The LARS® AC Band device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The LARS® AC Band device is intended for single use only.

Device Description

The LARS® AC Band device is a knitted surgical scaffold manufactured from poly(ethylene terephthalate) (PET) which is non-biodegradable. The LARS® AC Band device is available in 1 size which is 6mm wide by 400mm in length with a loop at one end and is secured by sutures. The use of high strength #2, non-resorbable single use sterile sutures is recommended. The construct permits the mesh to be cut into any desired size without unraveling. The device is supplied sterile, for singlepatient use.

AI/ML Overview

Here's an analysis of the provided text regarding the LARS® AC Band Device's acceptance criteria and studies:

Based on the provided FDA 510(k) summary, the device is a medical implant, and the documentation primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against specific acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested points related to AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable to this submission as it's for a physical medical device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the submission):

Acceptance Criteria (Inferred)	Reported Device Performance
Material Equivalence: The device material should be comparable to or the same as the reference device.	The LARS® AC Band device material (poly(ethylene terephthalate) (PET)) is the same as the Surgicraft Surgical Mesh System (K072370) reference device.
Indications for Use Equivalence: The intended use should be identical to the predicate device.	The LARS® AC Band device's indications for use are identical to the LOCKDOWN™ Acromioclavicular (AC) device (K091207) predicate device.
Design Similarity: The device design should be similar to the predicate device.	The LARS® AC Band device's design is similar to the LOCKDOWN™ Acromioclavicular (AC) device (K091207) predicate device.
Tensile Strength: Device should withstand expected tensile forces.	Non-clinical testing for tensile strength was conducted. (Specific values not reported in this summary)
Tear Strength: Device should demonstrate adequate resistance to tearing.	Non-clinical testing for tear strength was conducted. (Specific values not reported in this summary)
Burst Strength: Device should exhibit sufficient burst resistance.	Non-clinical testing for burst strength was conducted. (Specific values not reported in this summary)
Biocompatibility: Device materials should be biocompatible.	Biocompatibility testing was conducted. (Specific results not reported in this summary)
Clinical Performance Equivalence: Clinical outcomes should be comparable to or better than the predicate device, considering factors like wear, fracture, particulates, and inflammatory response.	Review and analysis of published clinical data and test reports were conducted, covering wear of surrounding bone, bone fracture, device wear, particulates, and inflammatory/biologic response. (Specific comparative outcomes not reported in this summary)

Regarding the specific questions:

A table of acceptance criteria and the reported device performance: See table above. The acceptance criteria are largely inferred from the substantial equivalence claim and the types of non-clinical and clinical reviews performed. The "reported performance" is that these tests/analyses were conducted, implying acceptable results for the claim of substantial equivalence. Specific quantitative acceptance criteria or performance metrics are not provided in this 510(k) summary for a physical device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test set sample size: Not applicable in the context of an AI/algorithm test set. For the non-clinical mechanical tests (tensile, tear, burst), standard engineering sample sizes would have been used, but these are not specified. For the clinical data review, the "sample size" would refer to the number of patients/cases in the published literature reviewed, which is not provided.
- Data provenance: Not specified for the clinical data review. It's likely a review of existing global literature, but no details are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is a physical medical device submission, not an AI/algorithm where expert ground truth is typically established for image/data interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.
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, this is a physical medical device, not an AI-assisted diagnostic tool.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical testing, the "ground truth" would be the measured physical properties according to established engineering standards. For the clinical review, the "ground truth" would be the reported clinical outcomes in the published literature and test reports.
The sample size for the training set: Not applicable; this device does not involve a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable; there is no training set for this physical device.

Summary of the Study for Substantial Equivalence:

The study conducted was primarily a non-clinical testing program combined with a review and analysis of published clinical data and test reports.

Non-Clinical Testing: Included mechanical tests (tensile strength, tear strength, burst strength) and biocompatibility testing of the LARS® AC Band device itself. The summary implies these tests demonstrated the device's physical properties are suitable and comparable to the predicate/reference devices.
Clinical Testing/Review: This was not a de novo clinical trial for the LARS® AC Band device. Instead, it involved a "review and analysis of published clinical data and test reports" related to the LARS® AC Band device or similar devices, focusing on aspects like wear, bone fracture, particulates, and inflammatory/biologic response at the surgical site. This review was presumably used to support the safety and effectiveness profile based on existing literature for the claimed indications.

The overall approach was to demonstrate substantial equivalence to existing legally marketed devices (LOCKDOWN™ Acromioclavicular (AC) device (K091207) as predicate, and Surgicraft Surgical Mesh System (K072370) as a reference for material). Substantial equivalence means the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

Corin USA Lucinda Gerber Global Regulatory Affairs Manager 12750 Citrus Park Lane, Suite 120 Tampa, Florida 33625

Re: K190143

Trade/Device Name: LARS® AC Band Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, MBI Dated: October 1, 2019 Received: October 2, 2019

Dear Lucinda Gerber:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190143

Device Name LARS® AC Band Device

Indications for Use (Describe)

The LARS® AC Band device is intended for single use only.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740

{3}------------------------------------------------

3. 510(K) SUMMARY

1. Applicant/Sponsor:Distributor	Corin USA12750 Citrus Park LaneSuite 120Tampa, Florida 33625Establishment Registration No .: 1056629
2. Manufacturer:	LARS SA5 Rue De La Fontaine21560 Arc-Sur-TilleFranceEstablishment Registration No: None
3. Contact Person:	Lucinda GerberGlobal Regulatory Affairs ManagerCorin USA1 (772) 321-2478Lucinda.Gerber@coringroup.com
4. Date:	January 28, 2019
5. Proprietary Name:	LARS® AC Band device
6. Common Name:	Fastener, Fixation, Nondegradable, Soft Tissue
7. Product Code(s):	MBI, HTN
8. Classification Name:	888.3040 - Fastener, fixation, nondegradable, soft tissue888.3030 - Single/multiple component metallic bone fixationappliances and accessories

9. Legally Marketed Devices to which Substantial Equivalence is claimed:

LOCKDOWN™ Acromioclavicular (AC) device (K091207) .

10. Legally Marketed Reference Devices

Surgicraft Surgical Mesh System (K072370) ●

11. Device Description:

{4}------------------------------------------------

12. Intended Use / Indications:

The LARS® AC Band device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The LARS® AC Band device is intended for single use only.

13. Summary of Technologies/Substantial Equivalence:

The LARS® AC Band device in terms of material is the same as the reference device Surgicraft Surgical Mesh System (K072370). The LARS® AC Band device is identical to the predicate LOCKDOWN™ Acromioclavicular (AC) device (K091207) in indications and material and is similar in design. Based on these similarities, Corin believes that the LARS® AC Band device is substantially equivalent to the predicate device.

14. Non-Clinical Testing:

Non-clinical testing and analysis was conducted on the LARS® AC Band device, including testing for tensile strength, tear strength, burst strength and biocompatibility testing.

15. Clinical Testing:

Review and analysis of published clinical data and test reports was conducted on the LARS® AC Band device, including wear of the surrounding bone and bone fracture, wear of the device, particulates and inflammatory/biologic response at the site of surgical placement.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.