The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

Acromioclavicular separation repairs ●
Deltoid repairs
Rotator cuff repairs
Biceps tenodesis

Knee

Extra-capsular repairs ●
o Medial collateral ligament
o Lateral collateral ligament
Posterior oblique ligament O
Patellar realignment and tendon repairs
Illiotibial band tenodesis ●
Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

Foot and Ankle

Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions

Device Description

The Ventix™ Link Knotless Anchor is a sterile, manually operated, single procedure anchor device for reattachment of soft tissue to bone. The anchor is preloaded on a disposable inserter. The Ventix™ Link Knotless Anchor incorporates design features that facilitate anchor placement under arthroscopic, open or limited access conditions in soft tissue to bone reattachment procedures. The Ventix™ Link Knotless Anchor is offered in two sizes, 4.75mm and 5.5mm, and can receive up to six suture ends. The anchor is made out of PolyEtherEtherKetone (PEEK). Zimmer Biomet TRU-LINK™, MaxBraid™ and/or MaxBraid™ BroadBand™ Tape, or Force Fiber® USP #1 or #2 sutures are to be only used with the Ventix™ Link Knotless Anchors.

The disposable inserter has a working shaft length (from handle to distal tip of anchor) of 6.1 in (155 mm) with an outer shaft diameter of 0.1875 in (4.76 mm). The inserter shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The inserter facilitates the placement of the implant into a hole prepared in the bone.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Ventix Link Knotless Anchor with Inserter."

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving the device meets them:

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

Based on the provided text, there isn't a specific table of "acceptance criteria" from a performance study that directly compares against the reported device performance in a quantitative manner. The document states that "Non-clinical testing data...demonstrated that the functionality and safety of the Ventix™ Link Knotless Anchor are adequate for its intended use and determination of substantial equivalence to the predicate device."

The non-clinical testing performed included:

Mechanical testing: Specifically, "pull-out strength."
Biocompatibility assessment
Pyrogenicity assessment
Shelf-life assessment
MRI safety assessment

While these are the types of tests conducted, the document does not report the specific quantitative acceptance criteria or the actual measured performance values for these tests. It only states that the results "demonstrated that the functionality and safety... are adequate."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical testing data" for mechanical testing, biocompatibility, pyrogenicity, shelf-life, and MRI safety. However:

Sample size: The specific sample sizes used for these non-clinical tests are not provided in this document.
Data provenance: The country of origin of the data is not specified. Given that the manufacturer is "Cayenne Medical, Inc." based in "Scottsdale, Arizona," it's likely the testing was conducted in the US or by a lab contracted by a US company, but this is not explicitly stated. The tests are non-clinical, so the terms "retrospective" or "prospective" are not applicable in the same way they would be for clinical trials.

3. 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)

This question is geared towards studies involving human interpretation or clinical expertise to establish a "ground truth" (e.g., in AI/diagnostic device studies).

Not Applicable: The studies conducted for this device were non-clinical (mechanical, biocompatibility, etc.). Therefore, there were no human "experts" in the sense of clinicians establishing a "ground truth" for diagnostic or predictive purposes related to the device's function. The "ground truth" in these engineering and material science tests would be established by validated test methods and material specifications, interpreted by qualified engineers/scientists, but these are not explicitly identified as "experts" for ground truth establishment in this context.

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

Not Applicable: As mentioned above, the studies were non-clinical and did not involve human interpretation requiring adjudication methods.

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 surgical implant (suture anchor). It is not an AI diagnostic or assistive device that would involve human "readers" or benefit from AI assistance in its direct use. Therefore, no MRMC comparative effectiveness study was done.

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

Not Applicable: This device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not relevant.

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

For the non-clinical tests:

Mechanical Testing (Pull-out strength): The "ground truth" would be established by engineering standards and specifications (e.g., a certain force in Newtons/pounds the anchor must withstand) as determined by the device design and potentially industry standards. The test results would then be compared against these predefined physical requirements.
Biocompatibility, Pyrogenicity, Shelf-life, MRI Safety: The "ground truth" for these tests is compliance with established international standards (e.g., ISO, ASTM) and regulatory guidelines for material safety, sterility, stability, and compatibility.

The document does not explicitly detail these "ground truths" but implies that the tests confirmed "adequacy" against such standards.

8. The sample size for the training set

Not Applicable: This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The "training" for a physical device happens during its design and manufacturing process, using engineering principles and material science.

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

Not Applicable: As per point 8, there is no "training set" in the context of an AI/machine learning device. The design and manufacturing processes are validated against engineering and regulatory standards, but this isn't analogous to establishing "ground truth" for a training set in AI.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 21, 2018

Cayenne Medical, Inc. Shima Hashemian QA/RA Associate Director 16597 N. 92nd Street, Suite 101 Scottsdale, Arizona 85260

Re: K180274

Trade/Device Name: Ventix™ Link Knotless Anchor with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 30, 2018 Received: January 31, 2018

Dear Ms. Hashemian:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

Page 2 - Ms. Shima Hashemian

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Device Name: VentixTM Link Knotless Anchor with Inserter

Indications for Use:

The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

Acromioclavicular separation repairs ●
Deltoid repairs
Rotator cuff repairs
Biceps tenodesis

Knee

Extra-capsular repairs ●
- o Medial collateral ligament
- o Lateral collateral ligament
- Posterior oblique ligament O
Patellar realignment and tendon repairs
Illiotibial band tenodesis ●
Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

Foot and Ankle

Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Summary

Cayenne Medical, Inc.

Ventix™ Link Knotless Anchor with Inserter

Administrative Information

Date of summary:	03/19/2018
Manufacturer Name:	Cayenne Medical, Inc.16597 N. 92nd St., Suite 101Scottsdale, AZ 85260Telephone (480) 458-2196FAX (480) 502-3670
Official Contact:	Shima Hashemian16597 N. 92nd St., Suite 101Scottsdale, AZ 85260Shima.Hashemian@zimmerbiomet.comTelephone (480) 458-2196FAX (480) 502-3670

Device Name

Classification Name:	Smooth or threaded metallic bone fixation fastener
Trade/Proprietary Name:	Ventix™ Link Knotless Anchor with Inserter
Common Name:	Suture Anchor

Device Classification

FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nondegradable, and Soft Tissue is MBI.

Primary Predicate: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897)

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

Device Description

Indications for Use

The Cayenne Medical, Inc. Ventix™ Link Knotless Anchor is intended to be used for fixation of soft tissue to bone for the following indications:

{5}------------------------------------------------

Shoulder

Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff repairs
Biceps tenodesis

Knee

Extra-capsular repairs ●
- Medial collateral ligament O
- Lateral collateral ligament O
- o Posterior oblique ligament
Patellar realignment and tendon repairs
Illiotibial band tenodesis
Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

Foot and Ankle

Medial or lateral instability repairs/reconstructions ●
Achilles tendon repairs/reconstructions ●

Technological Differences

The Ventix™ Link Knotless Anchor is similar in its indication for use, intended use, design features, technology, and materials to the predicate device.

The subject Ventix™ Link device has the same intended use and similar indication for use as the predicate device, the Smith & Nephew FOOTPRINT Ultra PK Suture Anchor.

The subject device differs from the predicate device, Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, in terms of design features and the offered sizes.

Non-clinical Testing

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The results of mechanical testing (pull-out strength), and assessment of biocompatibility, pyrogenicity, shelf-life and MRI safety demonstrated that the functionality and safety of the Ventix™ Link Knotless Anchor are adequate for its intended use and determination of substantial equivalence to the predicate device.

{6}------------------------------------------------

Clinical Testing

Clinical testing was not used to establish substantial equivalence to predicate device.

Equivalence to Marketed Product

Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Ventix™ Link Knotless Anchor is substantially equivalent in indication and performance to the legally marketed predicate device, Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897). The substantial equivalence of Ventix™ Link Knotless Anchor is based on similarities in indications for use, intended use, design features, technology, and materials 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.