The Cuff Repair Plate™ is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

Device Description

The Cuff Repair Plate (CRP) is a fixable suture anchor plate that is designed to improve anchorage-to-bone strength during rotator cuff tendon-to-bone repair. When assembled, the device consists of a contoured, D-shaped buttress bone plate that is coupled to two anchor bolts. The plate is available in both right and left configurations. Anchor bolts are available in various lengths. Both the plate and the anchor bolts are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use. The CRP is for use with #2 or #5 polyethylene-based high-strength non-absorbable braided suture.

AI/ML Overview

The provided text describes a medical device, the Cuff Repair Plate (CRP), and its regulatory clearance through a 510(k) submission. However, it does not contain information about acceptance criteria, efficacy studies, or performance compared to specific metrics. The document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness based on mechanical testing.

Here's an analysis based on the provided text, highlighting what is present and what is missing concerning your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative targets (e.g., minimum pull-out strength, maximum bending). The document implies that the acceptance criterion is "substantial equivalence" to the predicate device in terms of performance.
Reported Device Performance: The document states that "Testing of the CRP device to demonstrate substantial equivalence included construct pull-out testing, CRP static three-point bending, and testing to evaluate the anchor bolt's torsional strength, insertion driving torque, and axial pull-out." However, no specific numerical results or comparison data from these tests are provided. Therefore, a table cannot be populated as requested.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned. It's safe to assume the mechanical testing was conducted in a laboratory setting, likely in the US, but this is not explicitly stated. The study is a pre-clinical mechanical study, not a clinical study involving human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable. This information is relevant for studies involving subjective assessment (e.g., image interpretation by radiologists). The described studies are mechanical performance tests, where "ground truth" is determined by objective measurements of force, torque, and displacement.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication is relevant for subjective assessments where multiple experts might disagree. Mechanical tests are objective.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is a type of clinical study. The provided document describes pre-clinical mechanical testing, not a clinical effectiveness study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not Applicable. This question is relevant for AI algorithms. The device described is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

Mechanical Test Results (Objective Measures): The "ground truth" for the tests mentioned (pull-out testing, three-point bending, torsional strength, insertion driving torque, axial pull-out) would be the objective measurements obtained from these physical tests. There is no subjective ground truth like expert consensus, pathology, or outcomes data mentioned in relation to these tests.

8. Sample Size for the Training Set:

Not Applicable. This question is relevant for AI algorithms. The device described is a physical implant, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As explained above, this device does not involve an AI algorithm with a training set.

Summary based on the provided text:

The 510(k) submission for the Cuff Repair Plate (CRP) relied on pre-clinical mechanical testing to demonstrate substantial equivalence to a predicate device (Synthes Button Plate). The tests included construct pull-out, static three-point bending, anchor bolt torsional strength, insertion driving torque, and axial pull-out. The document asserts that these tests showed the CRP to be safe and effective and substantially equivalent to the predicate device, implying that the performance met unstated acceptance criteria by being comparable to the predicate. No specific quantitative acceptance criteria or detailed numerical performance data from these tests are provided. The study did not involve human readers, clinical cases, or AI algorithms; therefore, many of the requested points are not applicable.

Summary

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107539

8. 510(k) Summary

1. Applicant
  FEB 2 4 2011

Shoulder Options, Inc. 3284 Scenic Drive Boise, ID 83703

Contact Person:

Mike Alexander, CEO Tel: (208)761-1176 Fax: (888)760-2993 Email: alexander@shoulderoptions.com

Application Correspondent:

Kapstone Medical, LLC 100 E. South Main St. P.O. Box 1458 Waxhaw, NC 28173

John Kapitan, President, Kapstone Medical LLC Contact Person: Tel: (704) 843-7852 Fax: (704) 831-5316 E-mail: jkapitan@kapstonemedical.com

Date Prepared: September 1, 2010

2. Device Name

Common/Usual Name: Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded bone fixation fastener Classification Name: Regulation Number: 888.3040 MBI Product Code: ll Classification: Orthopedic Panel:

3. Predicate Devices

The Cuff Repair Plate™ (CRP) is substantially equivalent to the following device:

510(k) Number	Device	Manufacturer
K994364	Synthes Button Plate	Synthes

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K102539

4. Description of the Device

5. Indications for Use

The Cuff Repair Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

6. Summary of Performance Data

Testing of the CRP device to demonstrate substantial equivalence included construct pull-out testing, CRP static three-point bending, and testing to evaluate the anchor bolt's torsional strength, insertion driving torque, and axial pull-out.

7. Safety & Effectiveness

The Cuff Repair Plate™ (CRP) is substantially equivalent to the Synthes Button Plate (SBP) (K994364). Both devices have the same "Indications for Use," are available by prescription only, and are provided non-sterile for single-use only. The CRP differs from the SBP in that the CRP uses anchor bolts for fixation, has a different plate design, and is made from titanium alloy. These differences do not negatively impact the overall safety and effectiveness of the device. Therefore, it can be concluded that the CRP is both a safe and effective device and is substantially equivalent to the SBP.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Shoulder Options, Inc. % Kapstone Medical. LLC Mr. John Kapitan 100 E. South Main Street P.O. Box 1458 Waxhaw, North Carolina 28173

FEB 2 4 2011

Re: K102539

Trade/Device Name: Cuff Repair Plate™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 22, 2010 Received: December 27, 2010

Dear Mr. Kapitan:

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

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Page 2 - Mr. John Kapitan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Biomctrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Aty B. R. h
for.

Mark N. Melkerson Director Division of Surgical, Orthoopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. Indications for Use Statement

510(k) Number (if known): __

Device Name: Cuff Repair Plate™

Indications for Use:

The Cuff Repair Plate™ is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkerson

(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices

510(k) Number K102539

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.