Search Results

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.

Ask a specific question about this device

The Geistlich Wound Matrix 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 Moh's surgery, post laser surgery, podiatric, wound dehiscence)
• · trauma skin wounds (abrasions, laceration, second degree burns, skin tears)

The device is an animal-sourced, acellular 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. The Geistlich Wound Matrix is terminally sterilized in its packaging.

The device has a thickness of 2.5-5mm and is offered in 3 sizes: 15 mm x 20 mm; 20 mm x 30 mm; and 30 mm x 40 mm. The device can be trimmed as needed.

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

This document is a 510(k) Premarket Notification from the FDA regarding the Geistlich Wound Matrix. It primarily establishes substantial equivalence to a predicate device and does not involve AI/ML performance data or a detailed clinical study with ground truth establishment in the way your request implies.

Therefore, many of the requested criteria cannot be directly extracted from this document, as they are not relevant to a 510(k) submission for a non-AI/ML device like a wound matrix. The document focuses on material composition, indications for use, and comparison to legally marketed predicate devices to assure safety and effectiveness.

Here's an attempt to address your points based on the provided document, noting where information is not applicable (N/A) or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or performance metrics for a device in the way an AI/ML product would. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of:

• Indications for Use: The subject device's indications must be the same as or a subset of the predicate device.
• Technological Characteristics: Key characteristics (material, design, sterilization, etc.) must be similar, and any differences must not raise new questions of safety or effectiveness.
• Performance Data (implicit): For this type of device, performance data (e.g., biocompatibility) is often derived from the established safety profile of the material or similar devices, rather than a clinical trial with specific performance endpoints.

(Deemed substantially equivalent to predicate, with the predicate having two additional indications which were excluded by the subject device, not raising new questions of safety/effectiveness). |
| Technological Similarity | Derived from porcine connective tissue, acellular, non-crosslinked, mostly collagen Type 1, bilayer (2.5-5mm thickness), terminally sterilized.

(Found similar to Miromatrix Wound Matrix (porcine liver, acellular, non-crosslinked, collagen Type 1, sterile) despite differences in tissue source, single vs. bilayer, and thickness, with these differences not raising new safety/effectiveness questions. Identical to MUCOGRAFT reference device). |
| Biocompatibility | "Because the material of the subject device is identical to the reference device (K102531), the existing biocompatibility, sterilization, and shelf life information fully applies."

(Implies the device meets biocompatibility standards established for the reference device, which is considered sufficient for equivalence). |
| Sterilization | Terminally sterilized in its packaging.

(Existing sterilization information from the reference device (K102531) fully applies, implying it meets standards). |
| Shelf Life | N/A - Not explicitly stated, but "existing...shelf life information fully applies" from the reference device (K102531). |

2. Sample Size for the Test Set and Data Provenance

• This document states: "Bench, animal, and clinical data are not necessary to support the substantial equivalence of a wound dressing."
• Therefore, there is no "test set" in the context of an algorithmic performance evaluation.
• The data provenance, in this case, would refer to the existing safety and effectiveness profile of the predicate device and the "reference device" (Geistlich MUCOGRAFT® Collagen Matrix, K102531), which the subject device is stated to be identical to in material and design. No new clinical or animal studies were conducted for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• N/A. No ground truth establishment by experts for a test set was performed as part of this 510(k) submission. The FDA's review process involves their own experts, but not in the context of creating a dataset for device evaluation in the way you describe.

4. Adjudication Method for the Test Set

• N/A. No test set was used in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• N/A. This is a non-AI medical device (wound matrix). MRMC studies are not relevant to its evaluation for substantial equivalence.

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

• N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• N/A. For this particular 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established performance and safety profiles of the legally marketed predicate device (Miromatrix Wound Matrix, K140510) and the reference device (Geistlich MUCOGRAFT® Collagen Matrix, K102531), to which the subject device is claimed to be substantially equivalent or identical. The basis for approval is that the new device is as safe and effective as a device already on the market, rather than meeting absolute performance criteria against an independent "ground truth" dataset.

8. The Sample Size for the Training Set

• N/A. No training set was used, as this is not an AI/ML device.

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

• N/A. No training set was used.

Ask a specific question about this device