(62 days)
OTC: Oculus Microcyn™ Skin and Wound Gel is intended for over the counter use for minor skin abrasions, lacerations, minor irritations and intact skin.
Professional Use: Under the supervision of a healthcare professional, Oculus Microcyn™ Skin and Wound Gel is intended for exuding wounds such as leg ulcers, pressure ulcer, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
Oculus Microcyn™ Skin and Wound Gel is a clear viscous, odorless, aqueous hydrogel. The gel will be supplied in 2 oz polyethylene terephthalate bottles with polypropylene disc top caps as described in Section 11.3
The provided text describes a 510(k) premarket notification for the Oculus Microcyn™ Skin and Wound Gel. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific performance metrics against pre-defined acceptance criteria for a new AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI algorithms is not applicable to this document.
Here's an breakdown of the information that is available and a note on what is not:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating safety and substantial equivalence to a predicate device through biocompatibility testing and manufacturing quality.
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Reported Device Performance:
- Biocompatibility: "Oculus Microcyn™ Skin and Wound Gel has been subjected to in-vitro and in-vivo biocompatibility testing (cytotoxicity, dermal irritation and dermal sensitization)." These tests "demonstrate the Oculus Microcyn™ Skin and Wound Gel is a safe for use as temporary dressing when in contact with abraded, breached or compromised skin."
- Antimicrobial Effectiveness: "USP Antimicrobial Effectiveness Testing was performed to support claims that the FAC inhibits contamination within the hydrogel." (No specific results are given beyond the claim of inhibition).
- Stability: "Extrapolated results from ongoing stability studies support a product shelf life of 18 months."
- Clinical Experience (Solution Form): "Clinical experience with the solution form of the product indicates the Oculus Microcyn™ Skin and Wound Gel is safe for its intended use." (This refers to a related product, not directly the gel).
Table (Based on available information):
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety for skin contact) | Demonstrated through in-vitro and in-vivo (cytotoxicity, dermal irritation, dermal sensitization) testing to be safe for use as a temporary dressing when in contact with abraded, breached, or compromised skin. Evaluation in accordance with ISO 10993 (cytotoxicity and sensitization). Safety established through biocompatibility testing in-vitro Cytotoxicity testing and sensitization testing across two species of animal. |
| Antimicrobial Effectiveness (Inhibition of contamination) | USP Antimicrobial Effectiveness Testing performed to support claims that the FAC inhibits contamination within the hydrogel. |
| Product Shelf Life (Stability over time) | Extrapolated results from ongoing stability studies support an 18-month shelf life. |
| Equivalence to Predicate Device (Safety and Effectiveness) | Similar in function and has the same intended use as the predicate device (LAM I.P.M.™ Wound Gel). "The safety evaluation meets the requirements as detailed by USP and ISO." "Information submitted to FDA... does not raise new questions of safety and effectiveness; and demonstrates that the device is at least as safe and effective as the legally marketed device." |
| Manufacturing Quality (Compliance with regulations) | Will be manufactured under GMPs and according to CFR 820. Manufacturing process validated before commercial production. cGMPs procedures will assure established specifications are met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided for the biocompatibility or antimicrobial effectiveness tests. The tests mentioned are laboratory-based and animal studies, not human clinical trials with "test sets" in the context of AI or diagnostic device evaluation.
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 applicable as the submission is for a wound care product based on physical properties and biocompatibility, not for a diagnostic device requiring expert interpretation or ground truth establishment in the conventional sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable for the reasons stated above.
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
- This type of study is not applicable as the device is a wound care gel, not an AI-assisted diagnostic or imaging product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a physical product (wound gel), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on standardized laboratory and animal testing protocols for biocompatibility (e.g., ISO 10993, USP) and antimicrobial effectiveness. For demonstrating substantial equivalence, the "ground truth" is also the characteristics and intended use of the legally marketed predicate device.
8. The sample size for the training set
- This information is not applicable as this is not an AI/machine learning device. The "training set" concept does not apply.
9. How the ground truth for the training set was established
- This information is not applicable as this is not an AI/machine learning device.
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