(174 days)
The Endophys Blood Pressure Monitor Model 651 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 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 standalone 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 Endophys Blood Pressure Monitor Model 651 is powered by a standard AC power adapter. The Endophys Blood Pressure Monitor Model 651 is used outside of the sterile environment and has standard alerts and alarms.
The Endophys Blood Pressure Monitor Model 651 has an operating pressure range of 0-300 mmHg with an accuracy of ±2mmHg or ±4% of the reading, whichever is greater.
The provided document is a 510(k) premarket notification letter and summary for a Blood Pressure Monitor. It outlines the device's indications for use, technological characteristics, and performance data provided to support substantial equivalence to a predicate device.
However, the request asks for information related to a study proving a device (presumably an AI/imaging device, given the context of "human readers" and "ground truth" derived from experts) meets acceptance criteria, specifically for applications like those that might involve image analysis or disease detection.
The provided document describes a Blood Pressure Monitor, which is a physiological measurement device, not an AI-assisted diagnostic imaging device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to the type of device described in the input text.
The acceptance criteria and performance data for a blood pressure monitor would typically involve accuracy against a reference standard, electrical safety, electromagnetic compatibility, and functional testing, as mentioned in the document. It does not involve AI model performance metrics like sensitivity, specificity, or AUC, nor does it involve human expert ground truth establishment for image interpretation.
Given this fundamental mismatch, I can only provide information relevant to the blood pressure monitor based on the provided text, recognizing that it addresses very different types of acceptance criteria and study methodologies than those implied by the prompt's structured questions.
Based on the provided document (K160945 for the Endophys Blood Pressure Monitor, Model 651), the following is applicable:
The device is a Blood Pressure Monitor, not an AI/imaging device requiring multi-reader studies or complex ground truth establishment by experts for diagnostic interpretation. Its acceptance criteria and performance studies are focused on its accuracy in measuring blood pressure and its electrical and safety compliance.
Acceptance Criteria and Reported Device Performance (for a Blood Pressure Monitor)
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Accuracy (Pressure Measurement) | ±2 mmHg or ±4% of the reading, whichever is greater (This is the device's specified operating pressure accuracy, implying this was the target for acceptance testing.) |
| Operating Pressure Range | 0-300 mmHg (This is a design specification that would have been verified.) |
| Functional Testing | "Met all specified criteria" |
| Electrical Safety (IEC 60601-1) | "Met all specified criteria" |
| Electromagnetic Compatibility (IEC 60601-1-2) | "Met all specified criteria" |
| Safety and Essential Performance for Invasive blood pressure monitoring equipment (IEC 60601-2-34) | "Met all specified criteria" |
Study that Proves the Device Meets Acceptance Criteria:
The document states that "The following performance data were provided in support of the substantial equivalence:"
- Functional Testing
- Electrical Safety (IEC 60601-1)
- Electromagnetic compatibility (IEC 60601-1-2)
- Safety and Essential Performance for Invasive blood pressure monitoring equipment (IEC 60601-2-34)
The conclusion states: "The modified Endophys Blood Pressure Monitor Model 651 met all specified criteria and did not raise new safety or performance questions. Based on the design verification performance the modified Endophys Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device."
Addressing the prompt's specific questions with respect to the provided document (and highlighting non-applicability):
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A table of acceptance criteria and the reported device performance
- See table above. The document primarily focuses on technical and safety standards compliance and intrinsic accuracy, not clinical diagnostic performance metrics.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the document for the performance testing. These are typically design verification/validation tests for electro-mechanical devices, often conducted in-house to demonstrate compliance with standards and specifications. The document does not indicate a clinical study with a patient test set size or data provenance details in the way an AI diagnostic device submission would.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device measures blood pressure. "Ground truth" would be established by a primary reference standard source for blood pressure measurement, not by human experts interpreting data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to expert consensus for complex diagnostic interpretation, which is not relevant to a blood pressure monitor.
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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 is a standalone physiological measurement device, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Partially applicable/Re-interpretation: The performance outlined (accuracy, electrical safety, etc.) is the "standalone" performance of the blood pressure monitor device itself. It operates as an algorithm (converting optical transducer data to electrical signals and displaying blood pressure) without human interpretive input beyond observing the displayed values. There's no separate "human-in-the-loop" aspect to its fundamental function for evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Based on standard practices for such devices: The ground truth for blood pressure measurement accuracy would typically be established by comparison to a highly accurate reference blood pressure measurement device (e.g., a manometer calibrated to a known standard, or another validated invasive blood pressure measurement system). It would not be expert consensus, pathology, or outcomes data in this context. The document does not explicitly state the reference method used.
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The sample size for the training set
- Not applicable. This is not a machine learning/AI device that requires a "training set" in the common understanding of the term for AI model development.
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How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).