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This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.

Device Description

Medical disposable sterile needle electrodes are sterile, single use products that penetrate the skin and directly contact the extracellular fluid during use, forming a good electrolyte interface. The pointed part of the needle electrode makes contact with the nerves, muscles, or other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires.

AI/ML Overview

This appears to be an FDA 510(k) clearance letter for a Medical Disposable Sterile Needle Electrode. The document describes the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.

Crucially, this document is for a medical device (a physical needle electrode), not a software/AI-driven device that would involve a test set, ground truth experts, MRMC studies, or training sets in the way your request describes. Therefore, many of the requested criteria are not applicable.

However, I can extract the information that is present and explain why other sections are not relevant.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this type of device are primarily based on non-clinical performance (physical and biological safety) and demonstrating substantial equivalence to a predicate device. There isn't a "performance" metric in the sense of accuracy, sensitivity, or specificity as one would find for an AI algorithm.

Test / Attribute	Acceptance Criteria (Implied by standard and "Pass" result)	Reported Device Performance
Non-Clinical Testing	Meets specified standards for functional performance.
Surface quality	Acceptable surface finish; no defects impacting safety or performance.	Pass
Sharpness index	Meets specified sharpness requirements for penetration.	Pass
Toughness	Withstands expected stresses without breakage or loss of integrity.	Pass
Connection strength	Connections (e.g., needle to wire) maintain integrity during use.	Pass
Electrical conductivity	Conducts electrical signals effectively as intended.	Pass
Conductive terminals and needle body insulation	Insulation prevents unintended electrical paths.	Pass
Sterility testing	Achieves and maintains sterility (SAL of $10^{-6}$).	Pass (and SAL $10^{-6}$ demonstrated)
Biocompatibility Testing	Meets biological safety requirements per ISO 10993-1 for subdermal communicating devices with muscle.
In vitro cytotoxicity	Non-cytotoxic (as per ISO 10993-5).	Non-cytotoxic
Skin sensitization	Non-sensitive (as per ISO 10993-10).	Non-sensitive
Intracutaneous reactivity	Non-irritation (as per ISO 10993-23).	Non-irritation
Acute systemic toxicity	Non-acute systemic toxicity (as per ISO 10993-11).	Non-acute systemic toxicity
Pyrogen	Non-pyrogenic (as per ISO 10993-11).	Non-pyrogenic
Sterilization	Validated according to ISO 11135:2014, achieving SAL of $10^{-6}$ and meeting EO residuals per ISO 10993-7.	Yes (meets ISO 11135, SAL $10^{-6}$, and ISO 10993-7 residuals)
Shelf-Life	Maintains performance and safety for stated duration.	3 years (based on accelerated and real-time aging)

2. Sample sized 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 to this type of device. The "tests" mentioned are physical and chemical laboratory tests on manufactured samples of the device, not clinical data sets of patients. There is no concept of "data provenance" in the context of clinical images or patient data.

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 is not applicable. There is no "ground truth" established by experts in the context of an electromyography needle electrode. The performance is assessed through standardized laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There is no "test set" requiring adjudication in the context of an electromyography needle electrode.

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 is not applicable. This is a physical medical device, not an AI software. MRMC studies are used for evaluating diagnostic imaging AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As mentioned, "ground truth" in the AI/software sense is not applicable. For this device, the "truth" is established by adherence to recognized international standards for biocompatibility (ISO 10993 series), sterilization (ISO 11135), and general physical performance testing (e.g., surface quality, sharpness, electrical conductivity).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device.

9. How the ground truth for the training set was established

This is not applicable. There is no "training set" or associated "ground truth" for a physical medical device. The "truth" is established through engineering design, material science, and adherence to established manufacturing and testing standards.

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