The Stryker Bioabsorbable Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL autografts and allografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The device is provided sterile and intended for single-use only.

Device Description

The Stryker Bioabsorbable Interference Screw System is made as a single unit from an absorbable polymer derived from Poly L-lactic acid (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The material, molding process, sterilization process for the line extension is equivalent to the predicate device, the Stryker Bioabsorbable Interference Screw System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Stryker Bioabsorbable Interference Screw System) and focuses on demonstrating substantial equivalence to a predicate device. It addresses the device's materials, design, intended use, safety, and efficacy. However, it does not contain the kind of information typically found in a study demonstrating a device meets acceptance criteria, particularly for an AI/ML-driven device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study that proves the device meets them, specifically because these elements are designed for evaluating AI/ML performance, which is not applicable to the Stryker Bioabsorbable Interference Screw System as described in this document.

Here's why and what the document does provide:

No AI/ML Component: The Stryker Bioabsorbable Interference Screw System is a physical medical device (an absorbable screw for ACL reconstruction), not an AI/ML software or system. Therefore, the concepts of "test set," "training set," "ground truth," "expert consensus," "MRMC study," "human readers improve with AI," or "standalone performance" are not relevant to its evaluation.
Substantial Equivalence: The document's primary purpose is to establish "substantial equivalence" to a predicate device (Stryker Bioabsorbable Interference Screw System, #K993166) already on the market. This is a regulatory pathway for many non-novel, traditional medical devices.
Performance Metrics for Substantial Equivalence: For this type of device, performance is typically assessed through:
- Material Equivalence: The document states, "The material... is equivalent to the predicate device."
- Molding Process Equivalence: "The material, molding process... is equivalent to the predicate device."
- Sterilization Process Equivalence: "The sterilization process... is equivalent to the predicate device."
- Mechanical Testing: "When comparing insertion torque and pullout test results, the line extension device has substantially equivalent performance to the predicate device."

To directly answer your numbered points based on the provided text, while acknowledging the mismatch in evaluation paradigms:

A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the acceptance criterion implicitly is "substantially equivalent performance" to the predicate device in key mechanical tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantially equivalent material of construction to predicate device.	"The material... is equivalent to the predicate device."
Substantially equivalent molding process to predicate device.	"The molding process... is equivalent to the predicate device."
Substantially equivalent sterilization process to predicate device.	"The sterilization process for the line extension is equivalent to the predicate device."
Substantially equivalent insertion torque to predicate device.	"insertion torque... has substantially equivalent performance to the predicate device."
Substantially equivalent pullout test results to predicate device.	"pullout test results... has substantially equivalent performance to the predicate device."
Validated sterility assurance level (SAL) of 10⁻⁶.	"sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550)... and validated to a sterility assurance level (SAL) of 10⁻⁶."

Sample sized used for the test set and the data provenance: Not applicable. Performance是以與predicate device作比較，而非透過獨立測試一個"test set"來評估。The mechanical tests mentioned (insertion torque and pullout) would have involved a sample size of manufactured screws, but the specific numbers are not provided in this summary. The data provenance would be laboratory testing conducted by Stryker.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is objective mechanical testing results against a benchmark (the predicate device), not expert interpretation of outputs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical performance, the "ground truth" is the objective results of physical material and mechanical tests (e.g., insertion torque values, pullout strength values), compared directly to the predicate device's known performance.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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NOV 1 3 2003

Image /page/0/Picture/2 description: The image shows the logo for Stryker Endoscopy. The word "stryker" is in a bold, sans-serif font, with the "s" and "t" connected. The word "ENDOSCOPY" is in a smaller, sans-serif font and is located below the word "stryker". There is a registered trademark symbol to the right of the "r" in "stryker".

SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name

Classification Name:

Common and Usual Name: Proprietary Name:

Screw, Fixation, Bone 21 CFR §888.3040, Class II Bioabsorbable Interference Screw Stryker Bioabsorbable Interference Screw System

Predicate Device

Stryker Bioabsorbable Interference Screw System, (#K993166), currently marketed by Stryker Endoscopy (San Jose, CA).

Summary

The Stryker Bioabsorbable Interference Screw System is for use in surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL autografts and allografts, including the patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The Stryker Bioabsorbable Interference Screw System is made as a single unit from an absorbable polymer derived from Poly L-lactic acid (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The material, molding process, sterilization process for the line extension is equivalent to the predicate device, the Stryker Bioabsorbable Interference Screw System.

The Stryker Bioabsorbable Interference Screw System is substantially equivalent in material of construction, overall design, intended use, safety, and efficacy to the Stryker Bioabsorbable Interference Screw System (#K993166) currently in commercial distribution. When comparing insertion torque and pullout test results, the line extension device has substantially equivalent performance to the predicate device, and is considered substantially equivalent to the Stryker Bioabsorbable Interference Screw System.

Contact:

Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2148

October 1, 2003 Date:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K033252

Trade Name: Stryker Bioabsorbable ACL Screw - Addition of 12 x 35 mm screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC. MAI Dated: October 1, 2003 Received: October 17, 2003

Dear Ms. Murphy:

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.

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Page 2 – Ms. Melissa Murphy

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. 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-_. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Melkerson

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

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October 1, 2003

KO 3 510(k) Number if known: 3 2 5

INDICATION FOR USE:

The Stryker Bioabsorbable Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL autografts and allografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The device is provided sterile and intended for single-use only.

R. Mark A. Mulkeran

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

510(k) Number K033

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) OR

Over-the-Counter Use

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.