(109 days)
This device is a manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently.
The Stimulating Hemostat and other manual instruments are dissectors modified by insulation and application of a connecting pin for connection to nerve stimulation. The specific instruments cleared for this modification in this 510(k) are the following:
- Scissors Hinge Hemostat, curved, fine
- Box Hinge Hemostat, curved, fine
- Scissors Hinge Hemostat, right angle
- Mosquito Hemostat, curved, fine
- Halsted Hemostat, curved
- Crile Hemostat, curved
- Kelly Hemostat, curved
- Schnidt Hemostat, curved, fine
- Gemini Hemostat, curved, fine
- Petit Point Mixter, right angle
- McCabe Dissector, curved, fine
- Jacobson Mosquito, curved, fine
- House Rosen Elevator, coarse
- Sheehy "Weapon", Large (2.4 mm)
- Probe, Ball tip
- Suction Stimulator (Neurovision model)
Here's an analysis of the provided text regarding the acceptance criteria and study for the Neurovision Dissection/Stimulating Accessory:
It's important to note that the provided documents (a 510(k) summary and the FDA clearance letter) describe a medical device that is a manual surgical instrument, not an AI/ML-based diagnostic or imaging device. Therefore, many of the typical acceptance criteria and study details relevant to AI devices, such as sensitivity, specificity, AUC, sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, are not applicable to this type of submission.
The "performance testing" described for this device focuses on reprocessing validation. The FDA clearance is based on the device being "substantially equivalent" to predicate devices, meaning it has similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness.
Here's a breakdown based on your requested information, highlighting what is present and what is not applicable:
Neurovision Dissection/Stimulating Accessory Acceptance Criteria and Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on 510(k) regulatory pathway) | Reported Device Performance (from submission) |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Same intended use.
- Similar technological characteristics.
- No new questions of safety or effectiveness raised. | The device is "substantially equivalent" to the predicate devices (Stimulating Hemostat K895676; Nerve Locator Monitor K110140).
Key Technological Similarities/Improvements:
- Modified existing instruments with insulation and connection pin for nerve stimulation.
- Uses same materials and method for insulating as predicate.
- Insulation covers hinging and tips for more precise nerve localization and reduced shorting. |
| Reprocessing Validation: - Cleaning instructions validated.
- Sterilization instructions validated. | Reprocessing validation testing for cleaning and sterilization instructions was conducted according to:
- ANSI/AAMI ST 79:2006
- AAMI TIR 12:2004
- AAMI TIR 30:2011
Conclusion: "These modified instruments present no additional issues with sterilization, safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is not an AI/ML or diagnostic device that uses a "test set" of data in the common sense. The "testing" referred to is engineering and reprocessing validation, not performance on a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth in the context of expert review of images or diagnostic data is not relevant for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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. This is a manual surgical instrument, not an AI-assisted diagnostic or interpretative system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a manual surgical instrument that is always "human-in-the-loop," as its function is to be manually operated by a surgeon. It does not operate as an algorithm or standalone system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the reprocessing validation, the "ground truth" would be regulatory standards and successful adherence to those standards, demonstrating the device can be safely cleaned and sterilized.
- For the substantial equivalence claim, the "ground truth" is the established safety and effectiveness of the predicate devices and the demonstration that the new device does not alter these or introduce new risks, based on engineering analysis and comparison of materials/design.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.