(73 days)
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:
Cranio/Maxillofacial: Repair and reconstruction or reattachment of tendons and ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
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 describes a medical device, the TALON™ Anchor Snap-Pak, and its clearance process through a 510(k) submission. This document is a regulatory submission for a physical medical device, not a software or AI-powered diagnostic tool. Therefore, many of the requested categories for AI/software device evaluation (like ground truth establishment, training sets, multi-reader studies, effect sizes for human improvement with AI assistance) are not applicable.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance Study for TALON™ Anchor Snap-Pak
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance |
|---|---|
| Pull-out force (preserved human cadaver skull) | Demonstrated strength comparison against Mitek Micro Anchor (predicate) |
| Strength comparison (TALON vs. Mitek Micro Anchor) | Demonstrated comparable strength to Mitek Micro Anchor (predicate) |
Note: The document states that "safety and performance data has been provided to support substantial equivalence." The specific numerical or statistical acceptance criteria for pull-out force and strength comparison are not explicitly detailed in this summary. The conclusion states that the device was found substantially equivalent based on these data, implying the performance met the thresholds for equivalence to the predicate device.
Regarding the other requested information, the document does not provide details for the following as it pertains to a physical implantable device, not an AI/software device:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable as this is not an AI/software device. The testing was conducted on "preserved human cadaver skull." No specific sample size for cadavers is given in this summary.
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. This is not an AI/software device requiring expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for a physical device performance study. The "ground truth" here would be the physical measurement of pull-out force and strength, which are objective engineering measurements.
8. The sample size for the training set
- Not applicable. This concept applies to AI/machine learning models, not physical device testing.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Relevant Information from the Provided Text:
- Device: TALON™ Anchor Snap-Pak (bone fixation staple).
- Purpose of Study: To demonstrate substantial equivalence to predicate devices (K931782 - Mitek LS Anchor, K962511, K982420 - Mitek Micro Anchor).
- Key Performance Tests:
- Pull-out force (using preserved human cadaver skull).
- Strength comparison (TALON vs. Mitek Micro Anchor).
- Conclusion: The device was found to be substantially equivalent based on safety and performance data, similarities in design, operating principle, materials, biocompatibility, and sterilization method. The specific numerical results of the "pull-out force" or "strength comparison" that met the acceptance criteria for substantial equivalence are not provided in this summary.
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DEC 1 6 1999
510(k) Summary
| Trade Name: | TALON™ Anchor Snap-Pak |
|---|---|
| Sponsor: | Mitek Products |
| 60 Glacier Drive | |
| Westwood, MA 02090 | |
| Registration #1221934 | |
| Contact: | Paula E. Bulger |
| Regulatory Affairs Project Manager | |
| Mitek Products | |
| 60 Glacier Drive | |
| Westwood, MA 02090 | |
| Fax: (781) 461-9166 | |
| Phone: (781) 251-2700 | |
| 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 and reconstruction or reattachment of tendons and ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, maxilla, zygoma and periorbital bones of the skull.
Safety and Performance:
The following safety and performance data has been provided to support substantial equivalence of TALON™ Anchor Snap-Pak:
| Performance testing: Pull-out force (preserved human cadaver skull) |
|---|
| 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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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 6 1999
Ms. Paula E. Bulger Regulatory Affairs Project Manager Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts
K993327 Re :
Talon™ Anchor Snap-Pak Trade Name: Requlatory Class: II Product Code: DZL October 1, 1999 Dated: Received: October 4, 1999
Dear Ms. Bulger:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಳ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Bulger
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 regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in yitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,
Patricio Cucente /Koz
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1_ of __ of _
510(k) Number (if known): K993327
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:
Cranio/Maxillofacial: Repair and reconstruction or reattachment of tendons and ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, ಇಂಡ General Hospital Devi . in | Number __
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.