(437 days)
Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.
Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, moistening, debridement and removal of foreign material including debris from of skin abrasions, minor irritations, cuts and intact skin.
Spectricent Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).
Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.
This document is a 510(k) premarket notification for a medical device called "Spectricept Skin and Wound Cleanser." It seeks to demonstrate substantial equivalence to a legally marketed predicate device (Microcyn Plus Wound Care Solution). The information provided focuses on non-clinical testing and comparison to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria in a human population.
Therefore, many of the requested elements regarding clinical studies, human readers, and ground truth establishment in a clinical context are not applicable or extractable from this document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, human performance sense, as it's primarily a non-clinical submission for substantial equivalence. Instead, it details various bench tests and biocompatibility evaluations that the device passed to demonstrate safety and effectiveness, and to show similarity to the predicate device.
| Test Category | Test Name | Acceptance Criteria (Implied by "Passed") | Reported Device Performance (Implied by "Passed") |
|---|---|---|---|
| Biocompatibility Testing | ISO 10993-3 Genotoxicity, Carcinogenicity and Reproductive Toxicity | Acceptable performance | Passed |
| ISO 10993-5 - In Vitro Cytotoxicity | Acceptable performance | Passed | |
| ISO 10993-10 Irritation and Skin Sensitization. Direct Intracutaneous Injection Test | Acceptable performance | Passed | |
| ISO 10993-11 - Systemic Toxicity, Direct Systemic Injection Test | Acceptable performance | Passed | |
| ASTM F756 – Assessment of Hemolytic Properties | Acceptable performance | Passed | |
| USP – Bacterial Endotoxins Test | Acceptable performance | Passed | |
| Bench Testing | Visual Inspection | Meets specification | Passed |
| Package Integrity | Meets specification | Passed | |
| Shelf-life Testing | Supports a 12-month shelf life | Passed (for 12 months) | |
| pH | Meets specification (pH range 3.0-4.3) | Passed | |
| Free Available Chlorine (FAC) | Meets specification | Passed | |
| Fill Volume | Meets specification | Passed | |
| Time to Kill Assay (ASTM E2315) | Meets specification | Passed | |
| Preservative Effectiveness Testing (USP ) | Acceptable performance | Passed | |
| Bioburden (USP) | Meets specification | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical laboratory testing, not a clinical study involving human patient data. Therefore, the concept of a "test set" in the context of patient data, data provenance, or retrospective/prospective study design does not apply. The "samples" would refer to manufacturing lots or batches of the device product used for the various bench and biocompatibility tests. The document does not specify the number of samples used for each non-clinical test.
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 there was no clinical test set requiring expert ground truth establishment. The evaluations were based on standardized laboratory tests and their established evaluation criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical test set for human review or adjudication.
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 submission for a wound cleanser and does not involve AI or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a wound cleanser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the established scientific protocols, standards (e.g., ISO, ASTM, USP), and specifications for each test. For example:
- Biocompatibility: Standards like ISO 10993 define acceptable biological responses.
- Bench Testing: Specifications for pH range, FAC levels, fill volume, and performance criteria for preservative effectiveness or time to kill.
8. The sample size for the training set
Not applicable. This is not a machine learning model, 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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