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OptiMesh 500E is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement.

OptiMesh 500E is not intended for use in spinal indications.

OptiMesh 500E is an implantable PET device indicated for use as a cement restrictor in the femur and tibia. OptiMesh 500E is manufactured from polyethylene terephthalate (PET). The device is provided pre-loaded, for ease of handling, on a disposable holder made of stainless steel. The device is available in a variety of different sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text describes a 510(k) premarket notification for a medical device called OptiMesh 500E Cement Restrictor. This document establishes that the device is substantially equivalent to legally marketed predicate devices. However, it does not include information about specific acceptance criteria and a study proving those criteria are met in the way typically found for AI/ML-based devices with quantitative performance metrics.

The document is for a physical medical device (cement restrictor) and its clearance is based on substantial equivalence to existing predicate devices, not on meeting specific performance acceptance criteria from a clinical study with quantitative outcomes.

Therefore, the requested information elements related to AI/ML device performance (like sample size for test set, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) are not applicable to this type of device submission as described in the provided text.

Here's an analysis of what is available:

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

• Acceptance Criteria: The primary "acceptance criterion" for this type of device, as per the document, is demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance: Instead of performance metrics from a clinical study, the "performance" demonstrated is that the device is identical in materials and similar in configuration and principles of use to predicate devices. Configurational differences were addressed through testing, which found "no new questions of safety or effectiveness."

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

• Not applicable. This is a physical device submission focused on substantial equivalence through material and design comparison, supported by internal testing (not clinical trials with human participant test sets).

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. Ground truth as typically defined for AI/ML models is not relevant here.

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

• Not applicable.

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. This is not an AI-assisted device.

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

• Not applicable. This is a physical device.

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

• For this type of device, the "ground truth" would be related to engineering specifications, material properties, and mechanical performance demonstrated through non-clinical testing, rather than clinical outcomes or diagnostic accuracy. The text indicates "configurational differences... were addressed through testing," which implies mechanical or bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires training data in that sense.

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

• Not applicable.

In summary, the provided document relates to a traditional medical device (cement restrictor) seeking 510(k) clearance based on demonstrating substantial equivalence to already cleared predicate devices. The study that "proves" the device meets acceptance criteria primarily involves bench testing and comparison to predicate device specifications rather than clinical study data and performance metrics typically associated with AI/ML or efficacy trials.

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