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The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications:

• Repair/reconstruction of collateral ligaments, Flexor and Extensor Hand: tendons at the PIP (Proximal Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal Interphalangeal) joints for all digits.
• Repair/reconstruction of ligaments and tendons on the dorsal and Wrist: volar aspects of the carpal bones.

The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.

The provided text does not contain information about an AI device or a study comparing AI with human readers. The document is a 510(k) premarket notification for a medical device called "TALON Anchor Snap-Pak," which is a surgical anchor. The study described is mechanical testing of the anchor's physical properties, not an AI performance study.

Therefore, most of the requested information (related to AI, human readers, ground truth establishment for AI, training sets, etc.) cannot be extracted from this document.

Here's the information that can be extracted relevant to the performance testing of the TALON Anchor Snap-Pak:

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

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

• Sample Size: Not explicitly stated for each test.
• Data Provenance:
  • Pull-out force testing was performed on "preserved human cadaver hand and wrist."
  • Strength comparison was between TALON and Mitek Micro Anchor (presumably laboratory testing).

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

Not applicable. The study involves mechanical testing of a physical device, not expert interpretation of data.

4. Adjudication method for the test set

Not applicable. This refers to expert consensus for ambiguous clinical cases, not mechanical testing.

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.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

For the pull-out force, the "ground truth" would be the measured physical force required to pull out the anchor from the cadaveric bone. For strength comparison, the "ground truth" would be the measured strength of the devices.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable.

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