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The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

• · Periodontal/Infrabony defects
• · Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
• · Extraction sites (ridge maintenance/augmentation, implant preparation/ placement)
• Sinus lifts
• · Cystic cavities
• · Cranio-facial augmentation

For larger defects, a mixture of PerioGlas® with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

PerioGlas is a one-component resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate designed specifically for its absorbability and osteoconductive nature. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile. At time of use, the device is mixed with sterile water, saline, the patient's own blood or marrow, or with autogenous or allograft bone to form a wet sandy paste that is applied to the defect. PerioGlas is progressively resorbed and replaced by new bone tissue during the healing process.

The provided text is a 510(k) summary for the PerioGlas – Bone Graft Particulate device, seeking to expand its product claims to include "osteostimulative" properties. The document does not contain specific acceptance criteria with numerical targets or a study validating these criteria. Instead, it describes supporting data for the new claim.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document. However, based on the information provided, I can construct responses for the other requested points related to the supporting study.

Acceptance Criteria and Study for PerioGlas – Bone Graft Particulate (Osteostimulative Claim)

As stated, the document does not present a formal table of acceptance criteria with numerical targets. The purpose of the submission is to add a claim of "osteostimulative" properties based on in vitro and in vivo data. The acceptance here is the FDA's concurrence that the presented data supports this additional claim, implying that the provided evidence met their thresholds for substantiating a new product claim for a previously cleared device.

1. Table of Acceptance Criteria and the Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical targets in the document. The implicit acceptance criterion is that the presented in vitro and in vivo data sufficiently demonstrates "osteostimulative" activity as defined by increased osteoblast proliferation, differentiation, and superior osteoconduction/bone formation compared to hydroxyapatite devices at early time points.
• Reported Device Performance:
  • In vitro: Stimulation of osteoblast proliferation and differentiation as evidenced by increased DNA content and elevated osteocalcin and alkaline phosphatase levels in cell culture studies.
  • In vivo: Superior rate of osteoconduction and bone formation at early post-implantation periods compared to hydroxyapatite devices.

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

• Sample Size (In vitro): Not specified. The document states "in vitro osteoblast cell culture studies" but does not detail the number of experiments, replicates, or controls.
• Sample Size (In vivo): Not specified. The document states "in vivo study data" but does not detail the number of animals, specimens, or experimental groups.
• Data Provenance: Not explicitly stated. Given it's a pre-market notification, it's presumed to be data generated by or for the manufacturer. It does not mention country of origin or whether it was retrospective/prospective.

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

• Not applicable to this type of submission. This premarket notification relies on scientific study data (in vitro and in vivo) to support a physiological claim, not on expert adjudication of diagnostic interpretations. The ground truth is established by the experimental results themselves.

4. Adjudication Method for the Test Set:

• Not applicable. The ground truth is derived from scientific experimental measurements and comparisons, not human expert consensus needing adjudication.

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:

• Not applicable. This device is a bone graft particulate, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a bone graft particulate, not an AI or standalone algorithm.

7. The Type of Ground Truth Used:

• In vitro: Experimental measurements of biological markers (DNA content, osteocalcin, alkaline phosphatase levels) in osteoblast cell cultures.
• In vivo: Histological and/or other observational data on osteoconduction and new bone formation in animal models, measured and compared against a control (hydroxyapatite devices).

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its inherent biological and material properties validated through scientific studies.

9. How the Ground Truth for the Training Set was Established:

• Not applicable as there is no "training set" in the context of this device. The scientific and engineering principles behind the device's design and its biological interactions are established through foundational research in biomaterials and bone biology.

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