The Cayenne Medical, Inc. Short SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Cayenne Medical, Inc. Short SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle

। Hallux valgus reconstruction
। Midfoot reconstruction

Hand and Wrist

-Ulnar or lateral collateral ligament reconstruction
Repair/reconstruction of collateral ligaments
Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits —
-Scapholunate ligament reconstruction

Device Description

The Short SureLock™ All-Suture Anchor is a sterile (using ethylene oxide sterilization method), manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone. The all-suture anchor is preloaded with floating suture with needles and loaded on a disposable inserter. Short SureLock™ All-Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The Short SureLock™ All-Suture Anchor is offered in two configurations, 1.4mm anchor with one size 0 Ultra High Molecular Weight Polyethylene (UHMWPE) suture strand with attached needles and 1.4mm anchor with one size 2-0 UHMWPE suture strand with attached needles. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The needles attached to the floating suture are made out of medical grade stainless steel.

The anchor is formed by passing one end of a length of suture perpendicularly back through itself in alternating directions a number of times. This results in a construct resembling a ladder. The four suture tails are cut and trimmed. A floating suture is passed through the loops in the anchor to form the anchor construct.

The disposable inserter has a working shaft length of 4.14 cm with an outer shaft diameter of 4.0 mm. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor construct into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension to the floating suture limbs to expand and deploy the anchor in the bone tunnel. The floating suture limbs with needles are then released from the inserter and the inserter is removed.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Short SureLock™ All-Suture Anchor) and a corresponding FDA letter. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than establishing acceptance criteria and proving performance through a clinical study in the way a new drug or high-risk device might.

Therefore, many of the requested elements (e.g., acceptance criteria, detailed study design with sample sizes, expert ground truth, MRMC study, training set) typically associated with AI/ML device performance or clinical trials are not applicable to this 510(k) submission.

Here's an analysis based on the information available:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the traditional sense for a clinical or AI performance study. Instead, the acceptance criteria for a 510(k) are implicitly:
- Demonstrate that the new device is as safe and effective as a legally marketed predicate device.
- Show that differences in technological characteristics do not raise different questions of safety and effectiveness.
- For mechanical properties, demonstrate "comparable" performance to the predicate device.

Reported Device Performance:

Performance Metric	Acceptance Criteria (Implicit)	Reported Performance
Pull-out strength	Comparable to predicate device	"Testing showed that the Short SureLock™ Anchor ultimate pull-out strength was comparable to that of the predicate device."
Biocompatibility	Biocompatible for intended use	(Implied by use of medical grade stainless steel and UHMWPE, common in medical devices; no specific results given for this device, but usually relies on material characterization and ISO standards)
Sterility	Sterile	"...sterile (using ethylene oxide sterilization method)..."
Indications for Use	Broader indications for use should not raise different questions of safety and effectiveness.	"The subject device has a broader indication for use... The two added indications for use do not raise different questions of safety and effectiveness."

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

Sample Size: Not explicitly stated. The document mentions "Mechanical testing (pull-out strength) was performed" and implicitly implies a sufficient number of devices for the tests to be considered statistically valid and comparable.
Data Provenance: Not applicable. The testing described is in vitro mechanical testing, not human data.

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)

Not applicable. This device is a physical medical implant. Ground truth is established through physical and material science testing, not expert consensus on interpretations of data (like in an AI/ML context).

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

Not applicable. See point 3.

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

No. This is not an AI/ML device. It's a surgical implant.

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

No. Not an AI/ML device.

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

The "ground truth" for the mechanical testing would be the physical measurements of pull-out strength obtained from standardized mechanical testing equipment, following established test methods (e.g., ASTM standards). The comparison is against the predicate device's performance under similar testing conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. See point 8.

In summary: The provided document is a 510(k) premarket notification for a Class II medical device (suture anchor). The "study" proving it meets "acceptance criteria" is a non-clinical mechanical testing comparison against a legally marketed predicate device, demonstrating substantial equivalence in terms of safety and effectiveness for its intended use, rather than a clinical trial or AI performance study with detailed clinical metrics and ground truth establishment.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.

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

March 25, 2015

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

Re: K143473

Trade/Device Name: Short SureLock™ All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 16, 2015 Received: February 19, 2015

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: Short SureLock™ All- Suture Anchor

Indications for Use:

The Cayenne Medical, Inc. Short SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle

। Hallux valgus reconstruction
। Midfoot reconstruction

Hand and Wrist

-Ulnar or lateral collateral ligament reconstruction
Repair/reconstruction of collateral ligaments
Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits —
-Scapholunate ligament reconstruction

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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. SureLock™ All- Suture Anchor

ADMINISTRATIVE INFORMATION

Date of summary:	12/04/2014
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:	Short SureLock™ All- Suture Anchor
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. These devices are reviewed by the Orthopedic Joint Devices Branch.

INTENDED USE

Page 18 of 209

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510(k) Summary

tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Cayenne Medical, Inc. Short SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle

। Hallux valgus reconstruction
। Midfoot reconstruction

Hand and Wrist

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Ulnar or lateral collateral ligament reconstruction
-Repair/reconstruction of collateral ligaments
l Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits
--Scapholunate ligament reconstruction

DEVICE DESCRIPTION

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The following table summarizes the two configurations of the All-suture Anchor device.

Catalognumber	All-Sutureanchor size	Anchor-suture sizeand color	Floatingsuture size	Number offloatingsutures	Floating suturetype and color
CM-961400	1.4 mm	USP size 2 -White	USP size 0	1	Co-braidgreen/white
CM-961420	1.4 mm	USP size 2-White	USP size 2-0	1	Co-braidblue/white

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 Short SureLock™ Anchor and the predicate device. Testing showed that the Short SureLock™ Anchor 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 Short SureLock™ Anchor is substantially equivalent in indication and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Depuy Mitek MINILOK® QuickAnchor® Plus device (K071257) and Riverpoint Medical HS Fiber Polyblend nonabsorbable surgical suture (K100006). The substantial equivalence of Short SureLock™ Anchor is based on similarities in indications for use, intended use, design features, technology, a com and the predicate device.

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510(k) Premarket Notification

The subject Short SureLock™ device has the same intended use as the predicate device, the Depuy Mitek MINILOK® QuickAnchor® Plus. The subject device has a broader indication for use. The subject device is indicated for repair/reconstruction of collateral ligaments and Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits in addition to the predicate device indications for use. Cayenne Medical tested both predicate and subject devices for the range of the subject device indications using two bone block densities. The two added indications for use do not raise different questions of safety and effectiveness.

This subject device differs from the predicate device, Depuy Mitek MINILOK® QuickAnchor® Plus, in terms of the material of the anchor, the inserter role during deployment, 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.