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 Criteria	Reported Device Performance
Pull-out force	Performance 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.

Summary

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DEC - 2 1999

Mitek Products TALONTM Anchor Snap-Pak 510(k) Premarket Notifi September 28, 1999

510(k) Summary

Trade Name:	TALON™ Anchor Snap-Pak
Sponsor:	Mitek Products60 Glacier DriveWestwood, MA 02090Registration #1221934
Contact:	Paula E. BulgerRegulatory Affairs Project ManagerMitek Products60 Glacier DriveWestwood, MA 02090Phone: (781) 251-2700Fax: (781) 461-9166
Device Generic Name:	Staple, Fixation, Bone
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Product Code:	JDR (21 CFR 888.3030)
Predicate Devices:	K931782 - Mitek LS AnchorK962511, K982420 - Mitek Micro Anchor

Product 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.

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

Safety and Performance:

The following safety and performance data has been provided to support substantial equivalence of TALONTM Anchor Snap-Pak:

Performance testing: Pull-out force (preserved human cadaver hand and wrist) Strength comparison (TALON vs. Mitek Micro Anchor)

Conclusion:

Based on safety and performance data, similarities in design, operating principle, materials, biocompatibility and sterilization method, the TALON™ Anchor Snap-Pak has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Ms. Cynthia A. Sinclair Requlatory Consultant Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts

Re: K993261 TALON™ Anchor Snap-Pak Regulatory Class: II Product Codes: MBI and GAT Dated: September 28, 1999 September 29, 1999 Received:

Dear Ms. Sinclair:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Cynthia A. Sinclair

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil RP Ogden
James E. Dillard III for

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Mitek Products TALONTM Anchor Snap-Pak 510(k) Premarket Notification September 28, 1999

Page __ 1___ of ___ 1___

510(k) Number (if known): ا

Device Name: __TALON™ Anchor Snap-Pak

Indications for 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	NRO
Division of General Restorative
510(k) Number	K993261

Prescription Use	X
(Per 21 CFR 801.109)

Over-the-Counter Use
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Regulation Number and Section

N/A