The Bionx Impact™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Bionx Impact™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, osteoporotic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.

Device Description

Impact™ Suture Anchor is a smooth, cylindrical/conical shape, bioabsorbable, pushin suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Colour of green suture is D&C Green No 6, white suture represents original colour of polyester suture. Diameter of the anchor is 3.5mm and length 10.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a drill bit. The Impact™ Suture Anchor is made of poly-L/D-lactide copolymer.

AI/ML Overview

The provided text is a 510(k) summary for the Bionx Implants Inc. Impact™ Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device, its intended use, and contraindications. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC/standalone).

Therefore, I cannot fulfill your request for that specific information based on the provided text.

The text does include:

Device Name: Impact™ Suture Anchor
Intended Use: To reattach soft tissue to bone in orthopedic surgical procedures, either arthroscopic or open. It stabilizes damaged soft tissue in conjunction with postoperative immobilization.
Device Description: A bioabsorbable, screw-in (though later described as "push-in") suture anchor, preloaded with two non-absorbable #2 polyester sutures. Made from Self-Reinforced (96/4D) PLA Copolymer, 3.5mm diameter, 10.5mm length. Resorbs over several years, retains 90% strength for 20 weeks.
Predicate Devices: Numerous Bionx Implants Inc., Arthrex Inc., Innovasive Devices, Inc., Instrument Makar, Inc., Linvatec Corporation, Mitek Surgical Products, Acufex Inc., and DePuy Inc. suture anchors.
Material: Self-Reinforced (96/4D) PLA Copolymer, stated to be inert, non-collagenous, and non-pyrogenic. The poly-L/D-lactide material is the same as used in several previously cleared Bionx Implants Inc. devices.

Without the specific study information, I can only provide the structure of the requested table and indicate that the data is not available in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (as per document)
Mechanical Strength	N/A (Not specified in document)	Retains 90% strength through 20 weeks
Biocompatibility	N/A (Not specified in document)	Copolymer is inert, non-collagenous, non-pyrogenic through absorption
Resorption Rate	N/A (Not specified in document)	Completely resorbs over a period of several years in vivo
Material Composition	N/A (Not specified in document)	Manufactured from Self-Reinforced (96/4D) PLA Copolymer
Suture Type	N/A (Not specified in document)	Preloaded with two non-absorbable, braided, polyester #2 sutures

For the remaining points, the information is not available in the provided text:

Sample size used for the test set and the data provenance: Not specified. The document does not describe specific performance testing with a test set of data/samples, but rather relies on substantial equivalence to predicate devices and material properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is described.
Adjudication method 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. The device is a physical medical implant, not an AI/software device involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no external "ground truth" for performance is described in the context of a study. The substantial equivalence argument relies on material characteristics and predicate device equivalence.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses training sets.
How the ground truth for the training set was established: Not applicable.

Summary

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K030388

510(k) Summary Bionx Implants Inc. Impact™ Suture Anchor

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

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

Contacts:

Gerard S. Carlozzi President and Chief Executive Officer Phone: (215) 643-5000 (215) 653-0984 Facsimile:

Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5629

January 28, 2003 Date prepared:

Name of the device:

A.	Trade or Proprietary Name:	Impact ™ Suture Anchor
B.	Common Name:	Bioabsorbable suture anchor
C.	Classification Name:	Biodegradable soft tissue fixation fastener (87MAI)
D.	Device Product Code:	MAI
E.	Regulatory Classification:	Class II

Predicate Device:

The Impact™ Suture Anchor is intended for use in the reattachment of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. Duet™ Suture Anchor (K020056), SmartAnchor

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(K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuff™ (K001378) and BioCuff™ C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable CorkScrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K973381), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K990110), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex Inc. Suretac 6.0, 8,0 (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Anchor (K964921).

Intended Use:

The Bionx Impact™ Suture Anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with two non-absorbable, braided, polyester #2 sutures. The Impact™ Suture Anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer that retains 90% strength through 20 weeks and completely resorbs over a period of several years in vivo. The unique Self-Reinforced Copolymer provides high initial mechanical strength required for insertion and through the healing phase (20 weeks) with complete absorption occurring over several years. The unique absorption profile of the Copolymer allows the anchor to gradually loose strength as the collagen fibres of the repair form and gain strength. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The Impact™ Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach soft tissue to the bone.

The Impact™ Suture Anchor is contraindicated in the following conditions:

Surgical procedures other than those listed. 1.
Conditions that may compromise Anchor fixation (osteopenic, comminuted 2. bone, pathologic conditions in the soft tissues to be attached, etc.)
Conditions that may retard healing (poor blood supply, past or potential 3. infection, etc).
1. Active infection.
Conditions that may limit the patients ability or willingness to restrict న్. activities or follow directions during the healing period.
Foreign body sensitivity to materials. 6.
Patients with suspected or known allergy to the implant or suture materials. 7.

Device Description:

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with needles into single use, sterile, disposable driver and packaged into blister with a drill bit. The Impact™ Suture Anchor is made of poly-L/D-lactide copolymer. The poly-L/D-lactide material equals the raw material used in previously cleared Bionx Implants Inc. Duet™ Suture Anchor (K020056), SmartNail™ (K993074), Meniscus Arrow™ (K993453), SmartScrew ACL™ (K993073), SmartScrew (K012001), The Wedge™ (K000616), Contour Labral Nail (K003970), BioCuff (K001378) and BioCuff C (K013057).

Substantial Equivalence:

All of these devices have the same intended use and principles of operation and very similar technological characteristics. Furthermore, the minor technological differences between the Bionx Implants Inc. Impact™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wavy lines representing the feathers.

Public Health Service

APR 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants Ltd. Hermiankatu 6-8 L FIN-33720 Tampere Finland

Re: K030388

Trade/Device Name: Impact™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 28, 2003 Received: February 5, 2003

Dear Ms. Annala:

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

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Page 2 - Ms. Tuija Annala

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. 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 (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Miriam C. Provost

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

Enclosure

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INDICATIONS FOR USE

510(K) Number (if known): K030388

Device Name:

Impact™ Suture Anchor

Indications for Use:

(Please do not write below this line - continue on another page is needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

uriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030388

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.