The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.

Device Description

The SECURE-LOOP fixation device consists of a polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.

AI/ML Overview

The provided text describes the SECURE-LOOP device and its substantial equivalence to a predicate device, the Smith & Nephew Endobutton Continuos Loop (ECL) K980155. It focuses on comparing the technological characteristics and performance of the SECURE-LOOP with the predicate device rather than presenting specific acceptance criteria and a study to prove they are met in a traditional sense.

Instead of a typical AI/ML device study, the document describes a device equivalency study based on pre-clinical testing for a medical fastener.

Here's an analysis based on the information provided, formatted to answer your questions where applicable:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds. Instead, the criterion for the SECURE-LOOP device is substantial equivalence to the predicate device (Smith & Nephew Endobutton Continuos Loop (ECL) K980155) across several performance characteristics.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (SECURE-LOOP vs. Predicate)
Stiffness equivalence	Determined to be substantially equivalent to Endobutton Continuous Loop (ECL)
Tensile strength equivalence	Determined to be substantially equivalent to Endobutton Continuous Loop (ECL)
Cyclic fatigue testing equivalence	Determined to be substantially equivalent to Endobutton Continuous Loop (ECL)
Functional testing equivalence	Determined to be substantially equivalent to Endobutton Continuous Loop (ECL)
No new issues of safety and efficacy	Testing demonstrated that differences do not raise any new issues of safety and efficacy.
Similar safety and effectiveness profile	Based on pre-clinical testing, found to have a safety and effectiveness profile similar to predicate device

Study Details:

Sample size for the test set and data provenance:
The document does not specify the exact sample sizes (i.e., number of devices or test repetitions) used for the stiffness, tensile strength, cyclic fatigue, and functional testing.
The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond stating "pre-clinical testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the study involves device performance testing against a predicate, not human expert interpretation for ground truth establishment.
Adjudication method for the test set:
Not applicable, as it is a physical device performance comparison, not a ground truth establishment process involving multiple experts.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is typically for diagnostic imaging devices involving interpretation by multiple human readers, which is not relevant for this orthopedic fixation device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is generally relevant for AI/ML algorithms. For this physical device, the "standalone performance" is implicitly what was measured in the pre-clinical tests (stiffness, tensile strength, cyclic fatigue, functional testing) where the device's properties were characterized without human intervention in its function.
The type of ground truth used:
The "ground truth" in this context is the established performance characteristics of the predicate device which the SECURE-LOOP device is attempting to demonstrate equivalence to. The performance parameters (stiffness, tensile strength, cyclic fatigue, functional performance) of both the SECURE-LOOP and the predicate device are determined through laboratory-based physical/mechanical testing.
The sample size for the training set:
The concept of a "training set" is not applicable here as this is not an AI/ML device. The testing described is for performance validation, not for training a model.
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML model.

Summary

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

September 9, 2015

Xiros, Limited Stephen Seed Regulatory Manager Springfield House Whitehouse Lane Leeds LS19 7UE England

Re: K151601

Trade/Device Name: SECURE-LOOP Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 2, 2015 Received: June 12, 2015

Dear Mr. Seed:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in 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,

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) K151601

Device Name SECURE-LOOP

Indications for Use (Describe)

The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic 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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SECTION 5. 510(k) SUMMARY

In accordance with 21 CFR 807.92, the following information constitutes Xiros Ltd. 510(k) summary for the SECURE-LOOP.

I.SUBMITTER INFORMATION

Submitter`s Name:	Xiros Limited
Address:	Springfield HouseWhitehouse LaneLeeds LS19 7UEEngland
Telephone Number:	+44 (0)1132387200
Fax Number:	+44 (0)113 2387201
Contact Person:	Stephen Seed (Regulatory Affairs Manager)
Date:	01.09.2015
510(K) number:	K151601

II. DEVICE IDENTIFICATION

Name of Device:	SECURE-LOOP
Trade Name:	SECURE-LOOP
Common or usual name:	Suture retention device; Surgical Button, Polyester SurgicalSuture, ACL suspension fixation.
Classification Name:	Fastener, fixation, non-degradable soft tissue
Regulatory Class:	Class II
Product Code:	MBI
Regulation:	888.3040
Panel:	Orthopaedic

III. PREDICATE DEVICE

Smith & Nephew, Inc , Endobutton Continuos Loop (ECL) K980155. This predicate has not been subject to a design related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.

V. INDICATIONS FOR USE

The SECURE-LOOP fixation device is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.

VI. COMPARISIONS OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The SECURE-LOOP has the same technological characteristics as the predicate Endobutton Continuous Loop device, with respect to intended use, labelling, material composition, chemical formulation, design, design tolerances, functionality and use the same manufacturing methods.

VII. PERFORMANCE DATA

The SECURE-LOOP when tested against the Endobutton Continuous Loop (K980155) for stiffness, tensile strength, cyclic fatigue testing, and functional testing, was determined to be substantially equivalent. The testing demonstrated that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy. The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate.

Summary: Based on the pre-clinical testing performance, the SECURE-LOOP is found to have a safety and effectiveness profile that is similar to the predicate device.

VIII.CONCLUSION

The SECURE-LOOP is composed of the same material and has the same design as the predicate device. It is manufactured in the same manner and uses the same methods of that used to manufacture the predicate device.

Testing performed demonstrate that the SECURE-LOOP is substantially equivalent to the Smith &Nephew Endobutton CL fixation device.

Xiros therefore conclude the SECURE-LOOP is substantially equivalent to the Smith & Nephew Endobutton CL fixation 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.