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The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring.

The Synergy IOM System is a 2, 5, or 10 channel electromyograph.

The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for the "Oxford Instruments Synergy IOM System". This type of document generally confirms that a device is substantially equivalent to a predicate device and can be marketed. It does not typically contain detailed information about specific acceptance criteria or the study data used to demonstrate performance against those criteria in the way a medical device performance study report would.

Therefore,Based on the provided text, the following information is not available:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity, F1 score).
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or country of origin (e.g., retrospective or prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: No details on adjudication are available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This document does not mention such a study or its results.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The Synergy IOM System is described as an electromyograph for various physiological signal testing, implying it's a diagnostic tool that likely requires human interpretation, rather than a standalone AI algorithm. No AI algorithm performance is discussed.
7. The type of ground truth used: Ground truth definition is not discussed.
8. The sample size for the training set: There is no mention of a training set, as this is not an AI/ML device in the context of the document.
9. How the ground truth for the training set was established: Not applicable, as no training set is discussed.

What is available from the text:

• Device Name: Oxford Instruments Synergy IOM System
• Regulatory Class: II
• Product Code: IKN and CAB
• Indications for Use: "The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring."
• Study described: The document is a 510(k) premarket notification response, indicating that the device has been found "substantially equivalent" to legally marketed predicate devices. This equivalence is the basis for its clearance, rather than a specific performance study against defined acceptance criteria (as would be seen for novel devices or AI/ML components).
• Ground Truth (implied): For a 510(k) clearance based on substantial equivalence, the "ground truth" and performance of the predicate device (which is not explicitly named in this excerpt but would have been part of the 510(k) submission) serve as the benchmark. The implication is that the Synergy IOM System performs comparably to the predicate for the stated indications.

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