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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. For lateral clavicle fractures, the Suspension™ Clavicle Fracture Fixation System may also be used with the Suspension™ Acromioclavicular (AC) Repair System.

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)
2. Eight 2.7mm lengths of non-locking & locking bone screws
3. 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.

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

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.

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