(412 days)
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.
The subject device. Antibacterial bandage, is to be applied topically to the skin for the management of minor cuts, minor scrapes and minor burns. The subject devices are available sterile in three models. All of devices contain three layers: (1) adhesive backing layer (fabric or plastic); (2) exactly same antibacterial non-stick absorbent pad layer (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride); (3) release liner. Each model is available in different sizes with identical materials, chemicals and physical properties, therefore, size of the device will not affect the function and performance of products. All models of subject device, Antibacterial bandage, are for single use only and sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.
The provided text describes a 510(k) premarket notification for an "Antibacterial Bandage" (K221311) and compares it to a predicate device (K113583) and a reference device (K200821). The submission aims to demonstrate substantial equivalence, not to prove that the device meets specific acceptance criteria through a clinical study. Therefore, a direct answer to the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance metrics often expected for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity, MRMC studies) cannot be fully provided from the given document.
However, I can extract the non-clinical test conclusions which serve as the basis for demonstrating substantial equivalence based on performance and biocompatibility. These tests implicitly define "acceptance criteria" through their methodologies and the successful comparison to the predicate device.
Here's a breakdown of the information that can be extracted, framed as closely as possible to the request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list numerical "acceptance criteria" with corresponding "reported device performance" in a typical clinical study outcome format like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the successful completion of specified performance and biocompatibility tests, demonstrating equivalence to the predicate device or compliance with standards.
For Antibacterial Effectiveness, a specific quantitative measure is mentioned for both the subject and predicate devices:
| Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (Subject Device K221311) |
|---|---|
| ≥4 Log reduction (Antibacterial Effectiveness) | ≥4 Log reduction |
For other performance tests and biocompatibility, the reported "performance" is that the device "met the requirement" or "complied with the corresponding standards," or "was not different" from the control.
Here's how the other "acceptance criteria" and "reported performance" can be inferred from the non-clinical tests:
| Test/Category | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Tests | ||
| Liquid absorbency (EN 13726-1:2002) | Met requirements of standard/equivalent to predicate | Met the requirement |
| Moisture vapor transmission rate (EN 13726-2:2002) | Met requirements of standard/equivalent to predicate | Met the requirement |
| Peel strength (ASTMD3330/D3330M) | Met requirements of standard/equivalent to predicate | Met the requirement |
| Sterile barrier package testing (ASTM F88/F88M-15 & ASTM F1929-15) | Package maintains integrity | Maintained its integrity |
| Biocompatibility Tests | ||
| Cytotoxicity (ISO 10993-5:2009) | Complied with standard | Complied with standard |
| Skin sensitization (ISO 10993-10:2010) | Complied with standard | Complied with standard |
| Systemic toxicity (ISO 10993-11:2017) | Complied with standard | Complied with standard |
| Material mediated pyrogenicity (USP 151:2017 & USP-NF:2021 ) | Complied with standard | Complied with standard |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7:2008) | Complied with standard | Complied with standard |
| Animal Study (Wound Healing) | No difference from predicate in wound healing and local tolerance | No difference observed between subject device and predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Performance Tests & Biocompatibility Tests: The document does not specify sample sizes (e.g., number of bandages tested for peel strength) or the data provenance for these lab-based tests. These are typically performed in a controlled laboratory setting.
- Animal Study: A "porcine wound healing study" was carried out, indicating an animal model. The sample size for this study is not specified, nor is the country of origin of the animal data. It would be considered prospective for the animal subjects involved.
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 question is not applicable to the provided document. The device is an antibacterial bandage, not an AI or diagnostic device that requires expert review for ground truth establishment for a diagnostic test set. The ground truth for the non-clinical and animal studies is based on objective laboratory measurements and biological observations, not expert consensus on interpretations of images or signals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth in clinical studies involving human interpretation (e.g., radiologists reviewing images). The studies described here are non-clinical and animal studies.
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 MRMC study was done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for an antibacterial bandage.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical Performance Tests: Ground truth is established by the specified test methods and standards (e.g., EN 13726-1:2002, ASTM D3330/D3330M). The "truth" is the measured physical or chemical property of the bandage.
- Biocompatibility Tests: Ground truth is defined by the biological response observed according to the specific ISO standards (e.g., presence/absence of cytotoxicity, sensitization).
- Animal Study: Ground truth is based on observed wound healing performance characteristics and local tolerance in the porcine model.
8. The sample size for the training set
This question is not applicable. The device (antibacterial bandage) does not involve machine learning or AI, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
N/A