ANCHORMAN is a PEEK cortical tibial suspensory fixation device, and functions via the looping of a biological or artificial tendon graft through the loop component of the device. The tendon graft is then pulled through the tibial and femoral tunnels. The wing components of the device rest on the tibial cortex, facilitating tensioning on the femoral side (if required). The device then provides tibial suspensory fixation, supporting the graft until aperture healing occurs and the graft integrates with the bone, at which point the device does not bear load and is redundant.

AI/ML Overview

This document describes a premarket notification (510(k)) for the ANCHORMAN Tibial Ligament Fixation Device. The submission focuses on demonstrating substantial equivalence to a predicate device, the Arthrex Inc., Retrobutton.

Here's an analysis of the provided information regarding acceptance criteria and the study:

Key Takeaway: The device discussed is a medical implant (Tibial Ligament Fixation Device), not an AI/software as a medical device (SaMD). Therefore, the provided text does not contain information related to AI/SaMD testing methods such as test sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance. Instead, it focuses on mechanical, chemical, and physical performance of a physical medical device.

Therefore, the requested information regarding AI/SaMD specific testing (points 2, 3, 4, 5, 6, 7, 8, 9) is not applicable to this document. I will answer based on the information that is present for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device in terms of mechanical, chemical, physical, and handling characteristics. The reported device performance is presented in terms of comparative in-vitro testing.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported ANCHORMAN Device Performance
Mechanical Characteristics	Comparative in-vitro testing on human cadaveric tibiae was performed. The results for ANCHORMAN were compared to that of the predicate (Retrobutton). The results showed that ANCHORMAN possesses mechanical characteristics necessary to demonstrate substantial equivalence. Specifically, for relevant performance/clinical characteristics which may be affected by size (UTS, initial and cyclic displacement, and stiffness), ANCHORMAN's performance was confirmed to be equivalent with reference to clinically identified failure levels.
Chemical Characteristics	Although ANCHORMAN (made of PEEK) and the predicate (made of UHMWPE and Titanium Ti6Al4V) are composed of different materials and thus have chemical differences, both materials are long-established implant materials. Confirmatory biocompatibility testing verified their suitability. Comparative in-vitro testing further showed that the chemical differences do not raise any new questions of safety and effectiveness.
Physical Characteristics	Although ANCHORMAN and the predicate have different designs and materials, direct comparative performance testing in cadaveric tibiae confirmed that, when considering relevant performance/clinical characteristics affected by size (UTS, initial and cyclic displacement, and stiffness), ANCHORMAN's performance is equivalent with reference to the clinically identified failure levels.
Handling Characteristics	Direct comparative performance testing in human cadaveric tibiae confirmed that, when implanted properly, the relevant performance/clinical characteristics affected by size (UTS, initial and cyclic displacement, and stiffness) are equivalent with reference to the clinically identified failure levels. A cadaveric usability study for ANCHORMAN demonstrated the appropriateness of this technique for users, even in worst-case insertion and removal circumstances. These differences do not raise any new questions of safety and effectiveness.

Regarding AI/SaMD specific questions (Not Applicable to this device):

Sample size used for the test set and the data provenance: Not applicable. (No AI test set).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No expert ground truth for an AI test set).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. (No AI test set adjudication).
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. (No human readers or AI involved with this physical device).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (No algorithm).
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. (The "ground truth" for this device's performance is based on direct mechanical and physical testing against pre-defined clinical failure levels and comparison to a predicate device).
The sample size for the training set: Not applicable. (No AI training set).
How the ground truth for the training set was established: Not applicable. (No AI training set ground truth).

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Summit Medical Ltd. Sam Drew RA Manager - Projects Bourton Industrial Park Bourton on the Water, Gloucestershire GL54 2HO United Kingdom

July 25, 2017

Re: K170388

Trade/Device Name: ANCHORMAN Tibial Ligament Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 14, 2017 Received: June 14, 2017

Dear Sam Drew:

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

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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.

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,

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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Page 1 of 1

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K170388

Device Name

ANCHORMAN Tibial ligament fixation device

Indications for Use (Describe)

Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction

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 – K170388 Summit Medical Ltd ANCHORMAN

SUMMIT MEDICAL

SURGICAL PRODUCTS

Head office OrthoD Group Ltd Industrial Park Bourton on the Water Gloucestershire GL54 2HQ United Kingdom

+44 (0) 1451 821311 tel. info@orthod.com email website www.orthod.com

Date prepared	31/May/2017
Submitter	Summit Medical Ltd
Contact person	Sam DrewRA Manager - ProjectsSummit MedicalIndustrial ParkBourton-on-the-WaterGloucestershireGL54 2HQPhone: +44(0)1451 823350Fax: +44 (0)1451 821092Email: sam.drew@orthod.com
Name of device	ANCHORMAN cortical tibial fixation device
Classification	Classification - IIProduct Code - MBIClassification name - Fastener, Fixation, Nondegradable, Soft TissueClassification Rule - 888.3040Device Panel – 87 - "Orthopedic surgery"
Predicate device(s)	Arthrex Inc., Retrobutton cleared under K062747
Indications for use	Tibial fixation of biological ligament during orthopaedic reconstructionprocedures such as Anterior Cruciate Ligament (ACL) reconstruction
Device description	ANCHORMAN is a PEEK cortical tibial suspensory fixation device, andfunctions via the looping of a biological or artificial tendon graft through theloop component of the device. The tendon graft is then pulled through thetibial and femoral tunnels. The wing components of the device rest on thetibial cortex, facilitating tensioning on the femoral side (if required). Thedevice then provides tibial suspensory fixation, supporting the graft untilaperture healing occurs and the graft integrates with the bone, at which pointthe device does not bear load and is redundant.

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510(k) Summary Summit Medical Ltd ANCHORMAN

MMIT MEDICAL

SURGICAL PRODUCTS

Non-clinical testing	Comparative in-vitro testing on human cadaveric tibiae was performed andthe results for ANCHORMAN were compared to that of the predicate. Theresults showed that ANCHORMAN possesses mechanical, chemical, physicaland handling characteristics necessary to demonstrate that it is substantiallyequivalent to Retrobutton.
Clinical testing	Clinical data was not required to establish substantial equivalence betweenthe ANCHORMAN and the predicate device.
Chemical differences	Although ANCHORMAN and the predicate are composed of differentmaterials, and therefore have chemical differences, both PEEK(ANCHORMAN), UHMWPE and Titanium Ti6Al4V (RetroButton) are longestablished implant materials, with confirmatory biocompatibility testingverifying this. Comparative in-vitro testing on human cadaveric tibiae wasperformed and the results for ANCHORMAN were compared to that of thepredicate, and showed that the chemical differences between ANCHORMANand the predicate do not raise any new questions of safety and effectiveness
Physical differences	Although ANCHORMAN and the predicate have different designs andmaterials, direct comparative performance testing in cadaveric tibiaecomparing ANCHORMAN and the predicate device has confirmed that, whenthe relevant performance/ clinical characteristics which may be affected bysize (UTS, initial and cyclic displacement and stiffness) are equivalent withreference to the clinically identified failure levels.
Handling differences	Direct comparative performance testing in human cadaveric tibiae comparingANCHORMAN and the predicate device has confirmed that, when implantedproperly, the relevant performance/ clinical characteristics which may beaffected by size (UTS, initial and cyclic displacement and stiffness) areequivalent with reference to the clinically identified failure levels. Thecadaveric usability study for ANCHORMAN has demonstrated theappropriateness of this technique for users, even in worst case insertion andremoval circumstances. These differences do not raise any new questions ofsafety and effectiveness
Substantial equivalence	Based on the similarities in design, function, indications for use andfundamental scientific technology, the devices that are the subject of thissubmission are similar to the predicate devices and do not introduce any newrisks of safety or efficacy. Therefore, Summit Medical concludes that thesubject device is substantially equivalent to the predicate device.

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.