(143 days)
For Over-the-Counter Use: For management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, minor burns and intact skin.
Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and seconddegree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.
Simple Science Antimicrobial Wound & Skin Cleanser is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Simple Science Antimicrobial Wound & Skin Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). Simple Science Antimicrobial Wound & Skin will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.
This document is a 510(k) Pre-market Notification for a medical device called "Simple Science Antimicrobial Wound & Skin Cleanser." It is a submission to the FDA seeking clearance to market the device by demonstrating its substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
This document describes a medical device, not an AI/ML powered device, therefore, many of the requested fields (e.g. number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Demonstrate that the device is as safe and effective as predicate devices as per ISO 10993. | Met for cytotoxicity, sensitization, and irritation. Device is "as safe and as effective as its predicate devices." |
| Preservative Effectiveness | Demonstrate preservative effectiveness as per USP . | Met. Demonstrated effectiveness against: Proteus mirabilis, Serratia marcescens, antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), and Acinetobacter baumannii in solution. |
| Shelf-life Stability | Demonstrate stability and effectiveness for the claimed shelf life. | Product is "stable and effective for the entire shelf life of 12 Months." |
| Manufacturing | Manufactured under current Good Manufacturing Practices (cGMPs) guidelines and established manufacturing, quality, and product specifications. | "Process validations have been completed... Manufacturing controls have been established and implemented... Established cGMPs will assure the device manufactured... Meets all the established specifications prior to release." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a dataset for an AI/ML model. The performance testing described (biocompatibility, preservative effectiveness, stability) involves laboratory-based studies rather than a clinical dataset of patients. Therefore, information about data provenance and retrospective/prospective nature is not applicable here.
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)
Not applicable. This is a traditional medical device (wound cleanser), not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" for its performance is established through standard laboratory and chemical testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/ML device relying on expert review of a test set, adjudication methods are irrelevant.
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. This is a wound cleanser, not an imaging or diagnostic AI/ML device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm, AI, or software component mentioned that would operate in a standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on well-established laboratory and scientific standards:
- Biocompatibility: ISO 10993 toxicology standards.
- Preservative Effectiveness: United States Pharmacopeia (USP) standards, which involve specific microbial challenges.
- Stability: Direct measurement of product characteristics over time under controlled conditions.
- Antimicrobial activity: Testing against specific ATCC (American Type Culture Collection) bacterial strains.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant.
N/A