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

Simplex™ P SpeedSet Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack of 10-pack of 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. The working time of the Simplex™ P SpeedSet Bone Cement is approximately 4.8 minutes, with a dough time of 2.53 minutes and a setting time of 8.2 minutes.

The provided text describes a 510(k) premarket notification for a medical device (Simplex™ P SpeedSet Bone Cement) and an FDA clearance letter. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the way a modern AI/ML device submission would.

This document is for a traditional medical device (bone cement), and its clearance is based on substantial equivalence to previously marketed devices, not on performance metrics derived from a study with acceptance criteria.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this submission type and are not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Explanation: The device (Simplex™ P SpeedSet Bone Cement) gained clearance based on substantial equivalence to predicate devices (Simplex™ P and Palacos R bone cements), not through meeting predefined performance acceptance criteria from a clinical study. The submission focuses on demonstrating similarities in indications for use, monomer/powder components, and physical properties like dough time, setting time, and working time.

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. There is no "test set" in the context of an AI/ML study described for this device. The evaluation was
  based on comparing the new device's characteristics to predicates.

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. There is no "ground truth" established by experts in this context. The assessment is a comparison of product specifications and indications of use.

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

• Not applicable. No adjudication method for a test set is mentioned.

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 submission is not for an AI/ML device, so no MRMC study was performed.

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

• Not applicable. This is not an AI/ML algorithm.

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

• Not applicable. No ground truth in the context of AI/ML validation is used. The "truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

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

Summary of Device Evaluation in the Provided Text:

The evaluation for the Simplex™ P SpeedSet Bone Cement was based on demonstrating Substantial Equivalence to legally marketed predicate devices: Simplex™ P bone cement (PMA N17004) and Palacos R bone cement (K030902).

The key similarities highlighted for substantial equivalence (as per the "Substantial Equivalence" section) are:

• Same indications for use.
• Same liquid monomer.
• Similar powder component.
• Similar dough time, setting time, and working time.

The FDA's letter confirms that they "determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met the regulatory standard of substantial equivalence, which is the "acceptance criteria" for a 510(k) submission of this nature. The "study" (or rather, the comparative analysis presented in the 510(k) submission) showed that the new device shared fundamental characteristics and performance profiles with already cleared devices, making it equally safe and effective for its intended use.

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