FairFix QT Adjustable Button is intended to be used with single ended graft, during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.

FairFix Extenders are intended to be used in association with FairFix QT Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø6 - 11 mm tunnel.

Device Description

The FairFix QT Adjustable Button is a Medacta SportsMed device line extension providing a new adjustable loop solution meant for use with single-end graft during knee ligament reconstruction surgery (i.e. ACL, PCL).

The subject device consists of a metal elongated button with a pre-assembled, nonabsorbable adjustable suture loop, a graft tape to be coupled with the graft, a pulling suture (blue) to pull the construct through the bone tunnel and a flipping suture (white) to flip the button once the extracortical side has been reached.

The device is provided with two needled whipstitch sutures allowing implant graft connection and all the components are pre-assembled on a dedicated card, aiming to facilitate device handling.

AI/ML Overview

The provided FDA 510(k) summary (K223795) describes the FairFix QT Adjustable Button, which is a medical device for knee ligament reconstruction. It states that no clinical studies were conducted, and the substantial equivalence determination is based on non-clinical performance testing.

Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth establishment, which are typically derived from clinical studies or extensive performance validation against clinically relevant metrics, cannot be fully extracted from this document as it focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device.

However, I can provide the available information:

1. A table of acceptance criteria and the reported device performance:

The document summarizes the performance testing conducted to support substantial equivalence but does not explicitly present a table of quantitative acceptance criteria alongside reported device performance. It mentions "PERFORMANCE TESTING" aimed at a "Substantial Equivalence Assessment" between the FairFix QT Adjustable Button and the predicate "FairFix Adjustable Button".

2. Sample size used for the test set and the data provenance:

The document mentions "performance testing was conducted to written protocols" but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical studies were conducted, and therefore no expert-established ground truth for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical studies were conducted that would involve an adjudication method for a test set.

5. 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 device is a mechanical implant, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated in terms of clinical ground truth. The "performance testing" would have used engineering specifications and physical test results as the "ground truth" for evaluating mechanical properties.

8. The sample size for the training set:

Not applicable. This pertains to machine learning models, which are not relevant to this device.

9. How the ground truth for the training set was established:

Not applicable.

Summary of Available Information from the Provided Text:

The document focuses on demonstrating that the FairFix QT Adjustable Button is substantially equivalent to a predicate device (FairFix Adjustable Button System, K203259) through non-clinical performance testing.

Acceptance Criteria & Performance: The document states that "performance testing was conducted to written protocols" for a "Substantial Equivalence Assessment." It lists a few categories of non-clinical tests: Performance Testing (comparison to predicate), MR safety, Pyrogenicity (Bacterial endotoxin test, Pyrogen test), Biocompatibility, and Shelf-life evaluation. No specific quantitative acceptance criteria or detailed performance results are provided in this summary.
Study Type: Non-clinical (laboratory/bench-top) studies.
Sample Size: Not specified for any of the non-clinical tests.
Ground Truth: For the non-clinical tests, the "ground truth" would be established by validated test methods and engineering specifications.
Clinical Studies: No clinical studies were conducted. Therefore, there is no information on expert review, human-in-the-loop performance, or clinical outcomes data.

Summary

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January 17, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K223795

Trade/Device Name: FairFix QT Adjustable Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 15, 2022 Received: December 19, 2022

Dear Christopher Lussier:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Sara S. Thompson -S

For

Laura C. Rose, Ph.D. Assistant 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

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Indications for Use

510(k) Number (if known)

K223795

Device Name FairFix QT Adjustable Button

Indications for Use (Describe)

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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2.0 510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: December 15, 2022

II. Device

Device Proprietary Name:	FairFix QT Adjustable Button
Common or Usual Name:	Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener
Primary Product Code:	MBI
Regulation Number:	21 CFR 888.3040
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following primary predicate device:

FairFix Adjustable Button System, K203259, Medacta International SA A

Device Description IV.

The device is provided with two needled whipstitch sutures allowing implant graft connection and all the components are pre-assembled on a dedicated card, aiming to facilitate device handling.

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V. Indications for Use

FairFix QT Adjustable Button is intended to be used with single ended graft, such as quad tendon graft, during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.

Comparison of Technological Characteristics VI.

The subject device is substantially equivalent to the predicate device (K203259) with regards to the following characteristics:

button shape and dimensions;
adjustable loop shape and dimensions; ●
pulling and flipping suture; ●
materials:
biocompatibility:
device usage; ●
sterilization method:
shelf-life: and
packaging. ●

The subject implant differs from the predicate device (K203259) only for the presence of the graft tape and whipstitch sutures.

Discussion

Medacta International SA has not made any change to the indications for use, general design and shape, materials, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.

Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the FairFix QT Adjustable Button to the identified predicate device.

Performance Data VII.

Based on the risk analysis, performance testing was conducted to written protocols. The following tests and rationales are provided in support of the substantial equivalence determination:

Non-Clinical Studies

PERFORMANCE TESTING
- o FairFix QT Adjustable Button and FairFix Adjustable Button Substantial Equivalence Assessment

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0 MR safety evaluation
. PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is O equivalent to USP chapter <85>)
- o Pyrogen test according to USP chapter <151> for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
BIOCOMPATIBILITY evaluation ●
SHELF-LIFE evaluation

Clinical Studies:

No clinical studies were conducted. ●

Conclusion VIII.

The information provided above supports that the FairFix QT Adjustable Button 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.