(25 days)
HYALOMATRIX® is indicated for the management of wounds including: partial and full-thickness wounds; second-degree burns; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Moh's surgery , post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
HYALOMATRIX is a bilayered, sterile, flexible, and conformable wound dressing that acts as an advanced wound care device. It is comprised of a nonwoven pad entirely composed of HYAFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFF 11 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth.
The provided text describes a 510(k) submission for the HYALOMATRIX® wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or a "performance study" in the traditional sense (e.g., a clinical trial with predefined endpoints and statistical analysis) are described in the provided text. The submission primarily relies on biocompatibility testing and the assertion that "Clinical experience HYALOMATRIX as a wound dressing supports the safety and effectiveness of the device."
The closest approximations to "reported performance" are the general statements related to biocompatibility:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | HYAFF 11 (Drug Component) |
| Cytotoxicity | Neither cytogenic |
| Hemolysis | Not hemolytic |
| Acute Oral Toxicity | LD50 > 5,000 mg/kg |
| Acute Dermal Toxicity | LD50 > 2,000 mg/kg |
| Ocular Irritation | Not an ocular irritant |
| Dermal Irritation | Not a dermal irritant |
| Sensitization | Lack of sensitizing effect |
| Genotoxicity | No evidence of genotoxicity |
| Implantation (up to 1 year) | No treatment-related toxicity; degraded within 4 months |
| Pyrogenicity (LAL test) | Endotoxin levels within specification (≤0.2 EU/mg) |
| USP XXII (Plastic Containers tests) | No toxicity observed; no effect of leachables on safety |
| Silastic® Medical Adhesive Silicone, Type A (Component) | |
| Cytotoxicity | Cytotoxic effects in multiple cell culture assays (direct contact and extracts) |
| Pyrogenicity | Negative |
| U.S.P. Class V | Negative |
| Hemolysis | Negative |
| Implantation (90-day) | No noteworthy histological findings |
| Skin Sensitization | No skin sensitization response |
| Loctite cured film (Component) | |
| Intracutaneous Irritation | Non-irritating |
| Acute Toxicity | Not acutely toxic |
| Cytotoxicity | Non-cytotoxic |
| Hemocompatibility | Hemocompatible |
| Hemolysis | Non-hemolytic |
| Implantation | No treatment-related histopathological findings |
| U.S.P. Physicochemical tests | Passed |
| Overall Device (HYALOMATRIX®) | |
| Safety & Effectiveness | Supported by clinical experience (no specific data provided) |
Important Note: The "Cytotoxicity" for the Silastic® component is listed as having "cytotoxic effects." This is a critical finding, and it's unusual for a component description to include such a negative result without further context or mitigation strategies. However, the subsequent findings for "Loctite cured film" and the overall conclusion suggest that this might have been related to raw material testing or specific extraction methods, and the final device's performance was considered acceptable for its intended use. Without more detail, it's hard to interpret fully.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission does not describe a specific "test set" in the context of a clinical performance study with a predefined sample size of wounds or patients. The biocompatibility tests used animal models (e.g., guinea pigs for sensitization), in vitro cell cultures, and chemical analyses, but specific sample sizes for these individual tests are not detailed in the summary.
- Data Provenance: The biocompatibility data is likely from laboratory studies (in vitro and in vivo animal models). There is no mention of country of origin for this data or whether it was retrospective or prospective. The statement "Clinical experience HYALOMATRIX as a wound dressing supports the safety and effectiveness of the device" vaguely implies real-world usage but provides no specifics on the data source, size, or methodology.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as there was no comparative clinical performance study described that would require expert adjudication of results (e.g., wound healing assessment by multiple clinicians). Biocompatibility tests rely on established scientific methods and laboratory protocols rather than expert consensus on a 'ground truth'.
4. Adjudication Method for the Test Set
Not applicable. Since no specific test set or clinical performance study requiring human assessment is mentioned, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. There is no mention of an MRMC study or any comparative effectiveness study involving human readers with or without AI assistance. This device is a wound dressing, not an imaging or diagnostic AI-powered device.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical wound dressing and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is not relevant or described.
7. Type of Ground Truth Used
The "ground truth" in this context is derived from:
- Biocompatibility test results: These are objective measurements and observations from standardized in vitro and in vivo (animal) tests (e.g., cell viability, hemolytic index, irritation scores, histological findings).
- Clinical experience: While not explicitly detailed, the reference to "clinical experience" implies that observing actual patient outcomes with the device in practice forms a qualitative basis for safety and effectiveness, but it is not quantified as a "ground truth" through a rigorous study.
8. Sample Size for the Training Set
Not applicable. As this is a medical device (wound dressing) and not an AI/algorithm-based diagnostic or imaging tool, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no training set mentioned, the establishment of its ground truth is also not applicable.
In summary: The provided 510(k) summary for HYALOMATRIX® focuses on demonstrating substantial equivalence primarily through detailed biocompatibility testing of its components and a general statement about clinical experience supporting its safety and effectiveness. It does not contain information about prospective clinical trials with defined acceptance criteria, sample sizes for test or training sets, expert adjudication, or AI performance studies.
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