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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 current Clavicle Fracture Fixation System accommodates fractures covering the mid-section and distal portions of the clavicle. As proposed in this 510(k) notification, the sponsor wishes to extend the product line by including a plate specifically designed for mid-shaft (i.e., non-distal) clavicle fractures. Because the proposed mid-shaft plate would not cover the distal aspect of the clavicle, its design will be slightly different. The proposed mid-shaft plate will be approximately 2/3 of the length of the current large size clavicle plate. Because the proposed mid-shaft plate will not engage the articular capsule of the clavicle, the distal screw holes of the current plate are eliminated.

The proposed mid-shaft plate will be available in one size only with an overall length of approximately 100mm. The thickness of the plate will be the same as the Suspension™ clavicle plates now on the market. Likewise, the width of the mid-shaft plate will be the same as the mid-shaft portion of the current plates. The screws used to secure the proposed mid-shaft plate to the clavicle are the same as those used for the current Suspension™ clavicle plates.

As with the current Suspension™ Clavicle Fracture Fixation plates, the proposed mid-shaft plate will be composed exclusively of 316L stainless steel. Implantable components are intended for re-sterilization, but are for single-use only.

A hex driver with a handle and a hex driver shaft for hand-tightening bone screws is supplied with the device. These accessories are intended for re-use and re-sterilization. Drill bits are required for creating pilot holes for bone screws. These drill bits are included supplied with the clavicle plates and are steam sterilized by the hospital center.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

This 510(k) pertains to a device modification (a line extension) of an already cleared device, not a new device requiring extensive de novo performance studies. The core of the submission is to demonstrate that the modified device has not changed its performance characteristics and is substantially equivalent to its predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating this equivalence rather than establishing new performance benchmarks for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Interpretation: The "acceptance criteria" here are essentially the established performance and safety profile of the predicate device (K102095). The new device (K113405) meets these criteria by demonstrating that it has not changed in material, performance characteristics (via a functional test), or safety profile from the predicate.

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

• Test Set Description: The "test set" in this context refers to the physical devices (the proposed mid-shaft clavicle plates) that were subjected to functional testing.
• Sample Size: The document does not specify the exact number (sample size) of mid-shaft clavicle plates used for the functional tests. It states "Functional test conducted in accordance with ASTM F382-99." ASTM F382-99, "Standard Specification for Metallic Bone Plates for Osteosynthesis," outlines testing methodologies and often includes recommendations for sample size for various tests (e.g., fatigue, static bending). Without the full test report, the specific sample size performed by the sponsor is unknown.
• Data Provenance: Not applicable in the traditional sense of patient data. The "data" comes from in vitro functional testing of the device itself. Therefore, there's no country of origin or retrospective/prospective distinction for patient data.

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

• Not Applicable: This is a mechanical device submission, not an AI/software device that relies on expert interpretation for ground truth. The "ground truth" for this device is its mechanical properties as measured by standardized engineering tests.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this is a mechanical device, not an image-based or diagnostic AI/software device that would require adjudication of interpretations. The "test" results are objective measurements from mechanical testing.

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

• No: No MRMC study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. This submission is for a surgical implant, not a diagnostic tool.

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

• Yes (in concept, but for mechanical performance): The functional test performed according to ASTM F382-99 is a standalone performance test of the device's mechanical characteristics without human-in-the-loop performance influencing the device itself. The device's performance is objectively measured.

7. The Type of Ground Truth Used

• Engineering/Mechanical Performance Standards: The "ground truth" here is adherence to established engineering standards (ASTM F382-99) and demonstrating equivalent mechanical performance to a legally marketed predicate device. This is based on objective, quantifiable physical properties (e.g., strength, stiffness, fatigue resistance).

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/machine learning device. There is no "training set" in this context.

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

• Not Applicable: As there is no training set, this question is not relevant.

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