(80 days)
PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.
The provided text describes a 510(k) submission for the PressureWire® device, focusing on its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed performance metrics, or information about a study designed to prove the device meets acceptance criteria in the way typically expected for a medical imaging AI device or diagnostic tool.
Instead, the document states:
- "Biocompatibility and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues."
- "On the basis of the testing conducted, it may be concluded that PressureWire® satisfies specified safety and performance requirements."
- "PressureWire® is substantially equivalent to the predicate device."
This indicates that general performance and safety testing was performed, leading to the conclusion of substantial equivalence. The "performance data" mentioned is described broadly without specific quantitative metrics or a study design to meet defined acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer based on the absence of the requested information, and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Satisfies safety requirements | "satisfies safety... requirements" |
| Satisfies performance requirements | "satisfies... performance requirements" |
| Does not raise additional safety issues compared to predicate | "do not raise additional safety issues" |
| Substantially equivalent to predicate in basic material, design, construction, and mechanical performance | "similar in basic material, design, construction and mechanical performance to the predicate device." |
| Effective for intended use (directing catheter, measuring physiological parameters) | (Implied by substantial equivalence and predicate's known use) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. It's likely pre-clinical (bench/in-vitro) and possibly animal testing given the nature of a guidewire, but no details are provided. This is a medical device, not an AI model, so "country of origin of data" in the typical sense for AI data is not relevant here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not specified. This is a medical device for physical measurement and guidance, not an imaging diagnostic device requiring expert interpretation for ground truth. Ground truth would likely be established by physical measurements against known standards.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. As above, ground truth is likely established by physical measurements, not human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done, as this is a medical device, not a diagnostic AI intended to assist human readers in interpreting cases.
6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: Not applicable in the context of an "algorithm only" study. Performance tests would have been conducted on the device itself (standalone in a physical testing sense) to assess its functional characteristics (e.g., pressure measurement accuracy, steerability, biocompatibility). The document states "Biocompatibility and performance testing indicate..." which implies standalone testing of the device's physical properties.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated but would likely involve:
- Known Physical Standards: For pressure and temperature measurements (e.g., comparison against calibrated sensors).
- Material Science Standards: For biocompatibility and mechanical properties.
- Engineering Specifications: For design, construction, and mechanical performance.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes data-driven training. Device design and validation are based on engineering principles, materials science, and physical testing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As it's not an AI model, there isn't a "training set" in the machine learning sense. The "ground truth" for its development would be established through engineering specifications, material properties, and iterative design and testing.
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).