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The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The BrosMed Medical Co., Ltd.'s Parafleet SC 014, Parafleet SC 018, and Parafleet SC 035 PTA Balloon Dilatation Catheters underwent various performance tests to ensure substantial equivalence to predicate devices and suitability for their intended use.

1. Acceptance Criteria and Reported Device Performance:

The document lists several performance tests conducted, implying that the acceptance criteria for these tests were met to demonstrate substantial equivalence. The reported device performance is that "The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use."

While specific numerical acceptance criteria and precise performance values are not provided in the summary, the general categories of tests and their "met" status serve as the reported performance against inferred acceptance criteria derived from FDA guidance and predicate device characteristics.

Here’s a table summarizing the types of tests (representing categories of acceptance criteria) and the reported performance:

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

The document does not specify the exact sample sizes used for each of the performance tests. The data provenance (e.g., country of origin, retrospective/prospective) for these tests is also not explicitly stated in the provided text. However, it's typical for such bench and biocompatibility tests to be conducted in a laboratory setting by the manufacturer (BrosMed Medical Co., Ltd. in China) or a contract research organization.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable to the provided document. The submission pertains to a medical device's performance characteristics (e.g., mechanical, material, biocompatibility) rather than an AI/ML-driven diagnostic or prognostic device that would require expert-established ground truth for interpretation of images or patient data. The tests performed are objective, physical, and chemical evaluations.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. No subjective interpretation requiring adjudication is mentioned for the performance testing of these physical medical devices.

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

This section is not applicable as the device is a PTA Balloon Dilatation Catheter, not an AI-assisted diagnostic tool. Therefore, there is no human-in-the-loop performance or comparison with AI assistance.

6. Standalone Performance (Algorithm Only):

This section is not applicable as the device is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests in this context is established by objective engineering specifications, material standards, and regulatory guidance documents (e.g., FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff' and ISO 10993-1 for biocompatibility).

For example:

• Dimensional verification checks against the device's design specifications.
• Balloon Rated Burst Pressure tests against the manufacturer's specified burst pressure and regulatory safety limits.
• Biocompatibility testing assesses against established biological safety endpoints defined by ISO standards.

8. Sample Size for the Training Set:

This section is not applicable as the device is a physical medical device and does not involve machine learning or a "training set."

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

This section is not applicable for the same reasons as point 8.

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Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the illac, femoral, iliofemoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Tri-Wedge PTA Scoring Balloon Dilatation Catheter is an over-the-wire (OTW) peripheral balloon dilatation catheter. The catheter working length is 50cm, 75cm, 90cm and 150cm. Balloon diameters range from 3.0mm to 8.0mm. The balloon is made of a minimally compliant material with rated burst pressure of 20atm for Ø3.0-6.0mm and 16atm for Ø7.0-8.0mm. A coaxial double lumen catheter for balloon inflation and guide wire insertion is bonded to a female luer connector to form the proximal shaft. The balloon and the coaxial double lumen are welded to compose the distal of the catheter surface is coated with hydrophilic coating from the tip to the distal shaft. A scoring element with three parallel struts wraps around the balloon has radiopaque markers for positioning the balloon relative to the stenosis. The guide wire lumen is compatible with a standard 0.018-inch or 0.035-inch guide wire that enters from the catheter and extends out from the hub. The catheter is sterilized with EO and for single use only.

The provided text describes a 510(k) summary for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results typical of drug approvals or novel device PMAs. The document focuses on bench testing and an animal study. Therefore, some of the requested information, particularly regarding human clinical trial data (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details for AI), is not applicable or available in this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "The test results met all acceptance criteria," but it does not provide a table detailing specific numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests performed.

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

• Test Set (Bench Testing): The document does not specify the exact sample sizes (N) for each individual bench test. It mentions that "Standard bench performance tests were conducted."
• Test Set (Animal Study): The document refers to "the test group and the control group" in the animal study, but the specific sample size (number of animals) for each group is not provided.
• Data Provenance: Not specified in the document. Likely refers to internal laboratory testing conducted by BrosMed Medical Co., Ltd.

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

Not applicable. The reported studies are bench tests and an animal study, which do not typically involve human expert adjudication for ground truth in the same way clinical trials for diagnostic devices do.

4. Adjudication Method for the Test Set

Not applicable for bench and animal studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a physical medical device (scoring balloon catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

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

7. The Type of Ground Truth Used

• Bench Testing: The "ground truth" would be established by the specifications and engineering requirements for the device. For example, a balloon's rated burst pressure is a predefined specification the device must meet.
• Animal Study: The "ground truth" for the animal study (safety evaluation) was based on histological examination for inflammation, injury, and endothelialization scores, as well as observations of device performance (passage, dilation, withdrawal, coordination).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary of Device Acceptance Criteria and Study Findings (Based on Provided Text):

The acceptance criteria for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter were met through a series of bench tests and an animal study.

Conclusion from the document: The studies demonstrated that the Tri-Wedge PTA Scoring Balloon Dilatation Catheter met all acceptance criteria, showing substantial equivalence to the predicate device and raising no new questions of safety or effectiveness.

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The POT PTCA balloon dilatation catheter is indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
• balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only)

Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible Nylon balloon at its distal tip. It is typically a rapid exchange (Rx) type with a single-lumen catheter. It is a single-use device and available in various sizes.

Based on the provided text, the document is a 510(k) summary for the "POT PTCA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report with specific acceptance criteria, sample sizes, and expert adjudication for a novel AI/software device. As such, most of the requested information regarding an AI/ML device's acceptance criteria and study proving its performance is not present in this document.

However, I can extract the information related to performance testing for this physical medical device (a balloon catheter) and note the absence of data pertinent to AI/ML device evaluations.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (for the physical device, not AI/ML):

The document mentions that bench testing was performed and met all acceptance criteria. However, it does not explicitly list the specific numerical acceptance criteria for each test. It only states that the tests demonstrated the device performed as intended and did not impact functionality.

Information NOT available in the document, as it pertains to AI/ML device studies, not physical medical devices like this one:

1. Sample sizes used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here refers to physical bench tests, not a dataset for an algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering specifications and standardized testing, not expert consensus as in image interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its physical properties and mechanical performance, established by engineering standards and measurements.
7. The sample size for the training set: Not applicable (no AI/ML training involved).
8. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document (for a physical medical device):

• Device Name: POT PTCA Balloon Dilatation Catheter
• Purpose: To demonstrate substantial equivalence to a predicate device (Apollo Balloon Dilatation Catheter K133852 & K153742). This is a 510(k) submission for a physical medical device, not an AI/ML software.
• Study Type: Bench testing (in vitro) to assess physical characteristics and performance.
• Tests Performed:
  • Dimensional verification
  • Simulated Use
  • Balloon Rated Burst Pressure
  • Balloon Fatigue
  • Balloon Compliance
  • Balloon Inflation and Deflation Time
  • Balloon Burst (in stent)
  • Balloon Fatigue (in stent)
• Result of Tests: "In vitro bench testing met all acceptance criteria and demonstrated that the subject device performed as intended and did not impact the functionality of the device."
• Ground Truth (for this device): The ground truth for performance of this physical device is based on engineering specifications, recognized standards, and comparison to the predicate device's established performance.

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The balloon dilatation catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, poplited, tibial, peroneal, subclavian and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Tiche is an Over the Wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The device features a low profile balloon and tip. The working length of the catheter range from 40cm-135cm. A hydrophilic coating is applied from the distal shaft. The balloon dilatation catheter features a dual lumen shaft ending in a Y-hub manifold. The balloon has two radiopaque markers for positioning the balloon relative to the stenoses. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text describes the 510(k) summary for the Tiche PTA Balloon Dilatation Catheter. It outlines the device's technical specifications, intended use, and the performance testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain acceptance criteria for an AI/ML device, nor does it describe a study involving AI assistance for human readers, a standalone AI algorithm performance study, or a multi-reader multi-case (MRMC) comparative effectiveness study.

The document pertains to a traditional medical device (a balloon dilatation catheter) and the performance testing described is related to the physical and functional characteristics of this hardware device, not to the performance of an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance for an AI/ML device. The document discusses acceptance criteria for bench testing of the catheter (e.g., dimensional verification, balloon rated burst pressure, biocompatibility), and states that "The test results met all acceptance criteria." However, these are not relevant to AI/ML performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document details the following for the Tiche PTA Balloon Dilatation Catheter:

• Acceptance Criteria and Reported Device Performance: The document states that "The test results met all acceptance criteria." These criteria relate to various bench tests including:

  • Dimensional verification
  • Simulated Use
  • Balloon Rated Burst Pressure
  • Balloon Fatigue & Compliance
  • Balloon Inflation and Deflation Time
  • Catheter Bond Strength
  • Tip Pull Strength
  • Flexibility and Kinking
  • Torque Strength
  • Radiopacity
  • Coating Friction & Integrity
  • Particulate Evaluation
  • Catheter Body Bust Pressure
  • Balloon Rated Burst Pressure (in stent)
  • Balloon Fatigue (in stent)
  • Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity, Genotoxicity)
  • Sterilization Packaging and Shelf Life

  The performance reported for all these tests is that they "met all acceptance criteria."

The request specifically asks for information related to an AI/ML device, which is not what the provided document describes.

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The Artimes pro Balloon Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery in patients with myocardial ischemia.

The Artimes pro (Rx type) device is a coronary dilatation catheter designed for easy guidewire exchange. The catheter working length is 140cm. Lubricious coatings are applied to the distal section. Balloon diameters range from 1.0mm to 1.25mm. The balloon material is made of a semi-compliant material for diameter 1.0mm to 1.25mm with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube with a wire. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. The catheter has one radiopaque platinum/iridium marker band. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guide wire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is a 510(k) clearance letter for a medical device, specifically the Artimes pro Balloon Dilatation Catheter. It outlines the regulatory approval process and states that the device has been found substantially equivalent to predicate devices. However, this document does not contain the specific details about the acceptance criteria and the comprehensive study results as typically required for an AI/ML-based device.

The "study" mentioned in the document is a Good Clinical Practice (GCP) clinical study for the physical medical device (catheter), not a study assessing the performance of an AI/ML algorithm. Therefore, many of the requested points related to AI/ML device evaluation (like ground truth establishment, expert adjudication, MRMC studies, etc.) are not applicable to the information contained within this document.

Here's a breakdown of the information that can be extracted, and where the requested information is not present in this document:

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

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 (Clinical Study): Sixty (60) study subjects and sixty-one (61) target lesions.
• Data Provenance: Not specified in this document (e.g., country of origin, retrospective/prospective). However, the mention of "GCP clinical study" implies it was prospective data collected under Good Clinical Practice guidelines.

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 / Not present in the document. This document describes a physical medical device, not an AI/ML system requiring expert-established ground truth for a test set. This type of information would be relevant for devices that use AI to interpret medical images or data.

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

• Not applicable / Not present in the document. Adjudication methods are typically used when multiple experts review data for the purpose of establishing ground truth for AI algorithms. This document doesn't pertain to an AI algorithm.

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 / Not present in the document. MRMC studies are specific to evaluating AI/ML systems that assist human readers in tasks like image interpretation. This document is about a physical catheter.

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

• Not applicable / Not present in the document. This document is for a physical medical device, not an AI algorithm.

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

• For the clinical study: The "effectiveness" of the catheter would likely be assessed based on clinical outcomes relevant to balloon dilatation, such as successful dilatation of the stenotic portion of a coronary artery and improved myocardial perfusion, which would be observed during the procedure and in follow-up. This is a form of outcomes data or clinical assessment rather than expert consensus on images.

8. The sample size for the training set

• Not applicable / Not present in the document. There is no mention of a "training set" as this is not an AI/ML device. The "training set" concept is relevant for machine learning model development.

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

• Not applicable / Not present in the document. As above, no AI/ML training set is mentioned or implied.

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The balloon dilatation catheter is intended to dilate stenoral, iliofemoral, 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 dilatation post-deployment in the peripheral vasculature.

The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC (0.035") PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The catheter working length is 70, 90 and 150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work length range from 10mm to 150mm. The three PTA balloon dilatation catheters are filed in one 510(k) submission due to the similar/equivalent construction and identical material of the products. The comparison of them was summarized in Table 1. The differences only exist in the guide wire compatibility and the balloon configuration which have been controlled by the Design Verification. The balloon material is made of a non-compliant Nylon material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The three products of the non-compliant PTA (OTW type) balloon catheter family have different diameter of the guide wire port from max.0.014" to 0.035". The guide wire compatibility was shown in table 1. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is a 510(k) summary for the BrosMed Medical Co., Ltd.'s Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters. This document details the regulatory approval process for a medical device by demonstrating its substantial equivalence to previously cleared predicate devices.

It is crucial to understand that this document describes the acceptance criteria and study results for a medical device (balloon dilatation catheters), NOT for an Artificial Intelligence (AI) device. The questions posed in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance) are highly specific to AI/Machine Learning model evaluations, which are not applicable to the traditional medical device approval process described here.

Therefore, I cannot directly answer your questions as they relate to AI. However, I can extract the information relevant to the device's performance and acceptance criteria as presented in a traditional medical device context:

Here's a breakdown of the acceptance criteria and performance as described for these PTA Balloon Dilatation Catheters, framed as closely as possible to your request, while acknowledging the inherent differences:

The study conducted was a series of in-vitro performance tests and biocompatibility tests to demonstrate that the device meets predetermined acceptance criteria and is substantially equivalent to predicate devices. There is no mention of an "AI" component, data sets for training/testing AI models, or human expert consensus for "ground truth" derived from imaging.

Acceptance Criteria and Reported Device Performance (Table)

For a medical device like a balloon dilatation catheter, acceptance criteria are typically engineering specifications, material properties, and functional performance benchmarks. The document states that "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." Specific numerical acceptance criteria are not detailed in this public summary, but the types of tests conducted demonstrate the areas where performance was evaluated.

Specific parameters evaluated include: |
| Dimensional Verification | Met acceptance criteria. |
| Balloon Preparation | Met acceptance criteria. |
| Deployment & Retraction | Met acceptance criteria. |
| Balloon Rated Burst Pressure | Met acceptance criteria. (Rated Burst Pressure (RBP) stated as 18, 20, 22 atm for all models). The actual test result met or exceeded this. |
| Balloon Fatigue | Met acceptance criteria. |
| Balloon Compliance | Met acceptance criteria. |
| Balloon Inflation/Deflation | Met acceptance criteria. |
| Catheter Bond Strength | Met acceptance criteria. |
| Tip Pull Strength | Met acceptance criteria. |
| Flexibility & Kinking | Met acceptance criteria. |
| Torque Strength | Met acceptance criteria. |
| Radiopacity | Met acceptance criteria. |
| Coating Integrity | Met acceptance criteria. |
| Particulate Evaluation | Met acceptance criteria. |
| Balloon Burst (in stents) | Met acceptance criteria. |
| Balloon Fatigue (in stents) | Met acceptance criteria. |
| Biocompatibility | "The test results met all acceptance criteria..." Again, specific quantitative details are not provided, but the umbrella statement indicates successful performance.

Specific tests include: |
| Cytotoxicity | Met acceptance criteria. |
| Sensitization | Met acceptance criteria. |
| Hemocompatibility | Met acceptance criteria. |
| Pyrogenicity | Met acceptance criteria. |
| Acute Systemic Toxicity | Met acceptance criteria. |
| Intracutaneous Reactivity | Met acceptance criteria. |
| Genotoxicity | Met acceptance criteria (bacterial mutagenicity and in vitro mouse lymphoma). |

Since the device is a physical medical instrument and not an AI algorithm, most of your specific AI-related questions (2-9) are not directly applicable. However, I can provide the closest equivalent information from the document:

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

• Sample Size: The document does not specify exact sample sizes for each in-vitro or biocompatibility test. It generally states that "tests were conducted on the PTA balloon catheter." For physical device testing, sample sizes are typically determined by engineering and statistical principles to ensure sufficient data for reliability and statistical significance, but these are not disclosed in this summary.
• Data Provenance: The tests are performed by the manufacturer, BrosMed Medical Co., Ltd., based in Dongguan, China. The data originates from these internal, pre-market validation studies. All tests are inherently "prospective" in the sense that they are designed and executed to specifically test the device's performance against predefined criteria.

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

• This question is not applicable. "Ground truth" in the context of this device refers to objective measurements and adherence to engineering specifications and biological safety standards (e.g., a balloon bursting at or above its rated pressure, or a material not causing a cytotoxic reaction). There is no "expert consensus" in the sense of human interpretation of complex medical data for performance claims, as would be the case for an AI diagnostic tool.

4. Adjudication Method for the Test Set:

• This question is not applicable. Performance is based on objective measurements against engineering specifications and validated test methods, not on human interpretation or adjudication.

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

• No, an MRMC study was NOT done. This type of study is specific to evaluating diagnostic tools (often imaging-based AI) where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. This is not relevant for a balloon dilatation catheter.

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

• This question is not applicable as there is no algorithm or AI component to this device. Its performance is inherent to its physical design, materials, and manufacturing.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance validation is established through:
  • Engineering Specifications: Predefined performance metrics (e.g., burst pressure, dimensions, flexibility) that the device must meet.
  • Validated Test Methods: Adherence to recognized national and international standards for medical device testing.
  • Biocompatibility Standards: Compliance with established biological safety requirements for materials in contact with the human body.
  • Comparison to Predicate Devices: Demonstrating "substantial equivalence" means showing that the device performs similarly to or better than existing, legally marketed devices.

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. The device is designed, manufactured, and then validated through testing.

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

• This question is not applicable for the reasons stated above.

In summary, the provided document is a regulatory submission for a conventional medical device, not an AI/ML algorithm. The acceptance criteria revolve around the physical and biological performance of the catheter, and the "study" consists of a battery of engineering and biocompatibility tests designed to prove its safety and effectiveness relative to existing predicate devices.

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The balloon dilatation catheter is indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
• balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

The Apollo Balloon Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guidewire. Balloon diameters range from 2.0mm to 5.0mm. The balloon material is made of a minimally compliant material with a rated burst pressure of 22 atmospheres for Ø2.0- 4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively. The minimally compliant balloon material will allow high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube of nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm in length located on the proximal shaft, indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text describes a 510(k) summary for the Apollo Balloon Dilatation Catheter, a medical device. The information details the device's technical characteristics and performance data, but it does not describe a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop performance study.

Instead, the performance data section summarizes in vitro bench tests for the physical characteristics of the catheter. This is a very different type of study than what would be described for an AI-powered diagnostic device.

Therefore, many of the requested details, such as the sample size for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details, are not applicable to this document as it concerns an entirely different type of medical device evaluation.

However, I can extract the acceptance criteria and the reported device performance for the physical properties of the catheter as described.

Here's the information based on the provided text, while acknowledging that it does not correspond to an AI performance study:

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

Regarding the remaining points, they are not applicable because this document describes the evaluation of a physical medical device (catheter) through bench testing, not an AI/software-based diagnostic system.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" refers to physical samples of the catheter for in vitro bench testing, not a dataset of patient information. The document does not specify the number of catheters tested for each performance characteristic.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be engineering specifications and measurements, verified by qualified engineers or lab personnel.
4. Adjudication method: Not applicable. Bench testing relies on objective measurements against engineering specifications.
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 for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical characteristics, the ground truth would be established engineering specifications, material properties, and physical measurements (e.g., precise dimensions, burst pressures, bond strengths).
8. The sample size for the training set: Not applicable. This device is evaluated via physical bench testing, not machine learning model training.
9. How the ground truth for the training set was established: Not applicable.

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The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, 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 dilatation post-deployment in the peripheral vasculature.

The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters are over-the-wire (OTW) peripheral balloon catheters designed for Percutaneous Transluminal Angioplasty (PTA). These three PTA balloon dilatation catheters have been bundled in one 510(k) submission due to the similar/equivalent construction and identical material of the products. As summarized by the comparison between the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters in Table 1, the devices only differ in guidewire compatibility, balloon diameter, and balloon length. The devices are offered with catheter working lengths of 70, 90 and 150 cm. The guidewire compatibility includes 0.014" for the Polux device, 0.018" for the Minerva device and 0.035" for the Atropos device. The balloon diameters range from 1.5 mm to 10.0 mm, with balloon working lengths ranging from 5 mm to 200 mm. The balloon material is made of a semi-compliant Pebax material and offered in diameters 1.5 mm to 10.0 mm with a rated burst pressure of 14 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter depending on the pressure delivered. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

This document describes the BrosMed Medical Co., Ltd. Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters and their substantial equivalence to predicate devices. It does not contain information about an AI/ML device. Therefore, I cannot provide a response based on the request's specific requirements concerning AI/ML performance.

However, I can extract the acceptance criteria and study information related to the device performance of these balloon catheters, as presented in the provided text.

Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

The document primarily focuses on demonstrating the substantial equivalence of the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters to existing predicate devices (NanoCross Elite, Sterling, Mustang Balloon Dilatation Catheters). The "Performance Data" section summarizes the testing conducted to ensure the device's suitability for its intended use.

Here's a table based on the provided text, outlining the types of performance tests conducted and the general outcome:

Missing Information (Relevant to AI/ML, but not present in the document):

1. Sample size used for the test set and data provenance: Not applicable as this is not an AI/ML device or study. The document states "test results met all acceptance criteria" but does not detail sample sizes for the various performance and biocompatibility tests.
2. Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images) is not relevant here. The "ground truth" for these tests would be established by industry standards, engineering specifications, or biological assay controls.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
5. Standalone (algorithm only) performance: Not applicable.
6. Type of ground truth used: For this type of medical device, the "ground truth" for performance evaluations typically refers to established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards for medical devices, FDA guidance documents). For biocompatibility, it's based on established biological assays and toxicology principles.
7. Sample size for the training set: Not applicable as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study per the Document:

The document describes a 510(k) submission for PTA balloon dilatation catheters. The study conducted was a series of "in vitro performance tests" and "biocompatibility tests". These tests were designed to evaluate the physical characteristics, functional performance, and biological safety of the Polux, Minerva, and Atropos catheters. The overall conclusion is that the "test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." The intent was to demonstrate substantial equivalence to legally marketed predicate devices, not to benchmark the performance of an AI model.

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