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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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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.

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).
• 2. Eight (8) Lengths each of 2.7mm Non-Locking & Locking Bone Screws.
• 3. 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 .

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

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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