(274 days)
The MARS MS-700 Automatic Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived the use of the oscillometric method, The device also measures the heart rate.
MS-700 Automatic Digital Blood Pressure Monitor
The provided text is related to a 510(k) submission for the "MS-700 Automatic Digital Blood Pressure Monitor." It discusses safety and effectiveness. However, it does not contain the detailed clinical study information needed to fill out all aspects of your request.
Specifically, the document states:
- "Effectiveness information on the MS-700 can be found in Section C (Clinical Studies) of this submission."
- "Mars Metal Company, Ltd. will provide safety and effectiveness information on the MS-700 to interested persons upon request. This information will include adverse safety and effectiveness information that is relevant to a assessment of substantial equivalence. The information provided on request will also include clinical testing information."
Therefore, based only on the provided text, I can only partially address your request.
Here's what can be inferred or stated based on the given document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. For blood pressure monitors, acceptance criteria typically involve accuracy standards (e.g., AAMI, ISO 81060-2).
- Reported Device Performance: The document only generically states the device "measures the heart rate" and provides "signals from which systolic and diastolic pressures can be derived the use of the oscillometric method." No specific performance metrics (e.g., mean difference, standard deviation compared to a reference method) are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Provided: The document states clinical study information is in Section C and available upon request, but it does not detail sample size or data provenance.
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)
- Information Not Provided: This detail is not present in the given text. For blood pressure, ground truth is usually established by a highly accurate reference device and/or trained operators following specific protocols, not typically "experts" in the sense of image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Provided: The document does not discuss clinical study methodology in this level of detail.
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 / Not Provided: This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool requiring human reader studies like those for image interpretation. The concept of "human readers improve with AI" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Likely Yes (Implied): The device is described as an "Automatic Digital Blood Pressure Monitor" that uses the oscillometric method to derive pressures. This strongly implies it functions as a standalone algorithm without human interpretation of raw signals to determine the primary output (systolic, diastolic, heart rate). However, the specific study of its standalone performance is not detailed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information Not Provided: While typical ground truth for blood pressure monitors involves comparison to a gold standard (e.g., auscultation by trained observers with a mercury sphygmomanometer, or a highly accurate invasive measurement), the document does not specify how ground truth was established for the MS-700's clinical study.
8. The sample size for the training set
- Not Applicable / Not Provided: For a device based on the oscillometric method, it's unlikely there's a "training set" in the machine learning sense. The oscillometric algorithm is typically a pre-defined engineering solution based on physiological principles and signal processing, rather than a machine learning model that requires training data in the same way. If any calibration or tuning data was used, it's not mentioned.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: See explanation for #8.
Summary of what is present:
- Device Type: Automatic Digital Blood Pressure Monitor
- Method: Oscillometric method for deriving systolic and diastolic pressures, and measuring heart rate.
- Intended Use: For adult use only.
- Safety: Stated to operate similarly to other standard oscillometric devices, with emergency deflation valves for patient and power safety.
- Effectiveness: Stated to be covered in Section C of the submission, but details are not provided in the extracted text.
To fully answer your request, the "Section C (Clinical Studies)" document would be required.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).