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510(k) Data Aggregation
(146 days)
ASO CORP.
Antibacterial bandages are to be applied topically to the skin to help prevent infoctlon in minor cuts, scrapes, and burns.
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The provided text is a compilation of an FDA 510(k) clearance letter and an "INDICATIONS PAGE" for a medical device. This documentation announces the clearance of "Care Band Antibacterial Bandages" (and private label equivalents) and specifies their intended use.
Crucially, this document does not include information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth methods.
The letter from the FDA confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has been determined to be as safe and effective as a similar device already on the market. This substantial equivalence is typically established by comparing the new device's technological characteristics and intended use to the predicate device, not necessarily through de novo performance studies against explicit acceptance criteria in the 510(k) submission itself.
Therefore, for the request, I can only provide the following, with the understanding that most of the requested information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. | Not provided in the document. The FDA clearance letter states the device is "substantially equivalent" to predicate devices, implying its performance is comparable to devices already on the market. The intended use is "to help prevent infection in minor cuts, scrapes, and burns." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The document implies a comparison to historically marketed devices for substantial equivalence, but details of any test set or its origin are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method for the test set
- Not provided.
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/Not provided. This device is not an AI/software-as-a-medical-device that typically undergoes MRMC studies involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This is a physical antibacterial bandage, not an algorithm.
7. The type of ground truth used
- Not provided. For this type of device, ground truth for performance might involve antimicrobial efficacy testing (in vitro or in vivo) or clinical outcomes, but these details are not in the document.
8. The sample size for the training set
- Not provided.
9. How the ground truth for the training set was established
- Not provided.
In summary, the provided FDA 510(k) clearance letter and indications page confirm the 'Care Band Antibacterial Bandages' have received market clearance based on substantial equivalence to existing devices. However, this documentation does not contain the detailed study information often found in more extensive regulatory submissions or clinical trial reports that would specify acceptance criteria, explicit performance metrics, or study methodologies for demonstrating de novo performance.
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