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The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.

AI/ML Overview

The provided text is a 510(k) Summary for the ArthroCare Adjustable Fixation Device. It describes the device, its intended use, and non-clinical data establishing substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/algorithm performance.

Instead, it refers to:

Bench testing: "Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading."
Design Verification testing: "to demonstrate conformance to design and performance specifications."

The document explicitly states: "No clinical or animal data are included in this submission." This indicates that the regulatory submission primarily relies on non-clinical (bench) testing and comparison to predicate devices, rather than a study with human subjects, AI standalone performance, or MRMC studies.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be filled from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

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

The document mentions "conformance to design and performance specifications" and that "All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices" and "meet their design, performance, and safety specifications." However, no specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the exact reported performance values are provided in this summary. It only states that the device passes these unspecified criteria.

Acceptance Criteria	Reported Device Performance
Not specified in this document (e.g., specific thresholds for cyclic and static loading, design specifications)	Not specified quantitatively in this document (e.g., actual load values sustained, specific metrics from design verification tests). The document only states that the device "meets their design, performance, and safety specifications" and is "substantially equivalent" to predicates.

Regarding the study that proves the device meets the acceptance criteria:

Since this is a physical medical device (Adjustable Fixation Device for soft tissue to bone fixation), the "study" referred to is a series of non-clinical, bench-top tests, not a study of an AI algorithm's performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified for the bench testing.
Data Provenance: The document only mentions "simulated human bone substrate" for comparative testing, indicating laboratory-based, non-clinical data. No country of origin for data is relevant or mentioned as it's not a human study.
Retrospective or Prospective: Not applicable as this is bench testing on simulated materials.

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)

Not applicable. Ground truth for mechanical bench testing is typically based on engineering standards, material properties, and standardized testing protocols, not expert human interpretation.

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

Not applicable, as this refers to adjudication for human-interpreted data (like radiology reads) which is not part of this submission. The "ground truth" for bench tests is determined by physical measurements and engineering analyses.

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. An MRMC study is for evaluating diagnostic image interpretation by humans, often with and without AI assistance. This submission is for a physical orthopedic fixation device and does not involve AI or human readers for diagnostic tasks.

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

No. This device is not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

The "ground truth" for the non-clinical bench testing would be engineering specifications, material science properties, and adherence to established biomechanical testing standards. For instance, a certain load (in Newtons) or number of cycles might be the "ground truth" performance requirement that the device must meet or exceed.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained for this device.

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

Not applicable, as there is no AI algorithm being trained.

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