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The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty.

The OutFlo Aortic Valve Dilatation Balloon Catheter (marketing name: OutFlo) is a sterile, single use, Over-the-Wire (OTW) dual-lumen catheter with a hub at the proximal end and a balloon cluster at the distal end. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for blood flow. Thus, buildup of pressure in the ventricle is avoided. The dilation catheter is intended to be used in conjunction with a 14F or larger guiding catheter and a 0.035" or smaller guidewire, and Y-connectors, none of which are supplied by the manufacturer. The OutFlo Aortic Valve Dilatation Balloon Catheter is provided in five models. The only difference between the models are the balloon diameter.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text. It's important to note that the document is a 510(k) summary, which often provides high-level information rather than detailed study protocols. Therefore, some information might be missing or stated generally.

Device Name: OutFlo Aortic Valve Dilatation Balloon Catheter
Indications for Use: The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for the clinical study in a quantifiable manner (e.g., "X% success rate"). Instead, it describes the objectives and results. The primary clinical "acceptance criteria" can be inferred from the study's evaluation points.

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

• Sample Size (Clinical Test Set): 40 subjects.
• Data Provenance: The study was a "prospective, multi-center, observational study." The country of origin is not explicitly stated for the test data, but the submitter (DISA Medinotec) is based in Johannesburg, South Africa, which might be where some or all of the centers were located. However, this is an inference, not a stated fact.

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

The document states, "Performance of the device was evaluated by the investigators." It does not specify the number of individual experts per case or their specific qualifications (e.g., "radiologist with 10 years of experience"). "Investigators" typically refers to the physicians (e.g., interventional cardiologists) performing the procedures and assessing outcomes in a clinical trial. Given the nature of a valvuloplasty device, these would likely be highly experienced interventional cardiologists.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that "[p]erformance of the device was evaluated by the investigators." In a multi-center observational study, the primary investigators at each site would typically assess the outcomes for their patients. Central adjudication by an independent committee is common for clinical trials but is not mentioned here.

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 conducted. This study was a clinical observational study of the device's performance, not a comparison of human readers' performance with and without AI assistance. The device in question is a medical device (balloon catheter), not an AI-powered diagnostic tool.

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

N/A. This question is not applicable as the device is a physical medical instrument (a balloon catheter) used by a human operator, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth was established by clinical observation and assessment by investigators. This includes:

• Procedural Success: Determined by the medical professionals performing and observing the valvuloplasty procedure.
• Major Adverse Events (MAE) and Death: Clinically observed and reported.
• Ability to Allow Blood Flow / Eliminate Pacing: Assessed during the procedure by the clinical team.

8. The Sample Size for the Training Set

N/A. The provided information pertains to the clinical performance study of a physical medical device. There is no mention of a "training set" in the context of an AI/machine learning model, as this device itself is not an AI algorithm. The training for the device itself would come from its engineering and design processes, and validation from bench and clinical testing.

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

N/A. As there is no AI/ML component or "training set" in the context of this device, this question is not applicable.

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The ValvuloPro® Valvuloplasty Balloon Catheter is indicated for balloon aortic valvuloplasty.

The ValvuloPro® Valvuloplasty Balloon Catheters are indicated for balvoon aortic valvuloplasty. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation. The effective length of the catheter is 130cm. The y-connector consists of a balloon inflation port and a guidewire lumen. Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. The balloon catheter is supplied sterilized by ethylene oxide (EO) for single use.

The provided document is a 510(k) Summary for the ValvuloPro Valvuloplasty Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies or AI/software performance. Therefore, many of the requested categories related to AI/software performance, clinical studies, and ground truth establishment are not applicable.

Here's the breakdown of the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests conducted and states that "All tests were passed" for each category. It does not provide specific numerical acceptance criteria or detailed performance metrics. Instead, it refers to compliance with established standards (e.g., ISO, internal technical requirements).

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

• Test set sample size: Not explicitly stated for each test. The document mentions "Relevant testing was conducted on samples before and after aging to establish device shelf life," indicating multiple samples were used for performance tests.
• Data provenance: Not explicitly stated, but the tests are non-clinical, likely conducted in a controlled lab environment by the manufacturer (Dongguan TT Medical, Inc.) or their contracted labs. It is all prospective testing of the manufactured device.

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

• Not applicable. This section pertains to clinical studies or expert review of data for AI/software validation. The document describes non-clinical performance and biocompatibility testing against defined standards.

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

• Not applicable. This is relevant for clinical studies or expert consensus on clinical data. Non-clinical tests follow defined protocols and yield objective results.

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/software product that assists human readers.

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 an algorithm.

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

• Not applicable. For this type of device, "ground truth" refers to established engineering standards, material properties, and biological safety parameters defined in international standards (e.g., ISO 10993, ISO 11135, ISO 11607) and internal technical specifications. The device's performance is measured against these objective criteria rather than expert consensus on clinical cases.

8. The sample size for the training set:

• Not applicable. This refers to machine learning models.

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

• Not applicable. This refers to machine learning models.

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INOUE BALLOON™ A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.

INOUE BALLOON™ A is intended for the treatment of patients with aortic valvuloplasty (BAV). The device is transported over a guidewire as it is inserted through a percutaneous entry site and expanded with a predetermined amount of the diluted contrast medium by use of specified syringe with extension tube connected to the balloon inflation luer-lock hub. This results in the staged inflation of the balloon from hour-glass to barrel shape. The balloon is stretched and made thinner by pushing the inner tube in during passing thorough the introducer sheath. A radiopaque marker is provided for fluoroscopic positioning of the device across the valve.

This document is a 510(k) summary for the INOUE BALLOON™ A, a balloon aortic valvuloplasty catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance directly. Therefore, it does not contain the detailed clinical study information typically provided for AI/ML-driven devices.

Here's an analysis based on the provided text, addressing your questions where possible and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a formal table with quantitative targets for each performance metric, as might be found for a new clinical efficacy study. Instead, it lists various physical performance tests and states that the device "meets specifications." The performance is implicitly deemed acceptable if it is "similar to that described by the predicate device" and indicates the device is "as safe and effective as the predicate device."

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

This document describes pre-clinical performance data, primarily engineering and material tests, not tests on human clinical data. Therefore, the concept of a "test set" and "data provenance" related to patient data (country, retrospective/prospective) is not applicable here. The "sample size" would refer to the number of devices tested for each performance characteristic, which is not specified in this summary.

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

Not applicable. Ground truth from medical experts is relevant for diagnostic claims, often involving image interpretation. This device is a medical instrument (balloon catheter), and its performance data focuses on physical and material properties. Usability evaluations would typically involve feedback from clinicians, but the number and qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to establish a robust ground truth from multiple expert interpretations, typically in diagnostic or screening studies. This document does not describe such studies.

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 an interventional medical device, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

For the pre-clinical performance tests, the "ground truth" would be established by the defined test methodologies and expected outcomes (e.g., a burst strength test has a quantitative "ground truth" for the maximum pressure it can withstand). For biocompatibility, the ground truth is adherence to ISO 10993-1 standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a collection of pre-clinical performance data (i.e., laboratory and bench testing) designed to demonstrate that the INOUE BALLOON™ A functions as intended and is as safe and effective as its predicate device. This includes:

• Mechanical and Material Property Tests: Radio-detectability, surface integrity, corrosion resistance, peak tensile force, freedom from leakage, hub integrity, nominal size designation, guidewire compatibility, sheath compatibility, balloon minimum burst strength, balloon fatigue, inflation/deflation times, torquing, balloon preparation, bending, balloon over-inflation, and catheter removal.
• Biocompatibility Testing: According to ISO 10993-1 for short-duration contact with blood (

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The Conquest™ 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Atlas™ Gold PTA Dilation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the illac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Vida™ PTV Dilatation Cather is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
· A patient with isolated pulmonary valve stenosis.
· A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

The Vida™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

The Conquest™ 40 PTA 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 ultra 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 coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. 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 quidewire lumen. The over-the-wire catheter is compatible with 0.035" guidewires and is available in 50cm and 75cm working lengths. 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 re-wrap/refolding of the balloon. This product is not manufactured with any latex.

The Atlas™ Gold PTA 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 coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. 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. The over-the-wire catheter is compatible with .035" guidewire and is available in 80 cm and 120 cm working lengths.
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 to aid in re-wrap/refolding of the balloon. This product is not manufactured with any natural rubber latex.

The Vida™ PTV 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, noncompliant, 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 coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. 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. This product is not manufactured with any latex.

The Vida™ BAV Balloon Valvuloplasty 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. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. 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. This product is not manufactured with any latex.

The provided document describes the substantial equivalence determination for several medical devices, specifically balloon dilatation and valvuloplasty catheters. It does not present acceptance criteria or performance data for an AI/ML-driven medical device. Instead, it focuses on the engineering and material characteristics of physical medical devices and their comparison to previously cleared predicate devices.

Therefore, I cannot provide a response based on the requirements of your prompt, as the document does not contain information related to:

1. AI/ML performance testing: The document details physical device performance tests (e.g., trackability, burst strength, fatigue, biocompatibility), not AI model performance metrics like sensitivity, specificity, or AUC.
2. Test/training sets for AI/ML: There is no mention of data sets, sample sizes for AI training or testing, data provenance, or ground truth establishment relevant to an AI algorithm.
3. Expert adjudication or MRMC studies: These are concepts specific to the evaluation of AI systems, typically involving human readers or experts, which are not applicable to the physical devices described in this submission.

The document states: "The subject devices...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not specify what those "predetermined acceptance criteria" are for each test, nor does it present the reported device performance in detail (e.g., actual burst pressures achieved vs. minimum required). It lists the types of tests performed.

To fulfill your request, the input document would need to describe the development and validation of an AI/ML component, including its specific acceptance criteria and the results of studies demonstrating its performance.

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The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

The True® Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.

The provided text describes a 510(k) premarket notification for the True® Flow Valvuloplasty Perfusion Catheter, which claims substantial equivalence to a previously cleared predicate device (K152613). The core of the information regarding device performance and acceptance criteria comes from a post-market clinical study conducted on the predicate device, the TRUE-FLOW study.

Here's an analysis of the acceptance criteria and study data based on the provided text:

Acceptance Criteria and Reported Device Performance

The text describes two primary endpoints for the TRUE-FLOW study, which effectively serve as performance and safety acceptance criteria for the device's functionality during balloon aortic valvuloplasty.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: 24 subjects were included in the analysis population. 25 subjects were initially enrolled, but one withdrew consent post-discharge.
   • Data Provenance: The study (TRUE-FLOW) was a post-market clinical study conducted on the predicate device. The text does not specify the country of origin, but given the FDA submission, it implicitly aligns with US regulatory requirements and likely US-based data, though this is not explicitly stated. It was a prospective, observational study.

2. Number of Experts and Qualifications for Ground Truth:

   • The text does not provide information on the number or qualifications of experts used to establish ground truth for the test set. It describes clinical outcomes observed by the study, presumably by the treating physicians and study investigators, but there's no mention of independent expert review for ground truth establishment per se.

3. Adjudication Method for the Test Set:

   • The text does not specify any explicit adjudication method (e.g., 2+1, 3+1). Decisions regarding "successful dilatation" and "freedom from adverse events" would have been part of the study's pre-defined endpoints and data collection protocols, likely adjudicated by the study investigators or a clinical events committee, but the method is not detailed.

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

   • No, an MRMC comparative effectiveness study was not done. This study was a clinical performance and safety study of the device itself, not an evaluation of human readers' performance with or without AI assistance. The device is a physical catheter, not an AI diagnostic tool.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. The device is a physical medical device (catheter) used in a medical procedure, not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

6. Type of Ground Truth Used:

   • The ground truth for the performance and safety endpoints was based on clinical outcomes data from the patients undergoing the procedure. This includes observed success of aortic valve dilatation and the absence of pre-defined device-related or procedure-related adverse events.

7. Training Set Sample Size:

   • Not applicable. This study is not a machine learning model, so there is no concept of a "training set" in the context of this device. The data mentioned is for clinical validation of the device's performance and safety.

8. How Ground Truth for Training Set Was Established:

   • Not applicable, as there is no training set for a physical medical device.

In summary, the provided document focuses on the clinical performance and safety evaluation of a physical medical device. It outlines the specific performance and safety criteria (endpoints) that the device needed to meet and presents the observed outcomes from a prospective clinical study of the predicate device. The concepts of AI-related ground truth establishment, expert adjudication, MRMC studies, or training sets are not relevant to this type of device submission.

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The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

The True™ Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luerlock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum quidewire size are indicated on the package label.

The provided text describes a 510(k) premarket notification for a medical device, the True™ Flow Valvuloplasty Perfusion Catheter. It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not describe an AI/machine learning device or a study involving human readers or expert consensus on medical images. The "performance data" section (page 6) lists in vitro tests conducted on the physical catheter and its components (e.g., balloon diameter, catheter shaft length, burst pressure, biocompatibility tests). These are engineering performance criteria for a physical medical device, not AI model performance.

Therefore, many of the requested elements for an AI device's acceptance criteria and study proving its performance (e.g., sample size for test set, adjudication method, MRMC study, training set details) cannot be extracted from this document because it is not about an AI device.

Here's an attempt to address the parts that are applicable to this document, with a strong disclaimer that it is not an AI device:

Device: True™ Flow Valvuloplasty Perfusion Catheter

Type of Device: Physical medical device (catheter for balloon aortic valvuloplasty), NOT an AI/machine learning device.

Study Purpose (as described): To demonstrate substantial equivalence of the subject device to a predicate device by evaluating its technological characteristics and performance criteria through in vitro testing.

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

The document lists performance tests but does not provide a quantitative table of acceptance criteria and reported numerical performance values. It broadly states that the device "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

Below is a list of the types of performance criteria and tests mentioned, but no specific numerical values or pass/fail thresholds are provided in this document.

Regarding AI-specific criteria (not applicable to this document):

2. Sample sizes for test set and data provenance: Not applicable. The document describes in vitro engineering tests, not a dataset for an AI model.
3. Number of experts and qualifications for ground truth: Not applicable. Ground truth for an AI model (e.g., image annotations) is not relevant for a physical medical device.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This study focuses on the physical performance of a catheter, not on the impact of AI assistance on human readers.
6. Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
7. Type of ground truth used: For this device, the "ground truth" for performance is established through physical measurements, engineering specifications, and established biocompatibility testing standards. It's not based on expert consensus, pathology, or outcomes data in the context of diagnostic AI.
8. Sample size for training set: Not applicable. There is no AI model that requires a training set.
9. How ground truth for training set was established: Not applicable.

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The V8 Balloon Aortic Valvuloplasty Catheter is indicated for Balloon Aortic Valvuloplasty.

The V8 Balloon Aortic Valvuloplasty Catheter features an hour glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour glass shaped balloon with the undersized waist segment is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening. The V8 Balloon Aortic Valvuloplasty Catheter can be used as both a pre-dilatation and postdilatation device for self-expanding transcatheter heart valves.

While the provided document describes a medical device (V8 Balloon Aortic Valvuloplasty Catheter) and its substantial equivalence to a predicate device for FDA 510(k) clearance, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-based device.

This document is a 510(k) summary for a physical medical device, not a software or AI medical device. Therefore, the concepts of "test set," "ground truth," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance" are not applicable to the content provided.

The document discusses:

• Device Description: A physical balloon catheter for aortic valvuloplasty.
• Intended Use: Dilate aortic valve tissue.
• Technological Characteristics: Materials, sizes, shape (hourglass), compatibility with guidewire/sheath, radiopaque markers.
• Comparison to Predicate Device: The primary change is a reduced balloon bulb length (from 10mm to 8mm).
• Performance Data (Non-clinical): This section details the types of tests performed to demonstrate substantial equivalence, such as:
  • Biocompatibility (not re-tested due to no material change)
  • Sterility and shelf-life (not re-tested due to no packaging or worst-case device change)
  • Non-clinical performance evaluation of device delivery, inflation, deflation, and removal (summary below lists bond tensile strength, balloon rated burst pressure, balloon compliance).
  • In vivo evaluation (stated shape and principles of operation are the same as predicate).
  • Crucially, these are engineering/physical performance tests for the catheter itself, not clinical diagnostic accuracy or AI performance metrics.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria for an AI/algorithm study based on the provided text. The document focuses on demonstrating that a physical modification to an existing device does not raise new questions of safety or efficacy compared to its predicate.

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The TrueTM Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

The True™ Dilatation Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is noncompliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.

This document describes a 510(k) premarket notification for the True™ Dilatation Balloon Valvuloplasty Catheter. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K133569).

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance values in a side-by-side format. Instead, it lists the types of in vitro tests performed and states that the device "met all predetermined acceptance criteria." The acceptance criteria would likely be specified in the internal test protocols.

Given the information in the document, we can infer some of the tests that would have had acceptance criteria:

Notes on "predetermined acceptance criteria": These criteria would be derived from applicable standards, guidance documents, internal test protocols, and customer input. For a 510(k) submission, the primary goal is to show the new device performs as safely and effectively as the predicate, so acceptance criteria often reflect performance parameters established for the predicate or industry standards.

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

The document does not specify the sample sizes used for the "test set" (i.e., the units tested for performance). It only refers to "the subject device" and "the predicate device" in general terms. The tests listed are "in vitro tests," meaning they were conducted in a lab environment. The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. Since these are in vitro tests, the concepts of retrospective/prospective clinical data are not directly applicable.

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 section is not applicable. The document describes "in vitro tests" of a physical medical device (catheter). It does not involve human subjects, imaging data, or expert interpretations requiring a "ground truth" established by clinical experts.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of diagnostic outputs. The described tests are laboratory-based performance evaluations of a medical device.

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 section is not applicable. The submission is for a balloon valvuloplasty catheter, a mechanical device used in a medical procedure, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This section is not applicable. The device is a physical catheter, not a standalone algorithm.

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

This section is not applicable. As explained in point 3, the tests concern the physical and mechanical performance of a device, not diagnostic accuracy requiring a "ground truth" in the clinical sense. The "ground truth" for these tests would be the engineering specifications and tolerances to which the device must conform.

8. The sample size for the training set

This section is not applicable. The document describes a traditional 510(k) submission for a physical medical device, not an AI/Machine Learning algorithm that requires a "training set."

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

This section is not applicable. As explained in point 8, there is no training set for this device.

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The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

The True™ Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The quidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Three radiopaque markers are embedded in the balloon wall. These bands are positioned at the proximal and distal balloon shoulders, and in the middle. These bands are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the True™ Flow Valvuloplasty Perfusion Catheter:

Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report proving a device meets specific clinical acceptance criteria in a human population. Therefore, many of the requested items related to human studies (sample sizes, expert qualifications, adjudication, MRMC) cannot be directly extracted from this document, as the "studies" mentioned are primarily non-clinical (in vitro) performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance data categories and concludes that the device "met all predetermined acceptance criteria of design verification and validation." However, it does not provide a specific table detailing the quantitative acceptance criteria for each test or the exact numerical performance results. It merely states that the criteria were met.

Therefore, the table below reflects what is reported in the document:

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

• Sample Size: The document does not specify the sample sizes used for each individual non-clinical (in vitro) test. It simply lists the types of tests performed.
• Data Provenance: The tests are described as "in vitro tests," meaning they were conducted in a lab environment, not on human subjects. They are non-clinical studies. The country of origin of the data is not specified, but the applicant is "Bard Peripheral Vascular, Inc" located in Tempe, Arizona, USA.

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 and not provided in this document. Ground truth, in the context of expert consensus, typically refers to clinical data or interpretations by medical professionals. The studies described are primarily engineering and biocompatibility tests, not studies requiring expert clinical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in this document. Adjudication methods (like 2+1 or 3+1) are usually for resolving discrepancies in expert opinions on clinical test data. Since the tests are in vitro performance tests, such a method is not relevant.

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

An MRMC comparative effectiveness study was not done. This document describes a medical device (a catheter), not an artificial intelligence (AI) system or a diagnostic imaging tool that would typically involve human readers.

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

This information is not applicable. The device is a physical medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the in vitro performance and biocompatibility tests, the "ground truth" would be established by:

• Engineering specifications and design requirements: For mechanical, dimensional, and functional tests (e.g., balloon burst, trackability, inflation/deflation time).
• Standardized test methods and validated analytical techniques: For chemical, material interaction, and biological safety tests (e.g., MEM Elution, Rabbit Pyrogen Test, Thrombogenicity tests).
• Comparison to predicate device performance benchmarks: The overall conclusion relies on demonstrating "substantial equivalence" to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This document describes a physical medical device and its non-clinical testing, not an AI or machine learning product.

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

This information is not applicable. As stated above, there is no "training set" in the context of this device's evaluation.

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The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

The V8 Transluminal BAV Catheter System features an hour glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour glass shaped balloon, with the undersized waist segment, is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening.

This document describes a 510(k) premarket notification for the "V8 Transluminal BAV Catheter" (K150343). The purpose of this submission is not to introduce a new device, but rather to update the labeling of an existing device (V8 Transluminal BAV Catheter, K133607) and establish its substantial equivalence to another predicate (Z-Med/Z-Med II, K122012).

The key finding is that no new performance data or studies were conducted for this specific submission (K150343) because the device design, materials, and function remain identical to the predicate V8 device (K133607). Therefore, the acceptance criteria and the studies proving the device meets them refer to previous submissions (K133607 and K123111).

Given this information, I will synthesize the available information regarding the acceptance criteria and prior studies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission explicitly states "no design changes have been made to the predicate K133607 V8 device" and "performance testing performed during design verification and shelf life testing were not repeated because the design and materials of the device remain the same as the V8 predicate," the acceptance criteria and performance are referred to the previous submissions. The document lists the types of tests performed in the predicate design verification. Specific quantitative acceptance criteria are not explicitly stated in this document but are implied by the successful completion of these tests in the predicate device.

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

This document does not provide details on sample sizes for test sets for the initial predicate device studies. It only states that the performance testing was not repeated because the design and materials are the same. Therefore, the sample sizes and data provenance would refer to the original K133607 and K123111 submissions. The nature of these tests (design verification, shelf life, biocompatibility) implies bench and potentially in-vitro/animal studies, rather than human clinical trials for this type of device. There is no mention of country of origin or retrospective/prospective for the previous studies within this document.

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

This request is primarily applicable to studies involving interpretation of data (e.g., medical images). The listed tests are primarily engineering and material performance tests (e.g., burst pressure, tensile strength, biocompatibility, sterility). For such tests, "ground truth" is typically established by objective physical measurements and adherence to recognized standards, rather than expert consensus on interpretive data. Therefore, this question is not directly applicable in the context of the provided document.

4. Adjudication Method for the Test Set

As explained above, the tests are primarily objective physical and material performance evaluations. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., radiographic interpretations). This is not relevant to the types of tests described in the document.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a medical device (a catheter) through bench testing, material characterization, and reference to prior regulatory submissions. MRMC studies are typically performed for diagnostic devices, especially those involving human interpretation of complex data (like imaging algorithms), to assess the impact of a device on reader performance.

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

No, this question refers to the performance of an algorithm without human intervention, which is relevant for AI/ML devices. The V8 Transluminal BAV Catheter is a medical instrument (hardware), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable.

7. The Type of Ground Truth Used

For the performance data referred to from the predicate submissions (K133607 and K123111), the ground truth for tests like burst pressure, compliance, critical dimensions, tensile strength, kink resistance, and torque would be established through:

• Objective physical measurements: Using calibrated equipment and standardized test methods.
• Chemical/Biological analysis: For biocompatibility and sterility, adhering to ISO standards and laboratory protocols.
• Engineering specifications: The device is designed to meet specific engineering tolerances and performance parameters.

Ground truths like expert consensus, pathology, or outcomes data would typically be used for diagnostic or treatment effectiveness studies involving patient data, which are not detailed here as the primary evidence for this 510(k) submission.

8. The Sample Size for the Training Set

This question is only relevant for artificial intelligence or machine learning models. The V8 Transluminal BAV Catheter is a physical medical device. Therefore, the concept of a "training set" is not applicable.

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

As explained above, there is no training set for this type of physical device.

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