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The Highland Instruments CES and TUS Instrument Holder is intended for use in assisting holding and securing commercially available CES electrodes and diagnostic Transcranial Ultrasound System Probes in the desired position on the patient's head.

The Highland Instrument CES and TUS Instrument Holder is intended to position and hold in position the ultrasound probe of a Transcranial Ultrasound device while at the same time assisting in maintaining the position of electrodes used with a Cranial Electrotherapy Stimulator (CES) device and keeping the electrode lead wires free from entanglement and otherwise free from being disturbed by the patient. The Highland Instrument Holder allows for a physician to utilize a commercially available CES device while simultaneously observing/measuring cerebral regional blood flow in discreet areas of the brain. It further allows the physician to utilize a commercially available CES device while imaging the brain with transcranial ultrasound imaging probes that do not contain the Doppler option.

The provided 510(k) summary for the Highland Instruments CES and TUS Instrument Holder does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be presented for a diagnostic or AI-driven device.

This document describes a medical device that is an "instrument holder," which is a physical device used to position and hold other medical instruments (ultrasound probes and CES electrodes). Its substantial equivalence is based on its functional design and its ability to hold instruments, rather than on performance metrics related to diagnostic accuracy, sensitivity, or specificity.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or not present in this type of 510(k) submission for a physical positioning device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For this type of device, "acceptance criteria" are implied by its intended function and safety. The reported performance refers to "functional testing" and a "biocompatibility assessment," but detailed quantitative results or specific pass/fail criteria are not included in this summary.

Regarding the specific questions about studies proving the device meets acceptance criteria (which are more relevant to diagnostic/AI devices):

• 2. Sample size used for the test set and the data provenance: Not applicable. The "testing" mentioned is laboratory bench testing for mechanical function and biocompatibility, not a clinical study with a test set of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for an instrument holder.
• 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 device or a diagnostic device that requires reader performance evaluation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical stability and ability to hold instruments as designed, verified through engineering tests.
• 8. The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Functional Testing and Biocompatibility Assessment):

The submission states that "Descriptive information, laboratory bench testing and a biocompatibility assessment were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use."

• Type of Study: Laboratory bench testing and biocompatibility assessment.
• Objective: To demonstrate the device's ability to position and hold transducers/lead wires and its safety through material assessment.
• Methodology (briefly described): Testing was performed to demonstrate the ability of the device to position and hold a variety of transducers and lead wires. A biocompatibility assessment affirmed that the device introduces no new materials from consumer products.
• Results (general statement): The testing demonstrated the device's ability to perform its intended function and its safety. Specific quantitative results are not provided in this summary document.
• Conclusion: The device was deemed substantially equivalent to predicate devices based on its design, intended use, principles of operation, and the results of the functional and biocompatibility testing.

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