shoulder (Bankart repair) ankle (Mid-foot reconstruction) foot (Hallux valgus reconstruction) hand (Ulnar or lateral collateral ligament reconstruction) wrist (Scapholunate ligament reconstruction) pubis (For relief from Stress Urinary Incontinence due to urethral or bladder neck hypermobility with minimal or no cystocele).

Device 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 suture.

AI/ML Overview

The provided 510(k) Premarket Notification for the Mitek Mini QuickAnchor® Plus is for a medical device (bone anchor) and not for an AI/ML powered device. As such, most of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set, etc.) is not applicable to this submission.

However, I can extract information related to the device's acceptance criteria and the study that proves it meets those criteria, as presented in the document.

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

The document states that the safety and performance data was provided to support substantial equivalence due to a design modification. The performance testing focused on mechanical properties relevant to a bone anchor.

Acceptance Criteria Category	Reported Device Performance (Implied)
Insertion Force	Met acceptance criteria (no specific values provided, but conclusion of substantial equivalence implies satisfactory performance)
PullOut Force	Met acceptance criteria (no specific values provided, but conclusion of substantial equivalence implies satisfactory performance)
Suture Hole Interface	Met acceptance criteria (no specific values provided, but conclusion of substantial equivalence implies satisfactory performance)
Off-axis Insertion	Met acceptance criteria (no specific values provided, but conclusion of substantial equivalence implies satisfactory performance)

Note: The 510(k) summary typically does not include the specific numerical acceptance criteria or detailed results of the performance tests. The FDA's determination of "substantial equivalence" implies that these tests were conducted and the device performed comparably or better than the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a traditional medical device (bone anchor), not an AI/ML device relying on diagnostic or prognostic data. The "test set" here refers to physical performance tests on the device itself. The document does not specify sample sizes for these mechanical tests, nor the "provenance" of such test data (e.g., conducted in a lab, no patient data involved).

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)

This is not applicable. The "ground truth" for a bone anchor's performance is objective mechanical measurements (e.g., force in Newtons). There are no human experts establishing a "ground truth" in the way it would be for an AI diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are relevant for subjective interpretations or disagreements in diagnostic assessments, which is not the case for mechanical performance testing of a bone anchor.

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

This is not applicable. MRMC studies are for evaluating the performance of diagnostic tools (often involving image interpretation by human readers, sometimes with AI assistance). This device is a surgical implant.

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

This is not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device would be based on objective physical measurements derived from standard mechanical testing protocols (e.g., ASTM standards or equivalent internal protocols) for bone anchors. This would include measurements of force (insertion, pull-out) and assessment of material integrity/interface. There is no expert consensus, pathology, or outcomes data used as "ground truth" for these performance tests.

8. The sample size for the training set

This is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

This is not applicable. There is no training set for this device.

Summary

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Mitek® Products

Mini QuickAnchor® Plus

510(k) Premarket Notification July 23, 1999

K992487

510(k) Summary

Mitek Mini QuickAnchor® Plus Trade Name: Sponsor: Mitek Products 60 Glacier Drive Westwood, MA 02090 Registration #1221934 Christine Kuntz-Nassif Contact: Telephone: (781) 461-9700 Fax: (781) 461-9166 Smooth or threaded metallic bone fixation fastener Device Generic Name: According to Section 513 of the Federal Food, Drug, and Classification: Cosmetic Act, the device classification is Class II. HWC (21 CFR 888.3040) Product Code: K921873 - Mitek GII Mini QuickAnchor Predicate Devices: K930892 - Mitek Mini Anchor K936311 - Mitek Mini 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 suture.

Indications for Use:

Mitek Mini Anchors have been found substantially equivalent in previous Premarket Notifications for the following indications:

Shoulder:	Bankart Repair
Ankle:	Midfoot Reconstructions
Foot:	Hallux Valgus Reconstruction
Wrist:	Scapholunate Ligament Reconstruction
Hand:	Ulnar or Lateral Collateral Ligament Reconstruction
Pubis:	Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence

This current 510(k) allows modification of the Mini Anchor design in order to accommodate the line extension which includes the Mini 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 Mini Anchor for the design modification:

Insertion force, PullOut force, Suture Hole interface and Off-axis insertion. Performance testing:

Conclusion:

Based on 1) safety and performance data, and 2) similarities in design, operating principle, materials, biocompatibility and sterilization method, the Mitek Mini 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 U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.

SEP 2 1 19999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K992487

Trade Name: Mitek Mini QuickAnchor® Plus Regulatory Class:II Product Code: HWC Dated: July 23, 1999 Received: July 26, 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 legally marketed predicate 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 requirements, 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 vou 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) 594-4639. 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/dsma/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 . of

510(k) Number (if known):长ብዓ 24 ۶ 7

Device Name: __ Mitek Mini QuickAnchor® Plus

Indications for Use:

The Mitek Mini QuickAnchor® Plus is indicated for:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

Over-the-Counter Use
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(Division Sign-Off)
Division of General Restorative Devices

510(k) Number	K992487
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00000

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.