(101 days)
The Technomed Europe Kartush disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Kartush Disposable surgical stimulators are invasive devices used in the tissue dissection and monopolar stimulating. The instruments have different tip shapes for performing different dissection and stimulating procedures. The tip, tapered shaft, handle and connection pin are made of 1 pieces material. The instruments are designed for single-patient/multiple application use. The detachable lead wire has a safety DIN 42802 connector.
This document describes the premarket notification (510(k)) for Technomed Europe's Kartush Disposable Surgical Stimulators. It does not contain information about a study proving the device meets acceptance criteria in the way you've outlined for performance studies (e.g., diagnostic accuracy with medical imaging or other AI/software as a medical device).
Instead, this 510(k) submission establishes substantial equivalence to a predicate device (Medtronic Xomed Stimulus/Dissection Instruments, Ball-Tip Probes, K031003) for regulatory clearance. The "acceptance criteria" here are based on the comparison of characteristics between the proposed device and the predicate.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) for substantial equivalence, the "acceptance criteria" are effectively that the proposed device demonstrates characteristics that are "same as" or "equivalent to" the predicate device, especially regarding safety and effectiveness.
| Characteristic | Acceptance Criteria (Predicate Device K031003) | Reported Device Performance (Kartush Disposable Surgical Stimulators) |
|---|---|---|
| Indications for Use | Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery including spinal nerve roots. | Same |
| Base material | Stainless steel | Same |
| Electrical insulation | Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection | Same |
| Distal patient contact surface material | Stainless steel | Same |
| Proximal stimulator connector | Yes | Yes |
| IEC 60601-1 protected pin design | Touch proof connector | Same |
| Patient contact material | Biocompatible | Same |
| Use and delivery | Single use and sterile | Same |
| Non-clinical data | Performance characteristics of predicate device. | Bench testing confirmed equivalence in: |
- Dimensional measurements (current density)
- Impedance tests (through saline)
- Material comparison
- Dielectric strength test (shaft and handle insulation) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the context of a clinical study or a labeled "test set" for performance evaluation against a ground truth. The evaluation was based on a comparison of device specifications and the results of bench testing for the proposed devices against the characteristics of the predicate device.
- Data Provenance: The bench testing was conducted by Technomed Europe (manufacturer located in The Netherlands). The document does not specify if external labs were used or the specific origin of materials, but the testing was conducted by the manufacturer.
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)
Not applicable. This is not a study requiring expert consensus for ground truth on clinical data. The "ground truth" for this 510(k) is the established performance and safety profile of the predicate device, as already cleared by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical study involving human readers or cases requiring adjudication.
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 device is a surgical instrument (nerve stimulator/locator), not an AI-powered diagnostic tool. Thus, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this substantial equivalence submission is based on the previously FDA-cleared predicate device's design specifications, materials, and established indications for use and safety/effectiveness profile, as demonstrated through non-clinical (bench) testing. The non-clinical data (bench testing) performed on the proposed device aimed to confirm that its performance characteristics (e.g., current density, impedance, insulation integrity) were equivalent to those expected from the predicate.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for an AI/machine learning model. The basis of comparison is the predicate device's established regulatory clearance and characteristics.
§ 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.