(79 days)
The Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail. The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System. The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail indication may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. The T2 Recon Nail System indications include fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
This Traditional 510(k) submission is being supplied to the US FDA to address modifications made to the Gamma3 Target Device and addition of a new Distal Targeting Device to the Gamma3 (K043431) and T2 Recon Nail Systems (K102992) as well as the inclusion of the existing target devices in the Gamma3 and T2 Recon Nail Systems.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study that proves the device meets them:
Core Finding: This 510(k) pertains to a medical device accessory (targeting devices for intramedullary nails), and as stated in the document, clinical testing was not required. The "study" largely consists of non-clinical, bench-top testing and engineering evaluations. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study details) are not applicable in a clinical context.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as tested) | Study Details / Not Applicable (N/A) |
|---|---|---|
| Conditioning | Performed (details not explicitly stated in summary) | Non-clinical laboratory testing. The summary indicates "Conditioning" was performed, implying it met internal thresholds for material integrity or preparation. |
| Targeting Accuracy | Performed (details not explicitly stated in summary) | Non-clinical laboratory testing and engineering evaluations. This likely involved bench-top measurements to ensure the targeting devices guide the surgeon to the correct location within acceptable tolerances for the procedure. Specific numerical acceptable tolerances or reported accuracy are not provided in the summary. |
| Stiffness | Performed (details not explicitly stated in summary) | Non-clinical laboratory testing and engineering evaluations. This would ensure the targeting device maintains its structural integrity and precision during use and does not unduly flex or deform. Specific numerical acceptable tolerances or reported stiffness values are not provided in the summary. |
| Accommodation for 480mm Nails in Distal Targeting Device | Engineering Evaluations completed. The implication is that the design physically accommodates these nails as intended. | Engineering Evaluation. This would verify physical fit and functionality with longer nails without explicit numerical performance metrics in this summary. |
| Overall Substantial Equivalence | Demonstrated that the subject target devices are substantially equivalent to devices currently cleared for marketing. | Conclusion of the 510(k) process based on non-clinical testing and comparison to predicate devices. This is the overarching acceptance criterion for a 510(k). |
Detailed Breakdown of Study Information:
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A table of acceptance criteria and the reported device performance:
- See table above. The detailed acceptance criteria, including specific numerical thresholds for accuracy and stiffness, are not explicitly stated in this 510(k) summary. The summary only lists the types of tests performed, implying they met internal or standard criteria for substantial equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable (N/A) for clinical test set, as no clinical testing was performed. For non-clinical (bench-top) testing, the sample sizes are not specified in the summary.
- Data Provenance: Not applicable for clinical data. Non-clinical testing would have been conducted by Stryker Trauma AG or a contracted lab.
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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):
- Number of Experts: N/A, as no clinical testing was performed requiring expert ground truth in a diagnostic or clinical outcome context. For engineering evaluations, the "experts" would be the engineers performing the tests and evaluations.
- Qualifications of Experts: N/A for clinical experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: N/A, as no clinical testing was performed requiring adjudication of clinical data.
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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:
- MRMC Study: No, an MRMC study was not done. This device is a mechanical targeting accessory, not an AI-powered diagnostic tool, and no clinical comparative effectiveness study was performed or required.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: N/A. This device is a mechanical accessory; it does not have an "algorithm" in the sense of AI or image processing. Its performance is inherent to its mechanical design and function, used with a human surgeon.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: N/A for clinical types. For non-clinical testing (accuracy, stiffness), the "ground truth" would be established by engineering specifications, validated measurement tools, and physical standards.
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The sample size for the training set:
- Training Set Sample Size: N/A. This is a mechanical device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Training Set Ground Truth: N/A. There is no training set for this type of device.
Summary Conclusion from the Document:
The 510(k) summary clearly states: "Clinical testing was not required for this submission."
Therefore, the demonstration of substantial equivalence for the Gamma3 and T2 Recon Target Devices relies entirely on:
- Comparison of intended use, materials, and performance characteristics to predicate devices (K043431 Gamma3 Nail System and K102992 T2 Recon Nail System).
- Non-clinical laboratory testing (Conditioning, Targeting Accuracy, Stiffness).
- Engineering Evaluations (Accomodation for 480mm Nails in Distal Targeting Device).
The "study" proving the device meets acceptance criteria is the sum of these non-clinical tests and evaluations, which determined that the modified and new components were substantially equivalent to existing, cleared devices and did not alter the fundamental technology or safety/effectiveness.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.