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The JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Description

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications and include both Rapid Exchange (RX) and Over-The-Wire (OTW) designs. The over-the-wire design permits the use of standard 0.018 inch and 0.035 inch guidewires respectively (hereafter referred to as 18 OTW version and 35 OTW version), and the rapid exchange design permits the use of standard 0.018 inch guidewires (hereafter referred to as 18 RX version) as shown in Table 1 below. The JADE PTA balloon dilatation catheter is made of a minimally compliant material with a rated burst pressure of 16 atmospheres for 7.0mm diameters, 18 atmospheres for 4.5-6.0mm diameters and 20 atmospheres for 1.5-4.0mm diameter. Two radiopaque marker bands (Platinum/Iridium) are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. A hydrophilic lubricious coating is applied to the outside surface of distal section of the catheter. A Silicone coating is applied to wire lumen surface.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the JADE PTA Balloon Dilatation Catheter, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not pertain to an Artificial Intelligence/Machine Learning (AI/ML) device.

Therefore, the information required to answer the question about the acceptance criteria and study proving an AI/ML device meets those criteria, specifically concerning data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, is not present in the provided document.

The document focuses on in vitro performance tests and biocompatibility tests for a physical medical device (a balloon catheter), not a software-driven diagnostic or AI-assisted system.

Specifically, the document lists performance tests such as:

Visual Inspection
Dimensional Verification
Balloon Preparation, Deployment, and Retraction
Balloon Rated Burst Pressure (including in-stent)
Balloon Fatigue (including in-stent)
Balloon Compliance
Balloon Inflation and Deflation Time
Catheter Bond Strength
Tip Pull Strength
Flexibility and Kink
Torque Strength
Marker Band Radiopacity
Coating Integrity
Particulate Evaluation

And biocompatibility tests:

Cytotoxicity
Intracutaneous reactivity
Sensitization
Acute systemic toxicity
Hemocompatibility (Hemolysis, Complement activation, Partial thromboplastin time, Platelet and leukocyte counts, In vivo thromboresistance)
Pyrogenicity
Genotoxicity (bacterial mutagenicity test, in vitro mouse lymphoma Assay)

It concludes that "The test results met all acceptance criteria," but it does not specify what those numerical criteria were, only the types of tests performed. It certainly does not provide any details related to AI/ML device validation.

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K Number

K160941

Device Name

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

Manufacturer

Brosmed Medical Co., Ltd.

Date Cleared

2016-12-13

(253 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K141118,K132430,K103751

Intended Use

The balloon dilatation catheter is intended to dilate stenoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

Device Description

The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC (0.035") PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The catheter working length is 70, 90 and 150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work length range from 10mm to 150mm. The three PTA balloon dilatation catheters are filed in one 510(k) submission due to the similar/equivalent construction and identical material of the products. The comparison of them was summarized in Table 1. The differences only exist in the guide wire compatibility and the balloon configuration which have been controlled by the Design Verification. The balloon material is made of a non-compliant Nylon material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The three products of the non-compliant PTA (OTW type) balloon catheter family have different diameter of the guide wire port from max.0.014" to 0.035". The guide wire compatibility was shown in table 1. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

AI/ML Overview

The provided text is a 510(k) summary for the BrosMed Medical Co., Ltd.'s Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters. This document details the regulatory approval process for a medical device by demonstrating its substantial equivalence to previously cleared predicate devices.

It is crucial to understand that this document describes the acceptance criteria and study results for a medical device (balloon dilatation catheters), NOT for an Artificial Intelligence (AI) device. The questions posed in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance) are highly specific to AI/Machine Learning model evaluations, which are not applicable to the traditional medical device approval process described here.

Therefore, I cannot directly answer your questions as they relate to AI. However, I can extract the information relevant to the device's performance and acceptance criteria as presented in a traditional medical device context:

Here's a breakdown of the acceptance criteria and performance as described for these PTA Balloon Dilatation Catheters, framed as closely as possible to your request, while acknowledging the inherent differences:

The study conducted was a series of in-vitro performance tests and biocompatibility tests to demonstrate that the device meets predetermined acceptance criteria and is substantially equivalent to predicate devices. There is no mention of an "AI" component, data sets for training/testing AI models, or human expert consensus for "ground truth" derived from imaging.

Acceptance Criteria and Reported Device Performance (Table)

For a medical device like a balloon dilatation catheter, acceptance criteria are typically engineering specifications, material properties, and functional performance benchmarks. The document states that "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." Specific numerical acceptance criteria are not detailed in this public summary, but the types of tests conducted demonstrate the areas where performance was evaluated.

Acceptance Criteria Category	Reported Device Performance
In-vitro Performance	"The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." This general statement is provided for all in-vitro tests. Specific quantitative performance values against acceptance criteria are not published in this 510(k) summary.

Since the device is a physical medical instrument and not an AI algorithm, most of your specific AI-related questions (2-9) are not directly applicable. However, I can provide the closest equivalent information from the document:

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

Sample Size: The document does not specify exact sample sizes for each in-vitro or biocompatibility test. It generally states that "tests were conducted on the PTA balloon catheter." For physical device testing, sample sizes are typically determined by engineering and statistical principles to ensure sufficient data for reliability and statistical significance, but these are not disclosed in this summary.
Data Provenance: The tests are performed by the manufacturer, BrosMed Medical Co., Ltd., based in Dongguan, China. The data originates from these internal, pre-market validation studies. All tests are inherently "prospective" in the sense that they are designed and executed to specifically test the device's performance against predefined criteria.

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

This question is not applicable. "Ground truth" in the context of this device refers to objective measurements and adherence to engineering specifications and biological safety standards (e.g., a balloon bursting at or above its rated pressure, or a material not causing a cytotoxic reaction). There is no "expert consensus" in the sense of human interpretation of complex medical data for performance claims, as would be the case for an AI diagnostic tool.

4. Adjudication Method for the Test Set:

This question is not applicable. Performance is based on objective measurements against engineering specifications and validated test methods, not on human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was NOT done. This type of study is specific to evaluating diagnostic tools (often imaging-based AI) where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. This is not relevant for a balloon dilatation catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable as there is no algorithm or AI component to this device. Its performance is inherent to its physical design, materials, and manufacturing.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance validation is established through:
- Engineering Specifications: Predefined performance metrics (e.g., burst pressure, dimensions, flexibility) that the device must meet.
- Validated Test Methods: Adherence to recognized national and international standards for medical device testing.
- Biocompatibility Standards: Compliance with established biological safety requirements for materials in contact with the human body.
- Comparison to Predicate Devices: Demonstrating "substantial equivalence" means showing that the device performs similarly to or better than existing, legally marketed devices.

8. The Sample Size for the Training Set:

This question is not applicable. There is no "training set" in the context of a physical medical device. The device is designed, manufactured, and then validated through testing.

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

This question is not applicable for the reasons stated above.

In summary, the provided document is a regulatory submission for a conventional medical device, not an AI/ML algorithm. The acceptance criteria revolve around the physical and biological performance of the catheter, and the "study" consists of a battery of engineering and biocompatibility tests designed to prove its safety and effectiveness relative to existing predicate devices.

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