The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures. For lateral clavicle fractures, the Suspension™ Clavicle Fracture Fixation System may also be used with the Suspension™ Acromioclavicular (AC) Repair System.

Device Description

The subject device consists of the following implantable components:

Three sizes of clavicle fracture plate for each shoulder (i.e. small, medium, and large; each with Left & Right configurations)
Eight 2.7mm lengths of non-locking & locking bone screws
Eight 3.5mm lengths of non-locking & locking bone screws
Implantable components are included in a carrier case and must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but are for singleuse only. All implantable components are composed of stainless steel.
The optionally accompanying Suspension™ Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor with pre-threaded suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. Implantable portions of the device are: USP size 5 braided polyethylene suture, coracoid anchor, clavicle set screw, clavicle sleeve extension washer, clavicle sleeve.

AI/ML Overview

The provided text describes a 510(k) summary for the Suspension™ Clavicle Fracture Fixation System, a medical device, and not an AI/ML-based diagnostic or prognostic device. Therefore, the traditional "acceptance criteria" and "study" questions related to AI/ML device performance (e.g., sensitivity, specificity, human-in-the-loop studies, ground truth establishment by experts) are not applicable in this context.

Instead, the "acceptance criteria" for a medical device like this, under a 510(k) pathway, revolve around substantial equivalence to a predicate device. This is demonstrated primarily through performance testing, safety testing (biocompatibility, sterility), and engineering analysis to show that the device meets its intended use and does not raise new questions of safety or effectiveness.

Here's how to reframe the information based on the provided text, focusing on the substantial equivalence criteria for this mechanical device:

Device Acceptance Criteria and Supporting Study

Device Name: Suspension™ Clavicle Fracture Fixation System
Premarket Notification Number: K112923
Predicate Device: Smith & Nephew (K061352) and K102095 (previous version of the subject device) for components.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance	Comments
Mechanical Performance	Yield Load	Substantially equivalent to standard plates.	Demonstrated through cadaver and simulated bone testing.
	Stiffness	Substantially equivalent to standard plates.	Demonstrated through cadaver and simulated bone testing.
	Ultimate Load	Substantially equivalent to standard plates.	Demonstrated through cadaver and simulated bone testing.
	Failure Mode	Proposed method of application did not adversely impact construct integrity. Suture component of AC System failed before any damage to Clavicle Plate in pull tests.	Indicated robust design and appropriate failure sequence.
Material Safety	Biocompatibility	Previously demonstrated in K102095; no changes to materials.	Relied on prior submission for material safety.
Sterilization	Sterility Validation	Previously presented in K102095; no changes to methods or packaging.	Relied on prior submission for sterilization validation.
Design Integrity for New Configuration	Fretting/Corrosion (new AC System connection)	Engineering analysis determined new connection does not represent a new worst-case condition.	Addressed potential risks from combining two systems.
Intended Use	Fixation of Clavicle Fractures (adults)	Performance testing supported the intended use.	Demonstrated through mechanical testing in relevant models.

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

Test Set Description: Multiple cadaver shoulders and simulated bone.
Sample Size: Not explicitly stated as a number of samples or cases. The document uses phrases like "multiple cadaver shoulders" and "in all instances" for simulated bone testing, suggesting sufficient samples were tested to draw conclusions.
Data Provenance: The cadaver and simulated bone testing was conducted specifically for this submission to support the device's performance. The location of the test facility is not explicitly mentioned, but it's part of a US FDA 510(k) submission. It is a prospective set of tests conducted for regulatory submission.

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

Not Applicable (N/A). This is a mechanical device, not an AI/ML diagnostic. The "ground truth" is established by physical measurement of mechanical properties (yield load, stiffness, ultimate load) using an Instron™ device and observation of failure modes, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

Not Applicable (N/A). As this is mechanical testing, there is no human "adjudication" in the sense of consensus reading or clinical judgment. The results are quantitative measurements from the Instron™ device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable (N/A). This type of study is relevant for diagnostic performance, typically for image-based AI/ML systems where human reader performance is being evaluated with and without AI assistance. This device is an orthopedic implant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not Applicable (N/A). This question applies to AI/ML algorithms. The device is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through biomechanical testing data obtained from:

Measurements using an Instron™ device (for yield load, stiffness, ultimate load).
Observation of failure modes during testing.
Engineering analysis for specific concerns like fretting/corrosion.
Reference to previously established biocompatibility and sterility validation data from predicate devices/prior submissions.

8. The Sample Size for the Training Set

Not Applicable (N/A). There is no "training set" in the context of a physical medical device like an orthopedic implant. Training sets are relevant for AI/ML models.

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

Not Applicable (N/A). As there is no training set, this question is not applicable.

Summary

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DEC 2 7 2011

510(k) SUMMARY

December 23, 2011

Premarket Notification Number: K112923 Suspension™ Clavicle Fracture Fixation System

Device Classification: Class II (Ref. CFR 21 §888.3030) Single/multiple component metallic bone fixation appliances and accessories

Sponsor:

Suspension Orthopedic Solutions, Inc 1507 Richie Hwy. Suite 101 Arnold, MD 21012

Sponsor's Representative

Curtis Raymond Orchid Design 80 Shelton Technology Center Shelton Connecticut 06484 Telephone 203-922-0105

Device Description:

The subject device consists of the following implantable components:

1. Three sizes of clavicle fracture plate for each shoulder (i.e. small, medium, and large; each with Left & Right configurations)
1. Eight 2.7mm lengths of non-locking & locking bone screws
1. Eight 3.5mm lengths of non-locking & locking bone screws

Implantable components are included in a carrier case and must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but are for singleuse only. All implantable components are composed of stainless steel.

The optionally accompanying Suspension™ Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor with pre-threaded suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. Implantable portions of the device are: USP size 5 braided polyethylene suture, coracoid anchor, clavicle set screw, clavicle sleeve extension washer, clavicle sleeve.

Intended Use

Predicate Device(s):

No component of the subject device has been changed in its design, component material, sterilization method, or in any other way from that described in K102095. The sole change to

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KII2923

the device is to allow optional, concurrent use of the Suspension™ Acromioclavicular (AC) System in those instances where lateral clavicle fractures are encountered. Likewise, there have been no changes of any kind made to the Suspension™ Acromioclavicular (AC) System other than allowing its use in conjunction with the subject Clavicle Fixation Plate.

Performance Testing:

The subject device was tested in multiple cadaver shoulders using the proposed method of application. The subject device was compared to the currently marketed Smith & Nephew (K061352). Using an Instron™ device, assessments were made for yield load, stiffness, ultimate load and failure mode. Testing showed that the proposed method of application did not adversely impact the integrity of the construct and substantially equivalent results were observed compared to standard plates.

The subject device was tested in simulated bone. In all instances, the suture component of the subject Acromioclavicular System failed in pull tests before any damage was incurred by the Clavicle Plate. Testing showed that the proposed method of application did not adversely impact the integrity of the clavicle construct.

Engineering analysis has determined that the new connection between the clavicle washer sleeve in the Suspension™ Acromioclavicular Repair System and the subject clavicle plate does not represent a new worst case condition for concerns regarding fretting or corrosion.

Safety Testing:

Biocompatibility for the device was previously demonstrated in K102095. There have been no changes of any kind to the materials used in the device.

Sterility validation testing was previously presented in K102095. There have been no changes of any kind to the methods of sterilization or to the product packaging. Likewise, there have been no modifications to the design of any components of the device such that sterilization might be affected.

Additionally there have been no changes to the design, materials, packaging, sterilization or other features of the optionally accompanying Suspension™ Acromioclavicular (AC) System (K102143).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" and is arranged around the circumference of the circle.

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

Suspension Orthopaedic Solutions, LLC % Orchid Design Mr. Curtis Raymond Senior Regulatory and Quality Consultant 80 Shelton Technology Center Shelton, Connecticut 06484

DEC 2 7 2011

Re: K112923

Trade/Device Name: Suspension Clavicle Fracture Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, MBI Dated: September 30, 2011 Received: October 3, 2011

Dear Mr. Raymond:

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. Curtis Raymond

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milliken

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

K112923 510(k) Number (if known):_

Device Name: Suspension™ Clavicle Fracture Fixation System

Intended Use

The Suspension™ Clavicle Fracture Fixation System can be used for adult patients.

· The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation

of clavicle fractures. For lateral clavicle fractures, the Suspension™ Clavicle Fracture

Fixation System may also be used with the Suspension™ Acromioclavicular (AC)

Repair System.

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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ichel Nune

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number .

K12923

AS-

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.