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ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. AI.LOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine) and as a bone void filler in the extremitics and pclvis. These defects may be surginally created osseous defects or osseous defects created from traumatic injury to the bone.

ALLOMATRIX® Custom Putty is provided in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit (or BMA and local bone when used in the spine), the resultant putty cappthen he handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

The provided text describes a 510(k) summary for the ALLOMATRIX® Custom Putty, a bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or a diagnostic device. Therefore, many of the requested categories are not applicable.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance for ALLOMATRIX® Custom Putty

This submission is for a modification to a component of an existing device (ALLOMATRIX® Custom Putty) and focuses on demonstrating substantial equivalence, not on specific performance metrics or diagnostic accuracy as would be typical for an AI application. The "acceptance criteria" here relate to the successful verification that the modification has the desired effect and no unintended adverse effects, primarily through demonstrating substantial equivalence to a predicate device, and the "device performance" is based on these demonstrations.

• In vitro surrogate cell-based assay: Measures proliferation of Saos human osteosarcoma cells (osteoiniductivity index), correlated to athymic rat model and clinical results of DBM alone.
• In vitro immunoassay: Assays for native protein (BMP-2), correlated to athymic rat model for DBM alone and ALLOMATRIX® Putty.
  Note: The combination of DBM, CBM, and binding medium has not been evaluated for osteoinductivity, and correlation with human clinical performance is unknown. |
  | Viral Inactivation Validation | Processing method for DBM evaluated for viral inactivation potential using a panel of model human viruses.
  Results: Demonstrated suitable viral inactivation potential for a wide spectrum of potential human viruses. |

Non-Applicable Sections and Explanations:

The following sections are not applicable to this 510(k) summary because the device is a bone void filler, not an AI-powered diagnostic tool, and the submission is focused on demonstrating substantial equivalence for a component modification:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context would refer to the data used to evaluate AI performance. Here, testing involved a literature search, bench testing, and a canine study. Specific sample sizes for bench testing and the canine study are not detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a test set requiring expert ground truth in the context of diagnostic device validation. The "ground truth" for the osteoinductivity bioassay refers to correlation with athymic rat models and clinical results of DBM alone, not expert consensus on medical images or patient outcomes.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No such adjudication method is relevant to the type of testing described (bench, canine, in vitro assays).
4. 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 is not an AI-assisted diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the osteoinductivity potential, the "ground truth" for the DBM bioassay/immunoassay was correlated with results from an athymic rat model and, in one instance, with clinical results of DBM alone. This is not "expert consensus" or "pathology" in the typical diagnostic sense. For viral inactivation, the "ground truth" would be the demonstrated inactivation of specific model viruses.
7. The sample size for the training set: Not applicable. There is no AI algorithm being trained.
8. How the ground truth for the training set was established: Not applicable. There is no AI algorithm being trained.

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