The Bionx Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach ligaments to the shoulder bone, i.e., for repair of Bankart lesions or rotator cuff tears. The device may be attached to either the articular facet surface or to metaphyseal region of the bone, provided that the thickness of the cortex is less than 1.5 mm.

Device Description

The Bionx Suture Anchor is a threaded screw with a square head which is 15 mm in length and 3.8 mm in diameter. The design of the screw incorporates two channels which are cut transversely through the threads on opposite sides of the device to create a groove to hold the suture. To use the suture anchor, the surgeon first prepares the implantation site by drilling a 3.5 mm hole through the cortical bone into the cancellous bone. The surgeon then inserts the square head of the anchor into the square recess on the end of the insertion tool; an interference fit securely holds the anchor in place. A suture is then placed into the channels on either side of the anchor, threaded through a groove in the insertion tool's shaft, and held in place in a slot on the insertion tool's handle. The surgeon rotates the driver to screw the anchor into the hole and uses the suture to secure the ruptured ligament to the bone at the site of the anchor insertion. The ligament remains secured to the bone throughout the healing period. after which the anchor gradually degrades and is completely absorbed by the body. Thus, there is no need to surgically remove the anchor.

AI/ML Overview

The provided text is a 510(k) summary for the Bionx Biodegradable Threaded Suture Anchor from 1998. This type of regulatory document is used to demonstrate substantial equivalence to previously marketed devices and does not typically include detailed studies of the device's performance against specific acceptance criteria in the same way a clinical trial or a modern AI/software device would.

Based on the provided text, the "acceptance criteria" and "study" described are focused on proving substantial equivalence to predicate devices through technical characteristic comparison and performance testing for mechanical properties, rather than effectiveness in a clinical setting with human readers or AI.

Here's an analysis based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable table format, but are implied by the comparison to predicate devices and the required mechanical properties for a suture anchor. The "performance" is a qualitative statement of adequacy for intended use.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial Equivalence: Similar indications for use	The Bionx Suture Anchor is intended for use to anchor the suture to the bone in orthopedic procedures to reattach soft tissue to bone in the shoulder, similar to predicate devices.
Substantial Equivalence: Similar principles of operation	Similar principles of operation to predicate devices.
Substantial Equivalence: Similar technical characteristics	The Bionx Suture Anchor possesses similar technical characteristics to predicate devices. Minor differences in configuration (e.g., screw anchor vs. barbed/wedge) and materials (biodegradable polymer vs. titanium/polyglyconate) do not raise new safety/effectiveness questions as confirmed by performance testing.
Mechanical Strength: Adequate pullout strength for intended use	Performance data confirms adequate pullout strength.
Mechanical Strength: Adequate torsional strength for intended use	Performance data confirms adequate torsional strength.
Biocompatibility: Established for materials used	Polylactide materials are substantially the same as those used in other cleared implantable devices, and their biocompatibility is established in medical literature.
Degradation/Absorption: Complete absorption over time	Gradually degrades and is completely absorbed by the body.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the text. The document refers to "performance data" and "performance testing" but does not detail the methodology, sample sizes, or provenance of the data. It's likely these details would have been in the confidential 510(k) submission, not the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable and not provided. This document describes a medical device (implantable suture anchor), not a diagnostic or AI device where expert ground truth establishment for a test set would be relevant. The "ground truth" for the device's performance is its mechanical integrity and biocompatibility, likely assessed through laboratory testing.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-reader studies or for evaluating AI diagnostic performance.

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 information is not applicable and not provided. This document pertains to a physical implantable medical device, not an AI or software device that would assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. "Standalone" performance testing in this context refers to laboratory mechanical testing (pullout strength, torsional strength), not an algorithm's performance. The document states "performance data confirms that the Bionx Suture Anchor possesses adequate pullout strength and torsional strength for its intended use," which indicates standalone mechanical testing was performed.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established through:

Laboratory-based mechanical testing: Verifying pullout strength and torsional strength.
Material characterization and literature review: Ensuring biocompatibility and degradation properties align with established knowledge for similar materials (polylactide).
Comparison to predicate devices: Establishing substantial equivalence based on technical characteristics and indications for use.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train AI/machine learning models.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. As above, this concept relates to AI/machine learning.

Summary of Study Referenced:

The study referenced is the performance testing mentioned in the "Technical Characteristics" and "Summary Basis for the Finding of Substantial Equivalence" sections. This testing confirmed that:

The Bionx Suture Anchor possesses adequate pullout strength.
The Bionx Suture Anchor possesses adequate torsional strength.
The differences in technical characteristics (configuration, materials) from predicate devices do not raise new questions of safety or effectiveness as confirmed by this performance testing.

The specific details of these performance tests (e.g., number of samples, test conditions, quantitative results) are not included in this 510(k) summary, as it primarily focuses on demonstrating substantial equivalence to pre-existing cleared devices.

Summary

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+2785

510(K) SUMMARY FOR THE BIONX IMPLANTS, INC. BIODEGRADABLE THREADED SUTURE ANCHOR APR 1 4 1998

Submitter's Name, Address, Telephone Number, And Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall Suite 400 Bluebell, PA 19422

David W. Anderson. Contact: President and CEO (215) 643-5000 Phone: Facsimile: (215) 653-0984

Date Prepared

February 27, 1998

Name of the Device

Bionx Biodegradable Threaded Suture Anchor

Common or Usual Name

Bionx Suture Anchor

Classification Name

Biodegradable Soft Tissue Fixation Fastener

Predicate Devices

American Medical Electronics, Inc. Ogden Anchor (K950875) (1)
Zimmer, Inc. Statak® Soft Tissue Attachment Device (K962397) (2)
Arthrex, Inc. FASTak™ Suture Anchor (K960516) (3)
Mitek Surgical Products, Inc. GII Anchor (K953877) (4)
Smith & Nephew Endoscopy, Inc. Acufex® TAG Suture Anchor (5) (K961555)

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Indications for Use

Principles of Operation

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gradually degrades and is completely absorbed by the body. Thus, there is no need to surgically remove the anchor.

Technical Characteristics

The Bionx Suture Anchor, the American Medical Electronics, Inc. Ogden Anchor ("Ogden"), the Zimmer, Inc. Statak® Soft Tissue Attachment Device ("Statak®"), the Arthrex, Inc. FASTak™ Suture Anchor ("FASTak™"), the Mitek Surgical Products, Inc. GII Anchor ("Mitek GII"), and the Smith & Nephew Endoscopy, Inc. Acufex® TAG Suture Anchor ("Acufex® TAG") possess similar technical characteristics. All of these devices are intended for use to anchor sutures to the bone in orthopedic surgical procedures to reattach soft tissue to bone. The Bionx Suture Anchor, the Ogden, the Statak®, and the FASTak™ are all screw anchors, while the Mitek GII is a "barbed" anchor, and the Acufex® TAG is a wedge shaped anchor. However, this difference in configuration does not raise any new questions of safety or effectiveness because the devices incorporate similar features to ensure that they remain fixed in the bone. In addition, although the Bionx Suture Anchor is made of biodegradable polymers, while the Ogden, the Statak®, the Mitek GII, and the FASTak™ are composed of titanium, and the Acufex® TAG is composed of biodegradable polyglyconate, this difference in materials does not raise any new questions of safety or effectiveness. The polylactide materials used in the Bionx Suture Anchor are substantially the same as the materials that have been used in other previously cleared implantable devices. Moreover, the biocompatibility of these materials has been established in the medical literature, and all of the materials possess sufficient strength for soft

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tissue repair. Performance data confirms that the Bionx Suture Anchor possesses adequate pullout strength and torsional strength for its intended use.

Summary Basis for the Finding of Substantial Equivalence

Like the previously cleared Ogden, the Statak®, the FASTakTM, the Mitek GII, and the Acufex® TAG, the Bionx Suture Anchor is intended for use to anchor the suture to the bone in orthopedic procedures to reattach soft tissue to bone in the shoulder. Furthermore, all of the suture anchors possess similar principles of operation and technical characteristics. The minor differences in the technical characteristics of the two devices, such as differences in the configuration, do not raise new questions of safety or effectiveness, as confirmed by performance testing. Thus, the devices are substantially equivalent.

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Image /page/4/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is listed as 9200 Corporate Boulevard in Rockville MD 20850. The text is black and the background is white. The text is left-aligned.

APR 1 4 1998

Mr. Jonathan S. Kahan ·Partner Hogan & Hartson, L.L.P. Representing Bionx Implants, Inc. Columbia Square 555 Thirteenth Street, NW Washington, D.C. 20004-1109

K972783 Re: Bionx Biodegradable, Threaded Suture Anchor Requlatory Class: II Product Code: MAI and HWC Dated: January 30, 1998 Received: January 30, 1998

Dear Mr. Kahan:

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. ਸਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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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Paqe 2 - Mr. Jonathan S. Kahan

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,

Steptron Plveles

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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510(k) Number (if known):_

Device Name: Bionx Biodegradable Threaded Suture Anchor Indications For Use:

The Bionx Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach ligaments to the shoulder bone, i.e., for rotator cuff or Bankart lesion repair. The device may be attached to either the articular facet surface or to a metaphyseal region of the bone, provided that the thickness of the cortex is less than 1.5 mm.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephen Olvels

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

Prescription Use
(Per 21 CFR 801.109) X

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.