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The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash PTA Balloon Dilatation Catheter is designed for dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

This document describes the acceptance criteria and the study conducted for the Flash PTA Balloon Dilatation Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The study described is a series of in-vitro performance bench tests and biocompatibility tests. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size in terms of clinical cases is not applicable here. The samples for these tests would be physical devices or materials, not patient data.

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

Not applicable. The "ground truth" for the in-vitro and biocompatibility tests would be established through predefined scientific and engineering specifications, and validated laboratory methodologies, rather than human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance criteria are based on pre-defined specifications and validated laboratory testing, not human-reviewed clinical cases that would require adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory (in-vitro) and biocompatibility testing, not clinical studies involving human readers or patient cases.

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 (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

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

• Established Scientific and Engineering Specifications: For the in-vitro performance bench testing, the device's performance characteristics (e.g., burst pressure, inflation/deflation time, fatigue) must meet predetermined quantitative and qualitative standards.
• Regulatory Standards and Guidelines: For biocompatibility, the ground truth is defined by compliance with international standards such as ISO-10993 and FDA guidelines (e.g., Blue Book Memorandum May 1, 1995) which specify acceptable biological responses to the device materials.

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, as no training set was used.

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The GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, 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 GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial svstem and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.

Here's a breakdown of the acceptance criteria and study information for the GPSCath™ Balloon Dilatation Catheter, based on the provided document:

Acceptance Criteria and Device Performance

The document states that the purpose of the Special 510(k) is to revise the Instructions for Use (IFU) to illustrate a new balloon rated burst pressure and compliance table. This implies that the acceptance criteria are related to these physical properties and that the device performance met the new, higher specifications. While the exact numerical values for the original and new rated burst pressures, compliance, and other performance criteria are not explicitly detailed in a table, the document confirms that the device met them.

Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Details

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

   • Sample Size: Not explicitly stated in the document. The document mentions "bench top testing" but does not give specific numbers of devices or balloons tested for each criterion.
   • Data Provenance: The studies were "in vitro test data" and "bench top tests." This means the data was generated in a lab setting, not from human or animal subjects. The country of origin of the data is implied to be within the US, as Hotspur Technologies, Inc. is located in Mountain View, CA, and submitted the notification to the FDA.

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

   • This section is not applicable to this type of device and study. The testing for the GPSCath™ Balloon Dilatation Catheter involved physical bench-top performance metrics (e.g., burst pressure, compliance) rather than diagnostic interpretations requiring expert ground truth. The "ground truth" for these tests would be the measured physical properties of the device itself.

3. Adjudication method for the test set:

   • This section is not applicable as the study involved objective physical measurements, not subjective evaluations that would require adjudication.

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:

   • This section is not applicable. The GPSCath™ Balloon Dilatation Catheter is a medical device (a balloon catheter) and not an AI-powered diagnostic system. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.

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

   • This section is not applicable. This is a physical medical device, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant.

6. The type of ground truth used:

   • The "ground truth" for this device's performance assessment was physical measurement against predetermined specifications and applicable standards. For example, a burst pressure test would involve applying pressure until the balloon bursts, and that measured pressure would be compared to the specified rated burst pressure.

7. The sample size for the training set:

   • This section is not applicable. There is no "training set" in the context of this device. The phrase "training set" typically refers to data used to train machine learning models. This product underwent traditional engineering and quality assurance testing.

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

   • This section is not applicable for the same reason as point 7.

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The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and the 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 ELM is a coaxial PTA Balloon Dilatation Catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses.

The provided text describes a Special 510(k) Summary for the ELM PTA Balloon Dilatation Catheter, focusing on demonstrating substantial equivalence to a previously cleared device (K102645). This type of submission is for modifications to an already cleared device, not for a new device requiring extensive clinical trials for performance validation. Therefore, the study described is primarily focused on design verification and validation testing rather than human clinical trials or AI algorithm performance studies.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like accuracy, sensitivity, or specificity. Instead, it refers to "design verification and validation testing" performed according to ISO 10993 Part 1 for biocompatibility and a list of specific engineering tests. The "reported device performance" is implicitly that the device met these engineering test criteria, allowing for a substantial equivalence determination.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data. The tests performed are described as "non-clinical design verification/validation tests and analyses." These tests typically involve a sample of manufactured devices (e.g., a certain number of catheters for burst testing, or a specific quantity of material for biocompatibility). The exact number of units or samples tested for each engineering parameter is not mentioned.
• Data Provenance: The data provenance is from non-clinical design verification/validation testing conducted by the manufacturer, Creagh Medical, in Ireland. It is not patient or human data, so terms like "retrospective" or "prospective" do not apply in a clinical sense.

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

Ground truth as defined by expert consensus or interpretations is not applicable here, as the study is a non-clinical device validation. The "ground truth" for these engineering tests would be established by validated test methods, industry standards (e.g., ISO), and internal specifications, not by human expert interpretation of clinical data. Therefore, no experts in a clinical context were used for this purpose.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases. Since this study involves non-clinical engineering tests, these methods are not applicable. The "adjudication" for these tests would involve comparing test results against pre-defined engineering specifications and acceptance criteria.

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

No MRMC comparative effectiveness study was done. This type of study (comparing human readers with and without AI assistance) is relevant for AI algorithms interpreting medical images, not for evaluating the mechanical performance of a medical device like a balloon catheter.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study, implying an AI algorithm's performance, was not conducted. The device in question is a physical medical instrument (a catheter), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical engineering tests was based on:

• Engineering Specifications: Internal design requirements and performance limits for the device.
• Industry Standards: Compliance with relevant international standards, such as ISO 10993 Part 1 for biocompatibility.
• Validated Test Methods: Established laboratory procedures for measuring characteristics like burst pressure, tensile strength, and inflation/deflation times.

8. Sample Size for the Training Set

A "training set" as understood in machine learning (used to train an AI algorithm) is not applicable here. The device does not involve an AI algorithm, and the manufacturing process does not typically involve a "training set" of data in this context. The production and testing are based on established engineering principles and quality control.

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

Not applicable, as there is no training set for an AI algorithm.

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The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Boston Scientific Charger™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW) balloon catheter with a dual lumen shaft design. One lumen marked "WIRE" is used to pass the catheter over 0.035" (0.89mm) guidewires. The second lumen marked "BALLOON" communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are two radiopaque marker bands located under -the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.
The Charger™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 200 mm and with shaft lengths of 40 cm, 75 cm, and 135 cm.

This document is a 510(k) summary for the Boston Scientific Charger™ PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new performance claim. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not directly applicable or available in this submission.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or algorithm performance study with specific thresholds (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device (Mustang™ Balloon Dilatation Catheters, K103751) through comparison of technological characteristics and performance data. The "acceptance criteria" here are implicitly that the new device performs equivalently or comparably to the predicate device in various engineering and biological tests, without raising new safety or performance issues.

The reported device performance for the Charger PTA Balloon Dilatation Catheter is that it "has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." This implies the Charger device met the same or similar performance standards as the predicate.

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

The document primarily describes bench testing and biocompatibility testing.

• Test Set Sample Size: Not explicitly stated for each test, but standard engineering and biological testing typically involve specific sample sizes per test article/batch. These are generally much smaller than clinical study sample sizes.
• Data Provenance: The tests are described as "Biocompatibility testing and bench testing were performed," implying these were conducted by Boston Scientific Corporation (USA, where the submitter is located) within a controlled laboratory setting. This would be considered prospective testing for the purpose of this submission.
• The comparison data for the predicate device (Mustang™) is inherent in its marketing clearance (K103751).

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 this type of submission. The ground truth for bench testing (e.g., tensile strength, burst pressure) and biocompatibility testing (e.g., cytotoxicity, pyrogenicity) is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and laboratory protocols, rather than expert clinical consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic interpretation, which is not part of this device's performance evaluation for 510(k) clearance based on substantial equivalence. Performance is measured against engineering specifications and biological safety standards.

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 Balloon Dilatation Catheter, a physical medical device, not an AI software or diagnostic imaging tool. Therefore, MRMC studies and the concept of human readers improving with/without AI assistance are irrelevant.

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

Not applicable. See point 5. 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 performance evaluation in this 510(k) is based on:

• Engineering Specifications: Adherence to defined physical and mechanical properties (e.g., bond tensile strength, burst pressure, dimensions).
• Biological Safety Standards: Conformance to established limits for biocompatibility (e.g., non-cytotoxic, non-sensitizing, non-pyrogenic).
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (Mustang™) set the de facto standard for substantial equivalence.

8. The sample size for the training set

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

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

Not applicable. See point 8.

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