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510(k) Data Aggregation
(228 days)
The TIDAL Fusion Cage System is intended to be used as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk of limb loss. The TIDAL Fusion Cage System is intended for use as an accessory to the DynaNail TTC Fusion System. The TIDAL Fusion Cage System is not intended for standalone use. The TIDAL Fusion Cage System is intended for use with autograft and/or allogenic bone graft.
The subject TIDAL Fusion Cage System is a single-use, implant grade titanium alloy (Ti-6Al-4V) device, available in varying shapes, heights and diameters, designed to be used as an accessory to the DynaNail TTC System for ankle fusion.
The provided text describes a 510(k) premarket notification for a medical device called the "TIDAL Fusion Cage System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a traditional clinical study with acceptance criteria.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance: This is typically found in a clinical study report with predefined endpoints.
- Sample size used for the test set and data provenance: While a "retrospective, single arm, clinical evaluation" is mentioned, no specific sample size for a "test set" is provided.
- Number of experts used to establish ground truth and their qualifications: Ground truth establishment by experts is relevant for studies involving AI/image analysis, not for this type of device submission.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical implant, not an AI algorithm.
- Type of ground truth used: Not applicable in the context of this 510(k) submission.
- Sample size for the training set: Not applicable, as this is about a physical device, not an AI algorithm.
- How ground truth for the training set was established: Not applicable.
What the document does provide regarding device performance:
The document states that the TIDAL Fusion Cage System was subject to various benchtop and clinical performance tests to support the assertion of substantial equivalence. These tests primarily focus on the mechanical and material properties of the implant, comparing them to the predicate device.
Table of Benchtop Performance Tests (from section H. Comparison of Non-Clinical Performance):
| Acceptance Criteria (Implied: Meet performance of predicate/standards) | Reported Device Performance (Implied: Met criteria based on clearance) |
|---|---|
| Static Compressive Strength | Information not explicitly detailed in the document, but clearance implies successful demonstration. |
| Dynamic Compressive Strength | Information not explicitly detailed in the document, but clearance implies successful demonstration. |
| Static and Dynamic Compression-Shear Strength | Information not explicitly detailed in the document, but clearance implies successful demonstration. |
| Torsional Strength | Information not explicitly detailed in the document, but clearance implies successful demonstration. |
| Dynamic Construct Fatigue with Subsequent Fretting-Corrosion Analysis | Information not explicitly detailed in the document, but clearance implies successful demonstration. |
| Nitinol Corrosion Test | Information not explicitly detailed in the document, but clearance implies successful demonstration. |
| Wear Particle Analysis | Information not explicitly detailed in the document, but clearance implies successful demonstration. |
Regarding the "Clinical Performance Evaluation" (from section I):
The document mentions a "retrospective, single arm, clinical evaluation of the TIDAL Fusion Cage using an intramedullary (IM) nail for tibiotalocalcaneal (TTC) fusion."
- Study Design: Retrospective, single-arm clinical evaluation.
- Comparison: Clinical performance was "evaluated against an IM nail for TTC fusion" (though it's a single-arm study, this implies a comparison to known performance of IM nails).
- Effectiveness Endpoints: Joint salvage with the TIDAL Fusion Cage in place at last follow-up, perceived physical function, and deformity correction.
- Safety Outcomes: Absence of a subsequent secondary surgical intervention and device-related serious adverse events on the affected joints.
- Sample Size and Data Provenance: Not specified in the document.
- Ground Truth: The "ground truth" here would be the clinical outcomes (joint salvage, function, adverse events) as observed in the patient population studied. The method for establishing this (e.g., patient records review, clinical examination) is not detailed.
Conclusion from section J:
"Based on the data submitted, any differences of the TIDAL Fusion Cage System do not raise any different questions of safety or effectiveness, therefore, demonstrates substantial equivalence to the predicate device." This statement implies that the conducted tests and evaluations were sufficient to meet the FDA's criteria for substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.
In summary, the provided FDA clearance letter and 510(k) summary pertain to a physical medical device (implant) and do not describe an AI/software study involving ground truth, expert readers, or MRMC studies. The "acceptance criteria" here are demonstrating substantial equivalence through primarily benchtop testing and a limited clinical evaluation, not the performance metrics of a diagnostic algorithm.
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