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KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are available in adult sizes 7.0, 7.5, 8.0, 8.5 and 9.0mm with a Murphy Eve. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is reached via a normally open suction valve which includes a one-way port for rinsing the subglottic space with sterile saline (0.9% Sodium Chloride solution) or administering an air bolus to assist in maintaining a patent suction lumen patency. These devices are sold as disposable, sterile, single use, devices.

The provided text describes a 510(k) premarket notification for a modification to an existing medical device, the Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes. This is not a study proving device meets acceptance criteria in the sense of a new AI/software medical device.

The original device (K120985) was already cleared, and this submission (K131254) is for a "Special 510(k): Device Modification" where the only change is the raw material used to bond the cuff to the endotracheal tube. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that this change does not negatively impact the safety and effectiveness, and that the modified device remains substantially equivalent to the predicate.

Here's an analysis based on the provided text, structured to answer your questions where applicable, and noting where the information is not relevant to this type of submission (e.g., AI/software specific criteria):

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance Description of How Met |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Functional Performance | Suctioning Efficiency | Confirmed efficient suctioning. | Bench-top performance testing was conducted to confirm suctioning efficiency. |
| | ISO 5361:1999 (Anesthetic and respiratory equipment Tracheal tubes and connectors) | Conformance to standard. | Additional bench-top testing was conducted to assure conformance to this standard. |
| Biocompatibility | ANSI/AAMI/ISO 10993-3: 2003 (Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-6, 2007 (Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-10: 2010 (Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| Overall Conclusion | Demonstrating no concerns of safety or effectiveness for the modified device and substantial equivalence to the predicate. | "All results of testing met acceptance criteria and demonstrate no concerns of safety or effectiveness for the modified device." "Test results confirm that the device is as safe and effective and performs as well as or better than the predicate device." | Based on bench-top and biocompatibility testing against relevant standards. |

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

This is not a study involving a "test set" in the context of an AI/software medical device. The "testing" refers to standard medical device verification and validation activities (bench-top and biocompatibility testing) on the physical device. The exact sample sizes for these tests are not provided in the summary, but they would be determined by the requirements of the specific ISO/ANSI/AAMI standards referenced. Data provenance is not applicable as this is not a data-driven AI study.

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

Not applicable. There is no "ground truth" establishment by experts in the context of an AI/software algorithm for this physical device modification. The "ground truth" for device performance is based on meeting the specifications of the referenced standards and internal engineering requirements.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for this type of physical device testing.

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 not an AI-assisted device. No MRMC study was conducted.

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

Not applicable. This is not an AI/software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established performance requirements and safety profiles defined by:

• International Standards: ISO 5361:1999 (functional), ANSI/AAMI/ISO 10993 series (biocompatibility).
• Predicate Device Performance: The modified device must perform "as well as or better than" the predicate device (K120985).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

Not applicable. There is no training set. The "ground truth" for the overall device acceptability is based on compliance with established medical device standards and demonstrating substantial equivalence to the predicate device through bench-top and biocompatibility testing.

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KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are available in adult sizes 7.0, 7.5, 8.0, 8.5, and 9.0mm with a Murphy Eye. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is accessed via a normally open suction valve that includes a one-way port for rinsing the subglottic space with sterile saline (0.9% Sodium Chloride solution) or administering an air bolus to assist in maintaining a patent suction lumen patency. These devices are sold as disposable, sterile, single-use, devices.

The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes were studied to confirm suctioning efficiency and adherence to various standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• The document describes "bench-top performance testing," "biocompatibility testing," and "sterilization validation." It specifies that bench-top testing was conducted to confirm suctioning efficiency and conformance to ISO standards. Biocompatibility testing was conducted to assure conformance to ISO 10993 series standards. Sterilization validation was done according to ISO 10993-7, ISO 11135-1, and ISO 11607-1.
• The specific sample sizes for each type of test or the provenance of any data (e.g., country of origin, retrospective/prospective) are not detailed in the provided text. The testing appears to be primarily laboratory/pre-clinical in nature for device performance and safety, rather than clinical data from human subjects.

3. Number and Qualifications of Experts for Ground Truth

• This information is not provided in the document. The studies mentioned are primarily engineering/bench-top performance, biocompatibility, and sterilization validation, which typically rely on standardized tests and measurements rather than expert human interpretation for establishing ground truth in the way a diagnostic AI system would.

4. Adjudication Method for Test Set

• This information is not applicable or provided. The described studies are not based on human-interpreted "test sets" requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not conducted or described for this device. This device is an endotracheal tube, not an AI-assisted diagnostic tool for which human reader improvement would be measured.

6. Standalone Performance Study

• The studies described are for the "standalone" performance of the device itself as a medical product (endotracheal tube), evaluating its physical properties, biological safety, and sterilization effectiveness. It is not an algorithm, so "standalone" in the context of AI performance (algorithm without human-in-the-loop) is not applicable here. The device's performance was evaluated inherently without human intervention beyond conducting the tests.

7. Type of Ground Truth Used

• The ground truth used for these studies is based on:
  • Defined performance specifications: For suctioning efficiency.
  • International and national standards: ISO and ANSI/AAMI/ISO standards for physical properties, biocompatibility, and sterilization.
  • Laboratory measurements and assays: To demonstrate conformance to these standards (e.g., cytotoxicity tests, irritation tests, ethylene oxide residual measurements).

8. Sample Size for Training Set

• The concept of a "training set" is not applicable here. This is a physical medical device (endotracheal tube), not a software algorithm that undergoes machine learning training.

9. How Ground Truth for Training Set Was Established

• This question is not applicable as there is no training set for this device.

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