The WISORB™ malleolar screw is intended for use in bone-to-bone fixation in the metaphyseal area, distal humerous, trochanteric area and in the ankle where the bone is dense.

The WISORB™ malleolar screw is intended primarily for internal fixation of fractures with minimal displacement commonly seen in fractures of the ankle and foot, such as, transverse fibular fractures at or distal to the ankle joint (Danis-Weber Type A); low spiral fractures of the lateral malleolus, avulsion fractures of the medial malleolus (Dyputren; Danis-Weber Type-B), avulsion fractures of the posterior malleolus (Volkman's Triangle). Other fractures that maybe suitable for treatment with the WISORB™ malleolar screw include distal ractures (Type Colles), which typically occur at the metaphyseal portion of the bone proximal to the extensor tendon sheaths.

The WISORB™ malleolar screw is not intended for use in and is contraindicated for:

Fractures of cortical bone (diaphyseal area)
Situations of active or potential infection or where patient cooperation cannot be guaranteed.

Device Description

The WISORB™ malleolar screw is composed of 75% by wt (88% by volume) of the copolymer (L -co-D,L-lactide) (weight ratio 70:30), and 25% by wt (12% by volume) of sintered hydroxylapatite. The WISORB is a bioabsorbable, partially-threaded screw with a conical head and rounded bottom.

The WISORB™ has a single size with the following dimensions:

i. Length 30 mm
Thread diameter 4.5 mm ii.
iii. Thread length 11.64 mm
Shaft diameter 2.62 mm iv.
Head diameter 6.75 mm v.
Head depth 6.73 mm vi.

AI/ML Overview

The provided text describes a medical device, the WISORB™ Malleolar Screw, and its 510(k) submission for FDA clearance. However, it does not contain information about acceptance criteria, device performance metrics, or a study detailing these aspects.

The document is a summary of the safety and effectiveness, focusing on establishing substantial equivalence to predicate devices, not on proving new performance metrics against specific acceptance criteria.

Therefore, for your request, I can only provide the information that is present in the document.

Here's what I can extract:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states that "In vitro laboratory, mechanical testing and animal studies have been submitted that support the equivalence of the WISORB™ malleolar screw to other predicate devices," but it does not specify any acceptance criteria or report performance metrics from these studies.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present.
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): This information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.
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 present. The device is a physical screw, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device is a physical screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present. The document mentions "in vitro laboratory, mechanical testing and animal studies" were submitted, implying mechanical and biological outcomes were assessed, but specific "ground truth" establishment methods are not detailed.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

In summary, the provided text is a 510(k) summary for a medical device (a absorbable screw) and focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a detailed performance study with defined acceptance criteria and statistical analysis.

Summary

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'JUL 2 9 2002

11. SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY

WISORB™ MALLEOLAR SCREW

Koro222

SUBMITTER'S NAME AND ADDRESS:	CAMBRIDGE SCIENTIFIC INC.,180 FAWCETT STREET,CAMBRIDGE, MA 02138
CONTACT NAME:	DEBRA J. TRANTOLO, PH. D, PRESIDENT AND CEOCAMBRIDGE SCIENTIFIC, INC.(PHONE: 617-576-2663; FAX: 617-547-2663;E-MAIL: DTRANTOLO@AOL.COM).
Date Prepared:	January 2, 2002
NAME OF DEVICE:	WISORBTM MALLEOLAR SCREW
Classification name:	The classification name of the device is "smooth or threaded bonefixation fastener" as per FDA 21 C.F.R •888.3040.
Proposed regulatory class:	The WISORBTM malleolar screw is classified into class II.
Product code:	The code of the intended device is 88HWC-Bone Fixation Screw.
Predicate Devices:	1. Biofix® Bioabsorbable Self-reinforced Poly-L-Lactide,Fixation Threaded Rod (K952471)
	2. Biofix® Bioabsorbable Poly(Glycolic Acid),Threaded Rod (K920188)
	3. Biofix® Bioabsorbable Distal Radial Screw (K974876)
Int nded Uses:	The WISORBTM malleolar screw is intended for use in bone-to-bonefixation in the metaphyseal area, distal humerous, trochanteric area, andin the ankle where the bone is dense.The WISORBTM is intended primarily for internal fixation of fractureswith minimal displacement commonly seen in fractures of the ankle andfoot, such as, transverse fibular fractures at, or distal to the ankle jointincluding fractures of the lateral, medial and posterior malleolus. TheWISORBTM is intended for single use only.

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page 2 of 2

Devic De cription:

The WISORB™ has a single size with the following dimensions:

i. Length 30 mm
Thread diameter 4.5 mm ii.
iii. Thread length 11.64 mm
Shaft diameter 2.62 mm iv.
Head diameter 6.75 mm v.
Head depth 6.73 mm vi.

Substantial Equivalence:

The WISORB™ malleolar screw is substantially equivalent to other cleared bioabsorbable, internal fixation devices such as threaded rods and screws used in the fixation and maintenance of alignment of cancellous fractures of the malleolus and radius.

In vitro laboratory, mechanical testing and animal studies have been submitted that support the equivalence of the WISORB™ malleolar screw to other predicate devices.

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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 features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2002

Dr. Debra J. Trantolo President and CEO Cambridge Scientific, Inc. 180 Fawcett Street Cambridge, Massachusetts 02138

Re: K020222

Trade/Device Name: Wisorb™ Malleolar Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 16, 2002 Received: May 17, 2002

Dear Dr. Trantolo:

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 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.

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Page 2 – Dr. Debra J. Trantolo

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97), 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,
/ Mark n Mellkusan

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): K020122

Device Name:

WISORB™ malleolar screw

Indications for Use:

The WISORB™ malleolar screw is intended for use in bone-to-bone fixation in the metaphyseal area, distal humerous, trochanteric area and in the ankle where the bone is dense.

The WISORB™ malleolar screw is not intended for use in and is contraindicated for:

파 Fractures of cortical bone (diaphyseal area)
트 Situations of active or potential infection or where patient cooperation cannot be guaranteed.

(Please do not write below this line-Continue on other page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

for Mark A. Mulkerson

1 Restorative

510(k) Number K020222

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.