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Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimulan™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.

Stimulan™ Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 . 2H2O) and stearic acid.

This document is a 510(k) summary for the Stimulan™ Calcium Sulfate Bone Void Filler. It describes the device, its intended use, and its comparability to predicate devices. However, this document does not contain the detailed study information, acceptance criteria, test set, ground truth methods, or other specific performance data typically found in a clinical study report or a more comprehensive premarket notification submission.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be extracted or inferred based on the nature of a 510(k) submission:

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

   • Cannot be provided. The document states that Stimulan™ is "comparable" to predicate devices, referencing "equivalent design, materials and indications." A 510(k) primarily demonstrates substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness criteria. Specific quantitative performance acceptance criteria and results are not detailed in this summary.

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

   • Cannot be provided. This document does not describe a specific clinical study with a test set. It is a summary for a 510(k) application, which often relies on performance data from predicate devices, bench testing, or non-clinical studies rather than a prospective clinical trial with a defined "test set" in the context of device performance metrics like sensitivity/specificity.

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

   • Not applicable/Cannot be provided. As no specific "test set" or clinical study with adjudicated outcomes is detailed, there's no mention of experts establishing ground truth.

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

   • Not applicable/Cannot be provided. No adjudication method is described.

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:

   • No. This device is a calcium sulfate bone void filler, not an AI-powered diagnostic or imaging device. Therefore, an MRMC study related to AI assistance for human readers is irrelevant and not mentioned.

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

   • Not applicable. This device is a physical implant, not an algorithm.

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

   • Cannot be provided directly related to a "test set" for performance metrics like sensitivity/specificity. The 510(k) process for this type of device typically relies on demonstrating biocompatibility, mechanical properties, and resorption characteristics through pre-clinical testing (e.g., in vitro, animal studies) and comparing these to predicate devices, rather than establishing a ground truth for diagnostic accuracy.

8. The sample size for the training set:

   • Not applicable/Cannot be provided. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."

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

   • Not applicable/Cannot be provided. As there is no training set mentioned.

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