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Axon Systems' 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.

Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological 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 text describes a 510(k) premarket notification for Axon Systems' Subdermal Needle Electrodes. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device.

Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training) are not applicable to this type of submission as the core of a 510(k) is about demonstrating similarity to existing, legally marketed devices.

However, I can provide information based on what is available in the document:

1. Table of Acceptance Criteria and the Reported Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate devices, or that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states: "Axon Systems' Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This is the core performance claim in the context of a 510(k). Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided as they are typically not required for this type of submission unless a significant new technological feature is being introduced that affects performance beyond that of the predicate.

2. Sample size used for the test set and the data provenance:

• Not Applicable: This was a 510(k) submission focused on substantial equivalence to predicate devices. There is no mention of a "test set" in the context of a performance study with human subjects or a dataset. The evaluation likely involved technical comparisons and analysis of the device's design, materials, and intended use against the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: See point 2.

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

• Not Applicable: See point 2.

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 device is a Subdermal Needle Electrode, which is an invasive medical device for recording and stimulating biopotential signals. It is not an AI-powered diagnostic imaging device or software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not Applicable: This device is hardware and is used by a licensed physician or technologist. It does not operate as a standalone algorithm in the way AI software would.

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

• Not Applicable: The concept of "ground truth" as used in performance studies (e.g., for diagnostic accuracy) is not relevant here. The "truth" in a 510(k) is established by successfully demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it shares their fundamental safety and effectiveness profile.

8. The sample size for the training set:

• Not Applicable: See point 2. There is no mention of a "training set" as this is not an AI/machine learning device requiring such a component.

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

• Not Applicable: See point 8.

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