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Micro QuickAnchor Plus (Micro QA+ Anchor): The Micro QuickAnchor Plus is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Lateral canthoplasty.

Microfix QuickAnchor Plus (Microfix QA+ Anchor): The Microfix QuickAnchor Plus is indicated for fixationof soft tissue to bone, using suture for the in dications listed below. Hand: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Soft tissue attached to the parietal. Temporal ridge, frontal, mandible, maxilla, zygoma, and periobital bones of the skull.

Micro QA + with #3-0 Orthocord or #4-0 Orthocord / Microfix QA+ with #3-0 Orthocord or #4-0 Orthocord are a preloaded, disposable suture anchors/ inserters assembly for soft tissue repair to bone in the hand and skull. The anchor is dimensionally identical anchor to that of the Micro QA+ Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord / Microfix QA+ Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord.

The provided text describes a 510(k) summary for a medical device, the Micro QA+ Anchor / Microfix QA+ Anchor. It details the device's description, indications for use, and a statement about safety and performance. However, it does not contain the specific information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study using a test set with details like sample size, ground truth, expert qualifications, or adjudication methods.

The relevant section in the document states:

"Bench testing was performed demonstrating that the Micro QA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with #3-0 and #4-0 Orthocord met predetermined acceptance criteria."

This confirms that bench testing was done and met predetermined acceptance criteria, but it does not specify what those criteria were or what the performance results were in detail. It also doesn't mention a study designed to evaluate performance using a test set in the way a clinical or AI-based study would.

Therefore, for most of your requested points, the information is not available in the provided text.

Here is what can be inferred or explicitly stated from the provided text, and what cannot:

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

Reasoning: The document states "Bench testing was performed demonstrating that the Micro QA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with #3-0 and #4-0 Orthocord met predetermined acceptance criteria." However, it does not provide the specific criteria (e.g., tensile strength, pull-out force thresholds) or the quantitative results of the tests.

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

• Sample Size for Test Set: Not specified. The document mentions "bench testing" but does not give sample sizes or details about the number of anchors or tests performed.
• Data Provenance: Not applicable. This was bench testing, not a study involving human data or clinical outcomes.

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)

• Number of Experts: Not applicable. Ground truth as typically defined in clinical or AI studies (e.g., expert consensus on images or pathology) is not relevant for bench testing of a medical device's physical properties.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. As this was bench testing for physical properties, an adjudication method for interpreting results is not mentioned or typically used in the same way as in clinical image review.

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

• MRMC Study Done: No. This document describes a physical medical device (suture anchors), not an AI algorithm or diagnostic tool. A MRMC study is not relevant.
• Effect Size: Not applicable.

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

• Standalone Performance Test: No. This document describes a physical medical device and its bench testing, not an algorithm.

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

• Type of Ground Truth: For the "bench testing," the "ground truth" would be the engineering specifications and established test methods used to determine performance (e.g., material strength standards, mechanical testing protocols). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable. This document describes a physical medical device, not a machine learning model.

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