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Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

• Covering of implants placed in immediate or delayed extraction sockets
• Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants
• Alveolar ridge reconstruction for prosthetic treatment
• Recession defects for root coverage

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration.

Geistlich Mucograft® and Geistlich Mucograft® Seal are collagen matrices obtained by a standardized controlled manufacturing process. The matrices are made of collagen without further cross-linking. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

Available Products:

• Geistlich Mucograft® 15x20 mm .
• Geistlich Mucograft® 20x30 mm .
• Geistlich Mucograft® Seal 8 mm diameter .

The provided text does not contain information about acceptance criteria or a study proving that the GEISTLICH MUCOGRAFT® and GEISTLICH MUCOGRAFT® SEAL device meets specific acceptance criteria in the way described by the request (e.g., performance metrics like sensitivity, specificity, accuracy for an AI/device output).

Instead, this document is a 510(k) summary for a medical device (collagen matrix) indicating substantial equivalence to a predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to the data submitted to demonstrate substantial equivalence to legally marketed predicate devices, not typically a clinical trial with pre-defined performance acceptance criteria for a novel AI or diagnostic device.

The "acceptance criteria" here are largely implicit in the substantial equivalence determination process, which involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing it has:

• The same intended use as the predicate.
• The same technological characteristics as the predicate; OR
• Different technological characteristics, but the information submitted demonstrates that the device is as safe and effective as the legally marketed device, and it does not raise different questions of safety and effectiveness.

Here’s a breakdown based on the information provided, recognizing that it doesn't fit the typical format for AI/diagnostic device performance studies:

1. Table of Acceptance Criteria and Reported Device Performance:

• Sterilization validation: Relied upon data previously submitted in support of Mucograft®.
• Packaging materials: Relied upon data previously submitted in support of Mucograft®.
• Materials and Manufacturing: Made of collagen from veterinary certified pigs, purified, sterilized by gamma irradiation. Composed of two structures (smooth and porous) for tissue adherence and cell invasion. The materials, extraction, purification, and sterilization processes are consistent with the predicate. |
  | Effectiveness: Device is as effective as the predicate device (i.e., performs as intended). | - Intended Use: The device shares the same intended uses as the predicate: covering implants, localized gingival augmentation, alveolar ridge reconstruction, and recession defects for root coverage.
• Technological Characteristics: Geistlich Mucograft® is stated to be "the same as the predicate device, Mucograft®." Geistlich Mucograft® Seal is a "new size and shape" but has "the same chemical composition and same materials as the predicate device." It is noted that the differences in size and shape "do not change the intended use of the device."
• Bench-type evaluations: Confirmed that Geistlich Mucograft® Seal is "easily sutured in two extraction socket models." Evaluations by Geistlich and clinicians showed it could be "sutured readily to an extraction socket" and should be sutured "in a dry state." (These are more functional validation points rather than clinical effectiveness metrics).
• Performance testing (Animal and Clinical): Relied upon data previously submitted in support of Mucograft®. |
  | No new or different questions of safety and effectiveness. | - The submission concluded that "there are no new or different questions regarding safety and effectiveness if Geistlich Mucograft® and Geistlich Mucograft® Seal are used according to their intended use." This is the overarching "acceptance criterion" for 510(k) clearance. |

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

• The document primarily refers to "bench-type evaluations" and reliance on "data previously submitted in support of Mucograft®."
• For the bench evaluations of Geistlich Mucograft® Seal: "two extraction socket models" were used. No sample size for clinical or animal data for the new device is explicitly stated; instead, it relies on the predicate device's data.
• Data Provenance: The document does not specify country of origin for the studies underlying the predicate device. The bench evaluations for the new device were conducted by "Geistlich and by clinicians," but geographical location is not mentioned. The studies appear to be retrospective in the sense that existing data from the predicate device was leveraged.

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 document. The "evaluations by Geistlich and by clinicians" for suturing properties do not detail the number or qualifications of these clinicians. In a 510(k) for a device like this, ground truth is typically established by physical testing, animal studies, and clinical results from the predicate device, rather than expert consensus on diagnostic interpretations.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Given the nature of a collagen matrix and the substantial equivalence pathway, an adjudication method for a "test set" in the context of diagnostic performance (e.g., 2+1, 3+1) is not relevant to this submission.

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:

• Not applicable. This device is a collagen matrix for tissue regeneration, not an AI or diagnostic tool designed to assist human readers.

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

• Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For the overall substantial equivalence determination, the "ground truth" is that the predicate device (Mucograft®) is legally marketed and deemed safe and effective for its indications.
• For the new device's specific evaluations, the ground truth relates to physical properties (e.g., ease of suturing in extraction socket models) and, presumably, the clinical outcomes linked to the predicate device via animal and clinical performance testing. This would be physical testing results, animal study outcomes, and clinical outcomes data from the predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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