The Advance® Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.

The Advance® Salivary Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5. 2.0, 2.5 and 3.0 millimeters in a balloon length of 2 centimeters. The catheter is available in an outer diameter of 2.5 French and in a length of 30 centimeters. Hydrophilic coating is applied to the distal 15 centimeters of the catheter shaft, which provides a lubricious surface when wetted. The balloon catheter is supplied with a 0.014 inch (0.36 millimeter) diameter stainless steel mandrel wire guide in a length of 50 centimeters. It is sterile and intended for one-time use.

Acceptance Criteria and Device Performance Study

The provided text describes the Advance® Salivary Balloon Catheter with Wire Guide and the studies conducted to demonstrate its reliable design and performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes for each of the performance tests. It refers to "testing shows" and implies that sufficient samples were tested to meet the predetermined acceptance criteria for each test. The data provenance is not specified beyond the tests being conducted for regulatory submission for a device to be marketed in the USA. Given the nature of these engineering and performance tests, they are typically conducted in a controlled laboratory environment. The "Simulated Clinical Use" test specifically mentions a "human cadaver model," implying prospective testing in a controlled lab setting, likely in the country of manufacture (USA, given the applicant is Cook Incorporated in Bloomington, IN).

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable for most of the tests. The tests are engineering and performance-based, not reliant on expert interpretation for ground truth. For the "Simulated Clinical Use" test using a human cadaver model, while clinical utility is being assessed, the document does not specify the number or qualifications of experts who established the "ground truth" or evaluated the performance of the device in this context. It simply states that the "predetermined acceptance criteria were met," which would likely align with successful navigation and deployment as observed by the testing personnel.

4. Adjudication Method for Test Set

Not applicable. The tests described are objective, quantitative, or pass/fail engineering and performance tests, not requiring an adjudication method akin to clinical studies where multiple readers interpret results.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The studies described are focused on the device's inherent design and performance characteristics, not on a comparison of human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was performed. The entire section "Technological Characteristics" details various tests conducted on the device itself (e.g., bond strength, burst strength, fatigue, inflation/deflation time, corrosion resistance, visual/dimensional analysis, simulated use, balloon working length/catheter integrity, simulated clinical use). These tests assess the algorithm/device's performance in isolation from a human-in-the-loop scenario.

7. Type of Ground Truth Used

The ground truth used for these tests is based on engineering specifications, predetermined quantitative thresholds, and observable physical properties. For example:

• Bond Strength: Conformance to ISO 10555-1 standards.
• Balloon Minimum Burst Strength: Bursting at or above a specified pressure.
• Inflation and Deflation Time: Within 60 seconds.
• Resistance to Corrosion: Withstanding a tensile force greater than or equal to 5 N.
• Simulated Use: Catheter passing through a simulated stricture, removal force less than 0.95 lbf.
• Balloon Working Length: 2.0 cm ± 0.1 cm.
• Simulated Clinical Use: Observable successful introduction, tracking, compatibility, removal, and verifiable location in a cadaver model.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (catheter, balloon, wire guide), not an AI algorithm or a device that uses a "training set" in the machine learning sense. The "training set" concept is not relevant here.

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

Not applicable, as there is no "training set" for this type of medical device.

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The ac Wire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The ac Wire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).

The ac Wire device is a 0.035"" outside diameter, single use, disposable guidewire. The ac Wire device consists of a flexible guidewire that incorporates a low profile, radiopaque alignment element consisting of three loops with radiopaque markers that when open, form a "tulip" configuration designed to assist the physician in acquiring a reference plane under fluoroscopy.

The MediValve acWire is a guidewire intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. It may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it states that "descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use." The performance is evaluated against the predicate devices for substantial equivalence.

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

The document describes laboratory bench testing and biocompatibility testing. It does not specify a "test set" in the context of patient data or clinical images. The testing involved physical samples of the device or its components. The document does not provide details on the specific number of units tested for each functional test (e.g., how many guidewires were used for the tensile test, or how many loops for the loop deflection test).

• Data Provenance: The testing appears to be primarily laboratory-based and ex-vivo (as indicated by "Ex-vivo Performance Test" and "In Vivo Thromboresistance Study" which refers to animal studies rather than human clinical data). There is no mention of country of origin for any human data, as no human data is presented in the summary.

3. Number of Experts and their Qualifications for Ground Truth:

This information is not applicable as the summary describes bench and biocompatibility testing of a physical medical device, not an AI/software device that requires expert-established ground truth from medical images or clinical data.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above. There is no "test set" requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or imaging devices to compare human performance with and without AI assistance. The MediValve acWire is a physical guidewire that does not involve AI assistance for human readers.

6. Standalone (Algorithm Only) Performance:

No, a standalone performance evaluation (algorithm only without human-in-the-loop performance) was not done. This concept applies to AI algorithms and is not relevant to a physical guidewire device like the MediValve acWire.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance in this context is defined by:

• Engineering specifications and design requirements: Functional tests aim to verify that the device meets predetermined mechanical, physical, and performance specifications.
• Biocompatibility standards (ISO 10993-1): The "ground truth" for biocompatibility is conformance to established biological safety standards as determined by specific assay results.
• Predicate device characteristics: The ultimate "ground truth" for safety and effectiveness in a 510(k) submission is substantial equivalence to a legally marketed predicate device. This means the new device performs as well as, or better than, the predicate in relevant tests without raising new safety or effectiveness concerns.

8. Sample Size for the Training Set:

This information is not applicable. The MediValve acWire is a physical medical device and does not involve AI algorithms that require a "training set."

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

This information is not applicable as there is no training set for a physical guidewire device.

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The Cordis STEER-IT Deflecting Tip Guidewires are intended for use in angiographic and interventional devices within the coronary and peripheral vasculature.

The Cordis STEER-IT Deflecting Tip Guidewire is similar in design and materials to the Cordis Wizdom Steerable Guidewire, Lake Region Manufacturing, Inc. Mandrel Guidewire, and the Lake Region Manufacturing, Inc. Steerable PTCA Guidewire. The difference is that the STEER-IT Deflecting Tip Guidewire employs a handle mechanism, which deflects the distal tip in two directions. The handle mechanism is butted into a stainless steel hypotube, which is soldered to a nitinol hypotube. The handle mechanism is similar to the USCI Commander™ Deflection Handle, an accessory of the USCI PilotWire™ Deflectable Guide Wire. The distal end of the STEER-IT Deflecting Tip Guidewire (3mm or 7mm) of the nitinol inner core wire is flattened, looped around and joined to the nitinol hypotube. The handle mechanism operates the movement of the distal tip by gripping the inner moveable core and allowing limited movement in two directions.

The provided text describes a 510(k) submission for the Cordis STEER-IT Deflecting Tip Guidewire. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the information requested in the prompt, which is typically derived from clinical trials or performance studies, is largely not present in this document.

However, based on the text, I can infer and state what is available regarding acceptance criteria and performance:

Acceptance Criteria and Reported Device Performance

Study Information Pertaining to Acceptance Criteria:

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

   • The document does not specify a sample size for any "test set" in the context of clinical or large-scale performance studies. The testing mentioned (joint strength, torqueability, etc.) would have involved a sufficient number of samples to demonstrate compliance with internal specifications, but these numbers are not disclosed.
   • Data provenance is not specified beyond "in vitro testing." No information on country of origin or whether testing was retrospective or prospective is provided.

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

   • Not applicable. The submission focuses on in vitro engineering tests and substantial equivalence claims, not clinical efficacy or diagnostic accuracy requiring expert ground truth for a test set.

3. Adjudication method for the test set:

   • Not applicable. There is no mention of a test set requiring adjudication in this technical review.

4. 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 device is a medical guidewire, not an AI-powered diagnostic or assistive tool for human readers. Therefore, MRMC studies or AI performance metrics are irrelevant.

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

   • Not applicable. This is not an algorithmic or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the mechanical and physical tests, the "ground truth" would be established engineering specifications and industry standards for guidewire performance. For biocompatibility, it would be established ISO standards for medical device biocompatibility. There is no biological or clinical "ground truth" in the sense of disease diagnosis or outcome for this type of device submission.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. This is not an AI/ML device.

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