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Geistlich Bio-Flow® is intended for bone regeneration of contained defects around teeth or dental implants for the following uses:

1. filling of extraction sockets to enhance preservation of the alveolar ridge in contained situations with entirely intact, circumferential bone walls.

2. filling of contained periodontal defects of limited size with intact lingual and buccal walls, i.e. 3-wall intrabony defects.

3. filling of contained peri-implant defects of limited size to include 3-wall defects of a size up to 4 mm x 5 mm x 4 mm.

Geistlich Bio-Flow® is a flowable, sterile, biocompatible bone mineral plus collagen matrix consisting of Geistlich Bio-Oss® granules (K122894) and processed Geistlich Bio-Gide® collagen (K212463) in an 80:20 (dry weight) ratio. Geistlich Bio-Flow® is provided as dry granulated material pre-filled in a mixing syringe (0.2 cc or 0.5 cc fill volumes). Cannulas and a syringe for applying saline or blood to hydrate the product prior to extrusion are included with the product.

The provided text is a 510(k) Summary for a medical device (Geistlich Bio-Flow®), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics for a diagnostic or AI-based device. This document describes the device, its intended use, and non-clinical performance data to support its safety and effectiveness. It does not contain an "acceptance criteria" table with specific thresholds or a detailed study of an AI device's performance against ground truth as would be found in a typical AI/diagnostic device submission.

However, I can extract the relevant information from the document that best approximates the requested points based on the nature of this submission. Since this is a bone grafting material, the "performance" is assessed through non-clinical (material characterization and animal) studies rather than a multi-reader, multi-case study, or standalone AI performance.

Here's an interpretation based on the provided text:

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

The document doesn't explicitly state quantitative acceptance criteria or a performance table in the format typically used for AI/diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, "performance" is demonstrated through various non-clinical tests and a non-clinical animal study, with the overarching "acceptance criterion" being comparable performance to the predicate device in relevant biological and material characteristics.

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

• Test Set (Animal Study): The document states "a non-clinical performance study was conducted to support the indications for use for the device," and "In a study assessing new bone growth and device resorption (4, 8, and 12 weeks), at both 8 and 12 weeks, the bone substitute performance of the test and control groups was comparable."
  • Sample Size: The document does not specify the exact number of animals or defects studied.
  • Data Provenance: Non-clinical (animal study). No country of origin is specified. It is a prospective study as it involved conducting tests with the device.

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

• This information is not applicable to this type of submission. The performance study was an animal model, not a human reader study requiring expert interpretation to establish ground truth for a diagnostic output.

4. Adjudication method for the test set

• This is not applicable as it was not a human reader study. The animal study results would likely be evaluated by veterinary histopathologists or researchers in a blinded manner, but no specific adjudication method (like 2+1) is mentioned.

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 was not done. This device is a bone grafting material, not a diagnostic or AI-assisted device.

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

• No, a standalone performance study in the context of an algorithm or AI was not done.

7. The type of ground truth used

• For the non-clinical performance study (animal study), the "ground truth" would be established by histological analysis (e.g., measurements of new bone formation, defect fill, and resorption characteristics) and potentially other quantitative analyses in the animal model. This falls under outcomes data simulation in an animal model.

8. The sample size for the training set

• This concept (training set) is not applicable to the evaluation of this bone grafting material. There is no AI model being trained.

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

• This concept is not applicable as there is no AI model or training set.

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