(143 days)
The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The NuVasive Stimulation/Dissection Instruments are similar to existing Class I exempt manual surgical instruments described in 21 CFR 88.4540 Orthopedic Manual Surgical Instruments. The instruments consist of retractors, dilators (expanding set of cannula), a stimulating electrode, taps, drills, probes, needles, and screw drivers with proximal connectors to attach the instruments to a monopolar stimulator, and insulating sheaths to provide biocompatible electrical insulation to selected portions of the instruments. The distal surfaces of the instruments are selectively noninsulated and manufactured from durable biocompatible materials to provide for mechanical, manual dissection/resection, probing, and tissue stimulation.
The provided text describes the 510(k) summary for the NuVasive® Stimulation/Dissection Instruments. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of device performance against specific acceptance criteria.
Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted because the document primarily discusses comparison to predicate devices and non-clinical testing.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, stating that the device "meets or exceeds the performance of the predicate device."
| Feature | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Indications for Use | Same as predicate: Tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots. | The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots. (Matches) |
| Product Code | ETN | ETN (Matches) |
| Regulation Number | 874.1820 | 874.1820 (Matches) |
| Electrical Insulation | Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection. | Some instruments have electrical insulation on surfaces not intended to provide electrical contact with the patient and connection while others are used with an insulating accessory that provides electrical insulation on surfaces not intended to provide electrical contact with the patient and connection. (Equivalent functionality achieved through instruments or accessories) |
| Biocompatibility | Biocompatible materials. | Biocompatible: Anodized Aluminum, Stainless Steel, Radel (Materials listed are biocompatible) |
| Sterilization | Sterile for single use. | Some instruments are provided sterile for single use only while others are provided as non-sterile reusable instruments. (Different sterilization statuses, but within acceptable parameters for different instrument types) |
| Stimulation and Insulation Impedance | Meets or exceeds predicate device's performance. | Results showed that the subject Stimulation/Dissection Instruments meets or exceeds the performance of the predicate device. |
| Current Density Determination | Meets or exceeds predicate device's performance. | Results showed that the subject Stimulation/Dissection Instruments meets or exceeds the performance of the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "nonclinical testing" but does not detail sample sizes for these tests, nor the data provenance.
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)
This information is not applicable as the document describes non-clinical testing and comparison to predicate devices, not studies involving human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical testing, not a study involving adjudication of a test set by human readers.
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
This information is not applicable. The device is a physical surgical instrument (Nerve Stimulator/Locator), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical surgical instrument, not an algorithm. Standalone performance for an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing (Stimulation and Insulation Impedance, Current Density Determination, Biocompatibility, Sterilization Validation), the "ground truth" or reference would be established engineering standards, specifications, and regulatory requirements (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization validation, and internal performance specifications derived from predicate device performance).
8. The sample size for the training set
This information is not applicable. The device is a physical surgical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical surgical instrument, not an AI model.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.