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ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge. Filling of infrabony periodontal defects. Filling of defects after root resection apicoectomy and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. Filling of periodontal defects in conjunction with products intended for guided tissue regeneration (GTR) and guided bone regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).

ReproBone® is a sterile, single-use, resorbable bone void filler. ReproBone® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. ReproBone" has a highly interconnected, highly porous structure, similar to that of human cancellous bone, and is available in the form of granules of size range 0.5 - 1.0mm, and also 0.8-1.5mm. Following placement in the bony voids or gap, ReproBone® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. ReproBone® gradually resorbs and is replaced with bone during the healing process

The provided text describes a 510(k) premarket notification for a medical device called "ReproBone®", a resorbable calcium salt bone void filler. This document is a regulatory submission, not a scientific study report. Therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a formalized study with detailed performance metrics.

Specifically, the document does not contain the following information typically found in a scientific study proving device performance against acceptance criteria for an AI/CAD/software device:

• A table of acceptance criteria and reported device performance: The document states that "ReproBone was equivalent in terms of cell attachment and proliferation as well as bone formation and device reesorption" compared to a predicate device, but it does not provide specific quantitative acceptance criteria or reported performance values.
• Sample size used for the test set and data provenance: No dedicated "test set" is mentioned for evaluating performance against acceptance criteria. The "in vivo (animal) and in vitro cell studies" are described as comparative, but no sample sizes or data provenance details are given.
• Number of experts used to establish ground truth and their qualifications: This concept is not applicable as the studies described are in vivo (animal) and in vitro (cell) studies, not human image-based or clinical studies requiring expert ground truth.
• Adjudication method: Not applicable for the type of studies described.
• Multi-reader, Multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a bone void filler, not an AI/CAD system for image interpretation.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: For the in vivo and in vitro studies, the "ground truth" would be the biological measurements and observations from the experiments themselves (e.g., cell counts, bone formation assessments, resorption rates).
• Sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on regulatory compliance and substantial equivalence:

Acceptance Criteria and Device Performance (based on regulatory submission context):

The implied "acceptance criteria" are the demonstration of substantial equivalence to legally marketed predicate devices and compliance with relevant standards. The "performance" is reported qualitatively as equivalence.

Study Information (as presented in the 510(k) Summary):

1. A table of acceptance criteria and the reported device performance: See table above. The performance reported focuses on equivalence to a predicate device rather than meeting pre-defined numerical thresholds for new claims.

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

   • Sample Size: Not specified. The summary only mentions "in vivo (animal) and in vitro cell studies."
   • Data Provenance: Not specified, but given the submitter is "Ceramisys Ltd" from "Sheffield S2 1AS, England", it can be inferred the studies were likely conducted in the UK or under their oversight. No indication of retrospective or prospective nature is provided, but in vivo and in vitro studies are typically purpose-designed (prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for in vivo and in vitro studies involves direct experimental measurements and observations, not interpretations by medical experts as would be the case for diagnostic imaging algorithms.

4. Adjudication method: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance on diagnostic tasks, often with AI assistance, and is not relevant for a bone graft substitute.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical medical device, not a software algorithm.

7. The type of ground truth used: For the biological studies mentioned (in vivo and in vitro), the ground truth would be established through direct biological assays, histological analyses, and quantitative measurements of cell activity, bone formation, and material resorption.

8. The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, this 510(k) summary is a regulatory document to establish substantial equivalence for a physical medical device, not a detailed scientific report of a study proving performance against acceptance criteria for an AI/CAD/software device. Therefore, many of the requested details specific to AI/CAD studies are not present or applicable. The "study" mentioned consists of "in vivo (animal) and in vitro cell studies" aimed at demonstrating equivalence in biological response to a predicate device.

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