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Elcam Disposable Integrated Pressure Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for single use only.

Indications for the Disposable Integrated Pressure Transducer (DIPT) include:

Direct arterial blood pressure monitoring - central and peripheral
Pulmonary artery monitoring
Venous pressure monitoring
Left atrial monitoring when used with an air eliminator
Cardiac catheterization

The disposable Transducer in an extravascular blood pressure transducer that convert mechanical changes in pressure into electrical current that can be input into a pressure monitor. The disposable Transducer consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. One of the major components that the transducer include is an integral flush valve and Luer connector that can connect a flashing fluid source to the intravascular catheter.

The provided text is for a 510(k) summary for a medical device that does not involve AI/ML technology or image processing. The device is an "Elcam Disposable Integrated Pressure Transducer (DIPT)" used for direct measurement and monitoring of blood pressure.

Therefore, the requested information about acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.

The document states:

• Rationale for Substantial Equivalency: "Elcam is the manufacturer of the Disposable integrated pressure transducer substantially equivalent to the predicate device and also the manufacture of the predicate device. Both products are the same products. The claim for substantial equivalence is supported by the information provided in the 510(k) submission" (Page 1)
• Safety & Effectiveness: "The proposed and predicate devices are similar in design, materials of construction, components, intended use and labeling. Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above. Elcam Medical believes that the proposed device safe & effectiveness is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues." (Page 1)

This indicates that the device's approval is based on its substantial equivalence to a predicate device (K052828), which is also manufactured by Elcam, meaning they are essentially the same product. The "performance results" mentioned are likely standard engineering and bench testing for pressure transducers, not AI/ML performance metrics.

To answer your specific questions, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of AI/ML. The 510(k) relies on substantial equivalence to an existing device, implying it meets the same performance standards of that predicate.
2. Sample sized used for the test set and the data provenance: Not applicable/not provided for AI/ML. Any "test results and clinical data" mentioned are for the physical transducer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided for AI/ML.
4. Adjudication method: Not applicable/not provided for AI/ML.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
7. The type of ground truth used: Not applicable/not provided for AI/ML. For a physical device like this, performance would be validated against established physical standards and measurements.
8. The sample size for the training set: Not applicable/not provided for AI/ML.
9. How the ground truth for the training set was established: Not applicable/not provided for AI/ML.

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