(96 days)
The Ventrax Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart
The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The guiding sheath introducer may be used for percutaneous entry. The System consists of four components: a sheath, a pigtail dilator, a straight dilator and a J- tipped guidewire.
The provided text is a 510(k) Premarket Notification for the Ventrax™ Delivery System. It describes the device, its intended use, comparison to a predicate device, and various performance tests conducted. However, this document does not contain information about an AI-powered device or a study involving human readers or AI assistance.
Therefore, I cannot provide detailed answers to questions 1 through 9, as they are specifically geared towards the evaluation of an AI/ML-based medical device.
Based on the provided text, here's what can be inferred about the device's assessment, focusing on the device rather than an AI component:
- Type of Device: The Ventrax™ Delivery System is a non-AI percutaneous catheter system.
- Purpose of Assessment: The assessment is for substantial equivalence to a legally marketed predicate device (AMPLATZER® TorqVue® Delivery System K072313) to demonstrate safety and effectiveness for its intended use.
- Studies Conducted: The studies are primarily bench testing and biocompatibility testing to ensure the physical and biological properties of the device meet established standards.
Here's an attempt to answer the questions based on the available information, noting the absence of AI/ML specifics:
1. A table of acceptance criteria and the reported device performance
The document lists numerous performance tests, but it does not explicitly state specific acceptance criteria values or detailed reported performance results for each test. Instead, it indicates that "Performance testing of the Ventrax™ Delivery System was conducted based on the risk analysis and when applicable on the requirements of the following standards." The conclusion states that the device "meets the requirements that are considered essential for its intended use."
Without specific numerical acceptance criteria and performance data, a table cannot be fully constructed. The performance data listed are categories of tests, not their outcomes.
| Acceptance Criteria (Implied by Standards & Risk Analysis) | Reported Device Performance (Summary) |
|---|---|
| Adherence to ISO, ASTM, AAMI standards for: | Met the essential requirements for its intended use and demonstrated substantial equivalence to the predicate device. |
| - Sterilization (ISO 11135) | (Details not provided in this summary) |
| - Packaging (ASTM D1469, ISO 2233, ASTM D999, ASTM F2096, AAMI ISO 11607, ASTM F1929, ASTM F88/F88M, ASTM F1980, ASTM D5265) | (Details not provided in this summary) |
| - Intravascular introducers, dilators, guidewires (ISO 11070) | (Details not provided in this summary) |
| - Luer fittings (ISO 594-1, ISO 594-2) | (Details not provided in this summary) |
| - Biocompatibility (ISO 10993-1, -3, -4, -5, -7, -10, -11, -12) | Passed Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Hemolysis Complete, Complement Activation, Thrombogenicity). |
| - Risk Management (ISO 14971) | (Details not provided in this summary) |
| - Usability Engineering (IEC 62366-1) | (Details not provided in this summary) |
| - Bacterial Endotoxins (AAMI ST72) | (Details not provided in this summary) |
| Bench Performance Testing for: | (Details not provided in this summary, but the device passed these tests) |
| - Label Adherence and Condition | |
| - Tube OD, Sheath Tip to Dilator Gap, etc. | |
| - Simulated Use (Insertion, Device Exchange) | |
| - Joint Strengths, Leak Testing, Radiopacity, Curve/Orientation, etc. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for each bench or biocompatibility test. It lists the types of tests performed.
- Data Provenance: Not specified, but given it's a premarket notification for the US market, the testing would generally align with US regulatory requirements. The studies are prospective in the sense that they are conducted on new device samples specifically for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for this type of device is established by objective measurements against engineering specifications and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to expert adjudication in AI/ML performance evaluation studies. The device's performance is objectively measured against standards.
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
Not applicable. This is not an AI-powered device, and no MRMC study involving human readers and AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent to its physical design and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, material science standards, and established biological safety parameters defined by the listed ISO, ASTM, and AAMI standards. For example, a "Sheath Shaft Tensile Strength" test would have an engineering specification as its ground truth, not an expert consensus.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).