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The Pacific Plus PTA Catheter is intended to dilate stenoses in the illiofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.

The Pacific Plus PTA catheter is an Over the Wire (OTW) peripheral balloon catheter, specifically designed for percutaneous transluminal angioplasty (PTA) in stenosed vessel segments. The OTW catheter is used to guide the balloon to the stenosed vessel segment. The balloon is then inflated to dilate the vessel.

The catheter is a coaxial dual lumen device. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 in (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution.

The Pacific Plus PTA catheter is available in balloon diameters 4.0 mm - 7.0 mm, and balloon lengths from 20 mm to 300 mm, with 90 cm, 150 cm, and 200 cm catheter lengths. The distal section of the catheter includes a lubricious hydrophilic coating.

The provided text describes a 510(k) premarket notification for the Pacific Plus PTA Catheter. This document is a regulatory submission for a medical device and, therefore, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific clinical performance acceptance criteria in the manner one might find for a novel diagnostic or AI-driven decision support tool.

The "acceptance criteria" in this context refer to the benchmark performance of the predicate device and relevant industry standards for similar devices. The "study" proving the device meets these criteria is the bench testing and biocompatibility evaluation performed.

Here's an analysis of the provided information based on your request, keeping in mind the nature of a 510(k) submission for a catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a device like a PTA catheter, "acceptance criteria" are typically defined by engineering specifications, safety standards, and performance characteristics demonstrated by equivalent predicate devices, rather than clinical metrics like sensitivity/specificity for diagnostic AI. The "reported device performance" are the results of bench tests confirming these specifications are met or are comparable to the predicate.

• Ability to withstand rated burst pressure.
• Resistance to fatigue under repeated inflation/deflation.
• Specific balloon compliance (expansion profile).
• Acceptable inflation/deflation times. | - Balloon Preparation, Deployment and Retraction: Demonstrated to function as intended.
• Balloon Rated Burst Pressure: Met specified pressure limits, comparable to predicate.
• Balloon Fatigue: Demonstrated acceptable durability.
• Balloon Compliance: Within expected range, comparable to predicate.
• Balloon Inflation/Deflation Time: Within acceptable limits. |
  | Mechanical Integrity | - Sufficient bond strength between components.
• Acceptable catheter flexibility and kink resistance.
• Adequate torque strength for navigation.
• Integrity of hydrophilic coating. | - Catheter Bond Strength and tip pull test: Met specified strength requirements.
• Catheter Flexibility and Kink Test: Demonstrated acceptable flexibility and kink resistance.
• Catheter Torque Strength: Met specified torque limits.
• Catheter coating Integrity: Confirmed to be intact and functional. |
  | Safety | - Absence of unacceptable particulate matter.
• Biocompatibility (cytotoxicity, pyrogenicity, systemic toxicity, sensitization, intracutaneous reactivity, hemocompatibility). | - Particulate Evaluation: Met acceptable limits.
• Biocompatibility Testing: All tests (Cytotoxicity, Pyrogenicity, Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Haemocompatibility - Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Thromboresistance) were passed, concluding the device is biocompatible for its intended use. |
  | Sterility | Sterility assurance level and method. | Same sterility assurance level and method of sterilization as predicate. |
  | Packaging | Suitable packaging materials. | Similar packaging materials to predicate. |

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the bench tests. It refers to "internal risk analysis procedures" that determined the extent of testing. For medical device bench testing, the sample size is typically determined by statistical methods or established industry standards to ensure sufficient confidence in the results for each specific test (e.g., a certain number of catheters are tested for burst pressure, fatigue, etc.).
• Data Provenance: The data is "internal" research and development data, generated by Medtronic Vascular, Inc. through their bench testing and biocompatibility assessments. This is not clinical data, but rather engineering and laboratory testing data. The country of origin of the data is implicitly the USA, where Medtronic is headquartered and the submission was made to the FDA. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

• Not Applicable in the traditional sense. For a PTA catheter, "ground truth" for bench testing is established by engineering specifications, validated test methods (e.g., ASTM, ISO standards), and the performance characteristics of the legally marketed predicate device. This is not a situation where human experts are adjudicating clinical images or patient outcomes to establish ground truth for an AI algorithm. The "experts" involved would be Medtronic's R&D engineers, quality assurance personnel, and regulatory affairs specialists who designed the tests, conducted them, and interpreted the results against established standards and predicate performance. Their qualifications would be in engineering, materials science, and medical device regulations.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is not a study requiring adjudication by experts to establish ground truth. The results of the bench tests are objectively measured against predefined acceptance criteria (e.g., a specific burst pressure, a certain bond strength, pH levels for biocompatibility assays).

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

• No. This type of study is specifically relevant for diagnostic AI or decision support systems where human interpretation of data is a key component. The Pacific Plus PTA Catheter is an interventional medical device, not a diagnostic AI tool, so an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• No. This question is relevant to AI algorithms. The Pacific Plus PTA Catheter is a physical medical device. The "performance" being evaluated is its physical and mechanical characteristics in a standalone bench testing environment, but this is distinct from an AI algorithm's standalone performance.

7. The Type of Ground Truth Used

• For bench testing, the "ground truth" consisted of engineering specifications, international standards (e.g., ISO 10993-1), and the established performance characteristics of the legally marketed predicate device (K123358) and reference devices. These benchmarks define what constitutes acceptable performance for each test. For biocompatibility, the ground truth is established by conformity to the biological safety limits specified in ISO 10993-1.

8. The Sample Size for the Training Set

• Not Applicable. This question is relevant to machine learning/AI models. The Pacific Plus PTA Catheter does not involve a "training set" in the context of AI. The development of the catheter relies on engineering design principles, material science, and prior knowledge from predicate devices, not on training an algorithm with a dataset.

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

• Not Applicable. As there is no AI training set, this question is not relevant.

In summary, the provided document details a 510(k) submission for a physical medical device. The "study" demonstrating performance involved extensive bench testing and biocompatibility evaluation against engineering specifications, international standards, and the characteristics of predicate devices. This is fundamentally different from the evaluation of an AI-driven diagnostic or decision support system, which would involve clinical studies, ground truth established by expert consensus or pathology, and various performance metrics like sensitivity, specificity, or AUC.

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The Pacific™ Plus PTA catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Pacific Plus is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, a coaxial dual lumen shaft, and a distal dilatation balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guide wire with a maximum outer diameter of 0.018 inches (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. Two radiopaque marker bands are placed under the balloon segment of the catherser shaft to provide visual reference points for balloon positioning within the vessel.

The Pacific Plus catheter is compatible with guidewires with a maximum diameter of 0.018" (0.46 mm) and with 4F or 5F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90, 130 and 180 cm.

Balloon sizes range from 2.0mm to 7.0mm in diameter, with balloon lengths from 20mm to l 50mm. All balloons reach nominal diameter at 8atm (Nominal Pressure) and have rated burst pressure (RBP) of 22atm, 16atm, 14atm and 12atm depending on the balloon diameter and balloon length.

The manufacturer, Medtronic Vascular, studied the Pacific Plus PTA Catheter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Pacific Plus PTA Catheter were met through extensive bench and biocompatibility testing. The submission states, "All of the pre-determined acceptance criteria were met and results passed" for both bench and biocompatibility testing. No specific numerical thresholds for acceptance were listed in the provided text, but the qualitative statement confirms that the device performed as required.

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for the bench or biocompatibility tests. The data provenance is described as "bench testing" and "biocompatibility testing," implying laboratory-based studies. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, though the nature of the tests suggests prospective laboratory studies.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

This information is not applicable. The device is a medical catheter, and the "ground truth" for its performance is established through objective engineering bench tests and standardized biological evaluations (biocompatibility). There is no mention of human expert evaluation in establishing ground truth for the device's technical specifications.

4. Adjudication Method

Not applicable for this type of device and testing.

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

No MRMC study was performed. This type of study focuses on the effectiveness of human readers, often with and without AI assistance, typically in image interpretation or diagnostic tasks. The Pacific Plus PTA Catheter is a physical medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Pacific Plus PTA Catheter is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for the performance of the Pacific Plus PTA Catheter was established through:

• Bench Testing: Objective measurements and observations against pre-defined engineering and performance specifications and industry standards (ISO, ASTM).
• Biocompatibility Testing: Results from standardized biological assays and in-vivo tests to assess the device's interaction with biological systems, ensuring it meets safety criteria.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms or AI models. The development of the catheter involved design, material selection, and manufacturing processes, but not a training set in the context of AI.

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

Not applicable, as there was no training set in the context of AI/machine learning. The "ground truth" for the device's design and manufacturing was established through engineering principles, material science, and adherence to regulatory standards.

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