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The Endophys Blood Pressure Monitor Model BPM-30 is intended to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys PSS3 Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access. The Endophys Blood Pressure Monitor Model BPM-30 monitor is additionally intended for use in transport situations within hospital environments.

The Endophys BPM-30 Blood Pressure Monitor is an electronic device that provides compatibility between a physiological fiber optic blood pressure sensor (transducer) and conventional invasive arterial blood pressure inputs to a standard physiological patient monitor. The device converts the optical transducer data to electrical signals that are interpreted by a conventional patient monitor and/or are displayed directly on the BPM-30. The BPM-30 accurately emulates a fluidic arterial blood pressure transducer and supplies electrical signals to its output that are indistinguishable from a conventional fluidic blood pressure transducer.

The BPM-30 is implemented as a self-contained unit that has a fiber optic transducer connection as an input source and communicates with a patient monitor as its output. The BPM acts to directly emulate the electrical interface characteristics of conventional fluidic blood pressure transducers (that patient monitors are compatible with) while providing much more precise blood pressure data derived from a fiber optic transducer placed within an artery. Electrically emulating a conventional fluidic transducer uniquely allows a fiber optic pressure sensor to be used with a wide variety of existing physiological patient monitors without modification of those monitors. Systolic, diastolic, and mean blood pressure values are also displayed directly on the BPM-30 every four seconds.

The BPM-30 is powered by a standard AC power adapter. The BPM-30 also has an internal battery supply that will automatically recharge and maintain operation during brief (up to 30 minutes) power interruptions. The BPM-30 is used outside of the sterile environment and has standard alerts and alarms.

The BPM-30 has an operating pressure range of -30 to 300 mmHg with an accuracy of ±1 mmHg plus ±1% of reading for pressures ≤ 50 mmHg and within ±3% of reading for pressures ≥ 50 mmHg

The provided text describes a 510(k) premarket notification for the Endophys Blood Pressure Monitor Model BPM-30. It outlines the device's description, intended use, and a comparison to a predicate device (Endophys Blood Pressure Monitor model BPM-20). While it mentions "Performance Data" and lists several types of testing conducted, it does not provide specific acceptance criteria or the reported device performance in terms of accuracy metrics against a ground truth as typically expected for proving the device meets those criteria.

Instead, the performance data section states: "The modified Endophys Blood Pressure Monitor 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 the safety and effectiveness profile that is similar to the predicate device." This indicates that the device was tested to meet internal design specifications and regulatory standards, and its performance was deemed similar to the previously cleared predicate.

Given the information provided, I cannot construct a table of acceptance criteria and reported device performance with specific numerical accuracy values. The document focuses on regulatory compliance and substantial equivalence to a predicate device, rather than a detailed clinical performance study with defined ground truth and expert evaluation.

However, I can extract the accuracy specification for the device, which would likely form part of its inherent design acceptance criteria.

Here's an attempt to answer the request based only on the provided text, highlighting what is implicitly or explicitly stated and what is missing:

Acceptance Criteria and Device Performance for Endophys Blood Pressure Monitor Model BPM-30

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Endophys Blood Pressure Monitor Model BPM-20) rather than presenting a detailed clinical study for novel performance claims. Therefore, specific numerical acceptance criteria and a detailed breakdown of reported device performance in a clinical setting against a robust ground truth (e.g., expert consensus, pathology) are not explicitly provided in the document.

The document does state the performance specifications of the device, which implicitly serve as acceptance criteria for its design and manufacturing.

1. Table of Acceptance Criteria and the Reported Device Performance

Based on the "Summary of Technical Characteristics as Compared to the Predicate Device" and "Device Description" sections, the key performance specification mentioned is accuracy:

It is important to note that the document does not provide raw data, statistical analyses, or specific clinical study results to demonstrate how these accuracy figures were met in a performance study with a test set. It merely states that the "modified Endophys Blood Pressure Monitor met all specified criteria." The "Performance Data" section lists types of testing (Software Verification, Electrical Safety, EMC, Packaging, Functional Testing) but does not detail the results of these tests in terms of the accuracy specifications.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document lists types of performance data (e.g., functional testing, electrical safety) but does not mention the sample size of a patient-based test set or a clinical study.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. There is no mention of the origin or nature of data for any performance testing.

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 does not describe a study involving expert readers or the establishment of ground truth in a clinical context (e.g., for interpretation of medical images). The testing appears to be primarily engineering verification and validation against technical specifications rather than a comparative clinical performance study.

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

Not applicable/None specified. Since there's no mention of a clinical test set requiring expert interpretation or adjudication, this information is not relevant to the provided text.

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. The device described (Blood Pressure Monitor) is not an AI-assisted diagnostic device that would typically undergo an MRMC study. It is a measurement device.

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

Yes, implicitly. The accuracy specifications (±1 mmHg plus ±1% of reading for pressures ≤ 50 mmHg, and within ±3% of reading for pressures ≥ 50 mmHg) are for the device itself, implying its standalone measurement performance. This is typically established through bench testing and calibration, which aligns with "Functional Testing" mentioned in the "Performance Data" section.

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

For a blood pressure monitor, the ground truth would typically be established by a highly accurate reference blood pressure measurement device (e.g., a calibrated pressure transducer or manometer) or a standardized pressure source in a laboratory setting. The document does not explicitly state the type of ground truth, but it would align with calibrated reference measurements used during functional and design verification testing.

8. The sample size for the training set

Not applicable/Not specified. This device is a traditional medical device, not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set.

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