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Simplex P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous Simplex™ P bone cement is also indicated for the fixation of arthroplasty. pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.

Simplex™ P Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use.

This document is a 510(k) summary for Simplex™ P Bone Cement, a PMMA bone cement. It focuses on demonstrating substantial equivalence to a previously approved device rather than providing a study on acceptance criteria with detailed performance metrics characteristic of AI/ML device submissions.

Therefore, most of the requested information regarding acceptance criteria, device performance, study design, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This document does not contain a table of acceptance criteria or reported device performance in the way an AI/ML device submission would. The core of this 510(k) summary is to demonstrate substantial equivalence to a predicate device.

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

• Not Applicable. This submission is for a traditional medical device (bone cement) and relies on demonstrating substantial equivalence to a predicate device. There is no "test set" in the context of an AI/ML model's performance evaluation. The data provenance would relate to the manufacturing and testing of the cement itself, not a dataset for algorithm evaluation.

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

• Not Applicable. As there is no test set for an AI/ML model, there are no experts establishing ground truth in this context. The "truth" in this submission relates to the chemical composition and manufacturing of the bone cement matching the predicate.

4. Adjudication method for the test set:

• Not Applicable. No test set or adjudication method is described for this traditional medical device submission.

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/ML device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable / Implied by Substantial Equivalence. The "ground truth" here is that the physical and chemical properties, as well as the manufacturing process, of the Simplex™ P Bone Cement are identical to those of the previously approved device (PMA N17004). This is a factual comparison of product specifications rather than interpreted data.

8. The sample size for the training set:

• Not Applicable. There is no training set for an AI/ML model in this submission.

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

• Not Applicable. There is no training set for an AI/ML model in this submission.

Summary regarding the device meeting acceptance criteria:

The document states that the "Simplex™ P powder and liquid monomer formula have not been modified and will be the same as what was approved in PMA N17004." This statement serves as the core "proof" that the device meets the implicit "acceptance criteria" for a 510(k) submission seeking substantial equivalence for a non-modified predicate. By being identical to a device already approved via a PMA (Premarket Approval, a more rigorous review pathway), the manufacturer asserts that all performance, safety, and effectiveness criteria previously met by the PMA device are inherently met by this identical 510(k) device. The study is fundamentally a comparison of the current device's formula and manufacturing to the approved predicate, rather than a clinical trial or algorithmic performance study.

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