(361 days)
OTC: Nixall™ Wound and Skin Care is intended for over-the-counter use (OTC) of the management of minor skin lacerations, minor abrasions, minor irritations, minor burns and intact skin. Professional Use: Nixall™ Wound and Skin Care is intended to be used under the supervision of a healthcare professional in the 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 second degree burns, grafted and donor sites.
Nixall™ Wound and Skin Care, is intended for over the counter and professional use as follows:
- OTC: Nixall™ Wound and Skin Care is for the management of , the irrigation of, the moistening of, and lubrication of minor skin abrasions, minor lacerations, minor burns, minor irritations, minor cuts, and intact skin.
Prescription Use: Nixal™ Wound and Skin Care is intended to be used by health care professionals in the management, via debridement of wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
Nixall™ Wound and Skin Care is a clear solution that aids in the removal of debris and foreign material from the application site. Foreign material and dirt debris are mechanically removed by the action of the wound cleanser moving across the wound bed on the application site with or without the assistance of a suitable wound dressing (i.e. gauze).
Nixall™ Wound and Skin Care will be supplied in High Density Polyethylene (HDPE) bottles of various volumes with dosing (spray) inserts and caps.
Nixall™ Wound and Skin Care is a clear, hypotonic liquid that helps in the removal of the debris and foreign material from the application site. Dirt, debris and foreign materials are removed by the mechanical action of the fluid moving across the wound bed or application site. Device components are Electrolyzed water 99.5615%, Sodium Chloride (NaCl) 0.4%, Hypochlorous Acid (HOCL) .035% Sodium Hypochlorite (NaOCl) .0035%. The solution preservatives are hypochlorous acid and sodium hypochlorite. The solution contains preservatives to suppress bacterial growth for up to one(1) year after the bottle is opened as referenced by testing in Appendix A in this application.
The provided text does not describe a study involving a device that uses AI or reports on the performance of a device against acceptance criteria in the context of AI or diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, it describes a traditional 510(k) premarket notification for a wound care solution (Nixall™ Wound and Skin Care). The "acceptance criteria" discussed are largely related to substantial equivalence to predicate devices, safety (biocompatibility), and product stability and effectiveness for its intended use, rather than diagnostic performance or AI model performance.
Therefore, many of the requested sections related to AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies cannot be extracted from the provided text.
Here is an attempt to address the relevant points based on the available information:
1. A table of acceptance criteria and the reported device performance
Based on the provided K113693 submission, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through various tests.
| Acceptance Criteria Category | Device Performance as Reported |
|---|---|
| Substantial Equivalence | Device is similar in function and has the same intended use as predicate devices (Oculus Puracyn™ Skin and Wound Cleanser, Vashe™ Wound Cleanser, Anasept™ Antimicrobial Skin and Wound Gel). Indications for use, device description, and performance testing support substantial equivalence. |
| Biocompatibility | Subjected to in-vivo biocompatibility studies to demonstrate safety and effectiveness for indications for use. (Specific criteria/results not detailed, but met). |
| Preservation Effectiveness | Supported by USP testing. (Specific criteria/results not detailed, but met). |
| Antimicrobial Properties (in solution) | Showed inhibited growth of Proteus mirabilis, Serratia marcescens, MRSA, VRE, and Acinetobacter baumannii in solution. (Specific criteria/results not detailed, but positive outcome). |
| Stability/Shelf Life | Stability study results demonstrate product is stable and effective for the entire shelf life (up to one year after bottle opened). (Specific criteria/results not detailed, but met). |
| Manufacturing Standards | Manufactured under cGMP guidelines, with established manufacturing, quality, and product specifications. Process validation completed. |
2. Sample sized 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 sample sizes for any of the performance tests (biocompatibility, preservation effectiveness, antimicrobial properties, stability). It does not provide information on data provenance (country of origin, retrospective/prospective). These types of details are typically found in the full study reports annexed to the 510(k) submission, not in the summary.
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 is not applicable as the device is a wound cleanser, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is objective laboratory measurements (e.g., bacterial inhibition, stability parameters, biocompatibility reactions).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and performance testing.
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 device is not an AI diagnostic tool or software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI algorithm. Its performance is inherent to its chemical composition and physical action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing of Nixall™ Wound and Skin Care would be based on:
- Physical/Chemical Standards: For stability (e.g., pH, concentration of active ingredients over time).
- Microbiological Standards: For preservative effectiveness (e.g., USP criteria for reduction of microbial load) and antimicrobial activity (e.g., zone of inhibition, colony count reduction in lab tests).
- Biological Endpoints: For biocompatibility (e.g., lack of cytotoxicity, irritation, sensitization in accordance with ISO standards).
- Clinical Observations (for in-vivo biocompatibility): Though specific details are not provided, in-vivo studies would observe biological reactions.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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