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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);

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

Geistlich Bio-Oss® spongiosa (cancellous) granules are natural non-antigenic porous bone mineral matrices. They are produced by removal of all organic components from bovine bone. Due to its natural structure, Geistlich Bio-Oss® is physically and chemically comparable to the mineralized matrix of human bone. Geistlich Bio-Oss® granules are available in small particles (0.25 - 1.0 mm) and large particles (1.0 - 2.0 mm).

A polymer syringe-like applicator has been designed to deliver the granules more precisely to the intended treatment site without having to use other sterile instruments. The Geistlich Bio-Oss® granules can be wetted with either the patient's blood or sterile physiological saline solution by injection directly through the filter cap of the syringe-like applicator Geistlich Bio-Oss Pen® After the filter cap is replaced with the angle cap applicator the granules can be applied directly to the surgical site.

During the manufacturing process of Geistlich Bio-Oss Pen® the granules are placed in a-the polymer syringe-like applicator, packaged in a polyethylene terephthalate tray and covered with a Tyvek lid, sealed and then sterilized by gamma irradiation. The sterilized device is placed in the protective packaging (outer box) along with its Instructions for Use, and is intended for single-use only.

Geistlich Bio-Oss Pen® will be available to the United States market in four versions: filled with 0.25 g, 0.5 g, or 0.7 g of small granules (0.25 – 1.0 mm) or filled with 0.5 g of large granules (1.0 - 2.0 mm).

The provided text describes a 510(k) summary for the Geistlich Bio-Oss Pen®, a bone grafting material. This summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically seen for diagnostic or AI-driven devices. Therefore, much of the requested information regarding AI performance, human reader studies, and detailed ground truth establishment is not applicable or available within this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Granules can be easily wet.
• Instructions for Use (IFU) are easily understood by clinical volunteers.
• Product can be easily used by clinicians. | Handling and Wetting:
• Bench testing confirmed Geistlich Bio-Oss® granules in Geistlich Bio-Oss Pen® could be easily wet.
• Testing confirmed IFU could be easily understood by clinical volunteers.
• Handling test with clinical volunteers demonstrated the Geistlich Bio-Oss Pen® could be easily used by clinicians.
• Confirmed granules could be easily mixed with normal saline or blood like those in glass vials. |
  | Biocompatibility:
• No change in biocompatibility due to new packaging configuration.
• No leachables or extractables.
• No clinically relevant growth inhibition. | Biocompatibility:
• Biocompatibility testing per ISO 10993-18 and ISO 10993-5 confirmed no leachables or extractables, and no clinically relevant growth inhibition. |
  | Substantial Equivalence:
• Demonstrates similar technological characteristics and intended use as predicate device (Geistlich Bio-Oss®), with the syringe-like applicator similar to RTR Syringe. | Substantial Equivalence:
• The results of these studies confirm the substantial equivalence of Geistlich Bio-Oss Pen® to its predicate device, Geistlich Bio-Oss®. |

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

The document mentions "clinical volunteers" for the handling test but does not specify the sample size for this test set. The data provenance is also not explicitly stated as country of origin, but it is implied to be a bench test conducted internally or by a contracted lab. The studies would be considered prospective for the specific tests performed to demonstrate equivalence for the new device configuration.

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

This information is not provided in the document. The "clinical volunteers" for the handling test are likely the "experts" in this context, but their number and specific qualifications (e.g., dentist, oral surgeon, experience level) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the bench tests (wetting and handling, biocompatibility), a formal adjudication method like "2+1" or "3+1" is unlikely to have been employed in the same way it would be for a diagnostic image interpretation study. The results would likely have been direct observations and measurements (e.g., can it be wetted, is it easy to use, are there leachables).

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

A MCRM study was not conducted, and this information is not applicable. The Geistlich Bio-Oss Pen® is a medical device (bone grafting material and applicator), not an AI-driven diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study for an algorithm was not conducted, and this information is not applicable, as this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

For the handling and wetting tests, the "ground truth" was established by direct observation and subjective feedback from clinical volunteers regarding the ease of use and wetting characteristics. This is a form of expert assessment of usability.

For the biocompatibility tests, the "ground truth" was established by standardized laboratory testing protocols (ISO 10993-18 and ISO 10993-5) with quantifiable outcomes (e.g., presence/absence of leachables, growth inhibition measurements). This is an objective, laboratory-based ground truth.

8. The Sample Size for the Training Set

This information is not applicable, as there is no "training set" in the context of this device's evaluation. This is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set."

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