The Bionx Bankart Tack is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions). When used in conjunction with appropriate postoperative immobilization, the Bionx Bankart Tack provides secure tissue stabilization throughout the healing period.

Device Description

The Bankart Tack is a cannulated tack with a round head and four circumferential rows of scaled edges along the distal end to securely fix the tack in the bone.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, comprehensive study designs, or detailed performance results that would allow for the complete filling of the requested table and study information. The document is a 510(k) summary for a medical device which focuses on demonstrating substantial equivalence to predicate devices, rather than providing an in-depth clinical trial report.

However, based on the available information, I can infer some aspects and highlight what is missing.

Analysis of the Provided Text:

The document states: "Additionally, performance testing and clinical studies have demonstrated that the insertion technique for the Bionx Bankart Tack provides adequate fixation for this intended use." and "Both the PLLA and polyglyconate materials are biocompatible and possess sufficient strength for this intended use, as demonstrated in clinical studies and performance testing." and "The minor differences in the technical characteristics of the devices do not raise new questions of safety or effectiveness, as confirmed by performance testing and clinical studies."

These statements indicate that some form of performance testing and clinical studies were conducted and confirmed adequate fixation, biocompatibility, and sufficient strength. However, the document does not detail these studies' methodologies, sample sizes, specific acceptance criteria, or precise performance outcomes. It primarily asserts that these studies support the substantial equivalence claim.

Inferences and Missing Information Summary:

Acceptance Criteria and Reported Device Performance: The document generally states "adequate fixation," "sufficient strength," and "biocompatible" as performance goals, implying these were the de facto acceptance criteria. However, no specific numerical thresholds or metrics are provided.
Sample Size and Data Provenance (Test Set): Not mentioned.
Number and Qualifications of Experts (Ground Truth): Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study: Not mentioned as a component for this 510(k) submission. 510(k)s typically focus on equivalence to existing devices rather than comparative effectiveness studies against unassisted human performance, especially for a physical implant.
Stand-alone Performance Study: The "performance testing and clinical studies" mentioned would likely involve standalone performance evaluation of the device's mechanical integrity, fixation strength, and biocompatibility, but details are not provided.
Type of Ground Truth: For a physical implant, "ground truth" would typically refer to objective measurements of mechanical properties (e.g., pull-out strength, degradation rate) from performance testing and clinical outcomes (e.g., successful reattachment, lack of adverse events) from clinical studies. The specific methods for establishing these are not detailed.
Training Set Sample Size: Not applicable since this is a physical device, not an AI/ML algorithm that requires a training set in the conventional sense.
Ground Truth for Training Set: Not applicable.

Based on the provided document, here is the most accurate response to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Adequate tissue fixation	Demonstrated adequate fixation
Sufficient mechanical strength	Possesses sufficient strength
Biocompatibility	Demonstrated biocompatibility
No new safety/effectiveness issues compared to predicates	Minor differences do not raise new issues

Note: The document states that performance testing and clinical studies demonstrated these, but does not provide specific quantitative acceptance thresholds or detailed performance metrics.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The document only generally refers to "performance testing and clinical studies."

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

This information is not provided in the text. For a physical implant, "experts" in establishing ground truth would typically refer to surgeons or pathologists involved in clinical assessments, or engineers/scientists performing laboratory tests. Their specific roles or numbers are not mentioned.

4. Adjudication Method for the Test Set:

Not applicable/mentioned. Adjudication methods like 2+1 or 3+1 are common in studies involving subjective interpretation (e.g., imaging reads by multiple radiologists) where expert consensus is needed. This document pertains to a physical implant where the "ground truth" would be more objective (e.g., mechanical test results, clinical outcomes).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study is not mentioned or implied by the document. This type of study is more relevant for diagnostic imaging AI devices where human readers' performance with and without AI assistance is compared. The Bionx Bankart Tack is a physical implant.

6. If a Standalone Performance Study was done:

Yes, implicitly. The document states "performance testing and clinical studies have demonstrated..." This suggests standalone evaluations were conducted to assess the device's mechanical, material, and functional properties independent of direct human-AI interaction comparisons. However, the details of these standalone studies (methodology, results) are not provided.

7. The Type of Ground Truth Used:

For the performance testing, the ground truth would likely be based on:
- Objective Measurements: Mechanical properties (e.g., pull-out strength from bone, degradation rate) assessed in laboratory settings.
- Biocompatibility Assessments: Standardized tests for material interaction with biological systems.
For clinical studies, the ground truth would likely be based on:
- Clinical Outcomes Data: Successful tissue reattachment, stability of the joint, absence of complications, healing assessed through follow-up examinations (e.g., imaging, physical exams).

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for this physical device.

Summary

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JAN - 6 1998

K973849

510(K) SUMMARY FOR THE BIONX IMPLANTS, INC.

BIOABSORBABLE BANKART TACK

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

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

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

Date Prepared

October 7, 1997

Name of the Device

Bioabsorbable Bankart Tack

Common or Usual Name

Bionx Bankart Tack

Classification Name

Biodegradable Soft Tissue Fixation Fastener

Predicate Device

Acufex Microsurgical Inc. Suretac® Polyglyconate Absorbable Fixator (K911837)

DePuy, Inc. DuPont Phantom Suture Anchor (K964521)

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Intended Use

The Bionx Bankart Tack is an absorbable device which is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions). When used in conjunction with appropriate postoperative immobilization, the Bionx Bankart Tack provides secure tissue stabilization throughout the healing period.

Principles of Operation

The Bionx Bankart Tack may be used in either open or arthroscopic surgical procedures. To use the Bionx Bankart Tack, the surgeon must first examine the shoulder joint to identify the site of the labral detachment, note any stretching within the capsule and ligaments, and ascertain the degree and direction of the instability. After the damaged soft tissue is properly aligned for reattachment to the bone, the Bionx Bankart Tack is then inserted through the labrum into a predrilled hole over a guide wire. The guide wire is removed, and the position of the tack is examined anteriorly to ensure that the soft tissue is securely fixed to the bone. Substantially the same approach is followed to insert the Acufex Suretac, and similar techniques are used to insert the DuPont Phantom.

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Technical Characteristics

The Bionx Bankart Tack, the Acufex Suretac, and the DuPont Phantom are intended for use in the fixation of soft tissue to bone in the repair of shoulder injuries. The Bankart Tack is a cannulated tack with a round head and four circumferential rows of scaled edges along the distal end to securely fix the tack in the bone. Like the Bionx Bankart Tack, the Acufex Suretac is a cannulated tack with a round head; however, the Suretac utilizes three raised rings along the circumference of the tack located in the middle of the shaft to fix the tack in the bone, as opposed to the scaled edges utilized by the Bankart Tack. The DuPont Phantom is secured in the bone by threading.

The Bionx Bankart Tack has substantially the same design configuration as the predicates with the exception of having scaled edges as opposed to raised rings or threading to secure the tack in the bone, and slightly different dimensions. These minor differences in design configuration do not raise any new issues of safety and effectiveness because all of the devices are secured in the bone by the same mechanism. Moreover, the question of whether the method of securing the device in the bone is sufficiently strong for this intended use is common to all of the devices.

To ensure proper alignment and fixation, the devices are each supplied with several customized insertion tools. The accompanying tools for both the Bankart Tack and the Suretac are substantially the same, and both sets of tools are

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manufactured from stainless steel and plastic. The minor differences in the insertion tools of the Bionx Bankart Tack and the Acufex Suretac do not raise any new issues of safety and effectiveness because the principles of operation and method of insertion of the two devices is the same. Additionally, performance testing and clinical studies have demonstrated that the insertion technique for the Bionx Bankart Tack provides adequate fixation for this intended use.

All of the devices are manufactured from absorbable polymers which degrade over time and are absorbed by the body. The Bionx Bankart Tack and the DuPont Phantom are made of poly-L-lactide (PLLA) polymer, while the Acufex Suretac is made of polyglyconate, which is a copolymer of polyglycolic acid and trimethylene carbonate. Both the PLLA and polyglyconate materials are biocompatible and possess sufficient strength for this intended use, as demonstrated in clinical studies and performance testing. Additionally, Bionx has previously received clearance from FDA to market other implanted pins and rods made from the same PLLA polymer used in the Bionx Bankart Tack.

Summary Basis for the Finding of Substantial Equivalence

Like the previously cleared Acufex Suretac and DuPont Phantom, the Bionx Bankart Tack is intended for use to reattach soft tissue to bone in the repair of shoulder injuries. All of the devices are specifically indicated for use in the repair of Bankart lesions. Furthermore, all of the devices have very similar principles of operation and technical characteristics. The minor differences in the technical characteristics of the devices do not raise new questions of safety or effectiveness, as

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confirmed by performance testing and clinical studies. Thus, the devices are substantially equivalent.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 1000

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

Re: K973849 Trade Name: Bioabsorbable Bankart Tack Regulatory Class: II Product Codes: MAI and HWC Dated: October 8, 1997 Received: October 8, 1997

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 reqistration, 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 Requlations, 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 Requlation (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 In addition, FDA may publish further announcements action. 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 requlations.

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510(k) Number (if known):_K973849

Device Name: Bionx Bankart Tack Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prision of General Restorative Device (10-ugic noisivid)

Prescription Use (Per 21 CFR 801.109)

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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.