SYNTHES 3.9 MM PELVIC SCREWS by SYNTHES (USA)

This submission (K013044) for the Synthes 3.9 mm Pelvic Screw does not contain a study demonstrating that the device meets specific acceptance criteria in the way a diagnostic AI/ML device would. Instead, this is a 510(k) premarket notification for a medical device (a bone screw), which focuses on demonstrating substantial equivalence to legally marketed predicate devices.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, ground truth establishment for AI, MRMC studies, etc.) are not applicable to this type of device submission.

Here's a breakdown of the relevant information provided in the document in response to your request, indicating where information is not applicable:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Acceptance Criteria (Implied by Substantial Equivalence Pathway)	Reported Device Performance (Synthes 3.9 mm Pelvic Screw)	Explanation/Context
Material Composition Must be biocompatible and suitable for implantation.	Stainless Steel	The device is made of stainless steel, a commonly used and accepted material for bone fixation devices. Substantial equivalence implies that this material is suitable given its use in predicate devices.
Mechanical Properties Must provide stable fixation for indicated uses.	"machined metallic screw with a hex drive head"	While specific mechanical properties (e.g., tensile strength, torsion resistance) are not explicitly detailed in this summary, the "substantial equivalence" claim means that the device's design and mechanical characteristics are comparable to legally marketed predicate devices, which are presumed to have acceptable performance for their intended use.
Indications for Use Must be safe and effective for its stated purpose.	Fracture fixation of the pelvis and periacetabular osteotomies.	The stated indications are for fracture fixation of the pelvis and periacetabular osteotomies. Substantial equivalence confirms that these indications are appropriate for a device of this type, aligning with the indications of predicate devices. The FDA's clearance implies they found the device safe and effective for these indications based on the comparison to predicates.
Device Design/Form Must be similar in design and principle of operation to predicate devices.	"manufactured in various lengths as threaded screws"	The device is described as a "machined metallic screw with a hex drive head." The submission states that "Documentation was provided which demonstrated the Synthes 3.9 mm Pelvic Screw to be substantially equivalent to other legally marketed devices," indicating design similarity.
Sterilization & Packaging (Not explicitly detailed in this summary but required for all implants)	(Not explicitly detailed)	Expected to be sterile and appropriately packaged for an implantable device, in line with predicate devices and general controls.

Sample size used for the test set and the data provenance: Not applicable. This is a medical device (bone screw) submission based on substantial equivalence, not a diagnostic AI/ML device requiring a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of medical device. "Ground truth" in the context of substantial equivalence for a bone screw refers implicitly to the established safety, effectiveness, and performance of legally marketed predicate devices, which have been proven through clinical use and regulatory review over time.
Adjudication method for the test set: Not applicable for this type of medical device submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are typically for diagnostic imaging devices or software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implantable device, not an algorithm.
The type of ground truth used: For this device, the "ground truth" for demonstrating substantial equivalence is based on the established safety and efficacy profiles of legally marketed predicate devices, which implies:
- Clinical history of similar devices.
- Performance standards met by similar devices.
- Regulatory acceptance of similar designs and materials.
- Bench testing (mechanical, material, biocompatibility) demonstrating comparability to predicates (though specific results are not in this summary).
The sample size for the training set: Not applicable for this type of medical device.
How the ground truth for the training set was established: Not applicable for this type of medical device.

Summary of the Study (Substantial Equivalence Demonstration):

The "study" referenced in this document is not a clinical trial or an AI/ML algorithm validation study. Instead, it is the submission of documentation to the FDA (510(k) premarket notification) demonstrating that the Synthes 3.9 mm Pelvic Screw is substantially equivalent to other legally marketed predicate devices.

The FDA's decision letter (K013044) states: "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...".

This means that Synthes (USA) provided data and analysis to convince the FDA that their new device is as safe and effective as existing devices on the market. This typically involves:

Comparing the device's design, materials (Stainless Steel), and fundamental scientific technology to predicate devices.
Comparing the intended use and indications (fracture fixation of the pelvis, periacetabular osteotomies) to predicate devices.
Likely, performing bench testing (e.g., mechanical strength, fatigue, biocompatibility) to show equivalent performance to predicates, though these specific test results are not detailed in the provided summary.
Addressing any differences and demonstrating they do not raise new questions of safety or effectiveness.

In summary, for a traditional medical device like a bone screw, "acceptance criteria" are generally met by demonstrating equivalence to a device that has already been accepted as safe and effective by the regulatory body. This is a different pathway than proving performance against a specific ground truth for a diagnostic AI/ML system.

Summary

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DEC 0 3 2001

K013044
page 1 of 1

3. Summary of Safety and Effectiveness Information

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact	Matthew M. Hull(610) 647-9700 ext. 7191
Name of the Device	Synthes 3.9 mm Pelvic Screw
Device Classification(s)	Class II, §888.3040 - Screw, Fixation, Bone
Substantial Equivalence	Documentation was provided which demonstrated the Synthes 3.9 mmPelvic Screw to be substantially equivalent to other legally marketeddevices.
Device Description	The Synthes 3.9 mm Pelvic Screw is a machined metallic screw with ahex drive head.
Indications	The 3.9mm pelvic screw is indicated for fracture fixation of the pelvisas well as for periacetabular osteotomies.
Materials	Stainless Steel

CONFIDENTIAL

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matthew M. Hull, RAC DEC 0 3 2001

Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K013044

Trade/Device Name: Synthes 3.9 mm Pelvic Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 6, 2001 Received: September 10, 2001

Dear Mr. Hull:

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 (OS) 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 -- Mr. Matthew M. Hull, RAC

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin hankeling of substantial equivalence of your device to a legally premarket nother 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 If you desire specific advice for your device direction of the other contact the Office of additionally 21 CFR Patt 809.10 for in Vitte different on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and abe Compliance at (301) 594-4657. Tidatorially, University, University, Also, please note the your device, prease contact and over in premarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket showly ackson the Other general information on your responsibilities under the Act may be obtained from the Other general miorination on your responsional 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. Milliken

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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2. Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

K013044/

Synthes 3.9 mm Pelvic Screw

The 3.9mm pelvic screw is indicated for fracture fixation of the pelvis as well as for periacetabular osteotomies.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

for Mark M. Melleum
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number: K013044

Synthes(USA) Synthes 3.9 mm Pelvic Screw 510(k)

CONFIDENTIAL

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.