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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 synthetic absorbable osteoconductive bone graft substitute Formosed of a calcium phospho-silicate bioactive glass, Bioglass . The device is in a particulate form of a size range 90-710 um. The device is intended for dental intraosscous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile, packaged either in a Tyvek-sealed PET-G cup or in a filled syringe within a second sterile barrier package. The device packages are protected by an outer shrink-wrapped cardboard box. 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.

The provided document is a 510(k) summary for the PerioGlas – Bioglass Bone Graft Particulate. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a dedicated study proving performance against such criteria. Instead, it leverages prior studies and the technological characteristics of the predicate device.

Here's an analysis based on the information available:

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

The document does not explicitly define acceptance criteria as a table with specific metrics and thresholds. Instead, it refers to the performance of the legally marketed predicate device (PerioGlas - Synthetic Bone Graft Particulate, K992416, K962492, K930115). The "reported device performance" is implicitly that it is equivalent to the predicate device, which has been deemed safe and effective.

The primary "performance" being evaluated in this 510(k) is that the modifications to the PerioGlas device (filled syringe packaging and gamma irradiation sterilization) do not negatively impact its safety and effectiveness.

Implicit "Acceptance Criteria" & "Reported Device Performance":

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

The document states: "The in vivo and clinical performance of this device was previously evaluated in K992416." This indicates that the safety and effectiveness data for the device's core functionality comes from previous submissions for the predicate device. Therefore, details about the sample size (for the test set) and data provenance (e.g., country of origin, retrospective/prospective) would need to be found in the K992416 submission or the other predicate device submissions (K962492, K930115).

For the current submission (K040278) which focuses on modifications, the "test set" would primarily involve engineering and sterilization validation. The description mentions "Packaging and labeling verification testing resulting from FMEA risk analysis was completed following design control." This implies internal testing, but no sample sizes or specific data provenance are provided for these validations within this document.

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

This information is not provided in the current document. Since the core performance relies on previous studies (K992416, etc.), details about expert involvement in establishing ground truth for those studies would be found in their respective documentation. For the current submission, which focuses on substantial equivalence based on modifications, there's no mention of expert-established ground truth specific to this 510(k).

4. Adjudication method for the test set

This information is not provided in the current document. As with ground truth, any adjudication methods for the performance data would have been part of the predicate device's studies (K992416 etc.).

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, particularly one involving AI, was not done. This device is a synthetic bone graft material, not a diagnostic imaging or AI-assisted device. The document predates widespread AI application in medical devices.

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

No, this is not an algorithm or software device. It is a physical medical device.

7. The type of ground truth used

The document implicitly relies on the ground truth established for the predicate device (K992416, etc.). This would typically involve:

• Clinical outcomes data: Healing, bone formation, absence of adverse events in patients.
• Histological assessment: Analysis of tissue samples to confirm bone formation or integration.
• Radiographic assessment: Imaging to monitor bone regeneration.

The specific details are not in this 510(k) summary, but would be in the predicate device's submissions.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device that requires a "training set."

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

This information is not applicable as this is not an AI/machine learning device.

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