(472 days)
NovoGen Wound Matrix is indicated for the management of wounds including:
· Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- · Chronic vascular ulcers
- · Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, single use device intended for use in local management of cutaneous wounds. It is manufactured from bovine type I collagen and 45S5 bioactive glass. When hydrated with wound exudate or sterile water, this product transforms into a soft conforming layer which is naturally incorporated into the wound over time.
The provided text describes the NovoGen Wound Matrix, a medical device, and its substantial equivalence determination by the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance).
Instead, it outlines the device's characteristics, its comparison to a predicate device, and a summary of non-clinical performance testing. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety and performance testing.
Here's a breakdown of the information provided, formatted to address your request as much as possible, with explicit notes where the requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Since there are no explicitly stated numerical acceptance criteria or thresholds in the document, this table will reflect the types of performance tests conducted and their qualitative results as stated in the submission.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Absorption Capacity (demonstrates appropriate fluid handling) | Testing performed. (Specific values or ranges not provided, but implies satisfactory performance given the conclusion of substantial equivalence). |
| Compression Recovery (demonstrates material integrity/shape retention) | Testing performed. (Specific values or ranges not provided). |
| Degradation Potential via Collagenase (demonstrates appropriate bio-resorption) | Testing performed. (Specific values or rates not provided). |
| Hydration Time (demonstrates proper hydration characteristics) | Testing performed. (Specific values or ranges not provided). |
| Tensile Strength (demonstrates mechanical integrity) | Testing performed. (Specific values or ranges not provided). |
| Viral Inactivation (demonstrates safety from viral contaminants) | Testing performed. (Specific methods or quantitative reduction not provided, but implies successful inactivation). |
| Wound Healing Performance (demonstrates effectiveness in promoting wound healing) | A full-thickness porcine wound healing study found equivalent wound healing performance for the NovoGen Wound Matrix when compared to the primary predicate device and untreated control sites. |
| Biocompatibility (demonstrates non-toxic, non-irritating, non-sensitizing properties) | Found to be biocompatible for its intended use when tested in compliance with ISO 10993-1. Cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, subacute systemic toxicity, implantation, genotoxicity, and endotoxin endpoints were addressed via testing. Chronic toxicity and carcinogenicity were addressed via a toxicological risk assessment. The Human Repeat Insult Patch Test (HRIPT) found no potential for eliciting dermal irritation or inducing sensitization. |
| Sterilization (demonstrates sterility assurance) | Gamma, 10^-6 SAL. (Implies successful sterilization). |
| Non-Pyrogenic (demonstrates absence of fever-inducing substances) | Yes. (Implies successful testing). |
2. Sample size used for the test set and the data provenance
- Porcine Wound Healing Study: "A full thickness porcine wound healing study" - Sample size (number of animals or wounds) is not specified. Data provenance is animal study (porcine).
- Biocompatibility (ISO 10993-1): Sample size not specified. Provenance is in vitro and in vivo (e.g., animal tests for systemic toxicity, implantation).
- Human Repeat Insult Patch Test (HRIPT): "Based on the test population who completed the study" - Sample size (number of human subjects) is not specified. Provenance is prospective human study. Specific country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not provided in the document. The studies performed (animal, biocompatibility, HRIPT) would typically involve trained personnel, but the specific number and qualifications of "experts" to establish a ground truth in the sense of clinical interpretation are not mentioned, as these are primarily laboratory and animal studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The studies described are not of a diagnostic nature requiring expert adjudication of results.
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
An MRMC study was not done. This device is a wound matrix, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical wound matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Porcine Wound Healing Study: The "ground truth" for wound healing would be based on direct observation and measurement of wound closure, tissue regeneration, and potentially histopathology in the porcine model. It's compared to a predicate device and untreated controls for equivalence.
- Biocompatibility Studies: Ground truth is established by standardized laboratory test results against established safety thresholds (e.g., cell viability in cytotoxicity, immune response in sensitization, absence of fever in pyrogenicity).
- HRIPT: Ground truth is clinical observation of skin reactions (irritation/sensitization) in human subjects.
8. The sample size for the training set
This is not applicable as the device is not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/machine learning algorithm.
N/A