The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction and of soft tissue grafts in ACL reconstruction.

Device Description

The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).

AI/ML Overview

The provided text does not contain any acceptance criteria or a study that proves the device meets specific criteria in the way a typical medical device study would be presented with performance metrics.

Instead, the document is a 510(k) premarket notification summary for a medical device (DePuy Profile™ Round Head Interference Screw and DePuy Phantom™ Resorbable Interference Screw). This means the manufacturer is seeking to demonstrate that their new device is "substantially equivalent" to an already legally marketed predicate device, rather than proving its safety and effectiveness through a new clinical trial with specific acceptance criteria.

The "Basis of Substantial Equivalence" section describes the rationale for this claim:

Materials and Design Similarity: The screws are similar in design and materials to previously cleared DePuy Advantage and Hyloc Interference screws.
Minor Differences: There are only minor design changes and fewer screw length options compared to previously cleared devices.
Additional Indication: The key difference is an additional indication for interference fixation of soft tissue grafts in ACL reconstruction.
Mechanical Testing: To support this additional indication, mechanical testing in cadaver bone was performed.

Here's how to address your specific points based on the provided text, while noting the limitations:

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

The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a table format as you would expect from a performance study.

Instead, it states:
"Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those of the previously cleared DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew indicated for interference fixation of soft tissue grafts in ACL reconstruction."

Acceptance Criteria (Implied): "Comparable" average insertion torque and pull-out strength to predicate devices.
Reported Device Performance: "Comparable" average insertion torque and pull-out strength.

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

Sample Size: Not specified. The text only mentions "cadaver bone" but does not give the number of samples or tests performed.
Data Provenance: The study appears to be a bench/mechanical study using "cadaver bone." The country of origin of this data is not specified, but the firm is located in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or a related facility. This would be considered prospective testing for the purpose of demonstrating substantial equivalence, although not a clinical trial.

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 question is not applicable to the provided document. The study was a mechanical/bench test on cadaver bone, not a diagnostic or clinical study requiring expert review to establish ground truth.

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

This question is not applicable. There was no clinical or diagnostic test set requiring adjudication. The comparison was based on quantitative mechanical properties (insertion torque and pull-out strength).

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 question is not applicable. The device is a bone screw, not an AI or imaging diagnostic device.

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

This question is not applicable. The device is a bone screw, not an algorithm.

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

For the mechanical testing, the "ground truth" (or reference) was the established mechanical performance (insertion torque and pull-out strength) of the predicate devices (DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew). The goal was to show comparability, not to establish a new clinical ground truth.

8. The sample size for the training set

This question is not applicable. There was no "training set" in the context of an AI/algorithm. If interpreted loosely as the historical data from which the "comparable" predicate devices were developed, that information is not provided.

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

This question is not applicable as there was no training set in the context of an AI/algorithm.

Summary

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K981670

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988
FIRM CONTACT:	Sally FoustRegulatory Submissions Associate
TRADE NAME:	DePuy ProfileTM Round Head Interference ScrewDePuy PhantomTM Resorbable Interference Screw
COMMON NAME:	Bone Screw
CLASSIFICATION:	888.3040 Smooth or threaded metallic bone fixation fastener
DEVICE PRODUCT CODE:	87 HWC

SUBSTANTIALLY EQUIVALENT DEVICES:

·DePuy Advantage Fixation Screw System (K961234)

· DePuv Hyloc Interference Screw (K955733)
· DePuy Phantom SofThread Soft Tissue Interference Screw (K980440)

• Linvatec BioScrew Absorbable Interference Screw (K960652, K960940)

·Smith & Nephew Doniov RCI Screw (K945687)

DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Interference Screw Systems are intended to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction and of soft tissue grafts in ACL reconstruction.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Profile Round Head and the Phantom Absorbable Interference Screws are similar in design and materials to the DePuy Advantage and Hyloc Interference screws which have been previously been cleared by FDA for interference fixation of bone-patellar tendon-bone grafts in ACL reconstruction. Aside from minor design changes and fewer screw length options, the only difference between this submission and the previously cleared submissions is the additional indication for interference fixation of soft tissue grafts in ACL reconstruction.

Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those of the previously cleared DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew indicated for interference fixation of soft tissue grafts in ACL reconstruction.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1998

Ms. Sally Foust Regulatory Submissions Associate DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K981670 DePuy Profile Round Head Interference Screw Trade Name: DePuy Phantom Resorbable Interference Screw Regulatory Class: II Product Codes: HWC and MAI May 11, 1998 Dated: Received: May 12, 1998

Dear Ms. Foust:

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 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 requirement, 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 requlation 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. Sally Foust

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 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cecelia M. Whitton, Ph.D.

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

Enclosure

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510(k) Number (if known)_ K 9816 70

Device Name DePuy Interference Screw Systems - Additional Indication/Intended Use

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

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Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

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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.