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When mixed to the proper consistency using the pre-measured mixing solution supplied in each package, CalForma Calcium Sulfate Bone Graft Barrier can be formed over bony defects. When used over a bone graft, CalForma provides a stable barrier to graft material migration.

CalForma™ Calcium Sulfate Bone Graft Barrier is a pre-measured formulation containing a proprietary formulation of accelerated SGCSH and HPMC (surgical grade calcium sulfate [alpha] hemihydrate / hydroxypropyl methylcellulose [or hypromellose]) and a hydrating solution (sterile water).

The provided text describes the CalForma™ Calcium Sulfate Bone Graft Barrier and its substantial equivalence to a predicate device (CAPSET® Calcium Sulfate Bone Graft Barrier, K943186). However, it does not contain a detailed study with acceptance criteria and specific performance metrics in the format requested. The document focuses on establishing substantial equivalence based on overall safety and effectiveness without presenting quantitative acceptance criteria or a comprehensive study report to prove individual criteria are met.

Here's an attempt to extract and infer information, acknowledging that specific quantitative details are absent for many requested points:

Acceptance Criteria and Study Details for CalForma™ Calcium Sulfate Bone Graft Barrier

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "modification does not affect the safety or effectiveness of the device" and "handling characteristics of CalForma™ were improved over the predicate." These are general statements of attainment rather than quantifiable acceptance criteria with specific thresholds.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document mentions "Animal testing" and "in vitro and in vivo testing." There is no indication of human clinical trials for this 510(k) submission.
• Data Provenance: Not specified, but likely from internal company studies given the nature of a 510(k) submission for a modified device. The document does not mention country of origin or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable/Not specified. The assessment appears to be based on animal and in vitro/in vivo testing results rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. There's no mention of a human expert-based test set that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not a diagnostic imaging device where MRMC studies are typically performed. The study focuses on the physical and biological properties of a bone graft barrier.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This is not an AI/algorithm-based device. The "performance" refers to the material's physical and biological behavior rather than an algorithm's output.

7. Type of Ground Truth Used

• For Safety and Effectiveness: The ground truth was established through animal testing (in vivo) and laboratory testing (in vitro) to assess biocompatibility and performance characteristics, comparing against the known characteristics of the predicate device.
• For Handling Characteristics: Ground truth was likely established through observational assessment during animal testing or potentially benchtop testing by researchers/technicians, comparing the handling of CalForma™ to CAPSET®.

8. Sample Size for the Training Set

• Not applicable/Not specified. This is a medical device, not an AI model, so there isn't a "training set" in the machine learning sense. The development of the device likely involved iterative testing and refinement, but this isn't framed as a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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