The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

Device Description

The ExpressBraid Graft Manipulation device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The suture may be all white or blue/white MaxBraid suture. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polyethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (-2)] cooper <0.5% by weight per 21 CFR Sec. 74.3045.

AI/ML Overview

This document describes the ExpressBraid Graft Manipulation device, a non-absorbable surgical suture. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in a clinical context with AI.

However, based on the provided text, we can extract details related to the performance testing conducted to support substantial equivalence. It's important to note that this is not a study assessing AI performance or human reader improvement.

Here's an analysis of the provided text in relation to your request, with the understanding that the "device" in this context is the ExpressBraid Graft Manipulation suture:

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

The document doesn't explicitly present a table of acceptance criteria with corresponding performance data in the typical sense for an AI device. Instead, it states that the device was tested against USP (United States Pharmacopeia) standards for non-absorbable surgical sutures and also compared to a predicate device.

Acceptance Criteria Category	Specific Criteria (Implicitly from USP)	Reported Device Performance
Tensile Strength	Meets USP requirements	Meets USP requirements
Diameter	Meets USP requirements	Meets USP requirements
Needle Attachment	Meets USP requirements	Meets USP requirements
Equivalence to Predicate	Performs equivalently to Arthrex #2 Suture	Testing concluded equivalent performance
Biocompatibility	Meets ISO 10993-1 standard requirements	Meets ISO 10993-1 requirements

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the performance testing (tensile strength, diameter, needle attachment, or comparative testing).
The data provenance is from laboratory testing performed by the manufacturer, Biomet Manufacturing Corp., as part of their 510(k) submission. No information on country of origin of the data or whether it's retrospective or prospective is given, as it's mechanical and biocompatibility testing, not clinical 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 the type of device and testing described. The "ground truth" for mechanical and biocompatibility testing is established by adherence to recognized standards (USP, ISO 10993-1) and direct measurement, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses or image interpretations, not for direct mechanical or chemical property testing.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant to AI-assisted diagnostic tools, not to a surgical suture. The document describes comparative performance between two sutures (the subject device and a predicate) in terms of mechanical properties.

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

This question is not applicable. This device is a physical surgical suture, not a software algorithm.

7. The type of ground truth used

The "ground truth" used for this device's performance assessment relies on:

Established standards: United States Pharmacopeia (USP) requirements for surgical sutures and ISO 10993-1 for biocompatibility.
Direct measurement and comparison: Mechanical and chemical properties were measured and compared to the predicate device.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. As there is no training set for an AI model, there is no ground truth established for one.

In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a surgical suture based on its mechanical properties and biocompatibility as compared to predicate devices and recognized standards. It does not contain information related to AI performance, clinical trials with human readers, or expert-based ground truth establishment as would be relevant for an AI/ML medical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 8, 2016

Biomet Manufacturing Corp. Mr. Adam Cargill Regulatory Affairs Specialist 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581

Re: K152868

Trade/Device Name: ExpressBraid Graft Manipulation Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: January 7, 2016 Received: January 11, 2016

Dear Mr. Cargill:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152868

Device Name ExpressBraid Graft Manipulation

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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 the ExpressBraid 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 August 12, 2005.

Sponsor:	Biomet Manufacturing Corp.
	56 East Bell Drive
	PO Box 587
	Warsaw, IN 46581
	Office: 574-267-6639
	Main Fax: 574-267-8137
	Establishment Registration Number: 1825034
Contact:	Adam Cargill
	Regulatory Affairs Specialist
Date:	January 7, 2016
Subject Device:	Trade Name: ExpressBraid Graft Manipulation

	Common Name: Non-absorbable Surgical Suture
	Classification Name:
	• GAT- Nonabsorbable poly(ethylene terephthalate) Surgical Suture(21 CFR 878.5000)

Legally marketed devices to which substantial equivalence is claimed:

Predicate Device:

Arthrex Suture - K122374

Reference Devices:

Teleflex Force Fiber - K033654/K040472

Device Description

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Intended Use and Indications for Use

Summary of Technological Characteristics

The ExpressBraid Graft Manipulation device has similar technological characteristics (design features, sizes, etc.) as the predicate.

. ExpressBraid Graft Manipulation has the same indications for use as the predicate Arthrex Suture (K122374).
Both ExpressBraid Graft Manipulation and Arthrex Suture are manufactured from UHMWPE.
Both ExpressBraid Graft Manipulation and Arthrex Suture meet USP Reference Standards.
ExpressBraid Graft Manipulation is provided with needles attached to the suture. Arthrex Suture is available with or without needles attached to the suture.
. ExpressBraid Graft Manipulation colorant used in the blue of the blue and white cobraid configuration consists of [phthalocyaninato (-2)] cooper <0.5% by weight per 21 CFR Sec. 74.3045. The dyes used in the Arthrex Suture may include D&C Blue No. 6, D&C Green No. 6, and Logwood Black.
MaxBraid Suture is identical to the Force Fiber Suture cleared in Teleflex 510(k)s K033654 and K040472.

Summary of Performance Data

ExpressBraid Graft Manipulation was testing in accordance with USP – non-absorbable surgical sutures for tensile strength, diameter, and needle attachment and meets the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.

Substantial equivalence testing was performed comparing ExpressBraid Graft Manipulation to the Arthrex #2 Suture. Testing concluded that the ExpressBraid Graft Manipulation will perform equivalently to the Arthrex #2 Suture.

All materials used in ExpressBraid Graft Manipulation were evaluated per ISO 10993-1 and meet the standard requirements for biocompatibility.

Substantial Equivalence Conclusion

The proposed ExpressBraid Graft Manipulation has similar intended use, design characteristics, and mechanical performance as the predicate Arthrex Suture. The performance data identified no new risks and substantial equivalence to the legally marketed predicate device.

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.