(90 days)
The Sapphire II PRO coronary dilatation catheter (1.0-1.25mm configurations) is indicated for: * balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (>70% stenosis) for the purposes of improving myocardial perfusion.
The Ø1.0-1.25mm Sapphire II PRO coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-1.25mm and lengths from 5-15mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. One radiopaque platinum marker band is centrally located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The information provided is about the Sapphire II PRO Coronary Dilatation Catheter (1.0-1.25mm configurations). This is a medical device, and the document describes a clinical study to assess its safety and effectiveness.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a pass/fail format for each criterion. Instead, it describes a primary endpoint for Device Procedural Success and secondary endpoints for effectiveness and safety, along with their observed results. I will construct a table reflecting these key outcomes.
| Acceptance Criteria (Study Endpoint Description) | Reported Device Performance (Sapphire II PRO) |
|---|---|
| Primary Endpoint: Device Procedural Success (Composite of): | 59/61 (96.7%) of patients (site-reported) |
| 1. Successful delivery, inflation, deflation, and withdrawal of the study balloon. | 60/61 (98.4%) of patients (site-reported) |
| 2. No evidence of vessel perforation, flow-limiting dissection (grade C or higher), or reduction in TIMI flow from baseline related to the study balloon. | 61/61 (100%) of patients (no procedural complications observed) |
| 3. Final TIMI flow grade of 3 at the conclusion of the PCI procedure. | 60/61 (98.4%) of patients (site-reported) |
| Secondary Peri-Procedural Endpoints (Effectiveness): | |
| Successful balloon delivery to the target lesion. | 61 (100.0%) |
| Successful inflation at the target lesion. | 60 (98.4%) |
| Successful deflation and withdrawal of the study balloon. | 61 (100.0%) |
| Absence of vessel perforation. | 61 (100.0%) |
| Absence of flow limiting dissection (Grade C or higher). | 61 (100.0%) |
| No reduction in TIMI flow from baseline related to the study balloon. (analyzable in 51 patients) | 51/51 (100.0%) |
| Final TIMI flow grade of 3 at the conclusion of the PCI procedure. | 60 (98.4%) |
| Absence of balloon rupture of the study balloon. | 60 (98.4%) (1 subject had balloons pin-holed and ruptured) |
| Improvement in Minimum Lumen Diameter (measured by QCA). (analyzable in 51 patients) | 49/51 (96.1%) |
| Lesion success (patient based). | 60 (98.4%) |
| Clinically significant arrhythmia (peri-procedural). | 0 (0.0%) |
| Secondary In-hospital Clinical Safety and Efficacy Endpoints: | |
| In-hospital MACE (composite of all death, target vessel MI or clinically indicated TLR). | 1 (1.6%) |
| Death (Cardiac). | 0 (0.0%) |
| Death (Non-cardiac). | 0 (0.0%) |
| MI (Target vessel MI). | 1 (1.6%) (peri-procedural, non-Q-wave MI, elevated CK-MB, did not require treatment) |
| MI (Non-target vessel MI). | 0 (0.0%) |
| Clinically indicated revascularization (TLR). | 0 (0.0%) |
| In-hospital Target Lesion Failure (TLF) (composite of cardiac death, target vessel MI or clinically indicated TLR). | 1 (1.6%) |
| In-hospital stent thrombosis (ST) within the target vessel. | 0 (0.0%) |
| Clinically significant arrhythmias requiring intervention. | 0 (0.0%) |
2. Sample size used for the test set and the data provenance
- Sample Size: 61 patients (67 lesions)
- Provenance: Prospective, open-label, multicenter, single-arm, observational study conducted at four (4) US sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "Angiographic Core Lab" and "Clinical Event Committee (CEC) adjudication" for various endpoints.
- Angiographic Core Lab: Responsible for reporting several secondary peri-procedural endpoints (e.g., vessel perforation, dissection, TIMI flow, MLD). The number and qualifications of experts in this core lab are not specified in the provided text.
- Clinical Event Committee (CEC): Responsible for adjudicating in-hospital clinical safety and efficacy endpoints (e.g., MACE, MI, TLR, TLF, ST). The number and qualifications of experts in the CEC are not specified in the provided text.
- Site Reported and Adjudicated: Some endpoints were site-reported and then adjudicated, implying review by professionals at the study sites, but specific numbers and qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document states:
- "Site Reported and Adjudicated" for some peri-procedural endpoints.
- "Core Lab Reported" for other peri-procedural endpoints.
- "Clinical Event Committee (CEC) adjudication" for in-hospital clinical safety and efficacy endpoints.
However, the specific adjudication method (e.g., 2+1, 3+1 consensus) used by the Core Lab or CEC is not detailed in the provided text.
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
There is no mention of an MRMC study or AI assistance in this document. This study is a clinical trial for a coronary dilatation catheter, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical instrument (a catheter) and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth was established through a combination of:
- Clinical observation and assessment: By the treating physicians at the study sites, reported as "Site Reported."
- Angiographic Core Lab analysis: Objective assessment of angiograms.
- Clinical Event Committee (CEC) adjudication: Expert review and classification of clinical events.
- Outcomes data: Such as the occurrence of MACE, MI, and TLR.
8. The sample size for the training set
This question is not applicable as the study describes a clinical trial for a physical medical device, not a machine learning model. There is no concept of a "training set" for the device itself in this context.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for the device.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.