(91 days)
The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.
The Ambu Neuroline Concentric Needle is a Single Patient EMG Needle Electrode and is used to measure an EMG signal when connected to the EMG equipment through a 5 pins reusable cable. The Electromyogram (EMG) records electrical activity within the muscle. It is used mainly to tell the difference between muscle diseases and nerve diseases. The Ambu Neuroline Concentric Needle is a sterile product.
The provided document is a 510(k) summary for the Ambu Neuroline, Disposable Concentric needle electrode. It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it details the non-clinical and biocompatibility tests performed for a traditional medical device (a needle electrode).
Therefore, I cannot populate the table or answer the questions as requested, as the provided input does not describe an AI/ML device or a study with such performance metrics.
However, I can extract the information provided about the non-clinical tests that were performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or reported performance for the device in a table format. It generally states that non-clinical tests were performed to "verify the functionality" and "ensure the functionality during the shelf life." The conclusion is that the device "fulfils the product specifications set for the design."
The non-clinical tests mentioned are:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Penetration and friction force | Verification performed according to DIN 13097. Fulfilled product specifications. |
| Electrical properties | Verification performed. Fulfilled product specifications. |
| Shelf life functionality (Ageing) | Performed to verify and ensure functionality during shelf life. Fulfilled product specifications. |
| Biocompatibility (Cytotoxicity, Hypersensitivity, Intracutaneous, Systemic Injection) | Passed; materials demonstrate appropriate levels of biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The tests are non-clinical, laboratory-based verification tests for a physical device, not a data-driven AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on medical images) is not relevant for these physical device verification tests.
4. Adjudication method for the test set
Not applicable.
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 is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For the physical device tests (penetration, friction, electrical properties, ageing), the "ground truth" would be objective measurements and adherence to established standards (e.g., DIN 13097) and internal product specifications. For biocompatibility, it's based on results from standardized ISO 10993-1 tests (e.g., cell viability, immune response).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).