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The Midas Rex MR8 Depth Stop attachment and tools are indicated for the incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

The Midas Rex MR8 Depth Stop attachment and tools are intended to create a cranial access hole of a known diameter and depth.

This document (K213454) is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study that proves the device meets those criteria.

Specifically, this submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a comprehensive study protocol and results for a new device's performance against specific acceptance criteria. The document states that "The changes from the predicate, do not raise any new issues of safety and effectiveness" and that "The following testing was conducted to demonstrate that the modifications to the subject devices are as safe and effective as the predicate." This implies that the focus was on validating that the changes did not degrade performance, and the existing predicate device's performance serves as the benchmark.

Therefore, many of the questions asked cannot be directly answered from the provided text.

Here's an attempt to extract what is available and explain what is missing:

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

The document does not provide a table of acceptance criteria and reported device performance in the way you've requested. Instead, it describes a comparison to a predicate device to demonstrate substantial equivalence. The "performance" is primarily implied by the claim that the technological characteristics are similar and that conducted testing (Product Life Verification, Summative Validation, Biocompatibility Testing) supports the functionality, integrity, and safety and effectiveness for its intended use, making it "as safe and effective as the predicate."

The closest thing to "acceptance criteria" discussed are the aspects compared to the predicate, as shown in the table on pages 5-6. However, these are comparative features, not quantified performance criteria with acceptance thresholds.

2. Sample size used for the test set and the data provenance

The document mentions "Product Life Verification," "Summative Validation," and "Biocompatibility Testing." However, it does not specify sample sizes for any of these tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for a mechanical device modification, these would likely be engineering and bench testing, not clinical studies in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described (Product Life, Summative Validation, Biocompatibility) are typically engineering validation tests, not clinical studies requiring expert ground truth in the context of diagnostic AI.

4. Adjudication method for the test set

This information is not provided. As above, the described testing types do not typically involve adjudication methods for "ground truth" derived from expert consensus.

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

No MRMC study was done or mentioned. This device is a surgical drill accessory, not an AI software/diagnostic device.

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

Not applicable. This device is a mechanical surgical tool component, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" in the way it's typically applied to AI or diagnostic studies (expert consensus, pathology, outcomes data) is not relevant or discussed for this type of mechanical device submission. The "ground truth" for this device would be established by engineering specifications, material properties, and mechanical performance tests.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/machine learning product that requires a training set.

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

Not applicable. As above, this is a mechanical device.

Summary of Findings from the Document:

The K213454 submission demonstrates substantial equivalence primarily by:

• Comparing the subject device's features and intended use to a legally marketed predicate device (K191597).
• Highlighting that the differences are minor (e.g., extended depth setting, minor tool head geometry, new user task, compatibility with MR8 system) and do not raise new safety or effectiveness concerns.
• Stating that risk management (ISO 14971:2019) was conducted and found no new risks.
• Reporting that specific engineering tests were conducted: "Product Life Verification," "Summative Validation," and "Biocompatibility Testing," which "demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use."

The document's purpose is to show that the modified device is "as safe and effective" as the already cleared predicate, rather than to establish new, distinct performance criteria and demonstrate achievement of those from scratch.

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