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Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.

The Ad-Tech Spinal Electrode addressed in this premarket notification has identical materials, technological characteristics, sterilization procedures and packaging as the commercially available Ad-Tech Depth Electrode (K891920B). The device has similar intended use, materials and technological characteristics to the commercially available Nicolet Epidural Spinal Electrode (K882053). Like this device, the Ad-Tech Spinal Electrode is to be placed epidurally for monitoring evoked potentials.

The provided 510(k) summary for the Ad-Tech's Spinal Electrode does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Nicolet Epidural Spinal Electrode K882053) based on:

• Identical materials, technological characteristics, sterilization procedures, and packaging to a commercially available Ad-Tech Depth Electrode (K891920B).
• Similar intended use, materials, and technological characteristics to the Nicolet Epidural Spinal Electrode.

The document states: "Ad-Tech believes that the information provided in this premarket notification clearly demonstrate that it is safe and equivalent to the mentioned commercially marketed predicate device." This implies that the 'acceptance criteria' for this 510(k) submission was substantial equivalence, not specific performance metrics demonstrated through a detailed study on the new device.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission relies on equivalence.
2. Sample size used for the test set and the data provenance: Not applicable, no specific test set or study is described for the new device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission is for a medical device that established substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria for a new, innovative technology.

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