(205 days)
The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.
The Endophys Blood Pressure Monitor ("BPM") Model 651 is a blood pressure computer that computes and continuously displays systolic, diastolic, and mean blood pressure values. The BPM obtains an optical signal from the Endophys Pressure Sensing Sheath, which is a stand-alone catheterization sheath that is inserted percutaneously during intravascular diagnostic or interventional procedures. The BPM converts the optical transducer data to electrical signals and displays blood pressure measurements.
The provided text describes a 510(k) premarket notification for the "Endophys Blood Pressure Monitor" (K141615). However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a recognized standard). This document is a regulatory approval letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study against specific acceptance metrics.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document for the device | Not specified in document for the device |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document mentions "design verification testing" and "performance testing" but does not provide details on sample sizes for any test sets that would typically assess clinical performance.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document focuses on performance relative to predicate devices and general safety/effectiveness, not on a ground truth established by experts for a specific diagnostic task.
4. Adjudication method for the test set
- Not applicable/Not specified.
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 blood pressure monitor, not an AI/ML diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly detailed as a distinct 'standalone' study for an algorithm in the AI/ML sense. However, the device itself "computes and continuously displays systolic, diastolic, and mean blood pressure values" based on an optical signal. The "design verification testing" and "performance testing" would assess this standalone measurement capability. No specific metrics are provided.
7. The type of ground truth used
- The document states the device "continuously provide[s] systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath." The "ground truth" would implicitly be the established accuracy of pressure measurements against a recognized standard (e.g., an invasive catheter-based pressure measurement device or laboratory-calibrated pressure sensors), but this is not explicitly detailed with specific metrics or methodologies in the provided summary.
8. The sample size for the training set
- Not applicable/Not specified. This is not an AI/ML device in the modern sense that involves a separate training phase with a distinct dataset.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned for this type of device.
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).