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The Attain 6215 Venogram balloon catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.

The Medtronic Attain 6215 Venogram balloon catheter is designed for use within the coronary sinus for infusing contrast solutions for venogram imaging. It consists of extruded polymeric tubing with two lumens (inflation and infusion) in the main body of the catheter and a 1.25 cc controlled stroke volume syringe. The inflation lumen features a luer lock and stopcock at the proximal hub. Its distal end opens into a latex balloon, which is located near the catheter tip. The infusion lumen has a luer lock at its proximal hub.

The provided text describes the Medtronic Attain™ 6215 Venogram Balloon Catheter and its 510(k) submission. However, it does not contain the specific information required to complete the requested table and details about a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices, device description, indications for use, and regulatory clearance. It mentions "compatibility testing and incoming inspection of final packaged device" and "clinical use experience" but does not provide the detailed acceptance criteria or a formal study report with specific performance metrics.

Here's a breakdown of what CANNOT be extracted from the provided text based on your request:

• A table of acceptance criteria and the reported device performance: The document states that the catheter "passed all of the in vitro specified requirements" but does not list these specific requirements or their corresponding performance results.
• Sample sized used for the test set and the data provenance: Not mentioned.
• 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): Not mentioned.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device (catheter), not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for specific performance criteria. The "clinical use experience" suggests real-world performance, but details are lacking.
• The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance is:

• "The Attain 6215 Venogram balloon catheter passed all of the in vitro specified requirements, and ensures that the Attain 6215 Venogram balloon catheter meets all of its design and performance requirements."
• "The Attain 6215 Venogram balloon catheter has been used in two Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain 6215 Venogram balloon catheter has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus."

This suggests that some performance evaluation was conducted, but the specifics required to fill out your detailed request are absent from this 510(k) summary. A 510(k) often focuses on demonstrating substantial equivalence rather than presenting a full, detailed performance study report with explicit acceptance criteria and corresponding results in the manner you've requested for an AI device.

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The SafPace™ System is a two part system consisting of a Monitoring/Wedge Pressure Catheter and a Temporary Transluminal V- Pacing Wire. The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.

The SafPace™ System is a two part system consisting of a Monitoring/Wedge Pressure Catheter and a Temporary Transluminal V- Pacing Wire. The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.

The provided document is a 510(k) summary for the SafPace™ System, a medical device for temporary cardiac pacing and monitoring. This type of submission focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed clinical study data with acceptance criteria for a novel AI/software component. Therefore, much of the requested information about AI model performance, multi-reader studies, and detailed ground truth establishment is not applicable or available in this document.

However, I can extract the information that is present and describe why other requested details are absent.

Acceptance Criteria and Device Performance

The document describes the device's acceptable performance in terms of safety and effectiveness through comparisons to predicate devices and adherence to manufacturing quality control. There are no explicit, quantifiable acceptance criteria or reported device performance metrics in the format requested for a specific AI model's output (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are implied by the following statements:

• Substantial Equivalence: The device must be "substantially equivalent" in materials, form, and intended use to predicate devices, implying it meets similar safety and effectiveness profiles. This is the primary "acceptance criterion" for a 510(k) submission.
• Material Suitability: Materials used "have an established history of medical use and that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product."
• Manufacturing Quality Control: "All finished products are tested and must meet all required release specifications before distribution." This includes "physical testing, visual examination (in process and to: finished product)."
• Conformance to Design Specifications: "Physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Missing Information & Why

The following requested information is not present in the provided 510(k) summary because this document describes a traditional medical device (catheter and pacing wire), not an AI/ML-driven software product. Therefore, the concepts of "test sets," "training sets," "ground truth," "expert readers," and "AI models" are not applicable to this submission.

1. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for an AI model.
3. Adjudication method for the test set: Not applicable.
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: Not applicable. There is no AI component involved.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable. No training set for an AI model.
8. How the ground truth for the training set was established: Not applicable.

This 510(k) submission focuses on demonstrating the physical, functional, and material equivalence of the SafPace™ System to previously cleared devices for cardiac monitoring and provisional pacing. It relies on established engineering principles, material science, and manufacturing quality controls rather than data-driven performance metrics for an AI algorithm.

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