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The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles.

BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.

The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The provided text describes BIONEN Needle Electrodes (Disposable Concentric, Disposable Monopolar/Subdermal, and Disposable Monopolar Needle Electrodes) and summarizes the non-clinical tests performed to demonstrate their functionality and safety, asserting substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with quantifiable metrics for device performance (e.g., sensitivity, specificity, accuracy, or precision in signal recording) nor a study that directly proves the device meets such criteria through a clinical validation or comparative effectiveness study.

Instead, the document focuses on compliance with established standards for medical devices and material safety, and performance characteristics related to the physical integrity and electrical properties of the electrodes.

Therefore, many of the requested sections about acceptance criteria and study details cannot be fully extracted as they are not present in the provided text.

Here's a breakdown of what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria for device performance (e.g., signal-to-noise ratio, diagnostic accuracy) are not explicitly stated, nor are comparative performance values against the predicate devices for these aspects. The document focuses on performance related to physical attributes and safety.

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

• Test Set Sample Size:
  • Concentric Needle Electrode: Not explicitly stated for each test, but "Quality control tests are performed on every lot" with "100% control" for needle continuity and pole isolation. Penetration and friction force testing, and aging tests are mentioned but sample sizes are not provided.
  • Monopolar/Subdermal Needle Electrode: Tested on "10% of every lot" for sharpening, bevel/burrs, and needle continuity.
  • Biocompatibility:
    • Cytotoxicity: "Test article treated extract cells" - specific number not given.
    • Intracutaneous Reactivity: "Test article treated extract" - specific number not given.
    • Sensitization: Conducted "on guinea pig" - specific number not given, but refers to reports 408/10, 281/10, 1653 A-10 respectively.
  • Bioburden: "Bioburden tests and Dose Audit are performed every 9 months by a third laboratory on a sample of the specific batch manufactured." - specific sample size not given.
• Data Provenance: The studies are non-clinical laboratory tests, likely conducted in Italy where BIONEN s.a.s. is based. The FDA 510(k) summary is a submission for marketing in the USA. The biocompatibility reports have numbers (e.g., 408/10) but no country of origin is explicitly stated for the lab that performed them. These are retrospective tests conducted on samples of the manufactured devices.

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

• Not applicable / Not provided. The "ground truth" for these tests is based on objective measurements against established international and national standards (e.g., ISO, DIN, ASTM) and physical evaluations (visual, automated electrical checks). There is no indication of expert consensus for these technical performance parameters.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Since the studies are non-clinical technical and safety assessments against defined standards, an adjudication method for human interpretation is not relevant. Results are based on objective measurements or visual inspection against specified criteria.

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 document describes medical electrodes, not an AI or imaging device that would typically undergo an MRMC study. There is no mention of AI assistance or human reader performance.

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

• Not applicable. This document describes a physical medical device (electrodes), not an algorithm.

7. The Type of Ground Truth Used

• Objective Technical Standards and Laboratory Measurements: The ground truth for the device's acceptable performance is established by compliance with international and national standards (e.g., ISO, IEC, DIN, ASTM) for electrical properties, mechanical properties, sterility, and biocompatibility. This includes laboratory test results like cell viability rates, skin irritation grades, and sensitization responses.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This section discusses the performance characteristics of electrodes and does not involve a "training set" in the context of an algorithm or AI.

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

• Not applicable / Not provided. As there is no training set mentioned, the method for establishing its ground truth is also not relevant here.

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