(387 days)
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. IOM Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a 'touch-proof' safety connector(s) on the distal end.
All IOM Stimulator Probes are sterilized by Ethylene Oxide and single use only.
The IOM Stimulator Probes are composed by the part in contact with the patient that is medical grade stainless steels, then there is the handle part and cable in biocompatible plastic; finally the cable has a 'touch-proof' safety connectors.
The provided document is a 510(k) summary for the "IOM Stimulator Probes" and describes a comparison study against predicate devices to establish substantial equivalence. It does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically associated with clinical performance or algorithm evaluation (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device has similar technological characteristics to legally marketed predicate devices, and that differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested details, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, and training set information, are not applicable to the type of study presented in this document.
Here's an analysis of what is available in the document related to acceptance criteria and the "study" (which is a comparison for substantial equivalence):
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the acceptance criterion for regulatory clearance is establishing substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is demonstrated through a comparison of technological characteristics with predicate devices.
The document provides multiple comparison tables, one for each type of IOM Stimulator Probe. Below is a summarized example for one probe type, to illustrate how the comparison functions as "performance" in this context.
Table: Comparison of IOM Stimulator Probes (Example for Neural stimulator probe insulated monopolar)
| Specification | Acceptance Criteria (Implied by Predicate Performance) | Proposed Spes Medical Probe Performance | Discussion on Equivalence (Meeting Criteria) |
|---|---|---|---|
| Stimulating Surface Area (mm²) | ~4.7 mm² (from Rhythmlink PD) | 7.5 mm² | "The stimulating area is larger than the PD, this doesn't change in dangerous way current densities. So these two differences not affect the safety and effectiveness as compared to the predicate." |
| Tip Diameter (mm) | 0.75 mm (from Rhythmlink PD) | 1.2 mm | "The tip diameter is bigger in Spes Medica device... So these two differences not affect the safety and effectiveness as compared to the predicate." |
| Shaft Length (mm) | 100 mm (from Rhythmlink PD) | 45 mm | "The differences between the two devices are shaft length... Shaft is insulated and the length is only an ease of use... So these two differences not affect the safety and effectiveness as compared to the predicate." |
| Lead Length (cm) | 150 cm and 250 cm (from Rhythmlink PD) | 250 cm | "The cable length is the same 250 cm" |
| Bend Angle (degrees) | 0° (from Rhythmlink PD) | 0° | The bend angle is the same. |
| Material In Contact with Patient | Stainless steel (from PDs) | Stainless steel AISI 316L | Same material. |
| Touch Proof Connector | YES (from PDs) | YES | Same characteristic. |
| Single Use | YES (from PDs) | YES | Same characteristic. |
| Sterilization | EtO (from PDs) | EO sterilized | Same characteristic. |
The document includes similar comparison tables for:
- Neural stimulator probe bipolar hook (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe tripolar hook (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe monopolar ball (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe bipolar balls (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe bipolar concentric (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe bipolar minifork (compared to Medtronic)
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 applicable and not provided. The "study" here is a comparison of product specifications and characteristics against predicate devices, not a clinical study involving patients or a performance evaluation against a labeled dataset. There is no "test set" in the context of clinical data or algorithm performance.
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 and not provided. As above, there is no "test set" requiring expert ground truth in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 and not provided. This device is a surgical stimulator probe, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This device is a passive surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The "ground truth" equivalent would be the established specifications and performance of the legally marketed predicate devices, against which the new device's specifications are compared.
8. The sample size for the training set
This information is not applicable and not provided. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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.