The Suspension™ Acromioclavicular (AC) Repair System can be used for adult patients. The AC Repair System is indicated for securing suture to bone for acromioclavicular separations and coracoclavicular displacement.

Device Description

The Suspension" Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor, pre-threaded suture and other attachment accessories that eliminate the need for tying a knot in the suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. The suture is a USP size 5, co-braided, white/blue polypropylene, non-absorbable suture.

AI/ML Overview

The provided text describes a 510(k) summary for the "Suspension™ Acromioclavicular (AC) Repair System." This document is a premarket notification to the FDA for medical devices, asserting substantial equivalence to existing legally marketed devices. It focuses on demonstrating that the new device is as safe and effective as its predicates.

The information provided does not describe a study involving acceptance criteria for device performance based on statistical metrics like accuracy, sensitivity, or specificity, nor does it involve human readers, ground truth established by experts, or MRMC comparative effectiveness studies.

Instead, the "Performance" section outlines non-clinical testing for mechanical properties to demonstrate substantial equivalence. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's the breakdown of the information that is available or can be inferred:

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

The document states: "The device has been subjected to non-clinical testing including Driving Torque, Pull-Out Strength, Lock Screw Torque, Anchor Torque, and Suture Testing." It also mentions: "The axial pull test data was compared and analyzed."

However, specific numerical acceptance criteria (e.g., "Pull-Out Strength > X N") and the reported numerical performance data for these tests are not provided in the summary. The summary concludes that the device "perform[s] in a manner equivalent to the predicate devices," implying that the performance met unstated acceptance criteria derived from the predicate devices.

Acceptance Criteria (Inferred from Test Types)	Reported Device Performance (General Statement)
Driving Torque (must meet certain limits)	Performed in a manner equivalent to predicate devices.
Pull-Out Strength (must meet certain limits)	Axial pull test data was compared and analyzed; performed in a manner equivalent to predicate devices.
Lock Screw Torque (must meet certain limits)	Performed in a manner equivalent to predicate devices.
Anchor Torque (must meet certain limits)	Performed in a manner equivalent to predicate devices.
Suture Testing (must meet certain standards)	Performed in a manner equivalent to predicate devices.

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

The document does not specify the sample sizes for the "non-clinical testing" (Driving Torque, Pull-Out Strength, etc.). The data provenance is not explicitly mentioned but implies laboratory testing of the device itself. This is not patient data.

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

Not applicable. No ground truth based on expert medical opinion was established for these mechanical performance tests.

4. Adjudication method for the test set

Not applicable. No human adjudication was involved for these mechanical performance tests.

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 a 510(k) summary for a physical medical device (AC Repair System), not an AI diagnostic tool.

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

Not applicable. This is a 510(k) summary for a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be the direct measurement of the physical properties (e.g., force, torque) of the device components, compared against established engineering and material science standards, and performance characteristics of predicate devices. There is no expert consensus, pathology, or outcomes data used as ground truth for these specific tests.

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

Summary

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510(k) Summary

p5 1/2

Suspension TM Acromioclavicular (AC) Repair System (ref .: K102143)

DEC - 8 2010

December 3, 2010

Submitter/Regulatory Contact: Curtis Raymond Orchid Design - 80 Shelton Technology Center - Shelton, CT 06484

Sponsor/Manufacturer:

Suspension Orthopaedic Solutions, LLC 2635 Riva Road, Suite 100 - Annapolis, MD 21401

FDA Establishment Registration Number: Pending

Trade Name, Common Name, Classification:

Device Trade Name: Suspension™ Acromioclavicular (AC) Repair System

Device Common or Usual Names: Non-absorbable Suture Anchor & Accessories

Classification: Class II, 21 CFR 888.3030, JDR (Suture Anchor Accessories) & MBI (Suture Anchor)

Predicate Device:

The substantial equivalence of the AC Repair System is based on similarities in indications for use, design, and material composition to the following currently marketed predicate device:

AxyaLoop™ Non-absorbable Bone Anchor (K060970) �
0 AxyaLoop™ Self Tapping Bone Anchor (K052491)
0 TeleFlex Force Fiber Blue Co-Braided Polyethylene Suture (K063778)
� LM Anchor (K960825)

Description of the Device:

The system consists of the following implantable components that are included in the sterile blister package:

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4102143
pg 2/2

a USP size 5, co-braided, white/blue polyethylene suture (pre-threaded through the Coracoid Anchor)
Coracoid Anchor �
Clavicle Set Screw a

The following instruments are included in the sterile pack:

ള The Torque-Limiting Driver
The Coracoid Anchor Driver (a 3.0mm hex driver). o

The system includes non-sterile implantables included in a carier tray:

Clavicle Sleeve Extension Washer e
a Clavicle Sleeve

The following instruments are included non-sterile in a carier tray:

� 5.5mm Drill bit
ﮟ 4.0mm Drill Bit
o Suture Tensioner Device

Intended Use:

The Suspension " Acromioclavicular (AC) Repair System can be used for adult patients. The AC Repair System is indicated for securing suture to bone for acromioclavicular separations and coracoclavicular displacement. .

Technological Characteristics:

The subject devices are substantially equivalent to the predicate devices. Both the subject device and predicate devices are provided sterile and are single use. Both devices utilized braided polyethylene suture and manual surgical instruments. The devices are composed medical grade metals and have similar diameters. The axial pull test data was compared and analyzed.

Performance:

The material (316L Stainless Steel) selected is commonly used for orthopedic implants and has a long history of biocompatibility.

The devices have been subjected to recognized consensus standards for these types of devices and perform in a manner equivalent to the predicate devices. The device has been subjected to non-clinical testing including Driving Torque, Pull-Out Strength, Lock Screw Torque, Anchor Torque, and Sulure Testing.

Conclusion:

We believe that based on the predicate device comparison and the non-clinical testing performed the subject devices are substantially equivalent to the predicate devices and conclude that the subject devices are as safe and effective as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure in profile, with three flowing lines representing the hair or head. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Suspension Orthopaedic Solutions, LLC % Mr. Joseph Azary, Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, Connecticut 06484

[DEC --- 18 (200

Re: K102143

Trade/Device Name: Suspension Acromioclavicular Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MBI Dated: November 17, 2010 Received: November 19, 2010

Dear Mr. Azary:

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.

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 (reporting of medical

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Page 2 - Mr. Joseph Azary

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 Biometrics/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

A. B. Mr.

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

Enclosure

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Indications for Use

(revised)

510(k) Number (if known): K102143

Device Name: Suspension Acromioclavicular (AC) Repair System

Indications for Use:

ික්‍රමිණ දිස්ත්‍රී ලංකාව

The Suspension™ Acromioclavicular (AC) Repair System can be used for adult The AC Repair System is indicated for securing suture to bone for acromioclavicular separations and coracoclavicular displacement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melleson
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_KO2143

(Page 1 of 1)

DEC - 8 2010

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.