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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 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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