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InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is immediate or delayed guided tissue and bone regeneration.

• · in the context of a treatment of fenestration defects
• · in case of dehiscence defects
• · after apicoectomy and resection of retained teeth
• · in extraction sockets after tooth extractions
• · in case of immediate or delayed augmentation around implants in extraction sockets

InterCollagen® Guide is a resorbable collagen membrane, derived from porcine pericardium. InterCollagen® Guide is intended for periodontal and/or dental surgical procedures as a barrier membrane restricting the entry of rapidly proliferating non-osteogenic cells within the bone defect while allowing the ingrowth of slow-growing bone forming cells. The membrane is a bioresorbable barrier which eventually is remodeled and/or incorporated by the host tissue. InterCollagen® Guide is substantially resorbed within 15 weeks after implantation. It is adaptable and easy to handle. It can be trimmed to the desired size and conforms easily when hydrated. The product is terminally sterilized via gamma irradiation.

This FDA 510(k) summary describes the InterCollagen® Guide, a resorbable collagen membrane. The submission seeks to prove substantial equivalence to a predicate device, the Straumann Jason Membrane, rather than demonstrate strict acceptance criteria and performance against those criteria. Therefore, the response will be structured to extract relevant performance claims and the study details provided, even if they don't explicitly fit a "table of acceptance criteria" format with numerical targets.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission seeking substantial equivalence, explicit numerical "acceptance criteria" with defined thresholds are not typically presented in the same way as a de novo or PMA submission. Instead, the focus is on demonstrating similar performance to a legally marketed predicate device. The following table summarizes the key performance aspects that were evaluated and the results presented, which essentially serve as the "reported device performance" against the implicitly accepted standard of the predicate device's performance.

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

The primary "test set" for performance evaluation was the canine two-wall intrabony defect model.

• Sample Size: Not explicitly stated in terms of the number of animals or defects. The document mentions "End points for pathology, histology, histomorphology and micro-CT were taken after 2, 6, and 13 weeks," implying a longitudinal study.
• Data Provenance: Conducted as an animal study (canine model). The country of origin is not specified in the provided text. The study design was a comparison between the test article (InterCollagen® Guide), a predicate device (Jason membrane), and an empty control. This is a prospective study design for evaluating the device's performance post-implantation.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the animal study. Histology, histomorphology, and pathology evaluations are typically conducted by trained veterinary pathologists or researchers specialized in bone regeneration, but specific details are not provided.

4. Adjudication method for the test set

The document does not specify any adjudication method for establishing ground truth in the animal study. Evaluations of pathology, histology, histomorphology, and micro-CT are usually performed by experts, but whether independent reviews or consensus methods were used is not 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a resorbable collagen membrane for guided bone and tissue regeneration, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

A standalone performance study of an algorithm was not performed. This is a medical device (collagen membrane), not a software or AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal study:

• Pathology: Evaluation of pathological changes in tissues.
• Histology: Microscopic examination of tissue samples.
• Histomorphology: Quantitative analysis of tissue morphology (e.g., bone formation).
• Micro-CT: Three-dimensional imaging for bone volume and structure analysis.

These are considered objective biological and imaging endpoints, typically interpreted by experts, to establish the "ground truth" regarding the device's in-vivo performance and tissue response.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set."

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

This is not applicable as there is no training set for this type of medical device.

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InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for:

Filling of extraction sockets to enhance preservation of the alveolar ridge

Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps InterOss® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation.

The product is available in the following shapes and sizes:

| Type | Weight
(mg) | Dimension
(mm) | Ref# |
|-------|----------------|-------------------|----------|
| Block | 50 | 6 x 6 x 3 | IOC-50 |
| Block | 100 | 6 x 6 x 6 | IOC-100 |
| Block | 250 | 7 x 9 x 8 | IOC-250 |
| Block | 350 | 8 x 10 x 9 | IOC-350 |
| Block | 500 | 10 x 12 x 10 | IOC-500 |
| Plug | 150 | 6 x 10 | IOC-P150 |
| Plug | 250 | 8 x 10 | IOC-P250 |
| Plug | 400 | 11 x 9 | IOC-P400 |
| Plug | 450 | 10 x 12 | IOC-P450 |

The provided document is a 510(k) premarket notification for the InterOss® Collagen bone grafting material. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning device. The "acceptance criteria" and "device performance" in the tables are for the physical and chemical properties and biocompatibility of the bone grafting material itself, not for an AI-powered system evaluating its efficacy or providing diagnostic information.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone performance (algorithm only).
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a traditional medical device (bone grafting material), not an AI/ML medical device, and thus the requested AI-specific information is not present.

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InterOss® small granules are recommended for:

• Augmentation or reconstructive treatment of the alveolar ridge .
• . Filling of infrabony periodontal defects
• . Filling of defects after root resection, apicocectomy, 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)

InterOss® large granules are recommended for:

• . Augmentation or reconstructive treatment 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)

InterOss® is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps, InterOss acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process.

InterOss® is available in granule form and is packaged in vials or a syringe-like applicator.

InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm).

InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm).

The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting.

During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes.

All InterOss® products are supplied sterile and are intended for single use only.

The provided text describes the regulatory clearance of a bone grafting material called InterOss® and does not contain information about a medical device that relies on AI or offers performance metrics that would typically be described with acceptance criteria like sensitivity, specificity, or AUC, as commonly seen in AI/ML device descriptions.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" here are implied by the standards for bone grafting materials and the equivalence to the predicate devices.

Here's an attempt to structure the information based on the request, reinterpreting "acceptance criteria" as the properties and test outcomes required for substantial equivalence in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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