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Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.

The Opti-Plast Centurion 5.5F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accommodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheter is designed to be used in conjunction with a 0.035" diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labeled diameter and length at a 10 atmosphere Operating Pressure. The Rated Burst Pressure of the device ranges from 17-20 atmospheres, depending on balloon diameter (see attached table).

The provided text describes a medical device, the Opti-Plast® Centurion 5.5F PTA Catheter, and its performance testing for substantial equivalence to predicate devices, rather than a study using AI or digital health technology. Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document.

However, I can extract information related to the device's technical specifications and the bench testing performed.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for each performance test. Instead, it presents a comparison of technological characteristics between the proposed device and two predicate devices. The "reported device performance" are the characteristics of the proposed device itself, and the implicit acceptance criterion for the premarket notification (510(k)) is that these characteristics demonstrate substantial equivalence to legally marketed predicate devices, and that there are no new safety or effectiveness issues.

Performance Data (Bench Testing):
The document states: "The test results indicate that the Opti-Plast Centurion 5.5F PTA Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication."

Bench testing was conducted for the following characteristics:

• Balloon burst strength
• Balloon distensibility
• Balloon inflation/deflation time
• Balloon fatigue
• Joints and material strength
• Catheter balloon profile
• Introducer sheath compatibility
• Catheter flow rate and maximum injection pressure
• Deflatability and trackability
• Tip torque performance
• Puncture resistance ("toughness")
• Balloon scratch resistance
• Balloon fatigue (cycling to rated burst pressure) within a stent
• Balloon burst within a stent

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes bench testing of a physical medical device, not a study involving a test set of data (e.g., medical images, patient records). No human or animal data were used. The tests were performed in a laboratory setting. No country of origin for the data is specified, but the applicant is a US company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device testing, not a study requiring expert ground truth for interpretation of results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical device testing, not a study requiring adjudication of interpretations.

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 document pertains to a physical medical device (catheter) and no AI or human-in-the-loop performance studies were conducted or are relevant.

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

Not applicable. This document pertains to a physical medical device (catheter); there is no algorithm involved.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. For bench testing of physical characteristics, the "ground truth" generally refers to physical measurements and engineering specifications, not expert consensus or medical outcomes. For example, balloon burst strength is measured against a specified pressure.

8. The sample size for the training set

Not applicable. There is no training set as this is a physical medical device, not an AI/algorithm-based product.

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

Not applicable. There is no training set for this type of device.

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The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian or femoral vein.

The Vas-Cath Niagara™ catheter is a polyurethane catheter which allows for dialysis, hemoperfusion or apheresis. The Niagara™ catheter contains two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic nylon clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. Both a fixed and a removable suture wing are provided for securing the catheter after initial placement.

The cross-section of the oval shaft contains two round arterial and venous lumens. The arterial lumen exit is bevelled and is perforated with two holes. The venous lumen extends beyond the arterial lumen and ends with a soft atraumatic black tip. The Niagara™ catheters are available in a straight configuration with 15cm, 20cm, and 24cm insertion lengths; as well as in a pre-curved configuration with 12.5 cm, 15 cm and 20 cm insertion lengths.

This document describes a 510(k) submission for the Niagara™ Dual Lumen Catheter, seeking to demonstrate its substantial equivalence to a predicate device, the Vas-Cath Soft-Cell™ Catheter (K871488). Therefore, the study presented focuses on justifying this equivalence rather than establishing acceptance criteria against a clinical benchmark.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in a quantitative, pass/fail sense as one might find for a new device claiming superiority or meeting a specific performance threshold. Instead, it aims to demonstrate substantial equivalence by comparing the Niagara™ catheter to the predicate device across various characteristics and in vitro performance data.

The table implicitly defines the performance characteristics being compared, and the "reported device performance" are the values listed for the Niagara™ Catheter. The "acceptance criteria" can be inferred as "being comparable to or better than the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify exact sample sizes for the "in vitro performance data." It refers to "bench testing" but doesn't provide the number of units tested for elongation, tensile strength, leakage, recirculation, maximum pressure, vacuum, or flow rate.
• Data Provenance: The studies were in vitro (bench testing). The submitter, Vas-Cath Incorporated, is located in Mississauga, Ontario, Canada. Therefore, the testing likely occurred in Canada or a facility contracted by them. The data is prospective as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the presented data. The studies are in vitro performance tests of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation. The "ground truth" for these tests would be the measurement results obtained from validated testing methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, these are objective in vitro measurements, not subjective evaluations requiring adjudication by experts.

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 submission concerns a physical medical device (catheter), not an AI-based system or diagnostic imaging. Therefore, no MRMC study was performed, nor is there any AI involvement.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the in vitro performance tests would be the measured physical and mechanical properties of the catheters, derived from standard engineering and materials testing methods. For example, a flow meter would provide the ground truth for flow rate, and a pressure gauge for maximum pressure. These are objective measurements rather than expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set or ground truth for a training set was used.

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The Ultraverse™ Small Vessel Peripheral Balloon Dilatation Catheters are recommended for use in the peripheral vascular system, in the following vessels: renal, tibial, popliteal, femoral, and peroneal. This catheter is not for use in coronary arteries. The device is for single use only and must not be resterilized or reused.

The Vas-Cath Ultraverse™ PTA Catheter is a duai lumen catheter with a balloon mounted on its distal tip. One lumen accomodates the insertion guidewire and the second provides a channel for inflation on the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.016 inch diameter guidewire. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature. The balloon inflates to the stated diameter and length at an 8 atmosphere operating pressure.

Here's a breakdown of the acceptance criteria and study information for the Ultraverse™ PTA Balloon Dilatation Catheters, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative manner as typically seen in modern regulatory submissions (e.g., "sensitivity must be > X%", "accuracy must be > Y%"). Instead, the acceptance criteria are implicitly defined by demonstrating that the new catheter sizes maintain the same performance characteristics as the predicate device (K925485). The "reported device performance" refers to the results of the tests conducted to confirm this consistency.

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

• Sample Size: The document does not specify the exact numerical sample sizes for each characteristic test. It generally states that "The additional balloon and shaft sizes proposed in this submission were tested for the following characteristics." This implies a sufficient number of units were tested to demonstrate consistency.
• Data Provenance: Not explicitly stated, but given the device manufacturer is Vas-Cath Incorporated from Canada, the testing likely occurred internally or at a contracted lab. The data is retrospective in the sense that it's a report of completed tests for this submission.

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

Not applicable. This device is a medical instrument (catheter), and its performance evaluation involves engineering and material testing, not subjective expert assessment of images or clinical outcomes to establish a "ground truth" in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation is based on objective measurements from engineering tests, not subjective interpretations requiring adjudication.

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

No. This is a medical device (catheter) for angioplasty, not an AI diagnostic algorithm. Therefore, an MRMC comparative effectiveness study involving human readers is not relevant.

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

No. This is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by engineering specifications, material properties, and established performance characteristics of the predicate device. For example, the "ground truth" for burst strength would be the pressure at which the balloon is designed to withstand before bursting. The comparison is made against known and accepted standards for such devices and the performance of the previously cleared predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. (See #8)

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The Opti-Plast® XL 5.5 F PTA Catheter is recommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.

The Vas-Cath Opti-Plast® XL 5.5 F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accomodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.035 inch diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labelled diameter and length at a 5 atmosphere operating pressure.

Here's an analysis of the provided text regarding the Opti-Plast® XL 5.5F PTA Catheter, addressing the requested information:

Analysis of Acceptance Criteria and Study for Opti-Plast® XL 5.5F PTA Catheter

Based on the provided 510(k) summary, the device is a medical catheter and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to its physical and functional performance, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the characteristics of the predicate device (Opti-Plast® PTA Catheter K933483) and industry standards for such devices. The "reported device performance" refers to the results of the bench testing.

Note: For the dimensional characteristics (e.g., balloon diameter, operating pressure), the Opti-Plast® XL is different from the specific 10mm predicate balloon but is being compared for its safety and effectiveness, likely falling within acceptable variations for its intended use or being equivalent to the Medi-tech® XXL™ Balloon Dilatation Catheter (K952063) for its indications. The key assertion is that the overall performance based on the bench tests is substantially equivalent.

2. Sample Size for the Test Set and Data Provenance

The provided text only explicitly mentions "Bench testing." This implies the "test set" consisted of physical samples of the Opti-Plast® XL 5.5F PTA Catheter undergoing various laboratory tests.

• Sample Size: The document does not specify the exact number of catheters tested for each characteristic.
• Data Provenance: The data provenance is laboratory-based bench testing of the manufactured device. It is not related to patient data or human subjects.

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

This question is not applicable to this type of device submission. For a medical device like a catheter, "ground truth" is established through engineering specifications, material standards, and performance metrics defined by regulatory bodies and industry best practices. There are no human experts determining a "ground truth" in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

This question is not applicable as the "test set" involves physical device testing against predefined engineering and performance standards, not human interpretation or consensus. No adjudication method is described or implied.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., medical images, AI algorithms). The Opti-Plast® XL 5.5F PTA Catheter is an interventional device; its performance is assessed through bench testing, not human reading of cases.

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

No, a standalone (algorithm-only) performance study was not done. This question is relevant for AI or software as a medical device (SaMD). The Opti-Plast® XL 5.5F PTA Catheter is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering specifications and design parameters: The device is designed to meet specific dimensions, material properties, and functional characteristics.
• Industry standards: Performance characteristics (e.g., burst pressure, fatigue) are likely evaluated against recognized ASTM or ISO standards for angioplasty catheters.
• Predicate device performance: The performance of the Opti-Plast® XL 5.5F PTA Catheter in bench tests is compared against the established performance of the legally marketed predicate device (Opti-Plast® PTA Catheter K933483) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are used for machine learning algorithms.

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

This question is not applicable as no training set exists for this type of device.

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