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Synthes Calcium Sulfate Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Pellets are to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, they may be used at an infected site.

Synthes Calcium Sulfate Pellets are composed of a porous, osteoconductive, bone void filler material consisting of calcium sulfate dihydrate and stearic acid. When used according to directions, the biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days and replaced by natural bone.

The cylindrical pellets weigh approximately 100 mg and are supplied in capped, glass vials in sizes of 50, 100 and 200 pellets per vial. The product is pre-sterilized by gamma radiation and is not intended to be resterilized. It is for single use only.

Synthes Calcium Sulfate Pellets have the same dissolution rate, compression strength and mass to volume ratio characteristics as the predicate device.

The provided text is a 510(k) summary for the Synthes (USA) Calcium Sulfate Bone Void Filler Pellets. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a clinical study or acceptance criteria for device performance as would be found in a typical study report. Therefore, I cannot fully complete all sections of your request.

Here's what can be extracted and what cannot:

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

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

This information is not provided in the document. The 510(k) summary indicates that the device has the "same dissolution rate, compression strength and mass to volume ratio characteristics as the predicate device," implying a comparison or testing was done, but details of the test set are absent.

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)

This information is not provided in the document. This type of information is typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

This information is not provided in the document.

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

This type of study is not mentioned in the document. The device is a bone void filler, not an imaging or diagnostic AI system, so an MRMC study would not be applicable.

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

This concept is not applicable as the device is a physical bone void filler, not an algorithm.

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

For the physical characteristics mentioned (dissolution rate, compression strength, mass to volume ratio), the ground truth would likely be established through laboratory testing and measurements based on established engineering and materials science standards. For the resorption time, it would likely be based on animal studies or historical data from similar calcium sulfate products. However, the specific type of ground truth and how it was established for this specific device's tests is not explicitly detailed beyond stating it matches the predicate.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is typically for machine learning or AI models, which is not what this device is.

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

This information is not provided in the document and is not applicable for this device type.

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