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The Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre-dilatation catheter for enlarging coronary luminal diameters during PCI procedures.

Device Description

The Medtronic Sprinter Legend 1.25mm RX and OTW are balloon dilatation catheters designed to perform Percutaneous Transluminal Coronary Angioplasty (PTCA).

Sprinter Legend 1.25mm RX
The device consists of a semicompliant balloon mounted on a Rapid Exchange delivery catheter. The Sprinter Legend 1.25mm RX device has an effective length of 142cm. It will be available in a single balloon diameter of 1.25mm and in balloon lengths from 6mm to 20mm.

Sprinter Legend 1.25mm OTW
The device consists of a semicompliant balloon mounted on an Over-the-Wire delivery catheter. The Sprinter Legend 1.25mm OTW device has an effective length of 152cm. Similar to Sprinter Legend 1.25mm RX, Sprinter Legend 1.25mm OTW will also be available in a 1.25mm balloon diameter and with balloon lengths from 6mm to 20mm.

AI/ML Overview

This document describes the Sprinter Legend 1.25mm RX and OTW Balloon Dilatation Catheters for percutaneous transluminal coronary angioplasty (PTCA) procedures. It includes information on device description, indications for use, and a summary of a clinical study.

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Device: Sprinter Legend 1.25mm RX and OTW Balloon Dilatation Catheters

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are derived from its "Indications For Use" and the "Primary Endpoint" of the clinical study, which focuses on procedural success, device success, and lesion success. The reported device performance metrics are directly from the study results.

Acceptance Criteria (from Indications for Use & Study Primary Endpoint)	Reported Device Performance (from Clinical Study Results)
Device successfully used as a pre-dilatation catheter for enlarging coronary luminal diameters during PCI procedures. This is broken down into the following operational definitions:	Confirmed by:
Procedural Success:	100.0% (51/51)
- Delivery of the balloon catheter to the target lesion and dilatation of the lesion using the study device.
- No evidence of arterial perforation, flow limiting dissection, reduction in TIMI flow from baseline TIMI, or clinically significant arrhythmias following pre-dilatation step with the study device.
- TIMI 3 flow post-dilatation at the conclusion of the PCI procedure.
Device Success:	100.0% (51/51)
- Delivery of the balloon catheter to the target lesion and dilatation of the lesion using the study device.
- No evidence of arterial perforation, flow limiting dissection, reduction in TIMI flow from baseline TIMI, or clinically significant arrhythmias following pre-dilatation step with the study device.
Lesion Success:	100.0% (54/54)
- Delivery of the balloon catheter to the target lesion and dilatation of the lesion using any PCI method.
Acceptably low rates of adverse events (as demonstrated by secondary endpoints).	Achieved with generally low rates, e.g., MACE 2.0%.
Successful assistance of subsequent PCI to enlarge coronary luminal diameters.	MLD pre-procedure of 0.623mm to 2.173mm post-procedure.
Resulting TIMI 3 coronary blood flow post-procedure.	100% (54/54) of lesions.

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

Sample Size: 51 patients (54 lesions)
Data Provenance: Prospective, multi-center, single-arm open-label study conducted at two (2) study sites in the United States. Clinical follow-up was conducted post-procedure until discharge.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish ground truth. However, it mentions "angiographic core lab data" being used, which implies review by qualified personnel specializing in angiographic analysis.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It mentions "angiographic core lab data and if missing, site reported data" were used, which implies a hierarchical approach where core lab assessment is primary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a clinical study for a physical medical device (balloon dilatation catheter), not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

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 is a physical medical device.

7. The Type of Ground Truth Used

The ground truth was established through a combination of:

Clinical outcomes: Directly observed procedural outcomes (e.g., successful delivery, absence of complications like arterial perforation or flow-limiting dissection, TIMI flow), device performance, and patient safety events (MACE, death, MI, etc.).
Angiographic core lab data: For assessing aspects like TIMI flow and changes in Minimum Luminal Diameter (MLD).
Site-reported data: Used to supplement angiographic core lab data when missing, particularly for TIMI and Perforation.

8. The Sample Size for the Training Set

This document describes a clinical study for a physical medical device; it does not mention a training set in the context of machine learning or AI. The study itself serves to demonstrate the safety and effectiveness of the device.

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

As there is no mention of a training set (in the context of AI/machine learning) for this physical medical device, this question is not applicable to the provided text.

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