Search Results

MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms from wounds.

MIS Solution is a clear, colorless solution intended for cleansing and removal of 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 microorganism, from wounds. MIS Solution is provided in a soft polypropylene 500mL container with a spikeable port. MIS Solution is composed of water, citric acid, sodium citrate and sodium lauryl sulfate.

This document is a 510(k) summary for the device "MIS Solution," a wound irrigation solution. It focuses on demonstrating substantial equivalence to a predicate device, Next Science® Irrigation Solution (K161165).

Based on the provided text, a conventional comparative effectiveness study (like an MRMC study for AI devices) was not conducted. The primary studies are bench tests and biocompatibility studies aimed at showing the new device functions similarly and is as safe as the predicate device, rather than improving human performance or providing standalone AI output.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria and reported device performance in a table format for the primary "efficacy" aspect of debris removal. Instead, it describes performance in qualitative terms and through comparison to a predicate.

• Material Mediated Pyrogenicity (USP ): Passed.
• Guinea Pig Maximization Sensitization Test: Passed.
• Porcine Wound Healing: Did not inhibit normal wound healing over 25 days.
• Toxicological Risk Assessment (ISO 10993-17): Performed.
• Chemical Characterization of Extractables and Leachables: Performed.
• Irritation (Human): Determined to be a non-irritant. |
  | Safety: No adverse events or complications. | Human Repeat Patch Test (Clinical Study): No adverse events or complications. |

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

• Human Repeat Patch Test (Clinical Study):
  • Sample Size: Not explicitly stated, but implies multiple human subjects ("Human Repeat Patch Test"). The number of patches applied is also not stated.
  • Data Provenance: Prospective (clinical study), country of origin not specified but likely U.S. as FDA submission.
• Porcine Wound Healing Study (Animal Testing):
  • Sample Size: 16 domestic pigs were used. Each pig had eight wounds (four on the left and four on the right side of the animal's back). Two or three wounds per animal were assigned to a treatment group (subject device, predicate device, or negative control).
  • Data Provenance: Prospective animal study, country of origin not specified.
• Bench Tests (Compatibility and Irrigation Force Comparison, Combined Dissolution Efficacy): Sample size refers to the number of tests or runs; specific numbers are not provided. Data provenance is laboratory testing.

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

• This information is not provided in the document. For biocompatibility and animal studies, "ground truth" is typically objective measurements (e.g., pyrogenicity, irritation scores, wound healing progression assessed by researchers). For the bench tests, the outcomes are based on measurable physical properties (pressure, dissolution efficacy). There is no mention of experts establishing a "ground truth" in the way it would be for an AI diagnostic device reviewing images.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1 consensus) are typically relevant for human interpretation of data, particularly subjective data, where multiple readers provide initial reads. This is not applicable to the types of studies described (biocompatibility, bench tests, animal healing, human patch test), which rely on objective measurements and predefined test protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI device on human reader performance (e.g., radiologists interpreting images). The "MIS Solution" is a wound irrigation solution, not a diagnostic AI device requiring human interpretation of output.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The device is a physical solution, not an algorithm. The "standalone" performance would be its inherent chemical and physical properties as measured in the bench tests (e.g., dissolution efficacy) or its biological impact as measured in animal/human studies (e.g., wound healing, irritation).

7. Type of Ground Truth Used

• Biocompatibility Studies: Objective laboratory measurements, standardized test results (e.g., USP for pyrogenicity, ISO 10993 for irritation/sensitization).
• Animal Study (Porcine Wound Healing): Histological and macroscopic evaluation of wound healing progression, as measured by researchers using predefined assessment criteria.
• Human Repeat Patch Test (Clinical Study): Clinical assessment of skin irritation by qualified healthcare professionals based on visual inspection and patient reports, using standardized scoring.
• Performance Bench Testing: Quantitative physical measurements (e.g., pressure, dissolution rate) against established scientific benchmarks or the predicate device.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning algorithm, so there is no training set in the context of AI model development.

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

• Not applicable (as there is no training set).

Ask a specific question about this device