(146 days)
NeoMatriX® Wound Matrix is intended for 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, and wound dehiscence),
- · Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
- Draining wounds.
The device is intended for one-time use.
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. This device is derived from an amphibian farm-raised hybrid axolot! source from a closed herd in a dedicated facility. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation.
NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
The provided text describes the 510(k) summary for the NeoMatriX® Wound Matrix, a collagen wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria against predefined acceptance thresholds for an AI/CADe device.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable as this document describes a traditional medical device (wound matrix) and not an AI/CADe system.
The closest relevant information relates to the performance testing conducted to support the substantial equivalence claim.
Here's a breakdown of the information that is available or why certain sections are not applicable:
1. A table of acceptance criteria and the reported device performance
Not Applicable: This document is for a traditional medical device (wound matrix), not an AI/CADe device. Therefore, there are no specific performance metrics like sensitivity, specificity, accuracy, or AUC with corresponding acceptance criteria typically used for AI/CADe devices. The performance is assessed through various non-clinical and clinical tests to demonstrate safety and effectiveness for its intended use, mainly by showing it's comparable to existing predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Animal Test Set: Porcine testing was conducted. The specific sample size (number of pigs or wounds) is not explicitly stated.
- Human Clinical (Immunogenicity) Test Set:
- Human Repeated Insult Patch Test (HRIPT): 68 healthy subjects.
- Skin Prick Test (SPT): 22 healthy human subjects.
- Data Provenance: Not specified, but generally, such studies are prospective if conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable: For animal and human immunogenicity testing, ground truth is established through direct observation for adverse events, histological analysis (for animal testing), and skin reactions (for human patch/prick tests). These are objective measurements, not subjective interpretations requiring external expert consensus in the way an AI/CADe system would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable: Ground truth for the described tests (biocompatibility, sterilization, bench, animal, and human immunogenicity clinical testing) does not involve adjudication by multiple human readers in the context of diagnostic interpretation. Results are typically based on laboratory analyses, pathologist's reports (for histopathology), or direct clinical observation and scoring.
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
Not Applicable: This is not an AI/CADe device, and therefore, no MRMC study looking at human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable: This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Biocompatibility Testing: Compliance with ISO-10993-1 standards, results from standard laboratory assays (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subacute/subchronic toxicity, genotoxicity), and endotoxin testing.
- Sterilization Validation: Sterility assurance level of 10^-6 per ISO 11137.
- Bench Testing: Results of in vitro physio-chemical tests.
- Animal Testing: Histopathology (no necrosis, comparable epithelialization) and absence of adverse effects compared to predicate.
- Human Clinical Testing (Immunogenicity): Absence of skin reactions in HRIPT and SPT.
8. The sample size for the training set
Not Applicable: This is not an AI/CADe device; there is no training set mentioned.
9. How the ground truth for the training set was established
Not Applicable: No training set for an AI/CADe algorithm was used.
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