(266 days)
LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds
LUOFUCON® Silver Collagen Dressing is comprised of bovine collagen and silver chloride intended for the management of wounds. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria. LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing. LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.
The provided text is a 510(k) summary for a medical device (LUOFUCON® Silver Collagen Dressing) and describes its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and various tests performed to demonstrate its safety and performance. However, it does not explicitly state "acceptance criteria" as a set of quantified thresholds for performance, nor does it describe a study specifically designed to prove all elements of acceptance criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Puracol® Plus Ag MicroScaffold™ Wound Dressing), rather than defining and meeting specific, quantifiable acceptance criteria. The tests conducted are primarily to show that the subject device performs similarly to the predicate and meets general safety and performance standards for wound dressings.
Therefore, many of the requested fields cannot be directly extracted from the provided text in the manner specified. I will answer based on the information that is available, and indicate where information is not provided.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance outcomes. Instead, it states that "The results of the testing confirm that the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."
Here's an attempt to infer and summarize based on the provided "Performance Test-bench" section and the comparison table. It's important to note that the specific numerical acceptance criteria for each test are not provided in this document.
| Acceptance Criteria (Inferred from tests conducted) | Reported Device Performance (Summary) |
|---|---|
| Sterilization: Sterility Assurance Level 10⁻⁶ | Sterilized using Gamma radiation to SAL 10⁻⁶ per ISO 11137-1/-2. |
| Shelf-Life: Demonstrated stability over time | Real-time aging test conducted per FDA guidance; assumed to meet requirements. |
| Biocompatibility: (Various ISO 10993-1 tests) | Compliant with ISO 10993-1 standards and FDA Guidance; "raised no new safety concerns." |
| - Cytotoxicity | Acceptable |
| - Irritation | Acceptable |
| - Sensitization | Acceptable |
| - Material-mediated pyrogenicity | Acceptable |
| - Systemic Toxicity | Acceptable |
| - Genotoxicity | Acceptable |
| - Implantation | Acceptable |
| - Acute Systemic Toxicity | Acceptable |
| - Subchronic Systemic Toxicity | Acceptable |
| - Chronic toxicity | Acceptable |
| - Carcinogenicity (toxicological risk assessment) | Acceptable |
| Performance Test-bench: | All product performance requirements met; demonstrates substantial equivalence to predicate. |
| - Appearance | Acceptable (Implied, no specifics) |
| - Size | Acceptable (Implied, no specifics) |
| - Loss on drying | Acceptable (Implied, no specifics) |
| - Tensile strength | Acceptable (Implied, no specifics) |
| - Free swell absorption | Acceptable (Implied, no specifics) |
| - pH value | Acceptable (Implied, no specifics) |
| - Silver content | Acceptable (Implied, no specifics) |
| - Sterility | Acceptable (Covered under sterilization) |
| - Antibacterial effectiveness | "Effective against bacteria" (in vitro) |
| Animal-Derived Materials Safety: Compliant with FDA/ISO standards | Compliant with FDA guidance and ISO 22442 standards. |
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified. The document mentions "a series of bench tests" and "an in-vitro antibacterial effectiveness test" but does not provide the number of samples or specimens used for each test.
- Data provenance: Not specified. The tests appear to be laboratory-based ("bench tests," "in-vitro") conducted by the manufacturer or a contracted lab. There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical data, as this is a pre-market submission based on non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/software device that requires expert adjudication for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles for material properties, sterilization efficacy, and biological safety, as defined by international standards (e.g., ISO, FDA guidance).
4. Adjudication method for the test set
Not applicable. See #3.
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 device is a wound dressing, not an AI-assisted diagnostic or therapeutic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. See #5.
7. The type of ground truth used
For the non-clinical tests described:
- Sterility: Established by documented validation methods (ISO 11137-1/-2) demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.
- Shelf-life: Established by real-time aging tests compliant with FDA guidance.
- Biocompatibility: Established by adherence to ISO 10993-1 standards and FDA guidance, with specific tests conducted (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, etc.).
- Performance (Physical/Chemical): Established by standard laboratory testing methodologies for properties like appearance, size, loss on drying, tensile strength, free swell absorption, pH value, and silver content.
- Antibacterial effectiveness: Established by an in-vitro test.
- Animal-Derived Materials Safety: Established by compliance with FDA guidance and ISO 22442 standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See #8.
N/A