XBraid TT Suture Tape (herein referred to as the proposed device(s)) is a non-absorbable, sterile suture composed 100% of ultra high molecular weight polyethylene (UHMWPE). These devices are braided to be flat in shape and offered in white/violet coloration patterns. XBraid TT Suture Tape complies with USP standards for #2 suture with the exception of size classifications and needle attachment. Three configurations are being proposed that differ only in coloration pattern and dimensions. Each configuration will be cut to length and provided to the end user in a singleuse sterile barrier system (SBS).

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "XBraid TT Suture Tape". A 510(k) submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving a device meets specific performance acceptance criteria through a clinical study in the way an AI/ML device would.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and the study that was performed for this specific device.

Acceptance Criteria and Device Performance for XBraid TT Suture Tape

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (USP Standard for #2 Nonabsorbable Surgical Suture)	Reported Device Performance (XBraid TT Suture Tape)
Minimum requirements for knot pull tensile strength.	Meets or exceeds the minimum requirements.

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

Test Set Sample Size: Not specified in the document.
Data Provenance: Not applicable as this was non-clinical benchtop testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: "Ground truth" in the context of expert consensus is typically for diagnostic imaging or similar AI/ML applications. This device underwent benchtop testing against a standard.

4. Adjudication method for the test set:

Not Applicable: No adjudication for expert consensus was performed. Performance was measured against USP standards.

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: This is not applicable to a non-clinical benchtop study for a surgical suture.

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

Not Applicable: This is a physical medical device, not an algorithm. Benchtop testing is inherently "standalone" in that it doesn't involve human-in-the-loop performance for its core function.

7. The type of ground truth used:

USP Standards: The "ground truth" for performance was the minimum requirements set by the United States Pharmacopeia (USP) for #2 nonabsorbable surgical sutures, specifically for knot pull tensile strength.

8. The sample size for the training set:

Not Applicable: This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.

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

Not Applicable: No training set was used.

Summary of the Study:

Study Type: Non-clinical benchtop testing.
Objective: To verify that the XBraid TT Suture Tape devices meet or exceed the minimum requirements of USP standards for knot pull tensile strength of size #2 nonabsorbable surgical sutures.
Key Finding: The proposed devices demonstrated performance that meets or exceeds the specified USP standards.
Conclusion: Based on this performance data and comparison to the predicate device regarding intended use, materials, performance attributes, and technological characteristics (with only a colorant difference which was shown to be biologically safe and functionally acceptable), the device was deemed substantially equivalent to the predicate. Clinical testing was not required for this submission.

Summary

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

November 10, 2016

Stryker Ms.Taylor White Regulatory Affairs Analyst 5670 Greenwood Plaza Blvd., Suite 200 Greenwood Village, Colorado 80111

Re: K162310

Trade/Device Name: Xbraid TT Suture Tape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, Dated: August 15, 2016 Received: August 17, 2016

Dear Ms. White:

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 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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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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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)

K162310

Device Name

Xbraid TT Suture Tape Indications for Use (Describe)

Xbraid TT Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgieries.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY Xbraid TT Suture Tape

I. SUBMITTER

Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138

Contact Person: Taylor White, Regulatory Affairs Analyst Phone: 303-336-7285 Fax: 303-993-6195

Date Prepared: August 15, 2016

II. SUBJECT DEVICE

Name of Device:	XBraid TT Suture Tape
Model Numbers:	3910-900-017, 3910-900-018, 3910-900-019
Common or Usual Name:	Suture, Nonabsorbable, Synthetic, Polyethylene
Classification Name:	Nonabsorbable poly(ethylene terephthalate) surgical suture (21 CFR 878.5000)
Regulatory Class:	2
Product Code:	GAT

III. PREDICATE DEVICE

Predicate: Stryker Suture Tape, K150584 This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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V. INTENDED USE

XBraid TT Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The technological characteristics of design and generic material of construct of the XBraid TT Suture Tape devices are identical to the predicate device. Both the proposed and the predicate devices feature a braided multifilament design and are composed entirely of ultra high molecular weight polyethylene (UHMWPE). As such, XBraid TT Suture Tapes and the predicate devices are classified as Class I Sutures per USP standards.

Proposed and Predicate Device Differences:

Material Formulation

The singular difference in technological characteristics concerns the material formulation, namely, the colorant used. The predicate device is offered in white/blue coloration patterns, while the XBraid TT Suture Tape products are offered in white/violet patterns. The coloration patterns for the proposed and predicate devices are created by braiding colored and white (noncolored) suture strands. This difference in color is due to the proposed devices containing a different colorant than the predicate device. This difference in colorant has been shown to be biologically safe and functionally acceptable within the intended use of the devices. The intended use of the proposed and predicate devices is identical. The new colorant thus raises no new questions of safety and effectiveness and does not represent a significant change to materials of construct.

XBraid TT Suture Tape is substantially equivalent to the identified predicate device in regard to intended use, materials of construct, performance attributes, and technological characteristics.

VII. PERFORMANCE DATA

Non-clinical benchtop testing was performed to verify that the XBraid TT Suture Tape devices meet or exceed the minimum requirements of USP standards for knot pull tensile strength of size #2 nonabsorbable surgical sutures. Clinical testing was not required to demonstrate substantial equivalence for this submission.

VIII. CONCLUSIONS

The information presented within this traditional premarket submission demonstrates that XBraid TT Suture Tape is substantially equivalent to the predicate device and will perform as designed within the intended use.

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.