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Geistlich Bio-Gide® Perio is intended for the following uses:

• Augmentation around implants placed in immediate extraction sockets;
• Augmentation around implants placed in delayed extraction sockets;
• Localized ridge augmentation for later implantation;
• Alveolar ridge reconstruction for prosthetic treatment;
• Filling of bone defects after root resection, cystectomy, removal of retained teeth;
• Guided bone regeneration in dehiscence defects;
• Guided tissue regeneration procedures in periodontal defects.

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

The two products are being packaged together as a convenience kit for the ease of clinician use in periodontal regenerative procedures. In addition, Geistlich Bio-Gide® Perio will be packaged and sold as individual units.

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio.

Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by gamma irradiation.

Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications.

The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm.

Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

The provided text describes the Geistlich Perio-System Combi-Pack, a medical device for bone and tissue regeneration, and refers to performance data from published studies to demonstrate its substantial equivalence to predicate devices. However, the document does not contain the level of detail requested for acceptance criteria, specific device performance metrics, or study design parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information).

The document states:

• "Performance Data: A published nonclinical animal study provides histological evidence that Geistlich Bio-Gide® Perio, in combination with Geistlich Bio-Oss Collagen®, regenerates bone in 5 mm diameter rabbit femoral defects (1). Several published clinical studies demonstrate improvements in clinical attachment levels and probing pocket depths through 5-year follow-up versus the control (access flap surgery) (2,3,4). Histological evaluation of teeth in a case series demonstrated periodontal regeneration (5)."
• "The results of these published studies demonstrate the substantial equivalence of Geistlich Bio-Gide® Perio and Geistlich Bio-Oss Collagen® to their respective predicate devices."

Based on this, here's what can be extracted and what is missing:

Acceptance Criteria and Study Details for Geistlich Perio-System Combi-Pack

The provided K112575 submission indicates that the device's performance was evaluated through a review of published nonclinical and clinical studies demonstrating substantial equivalence to predicate devices. However, the specific, quantitative "acceptance criteria" for the device's performance as a whole, typical of what one might find for a diagnostic or AI-based device, are not explicitly stated in this document. Instead, the performance claims refer to evidence of bone regeneration and improvements in clinical metrics from prior studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds typically found in AI/ML device submissions. Instead, "performance criteria" are inferred from the outcomes described in the referenced studies, which relate to the intended use and demonstrate effectiveness comparable to predicate devices.

Missing Information Analysis:

The provided text does not contain the following information:

2. Sample size used for the test set and the data provenance: The document references external published studies. The sample sizes for these studies are not provided in this 510(k) summary. Data provenance (e.g., country of origin, retrospective/prospective) is also not detailed here, as these are summaries of individual publications.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information would be found within the methodologies of the referenced studies, but it is not included in the 510(k) summary. For histological evaluations, experts (e.g., pathologists, histologists) would have established ground truth, but their number and qualifications are not specified here.
4. Adjudication method for the test set: Not specified in this 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a bone and tissue regeneration material, not an AI/ML-based diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device (bone/tissue graft material), not an algorithm or AI.
7. The type of ground truth used:
   • Histology: For bone regeneration and periodontal regeneration, histology was used.
   • Clinical measurements: For clinical attachment levels and probing pocket depths, direct clinical measurements were used.
   • Outcomes: The ultimate "ground truth" related to the success of treatment in the clinical studies involves patient outcomes (e.g., sustained improvements over 5 years).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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