Search Results

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:

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.

Ask a specific question about this device

Disposable Pre-gelled Ag/AgCl Surface Electrodes are intended for recording/stimulation and monitoring of the Electromygraphy (EMG), Electroencephalograph(EEG) and Evoked Potential(EP) signals.

Friendship's Pre-gelled Ag/AgCl Surface Electrodes are disposable (for "single Use Only"). Used to detect electrophysiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The surface electrodes is comprised of top woven layer, carbon layer, Ag/AgCl layer and hydrogel layer on one end electrically connected to lead wire and a touch-proof connector on the other end.

The provided document describes the "Friendship Pre-gelled Ag/AgCl Surface Electrodes," a disposable device for detecting electrophysiological signals or providing electrical stimulation subcutaneously.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions a "simulated use test" but does not quantify the number of electrodes or participants involved.
• Data Provenance: The document does not specify the country of origin for the "simulated use test." It is implied to be related to the manufacturer's location in Xi'an, Shaanxi, China, but this is not explicitly stated as the origin of the test data. The biocompatibility data is from Katecho Inc. and refers to international ISO standards.
• Retrospective or Prospective: The "simulated use test" sounds like a prospective test, but without more details, it's difficult to confirm.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• The document states the device "was evaluated by health care professionals during a simulated use test."
• Number of Experts: Not specified.
• Qualifications of Experts: It collectively refers to "health care professionals," but no specific qualifications (e.g., years of experience, specialty) are provided.

4. Adjudication Method for the Test Set

• No specific adjudication method is mentioned for the "simulated use test." The evaluation by healthcare professionals seems to have led to a conclusion of "acceptable for its intended use" without detailing a multi-reader review process or conflict resolution.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a pre-gelled surface electrode, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone (algorithm only) performance study was not done. This device is a physical electrode, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance relies primarily on adherence to established voluntary standards (ANSI/AAMI EC12/2000 and IEC60601-1 for electrical performance) and biocompatibility testing against ISO standards, along with subjective evaluation by healthcare professionals during a simulated use test for overall acceptability.
• There is no mention of pathology, outcomes data, or expert consensus in the typical sense for a diagnostic device. The "ground truth" for substantial equivalence is based on direct comparison to already cleared predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (electrode), not an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device.

Ask a specific question about this device