The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded on an inserter with a polyester and PANACRYL, Poly (L-Lactide/Glycolide) synthetic absorbable] suture.

AI/ML Overview

The provided text describes a 510(k) submission for the "Mitek Rotator Cuff QuickAnchor® Plus," which is a sterile, disposable bone anchor. The submission focuses on the substantial equivalence of modifications to an existing device, not a new AI/software-driven medical device. Therefore, many of the requested categories related to acceptance criteria for AI performance, clinical study design for AI, and ground truth establishment are not applicable.

Here's an attempt to extract the relevant information based on the provided text, and note where information is not available due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (if stated)	Reported Device Performance (if stated)
Safety and Performance	Arc span test	Not specified (stated that data was provided to support substantial equivalence)
	Insertion force	Not specified (stated that data was provided to support substantial equivalence)
	PullOut force	Not specified (stated that data was provided to support substantial equivalence)
	Suture/Suture Hole interface	Not specified (stated that data was provided to support substantial equivalence)
Substantial Equivalence	Similarity in design	Stated as similar to predicate device
	Similarity in operating principle	Stated as similar to predicate device
	Similarity in materials	Stated as similar to predicate device
	Similarity in biocompatibility	Stated as similar to predicate device
	Similarity in sterilization method	Stated as similar to predicate device

Note: The document only states that "Performance testing: Arc span test, Insertion force, PullOut force, and Suture/Suture Hole interface" data was provided to support substantial equivalence. It does not disclose the specific quantitative acceptance criteria or the numerical results of these tests.

Information not available or not applicable based on the provided text:

Due to the nature of this 510(k) submission being for a mechanical medical device (bone anchor) and not an AI/software-driven diagnostic or prognostic tool, the following aspects are not detailed in the provided document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device. Performance testing would typically involve laboratory bench testing, not clinical data sets in the context of AI.
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. Ground truth as typically defined for AI models is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would relate to the physical properties measured in performance tests, not clinical labels.
The sample size for the training set: Not applicable, as there is no "training set" for a mechanical device.
How the ground truth for the training set was established: Not applicable.

Summary

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SEP 22 1999	510(k) Summary	K992611
Trade Name:	Mitek Rotator Cuff QuickAnchor® Plus
Sponsor:	Mitek Products60 Glacier DriveWestwood, MA 02090Registration #1221934
Contact:	Christine Kuntz-NassifTelephone: (781) 461-9700Fax: (781) 461-9166
Device Generic Name:	Smooth or threaded metallic bone fixation fastener
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Product Code:	HWC (21 CFR 888.3040)
Predicate Devices:	K915889 - Mitek Anchor

Product Description: The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded on an inserter with a polyester and PANACRYL, Poly (L-Lactide/Glycolide) synthetic absorbable] suture.

Indications for Use:

Mitek RC Anchors have been found substantially equivalent in previous Premarket Notifications for Rotator Cuff repair.

This current 510(k) allows modification of the RC Anchor design in order to accommodate the line extension, which includes the Mitek Rotator Cuff QuickAnchor® Plus, providing a pre-loaded single use anchor on a disposable inserter.

Safety and Performance:

The following safety and performance data has been provided to support substantial equivalence of the RC Anchor for the design modification:

Performance testing: Arc span test, Insertion force, PullOut force, and Suture/Suture Hole interface.

Conclusion:

Based on 1) safety and performance data, and 2) similarities in design, operating principle, materials, biocompatibility and sterilization method, the Mitek Rotator Cuff QuickAnchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized design of three human figures connected together, possibly representing unity or collaboration. The figures are arranged in a diagonal line, with the heads facing towards the upper right corner of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figures.

SEP 2 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christine Kuntz-Nassif Senior Regulatory Affairs Associate Mitek® Products 60 Glacier Drive Westwood, Massachusetts 02090

Re: K992611

Trade Name: Mitek Rotator Cuff QuickAnchor® Plus Regulatory Class: II Product Code: HWC Dated: August 03, 1999 Received: August 04, 1999

Dear Ms. Kuntz-Nassif:

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 of the Act. The general controls provisions 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 regulation (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 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 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.

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Page 2-Ms. Christine Kuntz-Nassif

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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _

510(k) Number (if known): 上9926 リ

Device Name: __ Mitek Rotator Cuff QuickAnchor® Plus_

Indications for Use:

The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________ OR Prescription Use _> (Per 21 CFR 801.109)

Division Sign-Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992611

Regulation Number and Section

§ 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.