1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where pation of operation vecause the effect of the implant upon the healing of growth plate has not been tested clinically.

Device Description

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074)

Lengths of implants are 16, 18, 20 and 25 mm. -
Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1
Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074).
Shelf life is same with SmartNail™ -
Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

AI/ML Overview

The provided document is a 510(k) summary for the "Bionx Implants Inc. 1.5mm Bone Fixation Kit." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically associated with a new device's efficacy or safety study.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The document aims to show that the new device is functionally the same as an already-approved device, thus not requiring new clinical performance studies.

Here's an analysis based on the available information:

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

Not applicable / Not explicitly stated. This document is a 510(k) submission aiming for substantial equivalence. It does not present a de novo study with specific performance acceptance criteria or a "reported device performance" against those criteria in the way new drug or novel medical device clinical trials would. The "acceptance criteria" here implicitly relate to demonstrating similarity to the predicate device.

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

Not applicable. There is no "test set" or clinical data presented from a study to prove performance. The submission relies on technological characteristics and intended use equivalence to the predicate device.

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)

Not applicable. No clinical test set data or ground truth establishment by experts is described as this is a substantial equivalence claim.

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

Not applicable. No clinical test set data requiring adjudication is presented.

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

Not applicable. This device is a bone fixation kit (a physical implant), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical bone implant, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the predicate device's pre-established safety and effectiveness. The new device aims to be substantially equivalent to that.

8. The sample size for the training set

Not applicable. No training set for an algorithm is relevant to this physical medical device submission.

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

Not applicable.

Summary of Device Acceptance & Study Information from the Document:

The acceptance of the "1.5mm Bone Fixation Kit" into the market is based on its substantial equivalence to a predicate device, the "Bionx Implants Inc. SmartNail (K993074)." The "study" in this context is the detailed comparison of the new device's characteristics against the predicate device to support the claim of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as implied by Substantial Equivalence):

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use (Same as predicate)	"1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments." (Identical to predicate's stated use, as per K993074 which is the predicate for this device)
Principles of Operation (Same as predicate)	Stated as having "the same...principles of operation" as SmartNail (K993074). Its function is to provide fixation for bone fragments.
Technological Characteristics (Similar to predicate)	Material: Composed of poly-L/D-lactide copolymer (Identical to SmartNail K993074). Lengths: 16, 18, 20, 25 mm. Diameter: 1.5mm (Identical to SmartNail K993074 1.5mm). Design: Identical with SmartNail K993074. Shelf life: Same with SmartNail. Packaging: Similar, sterile, disposable.
Safety and Effectiveness (No new issues)	"the minor technological differences... do not raise any new issues of safety or effectiveness."

Data Provenance and Ground Truth:

Data Provenance: The "data" proving equivalence comes from the specifications and characteristics of the new device and the known specifications and regulatory clearance of the predicate device (K993074). This is a descriptive comparison, not a clinical data collection.
Ground Truth: The "ground truth" for the new device's safety and effectiveness is inferred from the established safety and effectiveness of the legally marketed predicate device.

Conclusion:

This 510(k) summary is a regulatory submission focused on demonstrating substantial equivalence, not a clinical trial report. As such, the concept of "acceptance criteria" and "study results" pertains to meeting the requirements for substantial equivalence by comparing the device features and intended use to a legally marketed predicate device, rather than presenting de novo clinical performance data.

Summary

{0}------------------------------------------------

012000

JUL 1 8 2001

510(k) Summary Bionx Implants Inc. 1.5mm Bone Fixation Kit

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

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

Contacts:

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

Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: 358-3-316 5629 Facsimile:

June 15th, 2001 Date prepared:

Name of the device:

A:	Trade or Proprietary Name:	1.5mm Bone Fixation Kit
B:	Common Name:	Absorbable Bone Fixation Nai
C:	Classification Name:	Bone Fixation Nail
D:	Device Product Code:	MAI

Predicate Device:

Bionx Implants, Inc. SmartNail (K993074)

Intended Use:

Properly used, in the presence of adequate immobilization, 1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

{1}------------------------------------------------

Device Description:

The device description of the 1.5mm Bone Fixation Kit is as follows.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074)
Lengths of implants are 16, 18, 20 and 25 mm. -
Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1
Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074).
Shelf life is same with SmartNail™ -
Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

Substantial Equivalence:

Bionx Implants Inc. 1.5mm Bone Fixation Kit is substantially equivalent to the cleared Bionx Implants Inc. SmartNail (K993074) have the same intended use and principles of operation and very similar technological characteristics.

The instrument set is substantial equivalent with previously cleared Bionx Implants Inc. SmartNail (K993074). Furthermore, the minor technological differences between the Bionx Implants Inc. 1.5mm Bone Fixation Kit and the predicate devices do not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, possibly representing care or support.

ັງບໍ່ 1 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants, Ltd. P.O. Box 3 FIN-33721 Tampere Finland

Re: K012000

Trade Name: 1.5mm Bone Fixation Kit Regulation Number: 888.3030 Regulatory Class: II Product Codes: HWC and MAI Dated: June 15, 2001 Received: June 27, 2001

Dear Ms. Annala:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally b really is substantially equivalent (for the indications for use above and we nave determinou the actected predicate devices marketed in interstate commerce stated in unc encrosure) to logally manufacted of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and nave bech lectassified in accordance wre, market the device, subject to the general controls Costicity of the Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general vonanufacturing 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 (1 centuries) in the Code of Federal Regulations, Title 21, Parts 800 to 895. arresting Jour as 1999 views 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 mispections, the Food and Drage may result in regulatory action. In addition, FDA may publish comply with the Orize registerning 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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Page 2 - Ms. Tuija Annala

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 nonication. The I Dri Imanig of sussion 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 If you desire specific active rest diagnostic devices), please contact the Office of Compliance at additionally 607.10 for mirritie and ussions on the promotion and advertising of your device, (301) 591 1057. Tradition for at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers 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,

NSMut chleeting fo

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

Enclosure

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INDICATIONS FOR USE

01 2000

510(K) Number (if known):

Device Name:

1.5mm Bone Fixation Kit

Indications for Use:

1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured 1.3mm Done I ration interness and arthrodeses, for example in the fixation of non-load fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where patient be operation, because the effect of 1.5mm Bone Fixation Kit upon the healing of growth plate has not been tested clinically.

(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)

Over-The-Counter Use_ OR

BSmutheloora A canu

Division Sign Division of General, Restorative and Neurological Devices

510(k) Number KO12000

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.