The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.

Device Description

The BioactIF OSTEOTRANS"M Interference Screw is a stcrile, single-use interference screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Screws are provided with various sizes typical of other marketed fixation devices.

AI/ML Overview

This is a 510(k) summary for a medical device called the BioactIF OSTEOTRANS™ Interference Screw. It's a bioabsorbable interference screw used for ligament reconstruction surgery. The documentation provided does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner you've outlined for performance studies (e.g., accuracy, sensitivity, specificity, or human improvement with AI).

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This is a common pathway for medical device approval where the new device is shown to be as safe and effective as a legally marketed device, rather than requiring extensive de novo clinical trials for performance metrics.

Here's a breakdown of why your requested information isn't present in this specific document:

Type of Device: This is a mechanical implant (an interference screw), not a diagnostic or AI-driven device. Acceptance criteria for such devices typically involve mechanical strength, biocompatibility, degradation profiles, and manufacturing standards, not performance metrics like sensitivity, specificity, or human reader improvement.
Regulatory Pathway: The 510(k) pathway for medical devices emphasizes substantial equivalence. This means the manufacturer compares their device to existing, legally marketed predicate devices. The "study" mentioned here is primarily this comparison and demonstrative data (e.g., strength testing) to show it's "as safe and effective" as the predicates.
Focus of the Document: The provided text is a 510(k) summary and FDA letter, which details the device's intended use, description, and the outcome of the FDA's review (substantial equivalence). It doesn't contain the detailed study protocols or results of bench testing or clinical trials that might define acceptance criteria as you've requested for an AI/diagnostic device.

Therefore, many of your requested points are not applicable or cannot be extracted from this document.

However, I can provide what is available about how the device meets regulatory requirements based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

As noted, explicit "acceptance criteria" for performance metrics like sensitivity/specificity are not defined for this type of device in this document. Instead, the "performance" demonstrated is its equivalence to predicate devices in:

Acceptance Criterion (Implicit)	Reported Device Performance
Material Composition (HA/PLLA composites) for bioabsorption and mechanical properties	Manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Inherently similar to predicate devices regarding bioabsorption characteristics.
Design and Functional Characteristics (e.g., screw sizes, interference fit)	"The BioactIF OSTEOTRANS™ Interference Screw has very similar physical design features and functional characteristics as the predicate devices." "Screws are provided with various sizes typical of other marketed fixation devices."
Mechanical Strength for Fixation (implied requirement for an interference screw)	"Performance data demonstrate that the BioactIF OSTEOTRANS™ Interference Screw has the requisite strength... sufficient and sustained fixation for intended uses." (Specific numerical values for strength are not provided in this summary but would be in underlying lab reports).
Favorable Degradation Profile (implied requirement for a bioabsorbable device)	"favorable degradation profile sufficient and sustained fixation for intended uses." (Specific degradation timelines/profiles are not provided in this summary).
Indications for Use (fixation of grafts in ACL/PCL reconstruction)	"The BioactIF OSTEOTRANS™ Interference Screw is indicated for the same uses and anatomical regions as the predicate devices."
Substantial Equivalence to Predicate Devices (overall regulatory acceptance criterion)	"The BioactIF OSTEOTRANSTM Interference Screw is substantially equivalent in design, materials and intended use and principles of operation to the predicate devices."

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

This document does not specify a "test set" in the context of diagnostic performance. The "performance data" mentioned (strength, degradation) would typically come from bench testing (in vitro/ex vivo), not patient data.
Data provenance: Not specified, but generally, bench testing would be conducted in a laboratory setting associated with the manufacturer or a contracted lab.
Retrospective or prospective: Not applicable to the type of data discussed.

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)

Not applicable. There is no diagnostic "ground truth" to be established by clinical experts for this device in this summary. The "ground truth" for a mechanical device is its physical and chemical properties as measured in a lab.

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

Not applicable. No clinical expert adjudication is mentioned or relevant for this type of device and submission.

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 device is an implantable screw, not an AI-driven diagnostic tool or system designed to assist human readers.

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

Not applicable. This is not an algorithm or AI system.

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

For the performance data mentioned (strength, degradation), the "ground truth" would be established through laboratory testing and validated quantitative measurements according to established engineering and material science standards (e.g., ISO standards, ASTM standards).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. See point 8.

Summary

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K081390 page 192

AUG 1 2, 2008

510(k) Summary BioactIF OSTEOTRANS™M Interference Screw

Submitter's name :	Takiron Co., Ltd.
Submitter's address:	3-13 Azuchi-machi 2-chome, Chuo-ku, Osaka541-0052, Japan
Contact Person :	Kunihiro HataRegulatory Affairs Specialist7-1-19, Minatojimaminamimachi, Chuo-ku,Kobe, Hyogo, 650-0047, JapanPhone: +81 78 306 2601Fax: +81 78 306 2606
Date prepared:	May 9, 2008
Trade or proprietary name:	BioactIF OSTEOTRANSTM Interference Screw
Common or usual name:	Bioabsorbable interference screw
Classification name:	Bone fixation screw, Class II
Device product code:	HWC - 21 CFR 888.3040 Screw, Fixation, Bone

Establishment Registration Number:

Takiron Co., Ltd. has not yet obtained an Establishment Registration Number.

Legally Marketed Predicate Devices:

1. Biocomposites Ltd .; Biosteon™ Screw (K003641)
Biocomposites Ltd.; BioLok® Scrcw (K002070) 2.
Mitek Products; Mitek Biocryl Interference Screw (K013572) 3.
Smith & Nephew Inc.; Smith & Nephew HAPLA Interference Screw (K002274) 4.

Intended Use:

The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bonc-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.

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Device Description:

Summary of Technology:

The BioactIF OSTEOTRANS"M Interference Screw has the same technological characteristics (i.e., design and material) when compared to the predicate devices. Performance data demonstrate that the BioactIF OSTEOTRANS™ Interference Screw has the requisite strength and favorable degradation profile sufficient and sustained fixation for intended uses.

Substantial equivalence

The BioactIF OSTEOTRANS™ Interference Screw is indicated for the same uses and anatomical regions as the predicate devices.

The BioactIF OSTEOTRANS™ Interference Screw has very similar physical design features and functional characteristics as the predicate devices.

Therefore the BioactIF OSTEOTRANSTM Interference Screw is substantially equivalent in design, materials and intended use and principles of operation to the 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 consists of a stylized eagle or bird symbol on the right. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Takiron Co., Ltd % Mr. Kunihiro Hata Regulatory Affairs Specialist Medical Institute 7-1-19, Minatojimaminamimachi, Chuo-Ku, Kobe. Hyogo Japan 650-0047

AUG 1 2 2008

Re: K081390

Trade/Device Name: BioactIF OSTEOTRANS™ Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 9 2008 Received: May 19, 2008

Dear Mr. Kunihiro:

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 – Mr. Kunihiro Hata

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millerson

Mark N. Melkerson 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

Applicant: Takiron Co., Ltd. Ko81390 510(k) Number (if known): Device Name: BioactIF OSTEOTRANS"M Interference Screw

Indications For Use:

The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.

Prescription Use______________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801.109)

Over-The-Counter Use_

(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number K081390

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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.