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Diamond Burs are specially designed surgical accessories designed to help the surgeon cut and drill bone and bony structures during orthopedic procedures.

AI/ML Overview

The provided text is a 510(k) summary for a reprocessed medical device, specifically Alliance Medical Corporation Reprocessed Diamond Burs. This document describes the device, its intended use, and the basis for its substantial equivalence to a predicate device, which is typically established through various performance tests.

Here's an analysis to extract the requested information, noting that the document structure for a 510(k) summary does not align with a detailed clinical study report often provided for AI/ML devices. Therefore, some information expected for AI/ML device studies might not be present or directly applicable.

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

The document lists categories of performance testing rather than specific quantitative acceptance criteria or detailed reported performance values.

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	Bench and laboratory testing demonstrated performance.
Validation of Reprocessing	Bench and laboratory testing demonstrated performance.
Sterilization Validation	Bench and laboratory testing demonstrated performance.
Function Test(s)	Each individual Diamond Bur is tested for appropriate function of its components prior to packaging and labeling. Bench and laboratory testing demonstrated performance.
Packaging Validation	Bench and laboratory testing demonstrated performance.

Conclusion: "Performance testing demonstrates that Reprocessed Diamond Burs perform as originally intended." This indicates that the device met the established criteria for each test category, though the specific quantitative criteria are not detailed in this summary.

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 specify a "test set" in the context of clinical data or patient cohorts as would be relevant for an AI/ML device. The testing described is bench and laboratory testing, which applies to the physical reprocessed burs themselves.

Sample Size: Not explicitly stated for each test, but it implies a sufficient number of reprocessed burs were tested to ensure performance.
Data Provenance: Not applicable as it's not clinical data. The tests were conducted internally by Alliance Medical Corporation.
Retrospective or Prospective: Not applicable.

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 is not applicable to the type of device and testing described. The "ground truth" here is based on engineering specifications, test standards, and the original performance of new diamond burs, validated through bench and lab tests, not expert clinical interpretation of data.

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

Not applicable. The described testing involves objective laboratory measurements and validations, not subjective clinical assessments 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

Not applicable. This device is a surgical instrument, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This device is a physical surgical instrument.

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

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and functional requirements equivalent to the original, new device. This is confirmed through laboratory testing (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) to ensure the reprocessed device performs "as originally intended."

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set.

Summary of Device and Approval Context:

This 510(k) summary is for a reprocessed medical device. The core of the submission is to demonstrate that the reprocessed device is substantially equivalent to its predicate device(s). This is achieved by proving that the reprocessing methods restore the device to its original performance capabilities and safety profile. The "study" described is a series of bench and laboratory tests focusing on:

Biocompatibility: Ensuring the materials, after reprocessing, remain safe for contact with human tissue.
Validation of reprocessing: Demonstrating that the reprocessing steps (cleaning, decontamination) effectively remove contaminants and restore the device.
Sterilization Validation: Confirming the device can be consistently sterilized.
Function test(s): Verifying the bur's cutting ability, structural integrity, and other mechanical functions.
Packaging Validation: Ensuring the packaging maintains sterility and integrity until use.

The conclusion is that these tests demonstrate the reprocessed burs perform "as originally intended," thereby establishing substantial equivalence. The document does not provide the detailed quantitative results or specific pass/fail criteria for each test, which would typically be found in the full submission but are summarized for the 510(k) public abstract.

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