(172 days)
The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The NIMTM surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.
The provided document is a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM™ Surgeon Control Probes. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing. However, it does not contain information about an AI/ML-based medical device study.
The document details safety and effectiveness testing for a physical medical device (nerve stimulator probes), not a software algorithm that performs diagnostic or prognostic tasks. Therefore, many of the requested elements (like "AI vs without AI assistance," "ground truth," "training set," "multi reader multi case study," etc.) are not applicable to the information contained in this FDA clearance letter.
Based on the provided text, here's what can be extracted and what information is missing/not applicable:
1. A table of acceptance criteria and the reported device performance:
The document states that "Design performance testing was completed to ensure the functionality and intended use of the NIM™ Surgeon Control Probes was met in accordance with external standards, and device specifications via pre-defined acceptance criteria." It then lists the types of tests performed. It does not present a specific table with quantitative acceptance criteria and corresponding performance results. It generally states that the tests yielded "passing results."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality and intended use met in accordance with external standards and device specifications (pre-defined acceptance criteria) | Demonstrated "passing results" for all performance testing. |
| Compliance with ISO 11135:2014 for sterilization validation | Achieved sterilization validation. |
| Compliance with IEC 60601 for electrical safety & EMC testing | Achieved electrical safety & EMC compliance. |
| Compliance with ISO 10993-1:2018 for biocompatibility testing and risk analysis | Achieved biocompatibility and risk analysis compliance. |
| Stability testing for proposed shelf life | Stability confirmed for proposed shelf life. |
| Packaging performance to ISTA 3A and ASTM D4169 | Packaging performance validated for environmental conditioning and distribution simulation. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "Bench engineering test samples" but does not specify the sample size for any of the performance tests.
- Data Provenance: Not applicable in the context of this device's testing. The testing appears to be primarily lab-based engineering performance testing of physical prototypes, not data collection from patients or medical images. It's not a retrospective or prospective study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualification of those experts:
- Not applicable. This device is hardware for stimulating nerves, not an AI system requiring expert consensus for a "ground truth" diagnosis or image interpretation. The "ground truth" for this device's performance would be engineering specifications and standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This study is not evaluating expert interpretation of medical data. Performance is evaluated against objective engineering standards and specifications.
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 study was not conducted. The device is a surgical tool, not an AI software designed to assist human readers (e.g., radiologists) in interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its design and manufacturing.
7. The type of ground truth used:
- The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., IEC, ISO, ASTM) and the manufacturer's own pre-defined device specifications. It's not clinical diagnosis or outcomes data in the context of an AI study.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. Because no AI/ML model training set is involved, this question is irrelevant to the provided document.
In summary: The provided FDA clearance letter is for a traditional hardware medical device (nerve stimulator probes) and describes its performance testing against engineering and safety standards to demonstrate substantial equivalence to predicate devices. It does not contain information related to the development or validation of an AI/ML-based medical device.
§ 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.