The TRUESPAN Meniscal Repair System is intended for use in meniscal repairs and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

Device Description

The proposed device is an all-inside meniscal repair system. The implant consists of two rigid backstops (absorbable PLGA1 or non-absorbable PEEK2), size #2-0 Orthocord suture and UHMWPE braid. The implant system and applier are pre-assembled, and the whole device is sterile, for single patient use only. Compression of the fixation point is accomplished by pulling on the suture post to allow the two suture strands creating the bridge between the implants to lay tight on the surface of the fixation point. *1 PLGA: Poly(lactide-co-glycolide) *2 PEEK: polyaryletherketone

AI/ML Overview

The provided text is a 510(k) summary for the TRUESPAN™ Meniscal Repair System. It describes a medical device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about an AI-powered device or a study proving an AI device meets acceptance criteria.

Specifically, the document discusses:

Device Name: TRUESPAN™ Meniscal Repair System
Intended Use: Meniscal repair and meniscal allograft transplant procedures, anchoring the allograft to the meniscal rim.
Device Description: An all-inside meniscal repair system consisting of rigid backstops (absorbable PLGA or non-absorbable PEEK), #2-0 Orthocord suture, and UHMWPE braid. The system is pre-assembled, sterile, and for single patient use.
Safety and Performance: States that "Implant system strength was evaluated in vitro and after cyclic (bench top). The testing demonstrated substantial equivalence of performance to the predicate device. Biocompatibility is also confirmed based on biocompatibility data and justification. The proposed device has raised no new issue of safety and efficacy."
Substantial Equivalence: Concludes that the proposed device is substantially equivalent to the predicate device based on similar technological characteristics and comparable implant system strength.

Since the request asks for details about an AI-powered device and a study proving its acceptance criteria, and the provided text describes a meniscal repair system (a physical medical implant) and its mechanical/biocompatibility testing, I cannot fulfill the request using only the provided text. The information requested (acceptance criteria table, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training set details) is typical for AI/software as a medical device (SaMD) clearances, not for a physical implant like the TRUESPAN system.

Therefore, I cannot provide the requested table or answer the specific questions about AI device performance and studies based on the given document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

March 24, 2016

Medos International SARL % Yayoi Fujimaki Regulatory Affairs Senior Associate Depuy Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K153667

Trade/Device Name: TRUESPAN™ Meniscal Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 17, 2016 Received: February 18, 2016

Dear Yayoi Fujimaki:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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" (21CFR 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K153667

Device Name

Truespan Meniscal Repair System

Indications for Use (Describe)

The TRUESPAN Meniscal Repair System is intended for use in meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for the meniscal rim during allograft transplant procedures.

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)

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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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The logo features a geometric design to the left of the company name, "DePuy Synthes," which is in a bold, dark blue font. Below that, "MITEK SPORTS MEDICINE" is written in a smaller, lighter blue font. Underneath the company name is the text "COMPANIES OF" followed by the Johnson & Johnson logo in red.

510(k) SUMMARY TRUESPAN™ Meniscal Repair System

Date SummaryPrepared	December 18, 2015
Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Manufacturer	Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland
Contact Person	Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA	Telephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujima1@its.jnj.com
Name ofMedical Device	Trade Name: TRUESPANTM Meniscal Repair SystemCommon Name: Fastener, fixation, degradable, soft tissue
DeviceClassification	MBI - Smooth or threaded metallic bone fixation fastener, classified as Class II, regulated per 21 CFR 888.3040. Orthopedic panel
PredicateDevice	Predicate: Fast-Fix 360 Meniscal Repair System (K121861, K092508; Smith & Nephew) Reference: Ultra Fast-Fix Meniscal Repair System (K121861, K072322; Smith & Nephew) Reference: Omnispan Meniscal Repair System (K092836, DePuy Mitek)
Indications forUse	The TRUESPAN Meniscal Repair System is intended for use in meniscal repairsand meniscal allograft transplant procedures. The TRUESPAN Meniscal RepairSystem is intended to be used for anchoring the allograft to the meniscal rimduring allograft transplant procedures.
DeviceDescription	The proposed device is an all-inside meniscal repair system. The implantconsists of two rigid backstops (absorbable PLGA1 or non-absorbable PEEK2),size #2-0 Orthocord suture and UHMWPE braid. The implant system andapplier are pre-assembled, and the whole device is sterile, for single patient useonly. Compression of the fixation point is accomplished by pulling on the suturepost to allow the two suture strands creating the bridge between the implants to
	lay tight on the surface of the fixation point.1 PLGA: Poly(lactide-co-glycolide)2 PEEK: polyaryletherketone
Safety andPerformance	Implant system strength was evaluated in vitro and after cyclic (bench top). Thetesting demonstrated substantial equivalence of performance to the predicatedevice. Biocompatibility is also confirmed based on biocompatibility data andjustification. The proposed device has raised no new issue of safety and efficacy.
SubstantialEquivalence	The proposed device is an all-inside meniscal repair system. The proposeddevice consists of two rigid backstops and sutures. The technologicalcharacteristics are similar to the predicate device. Implant system strengthdemonstrated substantial equivalency of performance. Differences foundbetween the proposed and the predicate device are considered minor and do notraise questions concerning safety and efficacy. The proposed device isdetermined substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image contains the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The logo features a geometric design to the left of the text "DePuy Synthes" in a dark blue sans-serif font. Below this, "MITEK SPORTS MEDICINE" is written in a smaller, similar font. Underneath a thin line, the text "COMPANIES OF" appears above the Johnson & Johnson logo.

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.