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The Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

The Trilliant Surgical Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. It is available in six sizes, Ø7mm to Ø12mm in 1mm increments.

The provided document, a 510(k) summary for the Trilliiant Surgical Subtalar Implant (K103183), describes the device and its substantial equivalence to predicate devices. However, it does not contain information related to acceptance criteria, device performance metrics, or the specific study details you've requested for proving acceptance criteria.

This 510(k) summary focuses on demonstrating that the Trilliiant Surgical Subtalar Implant is substantially equivalent to already legally marketed devices based on its intended use, design, materials, and function. The summary explicitly states:

• "No clinical studies were performed" (Section 8. Clinical Test Summary).
• "The following tests were conducted: Compression testing comparing predicate and Trilliant Surgical Subtalar Implant." (Section 7. Non-clinical Test Summary).

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study methodologies, and performance metrics as it is not present in the provided text.

Here's a breakdown of why each requested point cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided. The document only mentions "compression testing" without detailing acceptance criteria or quantitative performance results.
2. Sample sized used for the test set and the data provenance: Not provided. The document mentions compression testing but doesn't specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies are reported.
4. Adjudication method for the test set: Not applicable, as no clinical studies are reported.
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: Not applicable. This is a medical device (implant), not an AI-powered diagnostic tool, and no clinical studies are reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical studies are reported. "Compression testing" would typically have a physical standard or engineering specification as a reference.
8. The sample size for the training set: Not applicable, as no AI/algorithm development is described.
9. How the ground truth for the training set was established: Not applicable, as no AI/algorithm development is described.

In summary, the provided 510(k) document is for a medical implant and relies on substantial equivalence to predicate devices, supported by non-clinical (compression) testing, rather than extensive clinical efficacy or AI-specific validation studies.

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