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The Neuroline, Disposable Monopolar needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.

The Ambu Neuroline Disposable Monopolar needle electrode is a Single Patient EMG needle electrode and is used to measure an EMG signal when connected to the EMG equipment. The Ambu Neuroline Disposable Monopolar needle is manufactured in different lengths and diameters. The Ambu Neuroline Disposable Monopolar needle is connected to the EMG equipment through a 1.5 mm touch proof connector according to DIN 42 802 either with a pre-attached cable or as a non-cable version to be used with Ambu's reusable cable for the Ambu Neuroline Monopolar. The Ambu Neuroline Disposable Monopolar needle electrode is a sterile product.

The provided text describes a 510(k) application for a medical device (Neuroline Disposable Monopolar needle electrode) seeking substantial equivalence to existing devices. It details the device's characteristics, intended use, and the non-clinical tests performed. However, it explicitly states that no clinical tests were performed for this updated version of the device. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria cannot be fully extracted from the provided text as it pertains to a clinical efficacy study.

Based on the provided text, the device's acceptance criteria and "proof" are based on non-clinical performance verification and biocompatibility testing, and by demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a series of non-clinical laboratory tests and biocompatibility tests. The document explicitly states: "The non-clinical tests performed are laboratory tests to verify the functionality of the Ambu Neuroline Disposable Monopolar needle electrode. The Ambu Neuroline Disposable Monopolar needle electrode is tested for penetration force, friction force and electrical properties. The verification of the sharpness and the friction of the needle was performed according to DIN 13097. Ageing tests are performed to verify and ensure the functionality during the shelf life of the product." and "The biological safety of the Ambu Neuroline Disposable Monopolar needle electrode has been assured through the selection of materials, which demonstrate appropriate levels of biocompatibility. Tests were selected on the basis of ISO 10993-1 - Biological evaluation of Medical Device."

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

• Sample size: Not specified. The description refers to "laboratory tests" and "biocompatibility tests" but does not provide specific sample quantities for the tested units or animals.
• Data provenance: The tests were performed in a laboratory setting, likely by the manufacturer (Ambu A/S). The specific country of origin for the raw data is not explicitly stated, but the manufacturer is based in Denmark. These are non-clinical, prospective tests, meaning they were conducted specifically for this regulatory submission to evaluate the device's performance against predefined standards.

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

This information is not applicable / not provided for this submission. The "ground truth" here is objective measurement against engineering specifications and biological safety standards (e.g., DIN 13097 for mechanical properties, ISO 10993-1 for biocompatibility). These do not typically involve human expert consensus for "ground truth" in the way a clinical diagnostic study would. The acceptance criteria were based on predefined engineering and biocompatibility standards.

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

This information is not applicable / not provided. Adjudication methods are typically used in clinical studies where human interpretation or a "gold standard" is debated. For non-clinical lab tests against objective standards, the test results (e.g., force measurements) either pass or fail the specified limit.

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. The document explicitly states: "No clinical tests were performed for the updated version of the Ambu Neuroline Disposable Monopolar needle because it has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Monopolar needle electrode." This is a needle electrode, not an AI-powered diagnostic device, so an MRMC study with AI assistance is irrelevant to this submission.

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

No. This is a hardware medical device (a needle electrode), not a software algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

The "ground truth" for the non-clinical tests involved objective measurements against established engineering standards (e.g., DIN 13097) and biological safety standards (ISO 10993-1). For example, for "penetration force," the ground truth is a specific force value that the needle must not exceed. For biocompatibility, it's the passing of established in vitro and in vivo biological assays.

8. The sample size for the training set:

Not applicable / not provided. As no clinical studies were performed and this is a hardware device (not an AI algorithm), there is no concept of a "training set" in the context of this 510(k) submission.

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

Not applicable / not provided. (See point 8).

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