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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.

Device Description

The Suspension™ Clavicle Fracture Fixation System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from 316L Stainless Steel.

The device consists of the following implantable components (some or all of which may be used based on the nature of the injury):

1. Three (3) Sizes of Clavicle Fracture Plate for Each Shoulder (i.e. small, medium, and large; each with Left & Right).
1. Eight (8) Lengths each of 2.7mm Non-Locking & Locking Bone Screws.
1. Eight (8) Lengths each of 3.5mm Non-Locking & Locking Bone Screws.

Implantable components are included in a surgical tray that must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but these components are for single use only.

The implants are used with instrumentation including:

Hex Driver .
- o Handle and a 2.5mm hex driver for hand tightening bone screws
Assorted Drill bits .
- o To create pilot holes for bone screws. The drill bits are compatible with most AO connections.
Drill Guide Assemblies .

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Suspension™ Clavicle Fracture Fixation System, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance	Study Type/Evidence
Biocompatibility	Material Selection	Material is commonly used for orthopedic implants with a long history of biocompatibility.	316L Stainless Steel is commonly used for orthopedic implants with a long history of biocompatibility.	Material analysis, common knowledge in orthopedics
Mechanical Performance	Torsional Strength	Equivalent to predicate device.	Performed in a manner equivalent to predicate devices.	Non-clinical testing
Mechanical Performance	Torsional Break	Equivalent to predicate device.	Performed in a manner equivalent to predicate devices.	Non-clinical testing
Mechanical Performance	Four Point Bending	Equivalent to predicate device.	Performed in a manner equivalent to predicate devices.	Non-clinical testing
Mechanical Performance	Screw Driving Torque	Equivalent to predicate device.	Performed in a manner equivalent to predicate devices.	Non-clinical testing
Comparative Analysis	Predicate Comparison	Substantially equivalent to predicate device (Smith & Nephew Peri-Loc locking bone plates, locking and non-locking bone screws for the upper extremity - K061352) in materials, sterility, and performance.	"The subject devices are substantially equivalent to the predicate devices. Both the subject device and predicate device have indications for clavicle... The devices are composed of the same materials, and have the same sterility. The devices are used with 3.5mm and 2.7mm locking or non-locking screws."	Predicate Device Comparison Analysis

2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing (e.g., mechanical tests like torsional strength, bending, screw driving torque) and a predicate device comparison analysis. These types of tests typically do not involve human subject data or "test sets" in the sense of clinical trials. The sample sizes for these mechanical tests are not specified in the summary, but would refer to the number of devices or components tested. The data provenance is internal to the manufacturer's testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The evaluations were based on engineering and material science principles, and comparison to a predicate device, not on expert consensus of clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as there was no clinical test set requiring ground truth adjudication by experts.

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
This information is not applicable. This device is a physical orthopedic implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical mechanical tests, the "ground truth" is defined by established engineering standards and comparative performance against the legally marketed predicate device. For the predicate comparison, the ground truth is the established safety and effectiveness profile of the predicate device (Smith & Nephew Peri-Loc locking bone plates, locking and non-locking bone screws for the upper extremity - K061352).

8. The Sample Size for the Training Set
This information is not applicable. This is a physical orthopedic implant, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.

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