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510(k) Data Aggregation
(30 days)
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents.
The ATB Advance® PTA Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents. The 6 Fr balloon catheter will be compatible with a 0.035 inch wire guide and an 8 Fr sheath. It will be supplied sterile, intended for one-time use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ATB Advance® PTA Dilatation Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Balloon Minimum Burst Strength: Burst at or above the minimum rated burst pressure. | Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. Predetermined acceptance criteria met. |
| Balloon Compliance: Meet labeled diameter within tolerance at the nominal pressure under simulated body temperature conditions. | Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. Predetermined acceptance criteria met. |
| Balloon Profile: Compatible with an 8 Fr sheath (< 0.113 inch profile). | Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with an 8 Fr sheath (< 0.113 inch profile). Predetermined acceptance criteria met. |
| Balloon Fatigue: Free from leakage and damage on inflation after 10 cycles of inflation/deflation (inflating to rated burst pressure, holding for 30 seconds and deflating). | Testing shows that balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation (inflating to rated burst pressure, holding for 30 seconds and deflating). Predetermined acceptance criteria met. |
| Sheath Compatibility: Compatible with an 8 Fr sheath. | Qualitative and quantitative evaluations show that the balloons are compatible with an 8 Fr sheath. Predetermined acceptance criteria met. |
| Balloon Bond Strength: Tensile force during proper clinical use should not fracture or rupture the balloon catheter bond (in conformance with ISO 10555-1: 1995). | Testing shows the tensile force during proper clinical use should not fracture or rupture the balloon catheter bond. In conformance with the applicable sections of ISO 10555-1: 1995, predetermined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes bench testing only. There is no mention of a "test set" in the context of patient data. The testing involves physical properties of the device (balloon, catheter).
- Sample Size: Not explicitly stated for each test (e.g., "how many balloons were tested for burst strength"). It only states "Testing shows..." which implies multiple units were tested to demonstrate conformity.
- Data Provenance: N/A, as this is laboratory bench testing, not clinical data.
- Retrospective/Prospective: N/A
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This 510(k) summary focuses on device design and performance through engineering and laboratory testing, not on clinical evaluations requiring expert interpretation of patient data or ground truth establishment.
4. Adjudication Method for the Test Set
N/A. Adjudication methods are typically used for clinical studies with subjective interpretations. The tests described are objective, measurable physical properties.
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
No. This document does not mention any MRMC study, human readers, AI, or comparative effectiveness with or without AI assistance. This device is a medical instrument (balloon catheter), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This concept is irrelevant to a physical medical device like a balloon catheter.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
N/A. For physical device testing, the "ground truth" is typically defined by engineering specifications, industry standards (like ISO 10555-1: 1995), and predefined acceptance thresholds derived from those specifications. For example, the ground truth for "Balloon Minimum Burst Strength" is the "minimum rated burst pressure."
8. The Sample Size for the Training Set
No "training set" is applicable here. The device is a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
No "training set" and therefore no ground truth establishment for it.
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(28 days)
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Intended to treat because is also intended for post-dilatation of balloonexpandable peripheral vascular stents.
The ATB™ Advance PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac. renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 or 6.0 French nylon tubing compatible with an 0.035-inch quidewire. It will be supplied sterile, intended for one-time use.
The provided text describes a 510(k) Pre-market Notification for the ATB™ Advance PTA Dilatation Catheter. It outlines the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria from an AI/ML perspective.
The "Test Data" section lists various in-vitro tests conducted on the device, inherently mechanical in nature. These are standard engineering tests for medical devices, not studies of an AI's performance.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, statistical performance metrics, sample sizes for AI training/testing, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not present in the provided document.
The document describes a traditional medical device submission for a physical catheter, not an AI or software as a medical device.
What the document does provide in relation to "tests":
The ATB™ Advance PTA Dilatation Catheter was subjected to the following physical/mechanical tests to assure reliable design and performance:
- Tensile tests
- Balloon inflation/deflation tests
- Balloon burst tests
- Balloon compliance
- Balloon fatigue tests
- Balloon profile
- Balloon burst within a stent
- Balloon fatigue within a stent
The document states: "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." However, specific numerical acceptance criteria for each of these tests and their corresponding reported performance values are not detailed in the provided text.
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