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The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a carbon fiber composite guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.

The provided document is a 510(k) summary for the OlecraNail™ Intramedullary Fixation System. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain a study that proves the device meets specific acceptance criteria.

The FDA clearance is based on the device's substantial equivalence to already legally marketed devices, not on the results of a new performance study with predefined acceptance criteria. The statement, "A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure," suggests that some engineering or bench testing was performed to demonstrate this equivalence, but the details of such testing, acceptance criteria, and specific performance results are not provided in this summary.

Therefore, I cannot populate the requested table and information points as they pertain to a performance study with acceptance criteria and reported device performance. The document explicitly states:

• "There are no changes in intended use, performance specifications or method of operation." This means the device relies on the established performance of its predicates.
• "Substantial equivalence for the OlecraNail™ Intramedullary Fixation System is based on their similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices..." This confirms the basis of clearance is similarity, not a new clinical performance study.

In summary, the provided text does not contain the information required to fulfill your request for an acceptance criteria table and study details. The FDA 510(k) clearance in this case is based on substantial equivalence through comparison to predicate devices, not on a new clinical or performance study with defined acceptance criteria for the device itself.

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The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a combination stainless steel/polyphenylsulfone guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.

The provided text describes a medical device called the OlecraNail™ Intramedullary Fixation System. It focuses on demonstrating the device's substantial equivalence to previously marketed devices and its mechanical performance.

However, the provided text DOES NOT contain information regarding:

• Acceptance criteria in a quantitative sense (e.g., target accuracy, sensitivity, or specificity values).
• Any studies involving patient data, human readers, or clinical outcomes.
• Ground truth establishment for any clinical data.
• Sample sizes for test or training sets related to clinical performance.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The "Non-Clinical Tests" section describes mechanical tests performed on the device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not specified. The tests were performed on "Olecranail™ intramedullary rods" and "the rod-guide junction." The exact number of units tested is not stated.
• Data provenance: Not applicable. These were non-clinical, mechanical integrity tests performed on the device itself, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. These were mechanical tests, not assessments requiring expert interpretation of clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is not a clinical study requiring adjudication.

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:

• No. The document describes mechanical tests of a physical orthopedic implant, not an AI-powered diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the mechanical tests, the "ground truth" would be the measured physical properties (elastic limits, rigidity, torsional strength, stress tolerance) as compared against established engineering standards and performance of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set" or corresponding ground truth.

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