(223 days)
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of 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)
BIO-OSS COLLAGEN® is a combination of purified cancellous natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by y-irradiation.
The provided text describes a 510(k) summary for the BIO-OSS COLLAGEN® device, focusing on a change in its manufacturing process. Therefore, the study described is not a performance study as typically understood for AI/ML medical devices. Instead, it is a validation study demonstrating that a change in the manufacturing process (specifically, the alkalinization step) does not compromise the device's safety, efficacy, or quality compared to the previously cleared version.
Here's a breakdown based on the information provided, framed to address your questions where possible:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Viral Inactivation | Efficient inactivation of Pseudorabies Virus (PRV) | Found to clear the product of PRV |
| Efficient inactivation of Porcine Parovirus (PPV) | Found to clear the product of PPV | |
| Efficient inactivation/removal of Reovirus type 3 (Reo 3) | Viral inactivation and removal (by rinsing) shown to clear the product of Reo 3 | |
| Product Quality & Safety | Compliance with final release specifications for the product | All tests were found to be within limits |
| Equivalence to Predicate | The change in alkalinization step should not affect safety, efficacy, or quality | Change in alkalinization step did not affect the safety, efficacy or quality of the product |
Study That Proves the Device Meets Acceptance Criteria
The study performed was a revalidation of the manufacturing process for BIO-OSS COLLAGEN® after a modification to the alkalinization step.
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Sample sizes used for the test set and the data provenance:
- Test Set: Four lots of product manufactured with the revised alkalinization step were tested.
- Data Provenance: Not explicitly stated, but it's implied to be internal testing commissioned by the company (Ed. Geistlich Soehne Ag für Chemische Industrie). Given the context of a 510(k) summary, these would be controlled laboratory studies rather than clinical data. It is a prospective validation relative to the manufacturing change, but not a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" here is objective laboratory measurements for viral inactivation and product specifications, not subjective expert assessment of medical images or patient outcomes.
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Adjudication method for the test set:
- Not applicable. The "adjudication" was based on meeting pre-defined laboratory testing limits and product specifications.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., images) with and without AI assistance. The BIO-OSS COLLAGEN® device is a bone grafting material, and this submission focuses on a manufacturing process change.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device, so "standalone algorithm performance" is not relevant.
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The type of ground truth used:
- The "ground truth" used for this revalidation study was laboratory test results for viral inactivation efficiency (measurement of viral load reduction) and pre-defined product release specifications (e.g., chemical composition, physical properties, sterility) that the finished product lots had to meet.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "training" here would be the development and optimization of the manufacturing process itself, which is not described in terms of data sets.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an algorithmic device. The ground truth for manufacturing process development would typically be process engineering principles, material science, and prior experimental data, not a labeled dataset.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.