(89 days)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.
The provided text describes a 510(k) premarket notification for the "Pressure Monitoring Kit with TruWave Disposable Pressure Transducers" (K141495). This is a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets acceptance criteria in the context of a new diagnostic algorithm or AI system.
Therefore, the information typically requested in your query regarding acceptance criteria and performance studies of AI/diagnostic algorithms (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, ground truth establishment) is not present in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through material biocompatibility and performance testing, without the need for the types of clinical performance studies you're asking about for AI/diagnostic algorithms.
However, I can extract the information relevant to what is present, which is comparative analysis and functional/safety testing, rather than an AI algorithm's performance.
Here's an interpretation based on the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Biocompatibility | Successfully passed in compliance with applicable ISO 10993 requirements. |
| Performance Testing | Successfully passed performance testing. |
| Substantial Equivalence | Demonstrated to be safe, effective, and substantially equivalent to the predicate device (Phoenix [TruWave] disposable pressure transducer) for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states that "performance testing was conducted", but no details about the sample size (number of devices, test conditions, etc.) or data provenance are given.
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 information is not provided in the document. The evaluation of this medical device is based on "performance testing" and "biocompatibility testing," not on establishing ground truth for a diagnostic algorithm with expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for diagnostic studies involving human interpretation or subjective assessments, which is not the nature of the testing described for this pressure transducer.
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
This is not applicable as the device is a disposable pressure transducer, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device would be its physical and functional specifications. The performance testing would have compared the device's output (e.g., pressure readings) against a known standard or established measurement. The document states that testing was done to "compare the proposed device to the predicate device", implying the predicate device's established performance serves as a comparative benchmark.
8. The sample size for the training set
This is not applicable as the device is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical medical device, not an AI algorithm.
§ 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).