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The DynaPulse 5200A Pathway is indicated for trained medical professionals to operate on patients at clinical settings to collect and measure blood pressure and pulse rate information. In addition, the DynaPulse DPS200A Pathway is indicated for patients at home who are capable and willing to selfadministrate this device upon prescription of their healthcare provider. The DP5200A monitor must be connected to an IBM PC-compatible computer that is concurrently running DP5200A Pathway PC Software. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Noninvasive blood pressure measurement system.

This looks like an FDA 510(k) clearance letter for the DynaPulse 5200A Pathway Blood Pressure Monitor System, rather than a detailed study report with acceptance criteria and performance metrics. Therefore, much of the requested information regarding detailed study results, sample sizes, expert qualifications, and ground truth establishment is not present in this document.

However, I can extract the following relevant information based on the provided text:

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

This document does not contain a table of specific acceptance criteria or reported device performance metrics (e.g., accuracy, precision) as would be found in a study report. The letter confirms substantial equivalence to a predicate device, implying that its performance is considered acceptable based on comparison to that predicate, but the specific metrics are not detailed here.

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

This information is not provided in the FDA clearance letter.

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)

This information is not provided in the FDA clearance letter.

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

This information is not provided in the FDA clearance letter.

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

This device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for which an MRMC study or "human improvement with AI" would be relevant. Therefore, this question does not apply to the device described.

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

The device is a non-invasive blood pressure monitor that requires a human to operate it and an IBM PC-compatible computer running specific software. It is not an "algorithm-only" device. The Indications for Use state, "Clinical judgment and experience are required to check and interpret the information delivered." This implies active human involvement.

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

The document does not explicitly state the "ground truth" used for testing the blood pressure monitor. For blood pressure devices, the typical ground truth in validation studies involves comparison against a reference standard (e.g., invasive arterial line measurements or a highly calibrated manual sphygmomanometer reading) performed by trained observers, following established protocols (e.g., AAMI, ISO standards).

8. The sample size for the training set

This information is not provided in the FDA clearance letter. The device itself is a measurement device, not a machine learning model that typically relies on a "training set" in the same way.

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

This information is not provided, and again, the concept of a "training set" and "ground truth establishment" in this context is generally for machine learning algorithms, which is not the primary nature of this blood pressure monitor.

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The DynaPulse 5000A Mini (ABP) is indicated for trained medical rofessionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring.

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The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report or technical documentation that describes acceptance criteria and device performance in detail. Therefore, most of the requested information cannot be extracted directly from this document.

However, I can extract what is implicitly stated about the device and the nature of its clearance:

Implicit Information from the Document:

• Device Name: DynaPulse 5000A Mini (ABP) Blood Pressure Monitor
• Regulation Number & Name: 21 CFR 870.1130, Non-Invasive Blood Pressure Measurement System
• Regulatory Class: Class II
• Product Code: DXN
• Indication for Use: "The DynaPulse 5000A Mini (ABP) is indicated for trained medical professionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring."
• Substantial Equivalence: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This is the core of the 510(k) process, meaning the device performs as safely and effectively as an existing, legally marketed device.

Information NOT available in provided text:

The document does not contain specific details about acceptance criteria, actual performance data, study design (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment. This information would typically be found in the 510(k) submission itself or in separate study reports, not the FDA clearance letter.

Therefore, I cannot populate the table or answer most of the questions based solely on the given text.

Answer based on available information:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Not specified in this document. The FDA clearance indicates the device met the criteria for substantial equivalence to a predicate device, which would involve demonstrating similar performance to a device cleared under 21 CFR 870.1130.
   • Reported Device Performance: Not specified in this document beyond being "substantially equivalent" to a predicate device.

2. Sample sized used for the test set and the 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 specified.

4. Adjudication method for the test set: 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, as this is a blood pressure monitor, not an AI diagnostic device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a "Non-Invasive Blood Pressure Measurement System" and an "ABP Blood Pressure Monitor," implying it's a standalone measurement device rather than an algorithm aiding human interpretation. The 510(k) clearance indicates it functions as intended as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. For blood pressure monitors, ground truth typically involves comparison to a recognized reference standard (e.g., intra-arterial measurement or another validated non-invasive method) in clinical studies.

8. The sample size for the training set: Not applicable and not specified. This device is not described as an AI/ML product requiring a training set in the conventional sense. Performance validation would involve clinical testing.

9. How the ground truth for the training set was established: Not applicable and not specified.

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The DynaPulse 500G is indicated for trained medical professionals to operate on partient at clinical settings to collect and measure blood pressure, pulser and pressure waveform information. In addition, the Dyllar uise 2000 is marcated to purchase week on the device does not send any administrate this device upon present and experience are required to check and interpret the information delivered.

DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor

This document is a 510(k) clearance letter from the FDA for the DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor. It does not contain the specific information requested about acceptance criteria, study details, or ground truth establishment. It primarily focuses on the regulatory approval and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the provided text.

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