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The Calcaneal Trauma System is indicated for the repair of intra and extra articular fractures of the calcaneus

The OrthoHelix Calcaneal Trauma System is a set of metallic (titanium alloy), implantable, bone fixation plates and screws. Its' intended function use is to stabilize fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.

The System includes four (4) fixation plates and forty five (45) screws. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti 6Al type 4V ELI per ASTM F 136.

The provided text describes a 510(k) Premarket Notification for the "Calcaneal Trauma System," a set of metallic bone fixation plates and screws. This notification focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study related to artificial intelligence (AI) performance. Therefore, many of the requested categories related to AI devices, such as acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies for AI performance, are not applicable to this document.

Here's an attempt to extract relevant information and address the non-applicable aspects:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This document does not describe a "test set" in the context of an AI study. The performance assessment relied on engineering analysis and comparison to a predicate device.
• Data Provenance: Not applicable in the context of an AI performance study. The performance data is derived from Finite Element Analysis (FEA) and hand calculations, which are engineering methods, not patient data trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is not an AI device, and no ground truth was established by medical experts in this context. The "ground truth" for this device's performance would be engineering specifications and the established performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no "test set" requiring expert adjudication as this is not an AI device.

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

• No. This is not an AI device, so an MRMC study comparing human readers with and without AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in the context of an AI performance study. The "truth" for this device's regulatory pathway relies on engineering principles (FEA, hand calculations) and demonstrated equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI device, and thus no training set was used.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI device.

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