The Allofix™ Push-In Anchor is indicated for use in soft tissue to bone fixation of the shoulder, elbow, ankle, and knee in association with adequate postoperative immobilization.

Device Description

The anchor, suture, and inserter are all packaged together. The kit contains one allograft anchor, loaded with one or two strands of #0 or #2 polyethylene or polyester suture, one white-blue co-braid and one white. The anchor and suture are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture resides within the inserter handle. The inserter, with the loaded anchor, et al, delivers the product to the site. The inserter is composed of a plastic body and a stainless steel tube. A drill or punch is provided to create a hole to deliver the anchor. The inserter contents are housed within a plastic tray. All components are single use and sterile.

AI/ML Overview

The Allofix™ Push-In Anchor is a medical device for soft tissue to bone fixation. The provided text outlines the device, its indication for use, and a summary of studies performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Design Requirements)	Reported Device Performance
Meets design input requirements for strength (Chapter 7, 8)	"The conclusion of the anchor insertion and fixation test confirmed that the Allofix™ Push-In Anchor meets design input requirements for strength (Chapter 7, 8)."
Allofix™ Push-In Anchor dimensions within design requirements	"The tests also confirmed that the Allofix™ Push-In Anchor dimensions were within design requirements."
Acceptable insertion repeatability	"Insertion repeatability was found to be acceptable..."
Pullout values for fixation strength must be at least comparable to predicate/similar devices	"...and pullout values for fixation strength exceeded those of metal and polymeric devices used for similar types of fixation."

Note: The specific numerical values or thresholds for these "design requirements" are not detailed in the provided text. The text only states that the device "meets" or "exceeded" them.

Study Details

Based on the provided text, the study conducted was a Biomechanical Testing study.

Sample size used for the test set and the data provenance:
- Sample Size: The text does not specify the exact sample size (number of anchors or test repetitions) used for the biomechanical testing.
- Data Provenance: The text does not provide information on the country of origin of the data or whether it was retrospective or prospective. Given it's a pre-market submission, it would inherently be considered prospective testing for the device's performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to a biomechanical testing study. Biomechanical studies typically involve objective measurements of physical properties (e.g., strength, dimensions, pullout force) rather than expert interpretation of data points to establish a "ground truth."
Adjudication method for the test set:
- Not applicable. As this was a biomechanical study, there would be no need for expert adjudication of results; the measurements are objective.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, where human readers interpret medical images. The Allofix™ Push-In Anchor is a physical medical device, and its evaluation relies on mechanical properties, not interpretation by human readers. Therefore, there's no discussion of human reader improvement with or without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As the Allofix™ Push-In Anchor is a physical implantable device, the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply. The device itself performs its function (fixation).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to the pre-defined design input requirements for strength, dimensions, insertion repeatability, and fixation strength. The tests directly measured these physical properties against those engineering specifications.
The sample size for the training set:
- Not applicable. This study is a biomechanical evaluation of a physical device, not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. There was no training set for this biomechanical study.

Summary

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K070347 pyzida

MAY 1 1 2007

Allofix™ Push-In Anchor 510(k)

VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

A. SPONSOR IDENTIFICATION

Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 Tel: 732-661-0202 http://www.mtf.org

B. ESTABLISHMENT REGISTRATION NUMBER 2249062

C. OFFICIAL CONTACT PERSON

Nancy Bennewitz Regulatory Affairs Submission Specialist Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 Tel: 732-661-2381 Fax: 732-661-2189 Nancy Bennewitz@mtf.org

D. DATE OF PREPARATION OF THIS SUMMARY January 19, 2007

E. PROPRIETARY (TRADE) NAME

Allofix™ Push-In Anchor

F. COMMON NAME

Bone Anchor

G. CLASSIFICATION NAME

Smooth or Threaded Metallic Bone Fixation Fastener Nonabsorbable Polyethylene Surgical Suture

H. REGULATION NUMBER

21 CFR 888.3040 and 21 CFR 878.5000

I. PROPOSED REGULATORY CLASS Class II

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Allofix™ Push-In Anchor 510(k)

J. DEVICE PRODUCT CODE

MAI, JDW, GAT

K. PANEL CODE

87 or Orthopedic Devices

L. DESCRIPTION OF DEVICE

M. INDICATIONS FOR USE

The Allofix™ Push-In Anchor is indicated for use in soft tissue to bone fixation of the shoulder, elbow, ankle, and knee in association with adequate post-operative immobilization.

N. PREDICATE DEVICE

The Allofix™ Push-In Anchor is substantially equivalent to the Mitek 3.5 mm Panalok® (FDA cleared. K970896).

O. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Both the Allofix™ Push-In Anchor and the Mitek 3.5 mm Panalok have the same indications for use. The Allofix™ Push-In Anchor is made from machined human allograft bone derived from the tibia or femur recovered from deceased donors. The Mitek Panalok® anchor is made from PLL (homopolymer poly(L(-)-lactice). Both the Allofix™ Push-In Anchor and its predicate require implantation into bone through use of an attached insertion device.

P. SUMMARY OF STUDIES

Biomechanical testing of the Allofix™ Push-In Anchor was performed to investigate whether the anchor meets design requirements. The conclusion of the anchor insertion and fixation test confirmed that the Allofix™ Push-In Anchor meets design input requirements for strength (Chapter 7, 8). The tests also confirmed that the Allofix™ Push-In Anchor dimensions were within design requirements. Insertion repeatability was found to be acceptable and pullout values for fixation strength exceeded those of metal and polymeric devices used for similar types of fixation.

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Transplant Foundation % Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 125 May Street Edison, New Jersey 08837

MAY 1 1 2007

Re: K070347

Trade/Device Name: Allofix™ Push-In Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, JDR Dated: April 13, 2007 Received: April 16, 2007

Dear Ms. Bennewitz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Nancy Bennewitz

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbeau Buehr

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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IV. INDICATIONS FOR USE

510(k) Number (if known): K070347

Device Name: Allofix™ Push-In Anchor

Indications for Use: The Allofix™ Push-In Anchor is indicated for use in soft tissue to bone fixation of the shoulder, elbow, ankle, and knee in association with adequate postoperative immobilization.

Prescription Use X (Per 21 CFR 801 Subpart D)

NO Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buehum

Division of General, Restorative, and Neurological Devices

510(k) Number K070347

Confidential

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.