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The Vado Steerable Sheath is indicated for introducing various catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.

The Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter exchange. A sideport with three-way stopcock is provided for aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a deflection knob, deflects the sheath tip. The steerable introducer features distal vent holes for aspiration and radiopaque markers to facilitate visualization under fluoroscopy.

The provided text describes the regulatory clearance of a medical device, the "Vado Steerable Sheath," and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or supporting studies that are typically associated with performance metrics of AI/ML models (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide the information requested in the prompt, as the document does not contain:

1. A table of acceptance criteria and reported device performance in the context of AI/ML metrics.
2. Sample size used for the test set or data provenance for an AI/ML model.
3. Number of experts or their qualifications for establishing ground truth for AI/ML validation.
4. Adjudication method for AI/ML ground truth establishment.
5. Information on a multi-reader, multi-case (MRMC) comparative effectiveness study for AI assistance.
6. Standalone performance (algorithm only) for an AI/ML model.
7. Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML validation.
8. Sample size for the training set of an AI/ML model.
9. How the ground truth for the training set was established for an AI/ML model.

The document focuses on the mechanical and material performance of a medical device (a catheter introducer), including:

• Biocompatibility tests: To ensure the device is safe for human contact.
• Bench performance tests: To assess physical characteristics like dimensions, leakage resistance, deflection, aspiration, and strength.
• Packaging integrity tests: To ensure sterility and product protection.

These tests are standard for a traditional medical device and are aimed at demonstrating that the device meets its functional and performance characteristics and is equivalent to the predicate device in terms of safety and effectiveness, not that it performs an interpretive or diagnostic function with AI/ML.

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The Vado® Bi-Directional Steerable Sheath is introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the heart through the interatrial septum.

The Vado® Bi-Directional Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible, stable catheter positioning in the cardiac anatomy. A hemostasis valve in the handle minimizes blood loss during catheter introduction and/or exchange. A side port with 3-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A deflection knob on the handle deflects the tip of the sheath clockwise ≥ 180° and counterclockwise ≥ 90°. Distal tip vent holes facilitate aspiration and a radiopaque marker permits visualization of the sheath tip under fluoroscopy.

The provided document describes the FDA 510(k) premarket notification for the Kalila Medical Vado® Bi-Directional Steerable Sheath (K162427). This notification is for a medical device (catheter introducer), not an AI/ML powered device, therefore much of the requested information (e.g., AI/ML specific sections like sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or available in this document.

However, I can provide information based on the device's technical and performance characteristics as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document details various performance tests conducted to demonstrate the device's functional and safety characteristics, in comparison to predicate devices, rather than explicit acceptance criteria with numerical performance targets that are then met. The general acceptance criterion for all tests is that the device "met its functional and performance characteristics in accordance with applicable industry standards and is equivalent to the predicate devices" and that differences "do not adversely affect safety and effectiveness."

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

The document does not specify the exact sample sizes used for each individual test. It states "representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing." This suggests a sufficient number of samples were tested to gain confidence in the results according to relevant standards. The data provenance is internal to Kalila Medical, Inc., as these are tests conducted by the manufacturer, or by laboratories contracted by the manufacturer, to support the 510(k) submission. These tests are inherently prospective in nature as they evaluate newly manufactured devices. There is no mention of country of origin of the data beyond the manufacturer's location in Campbell, California, USA.

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

Not applicable. This device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Its performance is evaluated through engineering and biological testing methods.

4. Adjudication method for the test set

Not applicable for a physical device. Performance is evaluated against objective engineering specifications and biological standards.

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-powered diagnostic device.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used

For this medical device, the "ground truth" is established by:

• Engineering specifications and industry standards: Performance characteristics (e.g., dimensions, deflection angles, tensile strength, leak resistance, radiopacity) are measured against predefined engineering tolerances and relevant international/consensus standards for catheter introducers.
• Biocompatibility standards: Tests (e.g., cytotoxicity, sensitization, irritation) are conducted according to ISO 10993 series standards, where the "ground truth" is compliance with established biological safety thresholds.
• Sterilization efficacy standards: Validation against established methods for ethylene oxide (EO) gas sterilization.
• Packaging integrity standards: Evaluation against packaging standards to ensure sterility and physical protection.

8. The sample size for the training set

Not applicable. This is not an AI-powered device and therefore does not have a training set in the AI/ML sense.

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

Not applicable. As this is not an AI-powered device, there is no training set or associated ground truth for a training set.

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The Vado Steerable Sheath is indicated for introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.

The Kalila Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter exchange. A sideport with three-way stopcock is provided for aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a deflection knob, deflects the tip 140°. The steerable introducer features distal vent holes for aspiration and radiopaque markers to facilitate visualization under fluoroscopy.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Kalila Medical Vado Steerable Sheath:

Acceptance Criteria and Device Performance for Kalila Medical Vado Steerable Sheath (K140420)

Based on the provided 510(k) summary, the device's acceptance criteria are derived from its functional and performance requirements, as demonstrated through a series of tests to establish substantial equivalence to the predicate device. The study primarily relies on non-clinical (bench and biocompatibility) testing, as no clinical testing was performed for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes categories of tests performed and states that the device "met its functional and performance characteristics in accordance with applicable industry standards and compares favorably to the predicate device." However, specific numerical acceptance criteria (e.g., minimum force, maximum leakage rate) and precise quantitative results are not explicitly detailed in the summary. The "reported device performance" is a general statement of compliance rather than specific measurements against a defined threshold.

2. Acute Systemic Toxicity
3. Hemocompatibility (Direct and Indirect)
4. Thrombosis
5. Sensitization
6. Irritation / Intracutaneous
7. Complement Activation
8. Pyrogenicity (rabbit pyrogen and bacterial endotoxin (LAL)) | No adverse biological reactions; compliance with relevant ISO standards for medical devices in contact with blood. | Met all biocompatibility requirements. |
   | Bench Tests | 1. Steerable Sheath and Dilator Visual Inspection
9. Steerable Sheath Dimension Inspection
10. Steerable Sheath Marker Band Location Measurement
11. Dilator Dimensional Inspection
12. Valve Leakage Resistance at 40kPa
13. Leakage Resistance at 300kPa
14. Device Preparation
15. Dilator Snap Disengagement Force
16. Dilator Insertion and Retraction Force
17. Shaft Deflection
18. Curvature Dimensions
19. Aspiration
20. Catheter Insertion Cycling and Flexion Cycling, with Flush
21. Bend Radius to Kink
22. Corrosion Resistance
23. Junction Strengths
24. Torque and Turns to Failure
25. Steerable Sheath Radiopacity Study | Device conforms to design specifications; functions as intended; withstands specified pressures; forces within acceptable ranges; maintains integrity under cycling/stress; visible under fluoroscopy. | Met all functional and performance requirements; comparable to predicate device. |
    | Packaging Integrity | 1. Pouch Seal Strength
26. Gross Leak Detection | Packaging maintains sterility and integrity of the device until use. | Met all packaging integrity requirements. |
    | Shelf Life | (Implicitly part of overall testing) | Device maintains performance and integrity over its stated shelf life. | (No specific details, but implied compliance) |
    | Sterilization | (Implicitly part of overall testing) | Device is adequately sterilized and maintains sterility. | (No specific details, but implied compliance) |

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

The document states that "representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing." However, no specific sample sizes for any of these tests are provided or mentioned in the summary.

Data Provenance: The data is entirely non-clinical (bench and laboratory-based). There is no information regarding the country of origin of the data, as it pertains to internal testing conducted by Kalila Medical to support market clearance. The data is prospective in the sense that the tests were designed and executed specifically for this 510(k) submission.

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

This section is not applicable as the study did not involve human interpretation or a "test set" in the context of image analysis or diagnostic performance. The "ground truth" here is objective measurement against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable. As the study comprised bench and biocompatibility testing, there was no need for an adjudication method as would be used in expert consensus for clinical data. Performance was determined by direct measurement and observation against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was NOT done. The submission explicitly states: "Clinical testing is not provided in this submission." Therefore, there is no information on how human readers would improve with or without AI assistance, as AI is not a component of this device, and no human-reader study was conducted.

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

Not applicable. The Vado Steerable Sheath is a physical medical device (a catheter introducer), not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Engineering specifications and design requirements: For dimensional accuracy, deflection, forces, etc.
• Industry standards (e.g., ISO for biocompatibility): For biological safety and material compatibility.
• Predicate device characteristics: For establishing substantial equivalence in performance and functionality.

Essentially, the ground truth is objective, measurable performance against predefined and accepted engineering and safety standards.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The ground truth for the device's development would have been established through a combination of engineering design, materials science, and functional requirements based on the intended use and predicate device.

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