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Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The electrodes are sterile and for single patient use only.

Xian Friendship Electronics Co., Ltd.s' Subdermal Needle Electrodes are disposable (for "Single Use Only"),sterile devices 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 subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment.

The safety connector is an industry standard DIN 42802 protected, "touch proof connector and cannot be connected to an AC outlet.

Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.

Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.

The provided document is a 510(k) summary for the Xian Friendship Electronics Co., Ltd.'s Subdermal Needle Electrodes, seeking clearance from the FDA for substantial equivalence to predicate devices. It does not contain information about a study proving device performance against specific acceptance criteria in the context of AI/ML or comparative effectiveness. Instead, it relies on demonstrating similarity to already cleared predicate devices.

Therefore, many of the requested sections (e.g., specific acceptance criteria for performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) are not applicable or not provided in the document.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance Study for Xian Friendship Electronics Co., Ltd.'s Subdermal Needle Electrodes

This submission primarily focuses on demonstrating substantial equivalence to predicate devices through similarities in materials, design, and function, rather than presenting a de novo study with explicit performance acceptance criteria typical of novel or AI/ML-driven devices.

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, explicit performance acceptance criteria and reported numerical performance metrics are not provided as they would be for a direct performance study. The "acceptance criteria" here are implicitly meeting the safety and effectiveness standards demonstrated by the predicate devices. The device meets these by being "identical" or "similar" in key characteristics.

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

• Sample Size: Not applicable. There was no formal "test set" of patient data or images in the context of evaluating performance metrics.
• Data Provenance: Not applicable. The submission relies on design and material comparisons to predicate devices, not on data from specific patients or studies.
• Retrospective or Prospective: Not applicable.

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

• Number of Experts: Not applicable. No ground truth establishment by experts was detailed for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable as no such study was performed or described.

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

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical medical electrode, not a software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the traditional sense of AI/ML or diagnostic device evaluation. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, which this new device aims to match through identical or similar design, materials, and function.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This document does not describe the development or evaluation of an AI/ML model, so there is no "training set."

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

• Ground Truth Establishment: Not applicable. There was no training set for an AI/ML model.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (implicit) acceptance criteria for safety and effectiveness is primarily a non-clinical comparative analysis against legally marketed predicate devices (Axon Systems, Inc.'s Subdermal Needle Electrodes (K050194), Rhythmlink International Subdermal Needle Electrodes (K022914), and Medtronic Functional Diagnostics A/S Disposable Monopolar Needle Electrodes (K990375)).

The manufacturer states:

• "The materials of construction of the Subdermal Needle Electrodes are identical to those for the Axon Systems, Inc.'s Subdermal Needle Electrodes and Rhythmlink International Subdermal Needle Electrodes."
• "The safety feature and other functional and performance characteristics of the Subdermal Needle Electrodes are identical to those 'Predicate Devices'. Those features and characteristics were already verified and validated."
• "Clinical studies were not deemed necessary regarding the Subdermal Needle Electrodes due to their similarity in materials, design and function to those 'Predicate Devices'."
• "The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use." (No further details on this simulated use test were provided, such as sample size, methodology, or specific criteria).
• Biocompatibility relies on the known biocompatibility of the materials (medical grade 304/316 series Stainless Steel) and prior testing reported in the predicate device 510(k) submissions.

In essence, the "study" is a justification for substantial equivalence based on direct comparison of design specifications and materials to already cleared devices, coupled with a brief mention of a simulated use test.

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