The SINEFIX is a PEEK implant which can be used to re-attach a ruptured rotator cuff tendon to the humerus of the shoulder. The implant can be used to re-attach complete or partially ruptured tendons up to 2 cm to facilitate the healing of the natural bone-tendon interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the tendon and attached to the humerus with the anchors. The medial anchor goes through the tendon, while the lateral anchor goes directly into the bone, lateral of the tendon.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called SINEFIX, a PEEK implant for soft tissue to bone reattachment in rotator cuff repairs. This document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the non-clinical testing of a physical implant.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from this document. However, I can provide information based on the non-clinical testing for the physical SINEFIX device.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test and then provide the exact performance results in a consolidated table. Instead, it lists the types of tests performed and concludes that the results demonstrate substantial equivalence.

Implied Acceptance Criteria (based on the type of tests performed and the conclusion of substantial equivalence):

Mechanical Performance: The device must perform comparably to predicate devices in terms of mechanical strength, pullout strength, and response to cyclic loading. This would imply meeting or exceeding the mechanical properties of the predicate devices or relevant ASTM/ISO standards.
Biocompatibility: The device must be biocompatible, meaning it does not cause adverse biological reactions. The acceptance criterion is compliance with ISO 10993-1.
Sterilization: The device must be able to be effectively sterilized to a sterility assurance level (SAL) of 10^-6. Acceptance criterion is compliance with ISO 11137-1/2.
Packaging: The packaging must maintain sterility and product integrity for the stated shelf life. Acceptance criterion is compliance with ISO 11607-1/2.
Reprocessing (for reusable instruments): Reusable instruments (if any are associated with the implant) must be able to be reprocessed effectively. Acceptance criterion is compliance with the FDA guidance on reprocessing medical devices.

Reported Device Performance:

The document states: "Results of the performed tests demonstrate that the SINEFIX are substantially equivalent to legally marketed predicate devices." This is the overarching reported performance. Specific numerical results are not provided in this summary.

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

For the non-clinical tests (insertion, pullout, cyclic loading, static tensile, dynamic testing, pyrogenicity, endotoxins, packaging, biological evaluation, sterilization validation, reprocessing validation), the sample sizes are not specified in this 510(k) summary. These tests are performed in a laboratory setting (not on human data), so terms like "country of origin of the data" or "retrospective/prospective" are not applicable.

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

This question is not applicable as the tests are non-clinical (mechanical, biological, sterility, etc.) and do not involve "ground truth" derived from expert interpretation of medical images or patient data. The interpretation of results would be done by laboratory personnel according to established scientific and engineering standards and protocols.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of human data or expert review. Non-clinical tests follow laboratory protocols and standards.

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 is for a non-AI/ML physical implant, not a diagnostic or prognostic AI tool.

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

Not applicable. This is for a non-AI/ML physical implant.

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

Not applicable for a physical implant's mechanical or material performance. "Ground truth" for these types of tests refers to established physical properties, chemical composition, and performance against defined standards (e.g., maximum load at failure, sterility assurance level).

8. The sample size for the training set

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set."

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

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set" or "ground truth" in that context.

Summary

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March 8, 2023

Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

BAAT Medical Products B.V. Jasper Springer, Ph.D. Regulatory Affairs Officer F. Hazemeijerstraat 800-Building A04 Hengelo, Overijssel 7555 RJ Netherlands

Re: K220966

Trade/Device Name: SINEFIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 8, 2023 Received: February 8, 2023

Dear Dr. Springer:

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 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

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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 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

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220966

Device Name SINEFIX

Indications for Use (Describe)

The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.

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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Traditional 510(k) Summary

Submitter Name:	BAAT Medical Products B.V.
Submitter Address:	F. Hazemeijerstraat 800 - Building A047555 RJ HengeloThe Netherlands
Phone Number:	+31-(0)88-5656600
Contact person:	Jasper Springer
Date Prepared:	March 30, 2022
Device
510(k) Number	K220966
Device Trade name:	SINEFIX
Common Name:	Not Applicable
Classification:	Smooth or threaded metallic bone fixation fastener (21 CFR Sec.888.3040)
Class:	II
Product Code:	MBI - Fastener, Fixation, Nondegradable, Soft Tissue
Review Panel:	Office of Health Technology 6: Orthopedic Devices
Predicate Device
Primary Predicate:	Coronet Soft Tissue Fixation System (K200028)
Reference devices:	Arthrex Tenodesis Screw Family (K051726)Acufex Spiked Washer System (K994202)Interference Screw (K062466)ZipE Knotless Tissue Repair and Attachment Devices (K162429)Bio-Button (K983843)FOOTPRINT Ultra PK Suture Anchor (K123579)SwiveLock Anchors (K101823)ExoShape Duo Soft Tissue Fastener (K132783)PITON Fixation Implant System (K091870)

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Description of the Device 4.

5. Intended Use/Indication for Use Statement

The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.

6. Summary of Technological Characteristics of the Device Compared to Predicate devices

A comparison of technological characteristics is made between the SINEFIX and the predicate devices in Table 5.1.

	Subject Device	Primary Predicate
510(k)	K220966	K200028
Device name	SINEFIX	Coronet Soft Tissue Fixation System
Manufacturer	BAAT Medical Products BV	CoNextions Medical, Inc.
Product code	MBI	MBI
Regulation #	888.3040	888.3040
Class	II	II
Image	Image: Subject Device	Image: Primary Predicate
Indications for Use	The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.	... intended for fixation of tissue to bone and tissue to tissue. This product is intended for the following indications:Shoulder: Rotator Cuff Repair...
Material	PEEK	PEEK, Stainless Steel
Size	Baseplate: 10mm x 8mm (17.7mm) - Plate thickness 0.7mmMedial Anchor: Ø3mm (4.42mm) x	Button: Ø 8.7mm x 2.4mm - Plate thickness 0.5mm

Table 5.1: Technical Comparison, Subject Device and Predicate.

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16.24mmLateral Anchor: Ø4.02 (6.8mm) X18.21mm	#2 suture (FiberWire® Suture, Arthrex):0.5mmAnchor: Ø 3.5mm x 12.3mm
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7. Summary of Performance Data and Design Controls

The SINEFIX has the same technological characteristics as the predicate devices including design, intended use and material composition.

The SINEFIX has been subject to non-clinical testing, including:

Insertion testing
ASTM F543-17 Pullout testing
ASTM F543-17 Pullout testing after cyclic loading
Static tensile test
Dynamic testing pullout strength after cyclic loading
. Pyrogenicity and endotoxins

In accordance with the guidance for Industry and FDA Staff: Bone Anchors - Premarket Notification (510(k)) Submissions, March 3, 2020.

. Packaging testing was performed in accordance with ISO 11607-1/2 and has proven a shelf life of 5 years;
Biological evaluation was performed in accordance with ISO 10993-1 and the Guidance for Industry and FDA Staff - Use of International Standard ISO 10993, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", September 4, 2020;
. Sterilization validation was performed in accordance with ISO 11137-1/2 and has proven a SAL 10-6:
. Reprocessing validation was performed for the cleaning, disinfection, steam sterilization and drying of the reusable surgical instruments in accordance with the Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 17, 2015;

Results of the performed tests demonstrate that the SINEFIX are substantially equivalent to legally marketed predicate devices.

8. Conclusion of Substantial Equivalence

The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the SINEFIX to interstate commerce. Substantially equivalence has been demonstrated to the cited predicate device.

Regulation Number and Section

N/A