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RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier.

This is a 510(k) premarket notification for "RegenerOss Allograft Putty Plus Mineralized." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a standalone clinical study report with detailed acceptance criteria and performance metrics typically seen for de novo devices or PMA applications. Therefore, many of the requested points related to device performance in a clinical setting and expert involvement in ground truth establishment are not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that a "rigorous design control process is the basis for a substantial equivalence determination" and that "verification and validation activities have been performed successfully, as identified by the risk analysis, ensuring the modified device is as safe and effective as the predicate device. The predetermined acceptance criteria have been met."

However, specific numerical acceptance criteria and reported device performance (e.g., success rates, effect sizes) for clinical use are not explicitly provided in the given text. The study primarily focuses on demonstrating comparable characteristics to a predicate device through non-clinical testing.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • The primary "test set" for the osteoinductive potential evaluation was conducted in an athymic rat ectopic bone growth model. The specific sample size (number of rats or implants) is not provided in the document.
   • The functional testing (solubility, handling) would have involved samples of the device material itself, but the number of samples is not specified.
   • The data provenance is from non-clinical laboratory studies (animal model and in-vitro material testing) conducted by Biomet/Biomet Interpore Cross. It is retrospective in the sense that it's part of a design control process validation for a modification.

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

   • This information is not provided. The assessment of osteoinductive potential involved "histological scoring of new bone formation." This typically involves trained pathologists or histologists, but their number and qualifications are not disclosed in this 510(k) summary.

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

   • This information is not provided. Given the nature of a 510(k) submission focused on substantial equivalence through non-clinical testing, formal clinical adjudication methods are not typically detailed.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a bone grafting material, not an imaging analysis AI or a diagnostic tool that involves human readers. Therefore, this question is not applicable to the submitted device.

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

   • Not applicable. This is a medical device (bone graft material), not an algorithm or AI system.

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

   • For the osteoinductive potential, the ground truth was based on histological scoring of new bone formation in the animal model. This implies a pathological assessment.
   • For functional testing, the "ground truth" refers to the measured physical and chemical properties of the material, which are scientifically quantifiable.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not a machine learning model, so there is no "training set." The development process involved design inputs and verification/validation, but not machine learning training.

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

   • Not applicable. As there is no training set for a machine learning model.

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