(142 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 is a 510(k) summary for a medical device, the TruWave Disposable Pressure Transducer. It describes the device, its intended use, and the regulatory determination of substantial equivalence.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which is what the prompt is asking for. The device described (a pressure transducer) is a physical medical device, not an AI/ML algorithm.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from the provided document as it is not relevant to an AI/ML device study.
The document discusses:
- Device Name: TruWave Disposable Pressure Transducer
- Regulation Number: 21 CFR 870.2870 (Catheter Tip Pressure Transducer)
- Indications for Use: For patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
- Substantial Equivalence: To predicate devices K171996 and K142749.
- Testing: Mentions "successfully passed biocompatibility and functional testing," but no details on the specific performance metrics or acceptance criteria for these tests are provided, nor is there any mention of AI/ML performance metrics. The "functional testing" broadly refers to the device's physical operation, not an AI algorithm's performance.
To answer your prompt, I would need a document detailing the clinical validation or performance study of an AI/ML medical device, including its acceptance criteria and how it was proven to meet them.
§ 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).