(259 days)
Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites.
Bios King Biocellulose Film is made of bacterial synthesized cellulose mesh with a selectively permeable structure allowing water evaporation, and thus provides a moist but not damp environment for wound healing. Bios King Biocellulose Film is resistible to the tensile force generated from the wound handing. It can adhere to wound beds without fixation devices.
The provided document is a 510(k) summary for the Bios King Biocellulose Film, a topical wound dressing. It details the device's characteristics and its substantial equivalence to predicate devices, focusing primarily on non-clinical tests.
However, the document does not contain information about a study proving the device meets acceptance criteria related to typical clinical performance metrics for AI/ML medical devices, such as sensitivity, specificity, or reader performance in diagnostic tasks. The "device performance" described here refers to physical and biological properties of the wound dressing, not diagnostic accuracy.
Therefore, many of the requested fields cannot be answered from the provided text as they pertain to clinical studies involving AI in diagnostics.
Here's the information that can be extracted or deduced from the document regarding the device's non-clinical performance and acceptance criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Sterilization validation test (ISO 11137-1, -2: 2006) | Sterile to 10⁻⁶ SAL after 25kGy gamma radiation |
| Shelf-life test (ASTM F1980-02) | 5 years after manufacturing |
| Endotoxin test (USP , USP ) | Lower than 20 EU/device; will not cause endotoxin hazard |
| Cytotoxicity test (ISO 10993-5:1999) | No cytotoxicity; will not cause cytotoxicity hazard |
| Intracutaneous reactivity test (ISO 10993-10: 2002, ISO 10993-12:2012) | No skin irritation; will not cause skin irritation hazard |
| Skin sensitization test (ISO 10993-10: 2010, ISO 10993-12:2012) | No skin sensitization; will not cause skin sensitization hazard |
| Heavy metal residue test (ICP-AES analysis) | Arsenic, cadmium, copper, mercury undetectable; lead 1000 g/25 mm (tensile resistant) |
Regarding the Study (Non-clinical Tests):
The document describes several non-clinical tests conducted to validate the safety and efficacy of the Bios King Biocellulose Film. These are in-vitro or in-vivo animal/material tests, not human clinical trials for diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for each individual test. The tests are general biocompatibility, physical property, and sterility tests, often requiring specific numbers of samples or subjects (e.g., animals for skin irritation) as per the referenced ISO or ASTM standards, but these numbers are not detailed in the summary.
- Data Provenance: The document does not specify the country of origin for the test data, though the submitting company is from Taiwan. The tests are non-clinical in nature.
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. Ground truth in the context of expert consensus is not relevant for these types of non-clinical tests. Standards like ISO 10993 define methodologies and criteria for chemical, biological, and physical properties, often determined by laboratory analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy, not for non-clinical material property or biocompatibility tests.
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 topical wound dressing, not an AI/ML diagnostic algorithm. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is established by the specific methodologies and quantifiable outcomes defined in the referenced international standards (e.g., ISO 11137 for sterility, ISO 10993 for biocompatibility, ASTM E96-95 for moisture vapor transmission). These typically involve laboratory analyses, physical measurements, and biological assays against defined thresholds.
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists.
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