(602 days)
For the management of the following: Minor Cuts, Minor Abrasions, Minor Lacerations, Minor Burns (1st degree burns)
Cerdak™ is a single-use, sterile, bio-compatible device made of Aluminum Oxide ceramic granules in a non-woven fabric sachet.
Cerdak™ dressing is provided in four configurations, they are: Basic, Aerofilm, Aerocloth and Drydoc and in several sizes ranging from 15mm X 25mm to 100mm X 250 mm.
CERDAK™ covers and provides moist wound environment.
The provided text describes the Cerdak Basic wound dressing (K153138) and its substantial equivalence to a predicate device. However, it does not contain the specific details about acceptance criteria, comprehensive device performance data, sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for a medical imaging AI device, nor does it detail a comparative effectiveness study (MRMC) or standalone performance metrics as requested.
The document primarily focuses on biocompatibility and a very high-level overview of a clinical study for a wound dressing, which is a different type of medical device than what the request implies (e.g., an imaging AI device).
Therefore, I cannot fulfill all parts of your request with the provided information. I will extract what is available and note the missing information.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance beyond biocompatibility. It states that the device was found to be "non-cytotoxic," a "negligible irritant," and a "non-sensitizer." For the clinical study, it reports "no statistically significant difference in infection rate and infection type" and "no statistical difference in complications." These are qualitative statements rather than specific numerical targets or thresholds.
| Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|
| Non-cytotoxic | CERDAK™ is non-cytotoxic and meets the requirements of the Test defined in ISO 10993-5 guidelines. |
| Negligible skin irritant | CERDAK™ is considered a negligible irritant after a single topical application to the skin of New Zealand White rabbits. |
| Non-sensitizer | CERDAK™ was found to be non-sensitizer. (No skin sensitization reactions were observed in both control and test sites of all the animals in the Guinea Pig Maximization Test). |
| Not statistically different in infection rate/type vs. control | "no statistically significant difference in infection rate and infection type between both the groups [CERDAK™ vs. normal saline control]." |
| Not statistically different in complications vs. control | "No statistical difference in complications among both the groups [CERDAK™ vs. normal saline control]." |
| Safe for wound covering, creates moist environment | CERDAK™ was found to be safe in covering the wounds and creating a moist wound environment. |
Note: The acceptance criteria are inferred from the reported performance, as explicit numerical or statistical criteria are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Biocompatibility Tests:
- Cytotoxicity: "Balb/c/3T3/ cells in-vitro condition using elution method" - No specific numerical sample size (number of tests/replicates) or provenance (country/retrospective/prospective) is provided for this in-vitro test beyond the cell line used.
- Primary Skin Irritation Test: "New Zealand white rabbits" - No specific number of rabbits is provided.
- Skin Sensitization (GPMT): "Guinea Pig Maximization Test - GPMT" - No specific number of guinea pigs is provided.
- Clinical Study:
- Sample Size: Not specified. The document only states "A clinical study was conducted on CERDAK™ using normal saline as control."
- Data Provenance: Not specified. It does not mention the country of origin of the data or whether it was retrospective or prospective.
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)
This information is not provided as the device is a wound dressing, not explicitly an AI imaging device requiring expert ground truth in the traditional sense. The "ground truth" for the biocompatibility tests comes from standardized biological assays and observation, and for the clinical study, it would be outcomes data (infection rates, complications) observed by clinical staff, but no details on expert qualifications are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the types of studies described (biocompatibility and a clinical study for a wound dressing). Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation tasks.
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
No, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or described. This type of study is relevant for AI image analysis tools, not for a physical wound dressing like Cerdak.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as Cerdak is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility: In-vitro assay results and in-vivo animal observations according to ISO 10993 guidelines.
- Clinical Study: Outcomes data, specifically infection rates, infection types, and complications.
8. The sample size for the training set
This is not applicable. Cerdak is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as Cerdak is not an AI model requiring a training set.
N/A