(28 days)
The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The Titanium Elastic Nail End Cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation. The threads are self-tapping with reverse cutting flutes to facilitate end cap removal. The back end of the cap is blunt to minimize soft tissue irritation.
This document is a 510(k) summary for the Synthes Elastic Intramedullary Nail (EIN) End Cap. It contains information about the device, its intended use, and its substantial equivalence to predicate devices. However, it does not describe acceptance criteria, a study that proves the device meets acceptance criteria, or any performance data in the way a clinical study would.
Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.
Here is a summary of what is available in the document, demonstrating why the requested information cannot be extracted:
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A table of acceptance criteria and the reported device performance: This information is completely absent. No acceptance criteria are stated, and no performance metrics (e.g., accuracy, sensitivity, specificity, or any other quantifiable measure) are reported for the device.
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Sample size used for the test set and the data provenance: This information is completely absent. There is no mention of a test set, sample size, or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is completely absent. There is no mention of experts or ground truth establishment.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is completely absent.
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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: This information is completely absent. The device described is a physical medical implant (an end cap for an intramedullary nail), not an AI-assisted diagnostic or decision support tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is completely absent. As mentioned, this is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is completely absent.
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The sample size for the training set: This information is completely absent.
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How the ground truth for the training set was established: This information is completely absent.
Conclusion:
The provided document is a regulatory submission for a medical device (Synthes Elastic Intramedullary Nail (EIN) End Cap) seeking 510(k) clearance. The purpose of a 510(k) summary is to demonstrate "substantial equivalence" to a predicate device, which primarily involves comparing design, materials, and intended use, rather than presenting detailed clinical performance data from a prospective study with acceptance criteria.
Therefore, the specific information you requested regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement for performance evaluation is not available in this document. Such details would typically be found in a separate clinical or non-clinical performance study report, which is not part of this 510(k) summary.
§ 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.