The SPEEDTRAP graft preparation system consists of a suture construct provided on a disposable delivery device. The SPEEDTRAP Graft Preparation system is offered in long and short configurations with white (undyed) and green/white (undyed) color options, including single and multi-pack (Qty. 4) offerings.

AI/ML Overview

This document is a 510(k) summary for the SPEEDTRAP Graft Preparation System, a medical device for soft tissue approximation. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found in an AI/software medical device submission.

However, it does describe the types of tests performed to establish equivalence.

Here's an analysis based on the provided text, highlighting the absence of the requested information for AI/software devices and interpreting the available data in the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria with corresponding performance data in the way one would expect for an AI/software medical device. Instead, it states that "Performance data equivalence was established using non-clinical testing, including suture diameter and suture tensile strength testing." It also mentions "bacterial endotoxin testing."

While not explicitly called "acceptance criteria," the regulatory standards and testing performed for substantial equivalence imply certain thresholds must have been met for these non-clinical tests.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Non-Clinical Testing:
Suture Diameter	Data established equivalence to predicate devices.
Suture Tensile Strength	Data established equivalence to predicate devices.
Bacterial Endotoxin	Device met requirements.
Material/Design Equivalence	"Comprised of the same materials and is similar in design to the predicate Size 2 ORTHOCORD (K040004; K043298) and ETHIBOND EXCEL (K946173), sutures."

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

Test Set Sample Size: Not specified. The document states "non-clinical testing" was performed, but the number of sutures or tests conducted for diameter, tensile strength, or endotoxin is not provided.
Data Provenance: Not applicable in the context of human data. These are non-clinical (laboratory/bench) tests on the physical device itself.

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

Not applicable. Ground truth, in the context of AI/software devices, refers to expert labeling or pathology. For this physical medical device, "ground truth" would be established by standardized measurement techniques and laboratory protocols for the non-clinical tests. No human experts are mentioned for establishing ground truth for these device performance metrics.

4. Adjudication Method for the Test Set:

Not applicable. This concept is for human expert review of cases, typically for AI/software validation. The performance tests described (suture diameter, tensile strength, bacterial endotoxin) are objective laboratory measurements, not subjective expert assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, usually in diagnostic imaging. The SPEEDTRAP Graft Preparation System is a physical surgical suture system, not an AI/software diagnostic tool.

6. If a Standalone Performance Study (Algorithm Only) was done:

No, a standalone (algorithm only) performance study was not done. This is specific to AI/software devices operating without human intervention. The SPEEDTRAP system is a manually implanted surgical device.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be the objective, measured values obtained through standardized laboratory testing methods. For instance, for suture diameter, the ground truth would be the measurement obtained using a calibrated micrometer; for tensile strength, it would be the force at break measured by a tensile testing machine according to a standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

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

In summary: The provided document is a 510(k) summary for a physical medical device (suture system). It details regulatory information and establishes substantial equivalence based on material, design, and non-clinical performance (suture diameter, tensile strength, bacterial endotoxin). The questions provided are primarily geared towards the validation of Artificial Intelligence/Software as a Medical Device (AI/SaMD), and thus, most of them are not directly applicable to the content presented in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads in profile, facing right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

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

November 7, 2016

Medos International SARL % Mr. Jeffrey Dzialo Depuy Mitek, A Johnson And Johnson Company 325 Paramount Dr. Raynham, Massachusetts 02767

Re: K161638

Trade/Device Name: SPEEDTRAP Graft Preparation System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 4, 2016 Received: October 6, 2016

Dear Mr. Dzialo:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161638

Device Name

SPEEDTRAP Graft Preparation System

Indications for Use (Describe)

The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.

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 SPEEDTRAP™ Graft Preparation System

SummaryPreparationDate	September 29, 2016
Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Jeffrey DzialoRegulatory Affairs SpecialistDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-977-3998Facsimile: 508-977-6911e-mail: JDzialo@its.jnj.com
Name ofMedical Device	Proprietary Name: SPEEDTRAP™ Graft Preparation SystemClassification Name: Polyethylene, suture, nonabsorbable, synthetic,Common Name: Suture
SubstantialEquivalencePredicateDevices	The SPEEDTRAP™ Graft Preparation System is substantially equivalent to,Primary Predicate:K040004: ORTHOCORD® Suture (USP Size 2, Violet) (April 13, 2004)Reference predicates:K043298: ORTHOCORD® Suture (USP Size 2, Blue) (Dec 10, 2004)K946173: ETHIBOND EXCEL Suture (USP Size 2, Green) (January 09, 1995)
DeviceClassification	Class II:Sec. 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture,product code GAT.
DeviceDescription	The SPEEDTRAP graft preparation system consists of a suture construct provided ona disposable delivery device.The SPEEDTRAP Graft Preparation system is offered in long and short configurationswith white (undyed) and green/white (undyed) color options, including single andmulti-pack (Qty. 4) offerings.
Indications forUse	The SPEEDTRAP suture construct is indicated for use in soft tissue approximation inorthopedic procedures.
Safety andPerformance	The determination of substantial equivalence for this device was based on a detaileddevice description, performance data equivalence, and conformance to consensus andvoluntary standards. Performance data equivalence was established using non-clinicaltesting, including suture diameter and suture tensile strength testing.The proposed SPEEDTRAP suture construct is comprised of the same materials and issimilar in design to the predicate Size 2 ORTHOCORD (K040004; K043298) andETHIBOND EXCEL (K946173), sutures. The proposed SPEEDTRAP sutureconstruct also met requirements of bacterial endotoxin testing.Based on the similarities of the intended use, materials, technological characteristics,and performance comparison to predicate devices, the SPEEDTRAP graft preparationsystem has been shown to be substantially equivalent to predicate devices under theFederal Food, Drug and Cosmetic Act.

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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.