Titanium Interference Screws are metallic bone screws used to provide fixation of patellar bone-tendon-bone grafts during anterior cruciate ligament (ACL) repair.

AI/ML Overview

This document is a marketing clearance (510(k)) for a medical device called "Titanium Interference Screws." It establishes substantial equivalence to a predicate device, meaning it's considered as safe and effective as a device already on the market, and therefore does not include detailed studies demonstrating performance against specific acceptance criteria in the way a clinical trial for a novel device would.

The provided document does not contain a study focused on proving the device meets acceptance criteria in a clinical or AI-related context, nor does it provide a table of acceptance criteria and reported device performance relevant to AI/diagnostic efficacy.

Instead, the document focuses on demonstrating substantial equivalence for the Titanium Interference Screws by comparing their characteristics and non-clinical performance to an already legally marketed predicate device. The "acceptance criteria" here refer to the regulatory safety and performance standards for a substantially equivalent device, rather than specific diagnostic metrics.

However, based on the non-clinical tests described, we can infer some "acceptance criteria" as they relate to the mechanical performance of the device.

Here's an analysis based on the information provided, inferring what could be considered "acceptance criteria" for this type of device and what was done to support its clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (Titanium Interference Screws) and not an AI or diagnostic device, the "acceptance criteria" are related to its mechanical and biological safety, not diagnostic performance. The document states that the test results "indicate the device and the modifications do not introduce any new risks to the device performance" and "the testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues."

Acceptance Criteria (Inferred from Non-Clinical Tests)	Reported Device Performance
Cyclic Loading Performance: Device withstands cyclic stress without failure or degradation that would introduce new risks.	"The test results indicate the device and the modifications do not introduce any new risks to the device performance."
Failure Torque Performance: Device's failure torque meets established safety limits (implies it's strong enough not to fail prematurely during use).	"The test results indicate the device and the modifications do not introduce any new risks to the device performance."
Insertion Torque Performance: Device's insertion torque is within acceptable limits for surgical implantation (implies it's easy/safe to implant).	"The test results indicate the device and the modifications do not introduce any new risks to the device performance."
Pull Out Strength Performance: Device maintains fixation strength in bone after implantation (implies it won't dislodge prematurely).	"The test results indicate the device and the modifications do not introduce any new risks to the device performance."
Bacterial Endotoxin Levels: Device meets sterility and pyrogenicity limits (≤20 EU/Device per USP41-NF36 Chapter <161>).	"demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices -Bacterial Endotoxin and Pyrogen Tests."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Cyclic loading testing of Titanium Interference Screws," "Failure torque testing of Titanium Interference Screws," etc., which implies a sample of devices were tested. Typical mechanical testing involves a statistically significant number of samples, but the exact count is not disclosed here.
Data Provenance: The tests are non-clinical, likely performed in an engineering lab environment. The country of origin of the data is not specified beyond being part of the submission from "Biomet Inc." in "Warsaw, Indiana" to the FDA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate performance, but they are in vitro (bench testing) rather than in vivo data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus is typically relevant for diagnostic or AI-driven devices where human interpretation provides a reference standard. For a mechanical implant device, the "ground truth" is defined by established engineering and biological safety standards (e.g., ASTM standards for mechanical properties, USP standards for endotoxins) and the expert interpretation is embedded within the test methodologies and regulatory review process.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic decisions. For mechanical testing, results are quantitative and either meet or do not meet pre-defined criteria; expert adjudication of test results is not typically part of the process, though expert interpretation of the implications of the results is part of the regulatory review.

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 is a clearance for a physical orthopedic implant (Titanium Interference Screws), not an AI or imaging device that would involve human readers or diagnostic interpretation.

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

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described, the "ground truth" is derived from:

Established engineering standards: For cyclic loading, failure torque, insertion torque, and pull-out strength, these likely refer to industry-accepted mechanical testing standards (e.g., ISO, ASTM standards for orthopedic implants). The "ground truth" is the established performance benchmarks or thresholds for these mechanical properties that ensure safety and effectiveness for the intended use.
Biological safety standards: For Bacterial Endotoxins, the "ground truth" is the regulatory limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161>.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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February 24, 2020

Biomet Inc. Saveetha Raghupathi Regulatory Affairs Specialist 56 East Bell Drive. PO Box 587 Warsaw, Indiana 46581

Re: K193451

Trade/Device Name: Titanium Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: December 12, 2019 Received: December 13, 2019

Dear Saveetha Raghupathi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, PhD Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K193451

Device Name Titanium Interference Screws

Indications for Use (Describe)

Titanium Interference Screws are intended for use in fixation of patellar bone grafts in ACL reconstruction.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for Titanium Interference Screws 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Primary Contact Person:	Saveetha RaghupathiRegulatory Affairs SpecialistTelephone: (877-652-0830 ext. 236)
Secondary Contact Person:	Jared CooperRegulatory Affairs ManagerTelephone: (574-372-1941)
Date:	December 12, 2019
Subject Device:	Trade Name: Titanium Interference ScrewsCommon Name: Bone Screw Fixation Device
	Classification Name:
	HWC- Screw, Fixation, Bone, Smooth or Threaded Metallic Bone Fixation Fastener (21CFR 888.3040)MBI - Fastener, Fixation, Nondegradable, Soft Tissue, Smooth or Threaded Metallic Bone Fixation Fastener (21CFR 888.3040)

Predicate Device(s):

Primary Predicate	510(k) Number
Arthrotek Interference Screw	K934469

Purpose and Device	Titanium Interference Screws are metallic bone screws used
Description:	to provide fixation of patellar bone-tendon-bone grafts
	during anterior cruciate ligament (ACL) repair.
	To submit a 510(k) for cumulative changes made to the system since original clearance: A line extension including part numbers with minor dimensional changes made to screw design; Manufacturing site location change; To update labeling in order to bring the Instructions for Use up to current practices.
Intended Use andIndications for Use:	These devices are intended for soft tissue repair and/or reconstruction.Titanium Interference Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Summary of TechnologicalCharacteristics:	The rationale for substantial equivalence is based on consideration of the following characteristics: Intended Use: Identical to predicate Indications for Use: Identical to predicate Materials: Identical to predicate Design Features: Similar to predicate Sterilization: Identical to predicate
Summary of Performance Data:(Nonclinical and/or Clinical)	Non-Clinical Tests: Cyclic loading testing of Titanium Interference Screws was performed to verify cyclic performance of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Failure torque testing of Titanium Interference Screws was performed to verify the failure torque of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Insertion torque testing of Titanium Interference Screws was performed to verify the insertion torque of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance.

The purpose of this submission is:

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Pull out strength testing of Titanium Interference . Screws was performed to verify the pull out strength of the device. The test results indicate the device and the modifications do not introduce any new risks to

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the device performance.

Bacterial Endotoxins Test (BET) per ANSI/AAMI ST 72:2011 as a part of cleaning validation was performed, demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices -Bacterial Endotoxin and Pyrogen Tests.
The testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues.

Clinical Tests:

None provided .
The subject device, Titanium Interference Screws, has identical intended use and indications for use to the predicate device. The subject device has similar technological characteristics to the predicate, and the information provided herein demonstrates that:
any differences do not raise new questions of safety and effectiveness: and
the subject device is at least as safe and effective as ● the legally marketed predicate device.

Substantial Equivalence Conclusion:

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.