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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 nail is a fixation device that has been previously cleared for marketing (K090091). Accessories are being added to the system that will offer optional advantages in terms of how the procedure is accomplished, specifically how the bone is cut, the drill holes are measured, and how the nail is removed.

The provided text describes a Special 510(k) application for accessories to an already cleared device, the OlecraNail® Intramedullary Fixation System. The focus of the submission is on demonstrating the substantial equivalence of the new accessories to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not explicitly stated. The text mentions "human cadaveric testing," but does not provide the number of cadavers or specimens used.
• Data Provenance: The origin of the cadavers (e.g., country) is not specified. The testing was likely conducted in a controlled environment as part of the regulatory submission process. It is a prospective study in the sense that the testing was conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided in the text. Human cadaveric testing implies the involvement of experts for setup, performance, and evaluation, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the text. For mechanical or functional testing like cadaveric studies, adjudication methods similar to those for clinical trials (e.g., 2+1, 3+1) are not typically applicable. The evaluation would likely involve objective measurements and expert assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was a MRMC study done? No.
• The device is a physical fixation system (intramedullary nail and accessories), not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance is not relevant or applicable to this type of medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in a sense.
• The "human cadaveric testing" can be considered a standalone performance evaluation of the device accessories' design and function. This testing evaluates the device's physical performance independent of an "AI algorithm" or human interpretation of data generated by the device in a clinical setting (since it's a surgical implant). The "standalone" here refers to the device's functional integrity as a physical product.

7. Type of Ground Truth Used

The ground truth for the cadaveric testing would be based on direct observation and objective measurements of the mechanical performance and functional integrity of the OlecraNail® accessories during surgical simulation or testing on human cadavers. This would include assessing proper bone cutting, accurate drill hole measurement, and effectiveness of nail removal, as implied by the stated purpose of the accessories. It is essentially an engineering-based ground truth related to mechanical performance and surgical technique.

8. Sample Size for the Training Set

This information is not applicable. The device is a surgical implant system, not a machine learning model that requires a "training set" of data. The development of the device's design would be based on engineering principles, predicate device designs, and expert surgical knowledge, rather than a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set in the context of this device. The design and validation relied on established engineering standards, biomechanical principles, and comparison to legally marketed predicate devices.

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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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