(346 days)
The Contreet Hydrocolloid Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears and pressure sores. The dressing can also be used for 2nd degree burns, 200 degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
Contreet Hydrocolloid Dressing is an antibacterial hydrocolloid dressing with silver providing an optimal moist wound healing environment. Contreet Hydrocolloid Dressing has demonstrated in-vitro antibacterial activity in certain strains known to be detrimental to wound healing. Contreet Hydrocolloid Dressing is a waterproof dressing with a semi-permiable film backing.
The provided text is a 510(k) summary for the Contreet Hydrocolloid Dressing, seeking substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or algorithm validation study would.
Instead, the summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "study" mentioned is an in-vitro antibacterial activity study, which is not a clinical study on human subjects with acceptance criteria typically associated with device performance against specific clinical outcomes.
Therefore, many of the requested fields cannot be directly answered from the information provided.
Here's an attempt to extract relevant details and note what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative clinical criteria for device functionality. The acceptance is based on demonstrating substantial equivalence to predicate devices. | In-vitro antibacterial activity: Demonstrated activity against "certain strains known to be detrimental to wound healing." (No specific strains or quantitative reduction provided). |
| Similarity in Intended Use with predicate devices (Comfeel Plus Ulcer Dressing, Acticoat 7 Dressing, Arglaes-AB Antimicrobial Barrier Film and Island Dressings). | Contreet Hydrocolloid Dressing is indicated for: low to moderately exudating wounds, leg ulcers, pressure sores, partial-thickness burns, donor sites, postoperative wounds, skin abrasions, colonized wounds (to support healing/reduce odor), and where infection risk exists/suspected, or with physician's discretion for infected wounds. Also suitable under compression bandaging for low to moderately exudating venous leg ulcers. |
| Similarity in Technological Characteristics with predicate devices. | Based on Comfeel Plus Ulcer Dressing (hydrocolloid dressing) with the additional incorporation of silver for antimicrobial properties. Shares antimicrobial silver with Acticoat 7 and Arglaes-AB. |
2. Sample size used for the test set and the data provenance:
- Not applicable for a clinical test set. The provided document describes an in-vitro antibacterial activity study.
- The sample size and data provenance for the in-vitro study are not specified in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the in-vitro study would be established by laboratory methods measuring bacterial reduction, not expert consensus on clinical cases.
4. Adjudication method for the test set:
- Not applicable. This applies to expert reviews of clinical data, which is not described.
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. This type of study is completely irrelevant to a hydrocolloid dressing. This is a medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This refers to AI algorithm performance and is not applicable to a hydrocolloid dressing.
7. The type of ground truth used:
- For the in-vitro antibacterial activity "study," the ground truth would be laboratory measurements of bacterial growth/reduction in a controlled environment.
- For the overall substantial equivalence determination, the "ground truth" is adherence to existing regulatory requirements and comparison to validated predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device and the type of evaluation described.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what the document implies about "proof":
The "proof" for the Contreet Hydrocolloid Dressing meeting its purpose (and being cleared by the FDA) is primarily based on:
- Substantial Equivalence: Demonstrated similarity in intended use and technological characteristics to legally marketed predicate devices (Comfeel Plus Ulcer Dressing, Acticoat 7 Dressing, and Arglaes-AB Antimicrobial Barrier Film and Island Dressings).
- In-vitro testing: Evidence of antibacterial activity against "certain strains known to be detrimental to wound healing." This in-vitro data supports the claim of antibacterial properties due to the incorporated silver but does not constitute a clinical study with acceptance criteria for wound healing outcomes in humans.
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