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Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed with bone during the healing process

Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.

The provided document ([K191074](https://510k.innolitics.com/search/K191074)) is a 510(k) premarket notification for a medical device called Sorrento™ Bone Graft Substitute. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, this document is a 510(k) premarket notification for a bone graft substitute, which is a physical device, and not an AI/ML-driven device. Therefore, the concepts of acceptance criteria, test sets, training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable to this document. The document describes a traditional medical device approval process based on biocompatibility, bench testing, and an animal study, not an AI/ML software validation study.

Therefore, I cannot extract the requested information about acceptance criteria and study that proves an AI/ML device meets them from this document. The document does not contain information about an AI/ML device.

If you intended to provide a document related to an AI/ML medical device, please provide that document.

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Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony you'd or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.

Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, non-pyrogenic, and for single use in double peel packages.

This document is a 510(k) premarket notification for the Sorrento™ Bone Graft Substitute. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, extensive study details for a device of this type (a bone graft substitute), and AI-specific metrics (like MRMC studies) cannot be fully extracted from this document, as it outlines a different regulatory approval pathway.

Here's a breakdown of what can be inferred and what cannot, based on the provided text:

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

• Acceptance Criteria: While not explicitly stated as "acceptance criteria" in the traditional sense of a performance study with numerical targets, the document establishes "substantial equivalence" as the primary regulatory acceptance criterion. This means the device must perform at least equivalently to the predicate device.
• Reported Device Performance: The document states that the Sorrento™ Bone Graft Substitute was compared to the predicate device (Vitoss® Scaffold Foam Bone Graft Material) in a non-clinical rabbit model. The "performance" was observed to be "at least equivalent."

| Criterion                                    | Acceptance Goal                                                                    | Reported Device Performance                                                |
| :------------------------------------------- | :--------------------------------------------------------------------------------- | :------------------------------------------------------------------------- |
| Substantial Equivalence to Predicate Device  | Device performs at least equivalently to the predicate device.                     | Demonstrated to have "at least equivalent performance characteristics" and "substantially equivalent" to the predicate device. |
| Design                                       | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Material Characterization                    | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Biocompatibility                             | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Sterilization                                | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Components of Device (Material)              | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Dimensional Specifications                   | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Physical Form (Sponge)                       | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Radiographic Evaluation (rabbit model)       | Performance comparable to predicate device.                                        | Study data demonstrated "substantially equivalent" with the predicate device. |
| Histomorphometric Evaluation (rabbit model)  | Performance comparable to predicate device.                                        | Study data demonstrated "substantially equivalent" with the predicate device. |
| ASTM F1088 compliance                        | In compliance with standard for beta tricalcium phosphate.                         | Supported by evaluation per ASTM F1088.                                    |
| ASTM F2212 compliance                        | In compliance with standard for collagen.                                          | Supported by evaluation per ASTM F2212.                                    |

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

• Sample Size: The document mentions a "Distal femoral defect model in rabbits." However, the number of rabbits or individual defects used in this study (i.e., the sample size) is not specified in the provided text.
• Data Provenance: The study was a non-clinical animal model (rabbits). The country of origin is not specified but is typically associated with the submitter (Haider Biologics, LLC, San Diego, California). It is prospective in nature, comparing the subject device to the predicate device following implantation.

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. For a non-clinical animal study involving radiographic and histomorphometric evaluation, experts (e.g., veterinary radiologists, pathologists) would typically be involved, but their number and specific qualifications are not detailed.

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

• This information is not provided as it pertains more to human reader studies often associated with AI/imaging devices. For an animal study, the evaluation method (e.g., blinded assessment by pathologists) would be relevant but is not described here.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving AI assistance, not for a bone graft substitute.

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

• No, this concept does not apply to a bone graft substitute. It's a bio-material, not an algorithm.

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

• For the non-clinical animal study, the "ground truth" for evaluating the performance was based on:
  • Radiographic evaluation: Likely interpreted by experts.
  • Histomorphometric evaluation: Involving tissue analysis, which typically uses pathology as the basis for evaluation by experts (e.g., histopathologists).
  • Comparison against the established performance of the predicate device.

8. The sample size for the training set

• This concept is not directly applicable. This is a medical device (bone graft substitute), not an AI algorithm that requires a "training set." The non-clinical study serves as a "test set" for performance evaluation against the predicate.

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

• See point 8; this is not relevant for this type of device.

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