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The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The provided text is a 510(k) premarket notification for medical devices (Pantera Pro and Pantera LEO catheters). It focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and performance data.

Crucially, this document does not contain information about studies related to Artificial Intelligence (AI) or machine learning (ML) models, nor does it provide details about human reader performance, expert adjudication, or ground truth establishment in the context of diagnostic or prognostic AI applications.

The "Performance Data" section solely mentions:

• Product performance - coating integrity and particulates
• Biocompatibility
• Microbiological - Bioburden
• Shelf-Life - coating integrity and particulates

These are standard performance metrics for physical medical devices like catheters, not for AI/ML software.

Therefore, I cannot provide the requested information for an AI/ML-based device based on this document. The information you're asking for would typically be found in a submission for a software as a medical device (SaMD) or an AI-enabled device, which this document is not.

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The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

BIOTRONIK's Pantera Pro is a sterile, single-use, intravascular balloon catheter for the dilatation of stenotic segments in coronary arteries or bypass grafts. The dilatation balloon is designed to inflate to a known diameter and length at a specific inflation pressure. Pantera Pro has balloon diameters ranging from ∅ 1.25 mm – 4.0 mm and balloon lengths ranging from ∅ 6 mm – 30 mm. All product sizes of Pantera Pro have a usable catheter length of 140 cm. The Pantera Pro has a soft tapered tip at the distal end of the catheter to facilitate advancement of the catheter. The balloon is folded to achieve a low crossing profile and is connected to the tip. The Pantera Pro has two coatings; a hydrophobic coating on the outer surface of the hypotube and a hydrophilic polymeric based coating on the outer surface of the distal outer shaft. In addition, a hydrophobic coating is applied on the balloons of sizes ∅ 2.5 – 4.0 mm whereas a hydrophilic coating is applied on the balloons of sizes ∅ 1.25 – 2.0 mm. The coating is activated by immersing the catheter in sterile saline prior to use. The Pantera Pro is compatible with guide wires of 0.014" (0.36 mm) diameter and guiding catheters with an inner diameter of ≥0.056" (1.42 mm; 5F). For all Pantera Pro product sizes, the nominal pressure (NP) required to achieve the nominal diameter is 7 atm and the rated burst pressure (RBP) is 14 atm.

The provided text describes a medical device, the Pantera Pro Coronary Dilatation Catheter, and its acceptance for market. However, it does not detail a study involving AI or human readers, so I will answer based on the information available regarding the device's performance through non-clinical testing.

The acceptance criteria for the Pantera Pro Coronary Dilatation Catheter are based on various in-vitro bench tests and biocompatibility testing, ensuring it meets performance specifications and is biologically safe for its intended use. The study proving the device meets these criteria is a non-clinical design verification in-vitro testing and biocompatibility assessment.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in terms of patient data or clinical samples for the non-clinical studies. Instead, the tests were performed on device samples (Pantera Pro Coronary Dilatation Catheter units). The sample size for each specific bench test (e.g., number of balloons tested for burst pressure, number of catheters for bond strength) is not explicitly stated in this summary but would be detailed in the full design verification report.

Data Provenance: The data provenance for these non-clinical tests is from in-vitro bench testing conducted by the manufacturer (BIOTRONIK, Inc.). There is no mention of country of origin for the data beyond the manufacturer's location in Lake Oswego, Oregon, USA. These are retrospective data in the sense that they are derived from controlled laboratory experiments and quality assessments during the device's development and validation, rather than prospective clinical trials.

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

This question is not applicable to the provided document. The "ground truth" for non-clinical performance and biocompatibility testing is established by engineering specifications, regulatory standards (e.g., FDA guidance documents, ISO standards), and pre-defined pass/fail criteria for each test. These are objective measurements and do not rely on expert consensus or interpretation of complex medical images or patient outcomes. The performance is compared against these objective, quantitative targets.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments to resolve discrepancies, often in imaging studies. Since the studies described are non-clinical, objective bench tests and biocompatibility assays, no adjudication method was employed. The results are quantitative and directly measured against established criteria.

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 explicitly states: "No clinical investigation has been performed for this device." Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of this device, and no human-reader studies were conducted.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (a catheter), not an artificial intelligence algorithm or software. Therefore, the concept of algorithm-only performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies relies on:

• Engineering Specifications: Defined parameters for device dimensions, material properties, mechanical performance (e.g., burst pressure, flexibility, bond strength).
• Regulatory Standards: Compliance with industry standards (e.g., ISO 10993 for biocompatibility) and FDA guidance documents setting performance expectations.
• Established Test Methodologies: Standardized methods to objectively measure performance against the above specifications and standards.

8. The Sample Size for the Training Set

This question is not applicable. The device described, the Pantera Pro Coronary Dilatation Catheter, is a physical medical device; it is not an AI/ML algorithm that requires a "training set" of data. Its design and performance are validated through engineering and biocompatibility testing as opposed to machine learning techniques.

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

This question is not applicable, as there is no "training set" for this physical medical device.

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