The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

Device Description

The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.

AI/ML Overview

This 510(k) premarket notification for the SmartScrew™ bioabsorbable fixation rod does not contain the detailed information typically found in a clinical study report or a pre-market approval (PMA) submission regarding acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through new clinical trials as would be required for a PMA. Therefore, most of the information requested in your prompt (e.g., specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not present.

The key points from this document relevant to your request are:

Basis of Approval: The approval is based on a determination of substantial equivalence to previously cleared predicate devices (K952471, K974876, K992947, K003077). This means the FDA found the new device to be as safe and effective as the predicate devices, not that it met specific, predefined performance acceptance criteria from a new study.
Similarities to Predicate Devices: The document explicitly states the new SmartScrew™ has the same indicated use, operating principle, basic design, dimensions, packaging, sterilization, shelf life, and trade name as the cleared SmartScrew (K003077). It further states that minor technological differences do not raise new issues of safety or effectiveness. This is the "proof" provided for a 510(k) – alignment with a device already deemed safe and effective.

Given this, I will answer the questions based on the absence of the requested information, which is characteristic of a 510(k) submission focused on substantial equivalence rather than new performance studies.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance (as per 510(k) Summary)
(Not explicitly defined in this 510(k) summary as performance criteria for a new study)	The device is substantially equivalent to predicate devices (K952471, K974876, K992947, K003077) based on: - Same indicated use - Same operating principle - Same basic design of threads - Same basic dimensions - Same packaging and sterilization methods - Same shelf life - Same trade name

Note: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This often involves comparison of technological characteristics and performance data (e.g., mechanical testing, biocompatibility) if differences exist, but not necessarily against predefined clinical performance thresholds for a novel device.

2. Sample size used for the test set and the data provenance

Not applicable. This 510(k) submission does not describe a new clinical "test set" or a new clinical study with a sample size. The approval is based on substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This 510(k) submission does not describe a new clinical study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This 510(k) submission does not describe a new clinical study involving a test set or adjudication.

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 (a bioabsorbable fixation implant) is a physical surgical implant, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical surgical implant, not an algorithm or AI device.

7. The type of ground truth used

Not applicable. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, manufacturing processes, and intended use, rather than through new clinical performance data that would require "ground truth" as typically understood in diagnostic or AI studies. The "ground truth" effectively comes from the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This 510(k) submission does not describe an AI/ML device that requires a training set.

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

Not applicable. This 510(k) submission does not describe an AI/ML device or a training set.

Summary

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K012001.

JUL 1 8 2001

510(k) Summary Bionx Implants Inc. SmartScrew™

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 Chief Executive Officer Phone: (215) 643-5000 Facsimile: (215) 653-0984

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

Date prepared: June 13, 2001

Name of the device:

A. Trade or Proprietary Name:
B. Common Name:

SmartScrew™ Bioabsorbable, Threaded, Fixation Rod

Classification Name: C.

Device Product Code: D.

Biodegradable fixation fastener, bone HWC

Predicate Devices:

Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471)

Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876, K992947)

Bionx Implants Inc. SmartScrew™ (K003077)

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Intended Use:

Device Description:

The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.

Substantial Equivalence:

The SmartScrew™ has the following similarities to the Bionx Implants The new SmartScrew™ has the following similarities to the cleared SmartScrew (K003077):

has the same indicated use -
uses the same operating principle -
incorporates the same basic design of thread "
utilizes the same basic dimensions
is packaged and sterilized using the same materials and processes -
has the same shelf life -
has the same trade name -

The predicate device is the Bionx Implants Inc. SmartScrew™ (K952471, K974876, K992947, K003077). These devices have very similar principles of operation and technological characteristics.

In summary, the SmartScrew™M described in this notification is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the SmartScrew™ and the predicate devices do not raise any new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2001

Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants, Ltd. P.O. Box 3 Hermiankatu 6-8L FIN-33721 Tampere Finland

Re: K012001

Trade Name: SmartScrewTM Regulation Number: 888.3040 Regulatory Class: II Product Codes: HWC and MAI Dated: June 14, 2001 Received: June 27, 2001

Dear Ms. Annala:

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 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). 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 (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. A substantially equivalent 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 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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Page 2 - Ms. Tuija Annala

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you of substantial equivalence of your device to a legally marketed nouthoution. The I Drian 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 11 you desire specific articles for a stic devices), please contact the Office of Compliance at additionally 607.10 for in 10 mile promotion and advertising of your device, (2017) 594-4639. I reading 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 miromation on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

tmblellmfor

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

Kollool

510(K) Number (if known):

Device Name:

SmartScrew™

Indications for Use:

The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or Specifically, it is intended for phalangeal fusion and fracture, immobilization. metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR Over-The-Counter Use_

(Per 21 CFR 801.109)

Psmt culture for cml

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

510(k) Number K012001

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.