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Geistlich Bio-Oss® is intended for the following uses:

• 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); and
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Bio-Oss Collagen® is intended for the following uses:

• Augmentation or reconstructive treatment of the 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 the maxillary sinus floor;
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cancellous) Block (referred as Geistlich Bio-Oss®) are intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.

Geistlich Bio-Oss® is serving as a matrix consisting of interconnected macro- and micropores. The material is highly porous and has a large inner surface area.

Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from bovine bone in a validated multistage purification process to remove the organic components.

Due to the interconnected macro and microporous system the device is hydrophilic and easv to moisten.

Geistlich Bio-Oss® is packed in a double sterile barrier system consisting of a glass vial and an outer blister. Geistlich Bio-Oss is sterilized according to validated processes by y-irradiation.

Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) bone mineral granules (Geistlich Bio-Oss®) and 10% collagen fibers in a block form.

The collagen facilitates handling and application of Geistlich Bio-Oss Collagen® and acts to hold the Bio-Oss particles at the desired place. The consistency of this material readily allows to take the shape of the defect. The collagen component is resorbed after application.

Geistlich Bio-Oss Collagen® is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.

Geistlich Bio-Oss Collagen® is serving as a matrix consisting of interconnected macroand micropores. The material is highly porous and has a large inner surface area.

Geistlich Bio-Oss Collagen®is a biocompatible bone mineral matrix and is manufactured from boyine bone and collagen from connective tissue of pigs certified for human consumption according to a controlled and validated multistage purification process. From the bovine bone all organic components are removed.

Due to the interconnected macro and microporous system the device is hydrophilic and easy to moisten.

Geistlich Bio-Oss Collagen® is packed in a double sterile barrier system consisting of an inner and an outer blister. Geistlich Bio-Oss® is sterilized according to validated processes by y-irradiation.

The provided text describes devices (Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen®) that are bone grafting materials. Instead of software, these are physical medical devices, and their acceptance criteria and evaluation method differ significantly from what would be expected for a software-based AI medical device.

Therefore, many of the typical questions for AI/ML device evaluations (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of device submission.

The "studies" described are bench tests comparing the new materials to previously cleared predicate devices using analytical methods.

Here's an interpretation of the relevant information provided:

Acceptance Criteria and Device Performance (for Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen®)

The acceptance criteria for these bone grafting materials are based on demonstrating substantial equivalence to predicate devices through physicochemical characterization. The goal is to show that the new devices, particularly with raw material from an alternative geographic source, are identical in composition and structure to the existing, cleared versions of Geistlich Bio-Oss®.

Study Information (Applicable to Physical Device Substantial Equivalence)

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

   • The "test set" here refers to samples of the Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® products manufactured with raw material from an "alternative geographic source."
   • These samples were compared against "standard manufacturing lots" of the devices.
   • The exact number of samples or batches tested for each analytical method (X-ray diffraction, FTIR, Mercury Intrusion Porosimetry) is not specified in the provided text.
   • Data provenance is manufacturing samples, not patient data.

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

   • N/A. This is a physical device characterization, not an expert-driven diagnostic evaluation. Ground truth is established by validated analytical chemistry and materials science techniques.

3. Adjudication method for the test set:

   • N/A. Not applicable for analytical comparisons. The methods produce quantitative or spectral data that are directly compared.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

   • No. This is a comparison of physicochemical properties of a material, not a diagnostic or prognostic aid requiring human interpretation.

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

   • N/A. This is a material, not a software algorithm.

6. The type of ground truth used:

   • The "ground truth" is based on the previously cleared predicate Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® products. The objective is to demonstrate that the devices produced with raw material from an alternative geographic source are identical in their critical physicochemical characteristics to the predicate versions already accepted by the FDA. This is established through:
     • Validated analytical chemistry techniques (X-ray diffraction, FTIR).
     • Materials science techniques (Mercury Intrusion Porosimetry).
     • Gravimetric analysis (moisture, calcium, phosphorous content).

7. The sample size for the training set:

   • N/A. Not applicable for this type of device and evaluation. There is no machine learning model being "trained."

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

   • N/A. Not applicable.

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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

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.

1. 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.

2. 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.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" was based on meeting pre-defined laboratory testing limits and product specifications.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filing of defects after root resection, apicocctomy, and cystectomy Filing 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 Regencration (GTR) and Guided Bone Regencration (GBR).

Filing of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are natural non-antigenic, porous bone mineral matrixes. They arc produced by removal of all organic components from bovinc bone. Due to its natural structure, BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are physically and chemically comparable to the mineralized matrix of human bone. It is available as cortical granules and blocks.

The provided text is a 510(k) summary for BIO-OSS devices. It states that the basis for substantial equivalence is that the devices are "substantially equivalent to Geistlich's existing products..." The only difference being an alternative geographic source for the bovine bone. The document “incorporates by reference all of the information on the use of BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen in the above referenced 510(k) submissions."

Therefore, the submission does not contain any new acceptance criteria or new study data proving the device meets acceptance criteria. Instead, it relies on the safety and effectiveness demonstrated in previous submissions for the predicate devices. This type of submission, focusing on a change in a non-critical aspect (like the source of raw material, with a demonstrated equivalent safety profile of the new source), typically references prior studies rather than conducting new ones.

Given the information provided in the input, I cannot answer the questions directly as the document does not present a new study with fresh acceptance criteria and device performance evaluation.

However, I can explain why the information isn't present based on the content:

• No new acceptance criteria or reported device performance: The submission is a 510(k) for a change in the bone source (from US to Australia) for an existing product. It claims substantial equivalence to predicate devices and incorporates by reference the information from those previous 510(k)s. This means no new performance criteria or new study results are presented in this specific document.
• No new sample size or data provenance for a test set: Since no new performance study is detailed, there's no new test set, sample size, or data provenance.
• No information on experts for ground truth or adjudication method: These details would be part of a new performance study, which is not included.
• No MRMC comparative effectiveness study: This type of study would be part of a clinical trial or performance evaluation, which is not present in this submission.
• No standalone performance (algorithm only) study: This implies the device is an algorithm or software, which is not the case for BIO-OSS, a bone filling material.
• No new ground truth type: No new ground truth is established as no new performance study is conducted.
• No new training set information: Similarly, no new training set details are provided.
• No new ground truth establishment for the training set: No new ground truth for a training set is established as no new study requiring one is described.

In summary, the provided 510(k) is an administrative update based on a change in raw material source for an already cleared device, not a submission detailing a new performance study.

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Augmentation or reconstructive treatment of alveolar ridge
Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy
rilling 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)

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Bio-Oss Collagen." It does not contain information about the acceptance criteria and study proving device performance as requested. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes or data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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