(164 days)
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.
| Test (Standard) | Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (Result for Wound Matrix PLUS / Fibro-Gide) |
|---|---|---|
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Not irritant | Not irritant |
| Sensitization (ISO 10993-10) | Not sensitizing | Not sensitizing |
| Acute systemic toxicity (ISO 10993-11) | No acute systemic toxicity | No acute systemic toxicity |
| Pyrogenicity (USP ) | Non-pyrogenic | Non-pyrogenic |
| Genotoxicity (ISO 10993-3) | Non-mutagenic, Not genotoxic | Non-mutagenic, Not genotoxic |
| Local tissue response (ISO 10993-6) | Acceptable local tissue response; No systemic toxicity | Local tissue effects: slight irritant. Systemic toxicity: No evidence of systemic toxicity |
| Subchronic systemic toxicity (ISO 10993-11) | No subchronic toxicity | No subchronic toxicity |
| Chronic systemic toxicity (ISO 10993-11) | No chronic toxicity | No chronic toxicity |
| Chemical Characterization (ISO 10993-18) | No product-related semi-volatile organic compounds detected | No product-related semi-volatile organic compounds were detected |
| Viral Inactivation (ISO 22442-3, ICH Q5A) | Support viral safety | Results support the viral safety of the device |
| Expiration Dating / Shelf Life (ISO 11607) | Support intended shelf life | Product shelf life of three years supported |
| Sterility Assurance Level (SAL) | SAL of 10-6 | SAL of 10-6 |
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.
N/A