The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws 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

Elbow, Wrist, and Hand

Biceps tendon reattachment
Ulnar or radial collateral ligament reconstruction
Lateral epicondylitis repair

Knee

Extra-capsular repairs
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs
Illiotibial band tenodesis

Foot and Ankle

Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy

Device Description

The Quattro® Bolt Tenodesis Screw is a sterile (using gamma radiation method), manually operated, single procedure device for reattachment of soft tissue to bone. The Quattro® Bolt screw is preloaded on a disposable driver. Quattro® Bolt device incorporates design features that facilitate screw placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The Quattro® Bolt tenodesis screw is offered in 5 different sizes, 5mm×10mm, 6mm×12mm×14mm, 8mm×16mm, 9mm×16mm. The screws are made out of PolyEtherEtherKetone (PEEK).

The disposable driver has a working shaft length of 14cm with an outer shaft diameter of 3.0 mm. The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic.

AI/ML Overview

The provided text is a 510(k) summary for the Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screw. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on non-clinical testing.

However, the document does not contain the detailed information necessary to answer your request about acceptance criteria and a study that proves the device meets those criteria, specifically:

Acceptance criteria table: No such table is present.
Reported device performance: While pull-out strength is mentioned as "comparable," no specific performance metrics or thresholds (e.g., in a table) are provided.
Sample size for the test set: Not mentioned.
Data provenance: Not mentioned.
Number of experts and their qualifications: Not applicable, as this is non-clinical mechanical testing, not a study involving expert assessment of images or clinical outcomes.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted; this is a non-clinical mechanical test.
Standalone algorithm performance: Not applicable; this is a physical medical device, not an AI algorithm.
Type of ground truth: For mechanical testing, the "ground truth" would be the measured physical properties, but the document doesn't detail how these were established beyond stating "mechanical testing (pull-out strength) was performed."
Sample size for the training set: Not applicable as there is no AI or ML training set.
How ground truth for the training set was established: Not applicable.

The document states:

"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. Mechanical testing (pull-out strength) was performed on the Quattro® Bolt tenodesis screw and the predicate device. Testing showed that the Quattro® Bolt tenodesis screw ultimate pull-out strength was comparable to that of the predicate device."

This indicates that a non-clinical mechanical testing study was performed, specifically measuring pull-out strength. The acceptance criterion for this test appears to be "comparable to that of the predicate device" in terms of ultimate pull-out strength. However, the specific numerical thresholds or target values for "comparable" are not provided in this summary.

In summary, based on the provided document, I cannot fulfill your request for a detailed table of acceptance criteria and associated study information because the document primarily focuses on demonstrating substantial equivalence through non-clinical mechanical testing, without providing the specific quantitative details you're asking for.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

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

January 23, 2015

Cayenne Medical, Incorporated Ms. Shima Hashemian Senior Quality Assurance/Regulatory Affairs Manager 16597 North, 92nd Street Scottsdale, Arizona 85260

Re: K143392

Trade/Device Name: Quattro® Bolt Tenodesis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 25, 2014 Received: November 26, 2014

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

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Page 2 - Ms. Shima Hashemian

forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Lori A. Wiggins -S

for 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

Device Name: Quattro® Bolt Tenodesis Screw

Indications for Use:

The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws 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

Elbow, Wrist, and Hand

-Biceps tendon reattachment
Ulnar or radial collateral ligament reconstruction —
-Lateral epicondylitis repair

Knee

-Extra-capsular repairs
- Medial collateral ligament O
- o Lateral collateral ligament
- о Posterior oblique ligament
-Patellar realignment and tendon repairs
Illiotibial band tenodesis

Foot and Ankle

Hallux valgus repairs -
-Medial or lateral instability repairs/reconstructions
-Achilles tendon repairs/reconstructions
-Midfoot reconstructions
| Metatarsal ligament/tendon repairs/reconstructions
-Bunionectomy

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X Prescription Use (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)

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510(k) Summary

Cayenne Medical, Inc.

Quattro® Bolt Tenodesis Screw

ADMINISTRATIVE INFORMATION

Date of summary:	11/25/2014
Manufacturer Name:	Cayenne Medical, Inc.16597 N. 92nd St., Suite 101Scottsdale, AZ 85260Telephone (480) 502-3661FAX (480) 502-3670
Official Contact:	Shima Hashemian16597 N. 92nd St., Suite 101Scottsdale, AZ 85260shashemian@cayennemedical.comTelephone (480) 502-3661FAX (480) 502-3670

DEVICE NAME

Classification Name:	Smooth or threaded metallic bone fixation fastener
Trade/Proprietary Name:	Quattro® Bolt Tenodesis Screw
Common Name:	Screw

DEVICE CLASSIFICATION

FDA has classified bone fixation fasteners as Class II devices (21 CFR 888.3040). The product code for fastener, fixation, nondegradable, soft tissue is MBI. These devices are reviewed by the Orthopedic Joint Devices Branch. These devices are reviewed by the Orthopedic Joint Devices Branch.

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INTENDED USE

The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws 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

Elbow, Wrist, and Hand

-Biceps tendon reattachment
-Ulnar or radial collateral ligament reconstruction
-Lateral epicondylitis repair

Knee

Extra-capsular repairs
- o Medial collateral ligament
- o Lateral collateral ligament
- o Posterior oblique ligament
Patellar realignment and tendon repairs -
-Illiotibial band tenodesis

Foot and Ankle

-Hallux valgus repairs
-Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions -
Midfoot reconstructions —
| Metatarsal ligament/tendon repairs/reconstructions
-Bunionectomy

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DEVICE DESCRIPTION

The Quattro® Bolt tenodesis screw is offered in 5 different sizes, 5mm×10mm, 6mm×12mm×14mm, 8mm×16mm, 9mm×16mm. The screws are made out of PolyEtherEtherKetone (PEEK).

NON-CLINICAL TESTING

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. Mechanical testing (pull-out strength) was performed on the Quattro® Bolt tenodesis screw and the predicate device. Testing showed that the Quattro® Bolt tenodesis screw ultimate pull-out strength was comparable to that of the predicate device.

EQUIVALENCE TO MARKETED PRODUCT

Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Quattro® Bolt tenodesis screw is substantially equivalent in indication and design principles to predicate device, which has been determined by FDA to be substantially equivalent to preamendment devices: Quattro® Link Knotless Anchor with Inserter (K122314). The substantial equivalence of Quattro® Bolt tenodesis screw is based on similarities in indications for use, intended use, design features, technology, and materials to the predicate device.

The subject Quattro® Bolt device has the same intended use as the predicate device, the Quattro® Link.

This subject device differs from the predicate device, Quattro® Link Knotless Anchor with Inserter, in terms of the implant design and the offered sizes.

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.