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Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree bums, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications: Microcyn Plus is intended for use in the management of skin abrasions, minor irritations, cuts, and intact skin.

The Oculus Microcyn Plus Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and use with devices intended for wound irrigation with a pH range of 3.5 - 6.0. The solution will be supplied in 40mL glass vials with Teflon lined closures.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets these criteria in the format requested.

The document is a 510(k) summary for a medical device (Microcyn Plus Wound Care Solution) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria through a detailed clinical or comparative effectiveness study.

Here's what can be extracted from the text related to performance, but it does not fulfill all the requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information for this Section: The document does not specify quantitative acceptance criteria (e.g., "pH must be between X and Y") for most tests, only that the device "meets specification and performance characteristics."

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified for any of the performance tests (biocompatibility, bench testing).
• Data Provenance: Not specified. These appear to be laboratory tests conducted on the device itself, rather than human or animal studies with specific geographical or temporal provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The tests performed are laboratory-based and do not involve expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable. The tests are laboratory measurements, not subjective evaluations requiring 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:

• No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported. This device is a wound care solution, not an AI diagnostic tool.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

• For biocompatibility: Adherence to recognized international standards and FDA guidance for biological evaluation.
• For bench testing (physical/chemical/microbiological): Adherence to predefined specifications and USP standards.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set.

Summary of what the document confirms regarding device performance:

The document primarily states that the Microcyn Plus Wound Care Solution underwent various laboratory tests to establish its safety and performance characteristics, specifically:

• Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Tests included Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity. The device is considered a "breached/compromised surface device with limited contact."
• Bench Testing: Performed to assess package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume, USP (Antimicrobial Effectiveness Testing), and USP (Microbial Enumeration Tests).

The conclusion is that the Microcyn Plus Wound Care Solution "meets specification and performance characteristics and is substantially equivalent to the predicate device." However, concrete numerical acceptance criteria and the detailed methodology for proving those criteria for each test are not explicitly provided in this 510(k) summary.

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