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The OrthoHelixTM Syndesmosis Fixation Devices are indicated as adjunct fixation in repair involving metaphyseal and periarticular small bone fragments and surrounding soft-tissues where screws are not indicated and as an adjunct in external and intramedullary fixation systems involving plates and rods with fracture braces and casting. Specifically, the Syndesmosis Fixation Devices are intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of ankle syndesmosis disruptions in connection with Weber B and C ankle fractures, as well as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The OrthoHelixTM Syndesmosis Fixation Devices are implant assembly constructs of metallic buttons and non-absorbable suture intended to aid in the reconstruction of bones in the hand, wrist, elbow, shoulder, foot, and ankle, particularly in the reconstruction of the syndesmosis joint in the ankle and the AC joint in the shoulder. The syndesmosis devices are offered in different configurations, one to be used with and one to be used without a plate. All metallic implant components are manufactured from titanium alloy. All suture implant components are UHMWPE non-absorbable suture.

The provided text is a 510(k) summary for a medical device (OrthoHelix™ Syndesmosis Fixation Devices) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device that would typically have acceptance criteria, study data, and ground truth establishment in the way described in your request.

The document discusses mechanical testing to verify the strength of the implant construct. This is a very different type of "study" than what would be performed for an AI/ML device.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document because it describes a physical medical device, not an AI/ML system.

Here's an attempt to answer based on the provided text, highlighting where information is not present or relevant:

1. Table of Acceptance Criteria and Reported Device Performance

(Specific quantitative results or specific acceptance thresholds are not provided in this summary. The summary states that the testing confirmed no new safety/effectiveness issues compared to predicates, implying the performance was deemed acceptable relative to established predicate device performance.) |

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device. For mechanical testing of a physical device, the "sample size" would refer to the number of devices tested. This specific number is not provided in the summary.
• Data Provenance: Not applicable in the context of an AI/ML device. The testing was mechanical testing of the physical OrthoHelix™ Syndesmosis Fixation Devices, not clinical data from patients.

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

• Not Applicable. This device is a physical implant, not an AI/ML device that requires expert-established ground truth from medical images or patient records. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured in a lab.

4. Adjudication Method for the Test Set

• Not Applicable. This is relevant for AI/ML studies involving human interpretation or clinical outcomes, not for mechanical testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is not an AI/ML device. Therefore, no MRMC study, human reader improvement, or AI assistance enhancement analysis was performed or is relevant.

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

• No. This is not an AI/ML device, so no standalone algorithm performance study was performed.

7. The Type of Ground Truth Used

• Mechanical Testing Results / Physical Properties: For this physical device, the "ground truth" for demonstrating substantial equivalence was derived from the results of mechanical tensile testing, which verified the strength and integrity of the implant construct. This is in comparison to the known performance of predicate devices.
• Not expert consensus, pathology, or outcomes data, as these relate to clinical data for diagnostics or prognostics, which is not the function of this device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.

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