(223 days)
Xian Friendship Disposable Nerve Stimulator Probes is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. Xian Friendship Disposable Nerve Stimulator Probes are sterile (EtO), single-patient-use device.
Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in three electrical configurations such as monopolar, bipolar and concentric forms according to the required application. 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. Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve. The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope. Concentric Probes is designed with an outer anode pole and center cathode pole separated by insulation. Tip diameter approx 1mm. Monopolar electrodes require a separate stimulator return electrode and the Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed. Bipolar probe has a fully insulated probe shaft with two 1 mm exposed flush tips. The anode and cathode tips can spread up to 3 mm apart and will penetrate tissue for stimulation current to flow.
This device is a nerve stimulator probe, not an AI/ML device. Therefore, the requested information elements related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, training/test set sample sizes, and expert qualification for ground truth) are not applicable and cannot be extracted from the provided text.
The provided document describes a 510(k) premarket notification for a traditional medical device. The study performed is a bench test to verify that the device meets design specifications and performance characteristics, and to demonstrate substantial equivalence to predicate devices.
Here's the relevant information about the acceptance criteria and study, as it pertains to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific quantitative acceptance criteria or detailed reported performance values. Instead, it states that "Bench testing for mechanical and electrical performance was conducted to verify that the device meets design specifications and performance characteristics in accordance with Xian Friendship Disposable Nerve Stimulator Probe's internal specifications." and also to demonstrate substantial equivalence to predicate devices.
The acceptance criteria are implicitly tied to the general performance characteristics of nerve stimulator probes and the characteristics of the predicate devices. These characteristics include:
| Feature/Description | Acceptance Criteria (Implicit, based on predicates) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Perform localized stimulation of neural tissue; locate, identify, and monitor cranial motor nerves, peripheral nerves, and spinal nerve roots during surgery. | Device performs as intended, substantially equivalent to predicate devices. |
| Mechanical Performance | Meet internal design specifications for integrity, durability, and functionality (e.g., handle, shaft, tip). | Verified through bench testing against internal specifications. |
| Electrical Performance | Meet internal design specifications for electrical conductivity, insulation, and stimulation delivery. | Verified through bench testing against internal specifications. |
| Material Composition | Stainless steel (SST 304) for shaft, PTFE for insulation, Medical Grade ABS for handle, Tin Plated Copper for lead wire, Medical Grade PVC for lead wire insulation. | Same materials as predicate devices. |
| Sterilization Method | EtO | EtO |
| Single Patient Use | Yes | Yes |
| Shelf Life | 36 months | 36 months |
| Connector Type | DIN 42802 "touch-proof" safety connector | Same as predicate devices. |
| Tip Shapes | Standard tip, Ball, Flush Tip, Hook (comparable to predicates) | Standard tip, Ball, Flush Tip, Hook |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the bench testing. In typical medical device bench testing for substantial equivalence, a representative sample of devices is tested, but the precise number is rarely detailed in the 510(k) summary.
- Data Provenance: The testing was conducted internally by Xi'an Friendship Medical Electronics Co., Ltd. The provenance is internal company testing, specifically for the purpose of this 510(k) submission. It is retrospective in the sense that the data was collected for assessing the manufactured device against existing specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable as the study involves bench testing of a hardware device's physical and electrical properties, not clinical data requiring expert interpretation for ground truth. "Ground truth" in this context refers to engineering specifications and performance standards.
4. Adjudication Method for the Test Set
- This concept does not apply. Bench testing for mechanical and electrical performance typically involves objective measurements against predefined engineering specifications, not subjective interpretation 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
- No, an MRMC study was not done. This is a traditional medical device (nerve stimulator probe) and does not involve AI or human "readers" in the context of image interpretation or similar diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is not an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this type of device study is primarily engineering specifications and established performance standards for nerve stimulator probes, as well as the characteristics and performance of the predicate devices. Compliance with these specifications (e.g., material composition, electrical output, mechanical integrity) serves as the ground truth.
8. The Sample Size for the Training Set
- This is not applicable. There is no "training set" as this device does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI/ML for this 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.