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With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.

PulsioFlex Monitoring System with Optional CeVox ™ Accessories

The provided text is a 510(k) premarket notification and does not contain detailed information about a study proving the device meets acceptance criteria. It mainly focuses on regulatory approval. Therefore, I cannot extract complete information for all the requested sections.

However, I can extract the acceptance criteria for oxygen saturation measurements from the "Indications for Use Statement" and state that no study details are provided in this document.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in this document.

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)

Not provided in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in this document.

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 as this is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is a standalone device measuring oxygen saturation. The document doesn't provide performance data from any study, standalone or otherwise.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not provided in this document. For oximetry, typically a co-oximeter is used as the reference standard (ground truth).

8. The sample size for the training set

Not applicable as this device is not described as having a training set (e.g., it is not an AI/ML model being trained).

9. How the ground truth for the training set was established

Not applicable.

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The PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitorinq is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

The PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor used as accessories to the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO). When coupled with the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO), the above device accessories, in connection with a central venous catheter, operate to measure and display cardiac output parameters.

The provided document is a 510(k) summary for the PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor. This submission is for market clearance based on substantial equivalence to predicate devices, not for a de novo device requiring extensive clinical trials and performance evaluation against predefined acceptance criteria. Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets them.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on demonstrating substantial equivalence to existing devices.
2. Sample sized used for the test set and the data provenance: Not applicable as a performance study against acceptance criteria is not described. The document pertains to substantial equivalence.
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): Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is a medical catheter and sensor system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The submission is based on the premise that the device has the "same intended use" and "technological characteristics are the same or similar" to legally marketed predicate devices. Performance is thus inferred through equivalence, rather than a new study against specific performance criteria.

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