K Number
K993261
Manufacturer
Date Cleared
1999-12-02

(64 days)

Product Code
Regulation Number
888.3040
Panel
OR
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.
Device Description

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.

AI/ML Overview

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

Acceptance CriteriaReported Device Performance
Pull-out forcePerformance testing conducted (specific values not provided in this summary)
Strength comparison (vs. Mitek Micro Anchor)Strength comparison conducted (specific values not provided in this summary)

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.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.