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Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.

This 510(k) clearance letter is for a medical device (Dorado™ PTA Balloon Dilatation Catheter), not an AI/Software as a Medical Device (SaMD).

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment) is not applicable to this document.

The document discusses the performance evaluation of a physical medical device, focusing on in vitro pre-clinical testing to demonstrate substantial equivalence to a predicate device. This includes:

• Performance Data: Trackability, Balloon Burst Strength, Balloon Fatigue, Sheath Compatibility, Dimensional Verification, Simulated Use, etc.
• Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility.

The acceptance criteria for this device would be engineering specifications and safety standards for balloon catheters, not statistical metrics for AI algorithm performance.

In summary, based on the provided document, I cannot answer the questions related to AI/SaMD acceptance criteria and study design. The document describes the clearance of a traditional physical medical device.

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The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

The provided FDA 510(k) Clearance Letter for the Aperta NSE PTA Balloon Dilatation Catheter describes a device that is substantially equivalent to a predicate device. This document does not contain acceptance criteria for performance of the device in a clinical setting (e.g., success rates, complication rates) nor does it describe a study proving such performance.

Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing (bench testing, biocompatibility, and packaging) in comparison to the predicate device. The acceptance criteria described are for these non-clinical tests.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, MRMC study, ground truth type, training set size) are not applicable to this document as it does not report on clinical performance or AI algorithm development.

Here's the information that can be extracted based on the provided document:

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

The document states that non-clinical testing was performed "After meeting all acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test or the detailed numerical "performance" results. It primarily indicates that the tests passed.

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

This information is not applicable as the document describes non-clinical (bench and lab-based) testing, not a clinical study on a test set of patient data.

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 information is not applicable as the document describes non-clinical testing.

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

This information is not applicable as the document describes non-clinical testing.

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

A MRMC comparative effectiveness study was not reported. This document is for a medical device (a catheter), not an AI-powered diagnostic tool.

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

This information is not applicable as the document is for a medical device (a catheter), not an AI algorithm.

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

For the non-clinical tests, the "ground truth" would be established by the expected performance characteristics based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and the predicate device's performance. For biocompatibility, it's based on established biological safety endpoints. The document does not specify the exact methods for establishing these "truths" for each individual test, but implies adherence to the FDA Guidance Document titled "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters issued on April 14, 2023."

8. The sample size for the training set

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm requiring a training set.

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

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm.

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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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The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.

The provided text is an FDA 510(k) clearance letter and its associated summary for a medical device: the "Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and rigorous statistical validation against predefined acceptance criteria.

Therefore, the information regarding acceptance criteria, study design for proving device performance, sample sizes for test sets, establishment of ground truth, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth for training data is not present in the provided text.

The document primarily outlines:

• Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion for this 510(k) submission is that the device must be shown to be "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use, similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: Instead of a detailed table of acceptance criteria and performance against them, the document lists bench tests performed to demonstrate that the small changes (expanded matrix of balloon sizes) compared to the predicate device do not compromise safety or effectiveness.

Here's a breakdown of what is available and what is missing from your request based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics in a table. The overall acceptance criterion is "substantial equivalence" to the predicate.

• Reported Device Performance: The document lists bench tests performed, indicating that the results "demonstrate that the technological differences identified do not raise new questions of safety or effectiveness." Specific quantitative results or acceptance criteria for these bench tests are not provided.

  Performed Bench Tests (as listed):

  • Rated burst pressure (RBP)
  • Inflation & deflation time
  • Balloon diameters at nominal pressure to RBP
  • Simulated use - Pushability & Trackability & Sheath Compatibility
  • Coating integrity (b)
  • Multiple inflation/fatigue & leak test
  • Tensile strength Balloon to Shaft (proximal bond)
  • Particulate
  • Balloon Length & Marker Band Position (Leveraged from predicate)
  • Radiopacity (Leveraged from predicate)
  • Ancillary Tool Compatibility (Guidewire) (Leveraged from predicate)
  • Catheter Effective Length (Leveraged from predicate)
  • Tensile Strength Manifold to Shaft (Manifold Bond) (Leveraged from predicate)
  • Tensile Strength (Distal / Tip Bond) (Leveraged from predicate)
  • Tip Profile (Geometry of the catheter most distal tip) (Leveraged from predicate)
  • Simulated Use, Push & Track (Leveraged from predicate)
  • Flexibility & Kink (Leveraged from predicate)
  • Coating Lubricity (Leveraged from predicate)
  • Coating Integrity (a) (Leveraged from predicate)
  • Torque Strength (Leveraged from predicate)

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

• Sample Sizes: Not specified. This document refers to bench testing of a medical device, which typically involves a number of units tested to engineering specifications, but these numbers are not disclosed.
• Data Provenance: The tests are bench tests, not clinical data, so country of origin/retrospective/prospective doesn't apply in the same way. The manufacturer is based in Ireland (Creagh Medical Ltd. dba Surmodics, Inc.).

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 part of a bench test evaluation for a substantial equivalence determination. Experts are not typically used to establish "ground truth" for physical device performance metrics like burst pressure.

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

• Not applicable to bench testing.

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 MRMC study was done. This device is a physical catheter, not an AI/software device that assists human readers.
• The document explicitly states: "No clinical studies were required for the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter."

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

• Not applicable as it's not an AI/software device.

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

• Not applicable. Performance is measured against engineering specifications and industry standards for physical device properties, not against "ground truth" derived from clinical data or expert consensus.

8. The sample size for the training set

• Not applicable; there is no training set for a physical medical device. (This is relevant for AI models).

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

• Not applicable; there is no training set.

In summary, the provided FDA document is a 510(k) clearance letter for a physical medical device, based on demonstrated "substantial equivalence" through bench testing, not clinical studies or AI model validation. Therefore, most of the detailed information requested regarding clinical study design, data characteristics, expert involvement, and AI model evaluation (points 2-9) is not found in this type of submission.

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The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature.

The Sterling Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semicompliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in to facilitate advancement of the catheter to and through the stenosis to be dilated. The product's catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The effective length of the balloon catheter is 200 cm; catheter markers indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm).

This document is a 510(k) summary for a medical device called the Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter. It seeks to demonstrate substantial equivalence to a predicate device.

The provided text does not contain information related to an AI/ML device or its performance criteria. Therefore, I cannot furnish the requested details regarding acceptance criteria, study methodologies for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document focuses on the bench testing performed to demonstrate substantial equivalence for this physical medical device (a balloon catheter), not a software or AI/ML product. The performance data section explicitly lists:

• Sterilization Testing
• Bench Testing (Dimensional Verification, Simulated Use, Balloon Inflation & Deflation Time, Catheter Bond Strength, Flexibility & Kink test, Torque Strength, Shaft & Bond Burst, Catheter Extension & Deflation, Packaging Testing, Design Validation Testing)

These are typical tests for a physical medical device to ensure its mechanical properties, function, and safety, not for evaluating an AI algorithm's diagnostic or predictive capabilities.

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The JADE PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for postdilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications with Over-The-Wire (OTW) structure. The overthe-wire design permits the use of standard 0.014 inch, 0.018 inch and 0.035 inch guidewires respectively.

This document is a 510(k) summary for the JADE PLUS PTA Balloon Dilatation Catheter. It does not describe an AI/ML powered device, therefore the requested information for acceptance criteria and studies are not applicable in the context of an AI/ML device.

The document discusses the substantial equivalence of the JADE PLUS PTA Balloon Dilatation Catheter to a predicate device, based on in vitro performance tests. The acceptance criteria and reported device performance mentioned relate to physical properties and functionality of the catheter, not to an AI algorithm's performance or accuracy.

The relevant information from the document is related to the device's physical performance testing:

Acceptance Criteria and Reported Device Performance:

The document states that "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the JADE PLUS PTA Balloon Dilatation Catheter design and construction are suitable for their intended use."

The specific performance tests conducted and the general nature of their acceptance criteria are listed:

The study that proves the device meets acceptance criteria is an in vitro performance test study conducted on the subject device in accordance with FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters" issued on April 14, 2023.

Given that this is a 510(k) summary for a physical medical device (balloon dilatation catheter) and not an AI/ML powered device, the following points are not applicable and therefore cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

This document is a 510(k) premarket notification for a medical device called the Aperta NSE PTA Balloon Dilatation Catheter. It is important to note that this submission does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device. The device described is a physical medical device (a balloon catheter), and the studies mentioned are non-clinical (bench and animal testing).

Therefore, I cannot provide the information requested in the format of AI/ML device acceptance criteria and study details. The document does not describe an AI/ML device or its associated performance metrics, test sets, ground truth, or human-in-the-loop studies.

Instead, the document details the non-clinical testing performed for the physical medical device to demonstrate its substantial equivalence to a predicate device. If you are interested in the "acceptance criteria" and "study" as presented in this specific document for the physical device, here's an interpretation:

The acceptance criteria are implicitly defined by the successful completion of the listed non-clinical tests in accordance with relevant FDA guidance and standards. The "study" refers to the entire body of non-clinical testing.

Here's a breakdown of what is available in the document regarding the physical device's non-clinical studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests performed. The "reported device performance" is summarized by the statement: "After meeting all acceptance criteria, non-clinical testing has demonstrated that the Aperta NSE PTA is substantially equivalent to the predicate." This implies that the device successfully passed all specified tests according to predefined thresholds (acceptance criteria), though the specific numerical thresholds for each test are not explicitly detailed in this summary.

2. Sample Size for Test Set and Data Provenance:

• Bench Testing: Sample sizes are not specified in this summary. The tests are typically conducted in a laboratory setting.
• Animal Testing: A "porcine peripheral artery model" was used for acute (Day 0) and chronic (Day 30) safety evaluation. The number of animals (sample size) is not specified. This is prospective data generated for the submission. The "country of origin of the data" is not specified but would be from the performing lab/facility.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
Not applicable. For a physical device, "ground truth" typically refers to established engineering specifications, material properties, and biological responses observed in animal models, rather than expert consensus on data interpretation.

4. Adjudication Method for the Test Set:
Not applicable. This is typically used for clinical trials or image interpretation studies, not for bench and animal testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is relevant for AI/ML diagnostic tools with human readers, which is not what this device is.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is based on:

• Established engineering specifications and design tolerances for physical properties and dimensions.
• Industry standards and FDA guidance for biocompatibility.
• Observed biological responses and safety endpoints in an animal model.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set for an AI/ML algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device (balloon catheter) and outlines its non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than the acceptance criteria and study details for an AI/ML product.

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The HP PTA Balloon Dilation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, popliteal, tibial, peroneal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

This catheter is not for use in coronary arteries.

The 0.0350" HP PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, double-lumen tube, stress diffusion tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to different dimensions by inflating to different pressures. The soft tip at the end of the balloon is intended to make the balloon catheter more easy to push to the stenosis position. The inner tube which connects to the tip tube is for guide wire passage and the pushing rod. The two marker bands wrapped around the inner tube are for positioning the balloon location with the use of in vitro monitoring equipment. The proximal end of the double-lumen tube is connected with the hub, which is used as the balloon filling channel and also as the push rod of the catheter. The hub is used to connect with the external pressure equipment for balloon filling. The stress diffusion tube can prevent the double-lumen tube from being folded.

The provided text is a 510(k) Summary for the HP PTA Balloon Dilatation Catheter (K231402). It outlines the device description, indications for use, technological characteristics, and performance data from bench and biocompatibility testing. The document states that the device met all acceptance criteria, but it does not contain information about a clinical study involving human patients or a standalone AI algorithm. Therefore, I cannot provide details on sample size for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, or ground truth establishment for such studies.

Here's the information that can be extracted from the provided text regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020)."

Below are the types of tests performed and the general statement of compliance, as specific numerical acceptance criteria and performance results for each test are not detailed in this summary.

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 approval is based on bench and biocompatibility testing, not human clinical data.

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. Ground truth from human experts is not relevant for bench and biocompatibility testing. The "ground truth" for these tests comes from established engineering and biological standards and methodologies.

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

• Not applicable. Adjudication methods are used in clinical studies with expert reviewers, not for bench and biocompatibility testing.

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 device is a physical medical device (balloon catheter), not an AI-powered diagnostic software.

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

• Not applicable. This is not an AI algorithm.

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

• The ground truth for the bench testing is based on established engineering principles, material science standards, and performance specifications derived from relevant FDA guidance documents and industry standards (e.g., ISO, ASTM). For biocompatibility, the ground truth refers to compliance with international standards such as ISO 10993-1 and ASTM F2888-19, which define acceptable biological responses and safety profiles for medical device materials.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable. This is not an AI algorithm requiring a training set.

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The Finesse Injectable™ PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Finesse InjectableTM PTA Balloon Dilatation Catheter is an over-the-wire balloon catheter for peripheral indications. The device features a semi-compliant balloon combined with a low-profile tip. The catheter is compatible with 0.014" (0.36 mm) guidewires and has a hydrophilic coating over its distal coaxial segment to facilitate advancement of the catheter to the treatment site. The Finesse Injectable™ PTA Balloon Dilatation Catheter has a working length of 150 cm, and is available with balloon working lengths of 20, 40, 60, 100, and 225 mm. There are two radiopaque marker bands located within the balloon working length (one proximal and one distal). These radiopaque marker bands, in conjunction with fluoroscopy, aid in the placement of the catheter's balloon segment. There is one additional radiopaque marker located distal of the exit holes to aid in locating their position relative to a guiding sheath distal tip. The catheter construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the guidewire and injection of fluids via the catheter's exit holes that are positioned proximal to the balloon. The proximal portion of the catheter comprises a hub that includes an extension tube with a female luer-lock port connected to a balloon inflation/deflation lumen, and a stopcock with female luer-lock port for fluid/contrast injection attached to the side port of a Touhy-Borst adapter that is in communication with the guidewire lumen.

The Finesse™ Injectable PTA Balloon Dilatation Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria for each test. However, it states that "Results from all tests were acceptable" and that the data "demonstrate that the Finesse Injectable™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate devices."

Based on the information provided, a table of acceptance criteria and reported device performance would look like this:

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

The document does not explicitly state the sample sizes used for each specific test mentioned under "Performance Data." It refers to "Design verification and validation" and "the following tests were conducted," implying a series of laboratory and bench tests.

• Sample size: Not specified.
• Data provenance: The performance data is generated through "Design verification and validation" testing. This typically implies prospective, internal laboratory testing conducted by the manufacturer (Summa Therapeutics, LLC). There is no indication of country of origin for the data or if it was retrospective.

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

This information is not applicable. The study is a device performance evaluation (bench testing and biocompatibility), not a clinical study involving the establishment of ground truth by experts for diagnostic or treatment effectiveness.

4. Adjudication method for the test set:

This information is not applicable, as it is a device performance study and not a study requiring expert adjudication of clinical outcomes or images.

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:

This information is not applicable. This is a 510(k) submission for a physical medical device (balloon catheter), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

This information is not applicable, as the device is not an algorithm or AI system.

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

This information is not applicable in the context of this device performance study. The "ground truth" for this device's evaluation is defined by engineering specifications, material standards, and established test methodologies for evaluating the physical and mechanical properties of balloon catheters and their biological safety.

8. The sample size for the training set:

This information is not applicable. This is a device performance study, not a machine learning or AI algorithm development that would involve training sets.

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

This information is not applicable, as there is no training set for this type of device submission.

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