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Wound Matrix PLUS is intended for the management of wounds including:

• Partial and full-thickness wounds
• Pressure ulcers
• Venous ulcers
• Diabetic ulcers
• Chronic vascular ulcers
• Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
• Trauma wounds (abrasions, lacerations,second-degree burns, and skin tears)
• Draining wounds
• Tunneled/undermined wounds

The device is intended for one-time use.

Geistlich Wound Matrix PLUS is an animal-sourced, acellular extracellular matrix (ECM) wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. Wound Matrix PLUS is terminally sterilized using gamma irradiation in its packaging.

The device is offered in various sizes and can be shaped to the required dimension using standard sterile instruments (scissors or scalpel).

The device is intended to be used by licensed healthcare practitioners and will be supplied sterile for single one-time use.

This appears to be an FDA 510(k) summary for a medical device called Geistlich Wound Matrix PLUS. It demonstrates substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria.

Therefore, the requested information cannot be fully extracted as such a study is not provided in this document. The document primarily focuses on demonstrating that the new device (Geistlich Wound Matrix PLUS) is as safe and effective as a legally marketed predicate device (ACell Inc.'s Cytal Wound Matrix) and a reference device (Geistlich Fibro-Gide) based on similar technological characteristics and performance data leveraged from the reference device.

However, I can extract information related to the performance data presented, which are mainly biocompatibility and viral inactivation studies, and explain why the other requested information is not applicable here.

Summary of Device Acceptance Information (Based on 510(k) Submission for Substantial Equivalence)

The provided document describes the Geistlich Wound Matrix PLUS seeking 510(k) clearance for substantial equivalence to a predicate device, ACell Inc.'s Cytal Wound Matrix (K152721), and referencing Geistlich Fibro-Gide (K171050) for performance data. This type of submission relies on demonstrating that the new device has similar technological characteristics and safety/effectiveness profiles to already cleared devices, rather than presenting a de novo study with explicit acceptance criteria for performance metrics like sensitivity or specificity.

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

Since this is a 510(k) submission for substantial equivalence based on biocompatibility and viral inactivation leveraged from a reference device, there are no explicit "acceptance criteria" presented in the sense of performance thresholds for a diagnostic or AI device (e.g., minimum sensitivity, specificity, or AUC). Instead, the performance criteria are that the device demonstrates biocompatibility and viral safety.

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

• Sample size for Biocompatibility Tests: The specific number of animals or cell cultures used for each biocompatibility test (e.g., number of rabbits for irritation, guinea pigs for sensitization, mice for systemic toxicity, rats for implantation) is not explicitly stated in this summary. These are standard in vitro/in vivo biological tests.
• Data Provenance: The biocompatibility and viral inactivation testing "was leveraged from the previously reviewed and cleared reference device (Geistlich Fibro-Gide (K171050) that is identical in composition and technology to the subject device." This implies the tests were conducted with the Fibro-Gide device. The location or specific laboratory where these tests were performed is not mentioned, nor is whether the data was retrospective or prospective relative to the Fibro-Gide submission.

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

• This is not applicable as the studies are focused on material properties (biocompatibility, viral safety, shelf life) and not on diagnostic accuracy requiring expert consensus or ground truth establishment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This is not applicable for biocompatibility and material property testing, which are lab-based assessments not requiring adjudication by experts.

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:

• This is not applicable. Geistlich Wound Matrix PLUS is a wound dressing (a physical matrix), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or human reader assistance analysis was performed.

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

• This is not applicable. The device is a wound dressing, not an algorithm or software. The performance data relates to its physical and biological properties.

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

• For biocompatibility tests, the "ground truth" is established by standard biological and chemical assays measuring specific toxicological endpoints (e.g., cell viability for cytotoxicity, inflammatory response for irritation, DNA damage for genotoxicity, systemic effects for toxicity tests).
• For viral inactivation, the ground truth relates to the measured reduction in viral titers.
• For shelf life, the ground truth is stability over time based on physical and functional properties.

8. The sample size for the training set:

• This is not applicable. There is no AI component or machine learning model that would require 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 device.

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Geistlich Bio-Gide® 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; and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Shape is indicated for:

• 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.

Geistlich Bio-Gide® Compressed is indicated for:

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

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; and
• recession defects for root coverage.

Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. 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 bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

Geistlich Bio-Gide® Perio 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. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich BioGide® 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.

Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. 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 bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

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® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio 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.

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. 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.

Here's an analysis of the acceptance criteria and supporting study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For all listed devices (Geistlich Bio-Gide®, Geistlich Bio-Gide® Shape, Geistlich Bio-Gide® Compressed, Geistlich Bio-Gide® Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft® and Geistlich Mucograft® Seal), the acceptance criteria are not explicitly stated as numerical thresholds. Instead, the criterion for acceptance is that the material properties remain unchanged when using an alternate supplier of porcine raw material compared to the predicate devices. The reported device performance is that these properties did remain unchanged.

Specific Performance Studies Conducted:

• Elongation: Verified to be unchanged.
• Suture pull-out test: Verified to be unchanged.
• Swelling: Verified to be unchanged.
• Differential Scanning Calorimetry (DSC): Verified to be unchanged.
• Collagenase digestion (to assess degradation): Verified to be unchanged.
• Scanning Electron Microscopy (SEM) (to assess optical differences): Verified to be unchanged.
• Viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007: Verified (leveraged from K171050).
• Biocompatibility, sterilization, shelf-life, and clinical performance: Leveraged from the applicant's own predicate devices, implying these aspects also remained consistent.

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

The document does not explicitly state the numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, the performance studies were conducted on "representative product" for each device to verify material properties. The provenance of this "representative product" is not specified (e.g., country of origin). The studies appear to be laboratory-based and not involving patient data, so the terms "retrospective" or "prospective" are not applicable.

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 studies performed are physical and chemical characterizations of the material, not clinical evaluations requiring expert interpretation of results. The "ground truth" for these tests would be the established scientific methods and parameters for each test.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the physical and chemical tests, it's unlikely a human-based adjudication method (like 2+1 or 3+1) would be used. The results of these tests are typically objectively measured and compared to established specifications or to the predicate device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a material change (alternate raw material supplier) and not a new diagnostic or therapeutic device requiring human interpretation of results.

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

This question is not applicable. The device is a physical bone grafting material/membrane, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on objective physical and chemical material properties and standards. The performance of the modified devices (with the alternate raw material supplier) was compared to the known performance and characteristics of the predicate devices. The determination of "unchanged" would rely on laboratory measurements meeting predefined specifications or falling within an acceptable range relative to the predicate device.

8. The Sample Size for the Training Set

This question is not applicable. This submission is about a physical medical device and a change in its raw material supplier. There is no machine learning model or "training set" involved.

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

This question is not applicable, as there is no training set for an AI/ML model.

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