(145 days)
The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) is intended for dilatation of stenosis in coronary arteries or bypass grafts.
The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
The Boston Scientific Emerge™ PTCA Dilatation Catheter (1.20 mm) is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There is a single radiopaque marker band located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.
The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) will be available in balloon lengths from 8 mm to 20 mm.
The provided text describes the 510(k) summary for the Boston Scientific Emerge™ PTCA Dilatation Catheter (1.20 mm). This is a medical device, and the "acceptance criteria" and "study" refer to the performance goals and the clinical trial conducted to demonstrate the device's safety and effectiveness for its intended use. There is no mention of "AI" in this document.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance (Emerge 1.20 mm PTCA Dilatation Catheter) |
|---|---|
| Device procedural success, defined as: |
- Successful delivery, inflation, deflation, and withdrawal of the study balloon.
- No evidence of vessel perforation, flow limiting dissection (grade C or higher), or reduction in TIMI flow from baseline related to the study balloon.
- Final TIMI flow grade of 3 at the conclusion of the PCI procedure. | Subjects: 98.3% (59/60)
Lesions: 98.5% (66/67)
Specifically:
- Failure of delivery, inflation/deflation, and withdrawal: 1.7% (1/60 subjects, 1.5% (1/67) lesions) due to unsuccessful delivery (failure to cross a lesion).
- Vessel perforation, flow limiting dissection, or reduction in TIMI flow: 0.0% (0/60 subjects, 0/67 lesions).
- Failure of final TIMI flow: 0.0% (0/60 subjects, 0/67 lesions). |
| Secondary Clinical Endpoints (Safety Events):
In-hospital MACE (cardiac and non-cardiac death, MI and TVR)
In-hospital stent thrombosis within the target vessel
Clinically significant arrhythmias requiring intervention | In-hospital MACE: 5.0% (3/60 subjects) - All Death or MI: 5.0% (3/60)
- All Death: 0.0% (0/60)
- MI: 5.0% (3/60)
- Q-Wave MI: 0.0% (0/60)
- Non-Q-Wave MI: 5.0% (3/60)
- TVR, Overall: 0.0% (0/60)
- In-hospital ARC Stent Thrombosis: 0.0% (0/60)
- In-hospital Clinical Significant Arrhythmias: 0.0% (0/60) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study) Sample Size: 60 subjects with 67 target lesions.
- Data Provenance: Prospective, open-label, multi-center, single-arm, observational study (called "EMERGE") conducted at 3 US sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the "number of experts" or their "qualifications" involved in establishing ground truth in the way one might for an AI model's test set. However, in a clinical trial setting for a medical device:
- The "ground truth" for success/failure, complications, and patient outcomes are typically determined by the treating physicians at the clinical sites based on their observations during the procedure and post-procedure follow-up.
- Adjudication committees (often composed of independent expert clinicians) are commonly used in clinical trials to ensure consistency and impartiality in evaluating clinical endpoints, especially adverse events. The "Secondary Endpoint Outcomes" table indicates "CEC adjudicated data" (Clinical Events Committee), suggesting that expert clinicians were involved in reviewing and determining the final classification of these events. The specific number and qualifications of these CEC members are not provided in this summary.
4. Adjudication Method for the Test Set
- The document states that "Secondary Endpoint Outcomes" are based on "site reported and CEC adjudicated data," indicating that a Clinical Events Committee (CEC) was involved in adjudicating safety endpoints. The specific method (e.g., 2+1, 3+1) is not detailed, but the use of a CEC implies a formal, expert-driven review process for critical events.
- For the primary endpoint, the data appears to be based on site-reported observations of procedural success, with definitions provided in the protocol.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This was a single-arm observational study evaluating the performance of the Emerge 1.20 mm PTCA Dilatation Catheter alone. It did not involve comparing human readers (clinicians) with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is about a physical medical device (a catheter), not an algorithm or AI.
7. The Type of Ground Truth Used
- The ground truth for the clinical study was based on clinical observations, procedural outcomes, and patient follow-up data collected during hospitalization.
- This includes direct measurements and assessments made by interventional cardiologists (e.g., TIMI flow grade, presence of dissection/perforation), as well as clinical event reporting and subsequent adjudication by a Clinical Events Committee (CEC) for safety endpoints (e.g., MI, death, stent thrombosis).
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The device was evaluated in a clinical study to assess its performance in real-world use.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8)
§ 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.