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The Fortitude Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not intended for use in spinal applications.

The Fortitude Cement Restrictor is a hollow, titanium allov device with teeth on two opposing flat sides. The device comes in various sizes and is offered in straight and tapered styles. The device is used to hold bone cement (PMMA) in the distal diaphyseal canal in patients requiring a cemented arthroplasty device.

The provided text is a 510(k) premarket notification for a medical device called the "Fortitude Cement Restrictor." This notification is concerned with demonstrating substantial equivalence to pre-existing devices, rather than presenting a study that proves the device meets specific acceptance criteria through performance metrics.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not applicable or cannot be extracted from this document, as a performance study in the context of specific quantitative acceptance criteria was not the primary focus of this type of submission.

Here's an attempt to address the requested information based only on the provided text, indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

This document does not present a table of specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other quantitative performance metrics) or reported device performance against such criteria. The submission is a 510(k) for substantial equivalence, which primarily focuses on comparing the new device's intended use, materials, and technological characteristics to predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a performance study with a test set. This is a 510(k) submission for substantial equivalence.

3. 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)

Not applicable. The document does not describe a performance study involving the establishment of ground truth by experts.

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

Not applicable. The document does not describe a performance study with an adjudication method.

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

Not applicable. The document describes a physical medical device (a cement restrictor) and not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

Not applicable. The device is a surgical implant, not an algorithm.

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

Not applicable. The document does not describe a performance study involving ground truth.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm.

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

Not applicable. The document does not describe a training set or its ground truth establishment.

Summary of what the document does provide:

• Device Name: Fortitude Cement Restrictor Prosthesis
• Proposed Classification Name: Hip. Cement Restrictor (21CFR 878.3300)
• Product Code: JDK
• Predicate Devices: Medtronic Sofamor Danek Cement Restrictor(s) (K012255 and K013014) and the Signus RABEA 1M Cement Restrictor (K990345).
• Device Description: A hollow, titanium alloy device with teeth on two opposing flat sides, available in various sizes and straight/tapered styles. It holds bone cement (PMMA) in the distal diaphyseal canal for cemented arthroplasty.
• Intended Use: As a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
• Specific Limitation/Warning: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates that while the device is cleared for its stated orthopedic uses, its use in spinal applications has not been evaluated or proven safe/effective.
• Nature of Submission: A 510(k) premarket notification demonstrating "substantial equivalence" to previously cleared devices based on intended use, materials, and technological characteristics, rather than a clinical performance study with defined acceptance criteria.

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