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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 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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