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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 end cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation.

The provided text describes a 510(k) summary for a medical device, the "Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line Extension". This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a novel AI/software device would.

Therefore, the document does not contain the information typically required to fill out a table of acceptance criteria and reported device performance for an AI/software device, nor does it describe a study like those requested in questions 2 through 9.

Here's why and what information is available:

• Type of Device: This is an implantable medical device (intramedullary nail end cap), not an AI or software device. Substantial equivalence for such devices often relies on comparison of design, materials, manufacturing processes, and intended use to a predicate device, rather than performance metrics from a clinical study with ground truth.
• Regulatory Pathway: The 510(k) pathway (K082148) for this device is focused on showing substantial equivalence to existing predicate devices (Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System - K081452 and Synthes Elastic Intramedullary Nail (EIN) End Cap - K053105).
• Lack of Performance Data: The 510(k) summary explicitly states "Information presented supports substantial equivalence" but provides no information about acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, F-score), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. These are all concepts relevant to the evaluation of AI/software as a medical device (SaMD) or AI-assisted devices, which this product is not.

In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a traditional medical device undergoing a 510(k) substantial equivalence review, not an AI/software device with performance criteria and a study as typically outlined for such technologies.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is completely absent.

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: 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.

6. 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is completely absent.

8. The sample size for the training set: This information is completely absent.

9. 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.

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