "substantially equivalent" to predicate K062996. "Bench testing... to confirm performance characteristics" was conducted, but no specific results are provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "bench testing."
- Data Provenance: Not applicable, as no clinical study or specific test set with provenance is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no expert-derived ground truth for a test set is mentioned.
4. Adjudication method for the test set:
- Not applicable, as no test set with adjudication is mentioned.
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:
- No. This is a medical device (electrode probe), not an AI diagnostic tool, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable, as no ground truth for performance evaluation is specified beyond the implicit demonstration of substantial equivalence to a predicate device based on its intended use and design characteristics.
8. The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/machine learning device.
§ 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).