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Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar Stimulating Instrument is sterile and for single use only.

The design of the Rhythmlink International Monopolar Stimulating Instrument is similar to existing stainless steel stimulating instruments. The device consists of a stainless steel wire with biocompatible electrical insulation applied to selected portions, and proximal connector provided to attach the instruments to a monopolar stimulator. The distal surface of the instrument is non-insulated stainless steel to provide for tissue stimulation. The Rhythmlink International Monopolar Stimulating Instrument with cable assembly is a protected pin design and meets requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.

The provided text is related to a 510(k) submission for a medical device called the "Rhythmlink International Monopolar Stimulating Instrument." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study with strict acceptance criteria and performance evaluation against those criteria. In these types of submissions, the "acceptance criteria" are often focused on showing that the new device is as safe and effective as the predicate device by meeting recognized standards and performing similar to the predicate under testing.

Here's an analysis based on the provided text, recognizing that it's a 510(k) summary and not a comprehensive study report:

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

The document does not explicitly state a table of acceptance criteria with specific quantitative thresholds for device performance. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device and adherence to relevant standards.

The key reported performance-related aspect is:

• IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12: The device (Rhythmlink International Monopolar Stimulating Instrument with cable assembly) meets the requirements of this electrical safety standard, specifically Clause 56.3(c) regarding protected pin design.

Acceptance Criteria (Implied from 510(k) context):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide information on a specific clinical "test set" with a defined sample size for performance evaluation in the way a diagnostic device might. The evaluation is focused on engineering and electrical safety standards compliance and comparison to a predicate device. Therefore, details like data provenance (country, retrospective/prospective) are not applicable in this context.

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 information is not applicable as the submission is for a surgical stimulating instrument (Class II) and not a diagnostic device requiring complex ground truth establishment by medical experts for performance evaluation in a clinical setting. The "ground truth" here relates to engineering specifications and electrical safety standards rather than clinical diagnostic accuracy.

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

This information is not applicable for the reasons stated in point 3. There was no clinical test set requiring adjudication.

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. The device is not an AI-assisted diagnostic tool or an imaging device, but rather a direct surgical instrument used for nerve stimulation. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

This is not applicable. The device is a physical surgical instrument and does not involve an algorithm.

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

The "ground truth" in this context is primarily derived from:

• Engineering specifications and standards: Specifically, compliance with IEC 60601-1 for electrical safety.
• Performance of the predicate device: The fundamental "ground truth" for a 510(k) is that the device performs at least as safely and effectively as the legally marketed predicate device (Medtronic Xomed Stimulation/Dissection Instruments, K031003).

8. The sample size for the training set

This is not applicable. As a physical surgical instrument, there is no "training set" in the context of machine learning or AI models.

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

This is not applicable for the reasons stated in point 8.

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