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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.

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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(Rx Only) Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.

(OTC use) Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.

Atteris Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. Atteris Antimicrobial Skin & Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The cleanser has a six month expiration due to the preservative that provides bactericidal and fungicidal properties through the action of the antimicrobial (PHMB).

A preservative, PHMB, at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and fungus Candida albicans within the product.

The provided text describes a 510(k) premarket notification for the Atteris™ Antimicrobial Skin & Wound Cleanser. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the document does not contain a study that establishes clinical acceptance criteria for the device's performance in a clinical setting (e.g., wound healing rates, infection reduction rates). Instead, the studies mentioned are to demonstrate the new device is as safe and effective as the predicate based on pre-defined regulatory and biocompatibility standards.

However, I can extract information related to the performance testing that addresses aspects of safety and effectiveness as required for substantial equivalence.

Here's an attempt to organize the information based on your request, focusing on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating equivalence in safety, performance, and specific product characteristics compared to a predicate device, rather than meeting specific clinical efficacy endpoints with numerical benchmarks.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify exact sample sizes for the test sets used in the biocompatibility, preservative effectiveness, or shelf-life studies. These would typically be detailed in the full study reports referenced (e.g., Toxikon reports, USP reports), but not in the 510(k) summary. For biocompatibility tests (ISO 10993), sample sizes are generally small (e.g., a few animals or cell cultures per test).
• Data Provenance: The biocompatibility studies were conducted by "Toxikon" (a contract research organization presumably based in the US or an ISO-certified lab). The USP testing is a standard methodology. Real-time aging studies are conducted on the manufacturer's product. The provenance of the data is generally from laboratory testing, which is prospective in nature for these specific tests. Country of origin for data is not explicitly stated but assumed to be from a reputable testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information (experts establishing ground truth for a test set) is not applicable to this 510(k) safety and performance testing. The "ground truth" for these tests are the established standards:

• For biocompatibility: ISO 10993 standards.
• For preservative effectiveness: USP monograph.
  Experts (e.g., toxicologists, microbiologists) would perform and interpret the tests according to these standards, but there isn't a "ground truth" derived from expert consensus on images or clinical outcomes in the context of this submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially those involving human interpretation of data (e.g., radiology reads, pathology diagnoses), to establish a consensus "ground truth." The tests performed here are laboratory-based and follow standardized protocols; outcomes are objective measurements or categorical determinations (e.g., cytotoxic/non-cytotoxic, effective/not effective).

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 510(k) clearance for an antimicrobial skin and wound cleanser, not an AI-powered diagnostic or assistive tool. No human readers or AI assistance are involved in the performance evaluation described.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims in this submission are based on:

• Standardized Laboratory Controls: For biocompatibility, the ground truth is whether the device materials elicit a toxic, irritating, or sensitizing response when compared to controls as defined by ISO 10993.
• Pharmacopoeial Standards: For preservative effectiveness, the ground truth is the reduction in microbial count defined by the USP antimicrobial effectiveness test.
• Physical/Chemical Measurements: For shelf life and other characteristics, the ground truth is the stability of physical/chemical properties over time.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device that requires a training set.

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