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Simplex P SpeedSet with Tobramycin bone cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

Simplex P SpeedSet with Tobramycin Bone Cement is a radiopaque bone cement premixed with antibiotic 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 powder pouch of 41.1 g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex P SpeedSet with Tobramycin Bone Cement is approximately 5.36 minutes, with a dough time of 2 pouristian and a setting time of 9.6 minutes.

This document is a 510(k) Summary for a bone cement device, not a study report or clinical trial. Therefore, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study that proves the device meets them.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study proving specific performance acceptance criteria for the new device itself.

However, based on the provided text, I can extract and infer some information, and explicitly state what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Acceptance Criteria": The acceptance criteria are inferred from the statement of "substantial equivalence" to predicate devices. For a 510(k), the primary "acceptance criterion" is that the new device is as safe and effective as a legally marketed predicate device. This often means demonstrating that key performance characteristics are the same or similar within acceptable tolerances, or that any differences do not raise new questions of safety or effectiveness. The document states:

• "The Simplex P SpeedSet with Tobramycin bone cement has the same indications, same liquid monomer and similar powder component as Simplex P with Tobramcyin bone cement (K014199 cleared 06 May 2003)."
• "The handling properties of Simplex P SpeedSet with Tobramycin are the same as those with Simplex P SpeedSet (K053198 cleared 26 January 2006)."

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

• Not Available. The document does not describe a "test set" in the context of a clinical study or performance evaluation with specific sample sizes. The "test" here refers to demonstrating equivalence, likely through bench testing, material characterization, and comparison of specifications, not a patient-based test set.

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

• Not Applicable/Not Available. As there's no described "test set" in the clinical evaluation sense, there are no experts establishing ground truth for such a set. The "experts" involved would be the engineers and scientists conducting the comparative analysis against predicate devices.

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

• Not Applicable/Not Available.

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 device is bone cement, an implantable material, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

• Not Applicable. This is not an algorithm-based device.

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

• Inferred based on 510(k) pathway: For a bone cement, "ground truth" for demonstrating substantial equivalence would primarily rely on bench testing and material property comparisons to established standards and the predicate devices. This would include tests for:
  • Mechanical properties (e.g., compressive strength, fatigue strength)
  • Biocompatibility
  • Leaching of antibiotic
  • Curing properties (working time, dough time, setting time)
  • Radiopacity
  • Sterility
• The document mentions "Indication For Use" and "Device Description" which are compared to the predicate's established performance and characteristics.

8. The sample size for the training set:

• Not Applicable/Not Available. The concept of a "training set" is relevant for machine learning algorithms. This document describes a medical device (bone cement), not an algorithm.

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

• Not Applicable/Not Available.

Summary of what the document does provide regarding "proof":

The "proof" for this device's acceptance is its demonstration of substantial equivalence to existing legally marketed devices (Simplex P with Tobramycin and Simplex P SpeedSet). This is the core of the 510(k) premarket notification pathway. The manufacturer asserts that because the new device has:

• The same indications for use.
• The same liquid monomer and similar powder component as a predicate with Tobramycin.
• The same handling properties as a predicate SpeedSet cement.

Therefore, it is considered as safe and effective as these predicates. The document implies that data from bench tests (e.g., for working time, dough time, setting time) were used to demonstrate these handling properties are "the same" or within acceptable limits when compared to the predicate Simplex P SpeedSet, but the specific data and acceptance criteria for these tests are not fully detailed in this summary.

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