(135 days)
Next Science™ Irrigation Solution is to be used with a jet lavage system and is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.
Next Science™ Irrigation Solution is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Next Science™ Irrigation Solution will be provided in a 1000 mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged with six (6) containers per case. The formulation for Next Science™ Irrigation Solution is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride and water.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Next Science Irrigation Solution:
I. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a structured table. Instead, it relies on a qualitative comparison to the predicate device regarding safety and effectiveness, supported by various tests. The core acceptance criterion is "Substantial Equivalence" to the predicate device, Prontosan Wound Irrigation Solution (K072876).
Since no numerical performance metrics are provided in the document, I cannot create a table with specific acceptance criteria and reported device performance. The information focuses on whether the device is at least as safe and effective as the predicate.
II. Study Details
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Sample Size used for the test set and data provenance:
- Test Set Description: The core "test set" for the critical animal study involved eight Yorkshire pigs.
- Data Provenance: The document does not specify the country of origin for the animal study. It was a prospective study designed to evaluate the effect of the irrigation solution.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish a "ground truth" for the animal study in the typical sense of expert annotation for AI algorithms. The assessment of wound healing was likely conducted by the study investigators based on observable physiological responses and histological analysis (though not explicitly detailed beyond "normal wound healing").
- Therefore, information on the number and qualifications of experts for ground truth establishment is not provided.
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Adjudication method for the test set:
- The document describes that "The four wounds were treated with the same control or test solution, or an empty control (no treatment)." This indicates a controlled experimental design where different treatments (test solution, control article, no treatment) were applied to wounds on the same animals.
- However, it does not describe an adjudication method for establishing ground truth, as it's not a human-reader interpretation study. The assessment of wound healing would be based on scientific observation and measurement.
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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 study was done. This device is a medical solution (irrigation solution), not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical solution, not an algorithm. Therefore, no standalone algorithm-only performance study was conducted.
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The type of ground truth used:
- For the animal study, the "ground truth" was based on biological outcomes or physiological response, specifically "normal wound healing." This would have been assessed through direct observation and potentially histological analysis of the wound sites over the 24-day study period.
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The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there's no ground truth to establish for it.
In summary, the provided document describes a medical device (an irrigation solution) and its substantial equivalence determination based on biocompatibility, functional performance, and animal testing, rather than an AI/software device requiring a test set for algorithm performance evaluation, human reader studies, or training sets.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.