Search Results

The Electronic Blood Pressure Monitor LD-568, LD-520, LD-522, LD-587 & LD-528 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.

Not Found

The provided text is related to a 510(k) premarket notification for an Automatic Digital Blood Pressure Monitor. It includes information about the device's regulatory classification, intended use, and substantial equivalence determination. However, this document does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies that you requested.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. This regulatory clearance often relies on demonstrating that the new device meets the same performance standards as the predicate, which would involve testing. However, the specific details of those tests, including the acceptance criteria and study results, are not present in this publicly available document.

To provide the information you requested, access to the full 510(k) submission document or related performance testing reports would be necessary.

Ask a specific question about this device

The Shanghai Little Doctor Automatic Digital Blood Pressure Monitor LD6&LD7 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal once the irregular heartbeat is detected.

Automatic Digital Blood Pressure Monitor, Model: LD6 & LD7

This document is a 510(k) clearance letter for a non-invasive blood pressure monitor, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study methodologies, or performance metrics from a clinical trial.

The document primarily focuses on:

• Device Identification: Automatic Digital Blood Pressure Monitor, Models LD6 & LD7.
• Regulatory Information: Regulatory Number (21 CFR 870.1130), Regulation Name (Non-Invasive Blood Pressure Measurement System), Regulatory Class (Class II (Two)), Product Code (DXN).
• Clearance Date: September 18, 2009.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
• Indications for Use: To measure systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive technique with an inflatable cuff around the upper arm. It also detects and signals irregular heartbeats.
• Usage: Over-The-Counter Use.

Missing Information:

The document does not provide any of the following requested details:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
6. Results of a standalone (algorithm only) performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is a regulatory clearance document, which confirms that the device has met the requirements for market entry based on substantial equivalence, but it does not detail the specific clinical performance study that would establish the quantitative metrics of the device's accuracy or effectiveness against specific acceptance criteria. For that information, one would typically need to review the full 510(k) submission or any accompanying clinical study reports, which are not included here.

Ask a specific question about this device

This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement.

Digital Blood Pressure Monitors SE-9000, SE-9200 and SE-9400 are intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement. There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents. The user interface panels of SE-9200 and SE-9400 have power button, mode button, memory button and liquid crystal display ("LCD") except that SE-9000 has power button, mode/pressure button, memory button, start button. SE-9000, SE-9200 and SE-9400 have memory capacity to store the 140 most recent measurement results. The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate. All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.

The provided document does not contain any information regarding specific acceptance criteria for performance, nor does it detail a study proving the device meets said criteria.

The document is a 510(k) summary for a blood pressure monitor, focusing on establishing substantial equivalence to a predicate device. It briefly touches on device characteristics, intended use, and general safety and effectiveness.

Therefore, I cannot provide the requested information. The document explicitly states:

• "This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)"
• The table in Paragraph 14 only compares technological characteristics and states "Identical" or "Similar" for categories like "Performance," "Design," and "Human factors." It does not provide quantitative performance metrics or acceptance criteria.

To answer your questions, I would need a different type of document, such as a performance study report or a detailed test plan with acceptance criteria.

Ask a specific question about this device

For the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e. age 18 and above. The product is recommended for use by patients capable of understanding written and/or oral directions in a home care environment.

The Nissei Model DS-1862 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations; an electromagnetic deflation-rate control valve, an eleven-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the thirty most recent measurement results for two patients plus the computed average of the stored readings; error displays, a standard arm cuff, and an optional large arm cuff.

The provided documents describe the Nihon Seimitsu Sokki Co. Ltd. (Nissei) Model DS-1862 Digital Blood Pressure Monitor and its substantial equivalence to a predicate device, the Nissei DS-181.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the performance specifications of the predicate device, which the new device (DS-1862) aims to match or improve upon. The reported device performance for the DS-1862 is stated as "SAME" across several key metrics, implying it meets or exceeds the predicate's specifications.

2. Sample Size Used for the Test Set and Data Provenance

The documents do not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). They only mention "bench and user testing" and "clinical testing data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable in this context. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting results with and without AI assistance. The study focuses on the device's accuracy compared to a validated predicate.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was effectively performed. The device itself is an automated system for measuring blood pressure. The "bench and user testing" and "clinical testing data" likely refer to the performance of the device's algorithm and hardware in isolation, as well as its use by individuals. The focus is on the device's intrinsic accuracy and functionality.

7. Type of Ground Truth Used

The ground truth for the accuracy assessment (±3 mm Hg for cuff pressure and ±5% for pulse rate) would typically be established by a validated reference measurement method. For blood pressure monitors, this usually involves:

• Auscultation by trained observers: Using a mercury sphygmomanometer and stethoscope, where multiple trained observers independently take readings, and their consensus or average is used as the reference.
• Invasive arterial pressure measurement: In a clinical research setting, direct intra-arterial pressure measurement can be used as the gold standard, though this is less common for routine validation of home-use devices.

The documents do not explicitly state which method was used, but the "Accuracy" specification (±3 mm Hg) is a standard requirement for blood pressure monitors and implies comparison against a highly accurate reference.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. While the device uses a "pressure measurement algorithm designed to detect, filter, process, and store pressure readings," the documents do not provide any information about a specific training set or its size. For older-generation oscillometric devices, the "algorithm" is often based on established mathematical models and signal processing techniques rather than a machine learning model that requires a distinct training phase with labeled data in the same way modern AI systems do.

9. How the Ground Truth for the Training Set Was Established

Given the lack of information on a specific "training set" in the context of modern machine learning, this information is not provided and likely not applicable in the typical sense for this type of device and its submission. The algorithms for oscillometric blood pressure measurement are generally developed and refined based on engineering principles and physiological understanding, and then validated with clinical testing against established reference methods.

Ask a specific question about this device

The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (diastolic & systolic) and pulse rate in adult patients with arm circumferences from 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

Not Found

This document is an FDA 510(k) clearance letter for A&D Engineering Inc.'s Digital Blood Pressure Monitors. Unfortunately, the provided text does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It refers to "indications for use" and "general controls provisions of the Act," but does not elaborate on the specific performance metrics or studies used to validate the device's accuracy or effectiveness.

Therefore, I cannot provide the requested information from the given input. To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which typically includes the performance data and study details.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The DS-181 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e., age 18 and above.

The Nissei Model DS-181 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of. measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations, an electromagnetic deflation-rate control valve, a six-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the seven most recent measurement results plus the computed average of the stored readings; error displays; a standard arm cuff; and an optional large arm cuff.

Acceptance Criteria and Device Performance Study for Nihon Seimitsu Sokki Co., Ltd. Model DS-181 Noninvasive Blood Pressure Measurement System

This document outlines the acceptance criteria and details of the study proving the Nihon Seimitsu Sokki Co., Ltd. Model DS-181 Digital Blood Pressure Monitor meets these criteria.

1. Acceptance Criteria and Reported Device Performance

The Model DS-181 system was evaluated against the accuracy criteria established in the ANSI/AAMI Standard SP10-1992. The document states that the device was "found to comply fully with the accuracy criteria established in the standard."

Note: The provided text does not explicitly state the numerical accuracy criteria from the ANSI/AAMI Standard SP10-1992. However, the FDA's acceptance of the 510(k) submission confirms that the device met the required accuracy for its intended use.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: The document indicates "clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992." While the exact number of subjects in the test set is not explicitly stated, adherence to this standard implies a sufficiently robust sample size as per the standard's requirements for clinical validation of blood pressure devices.
• Data Provenance: The studies were described as "clinical studies," implying human subjects. The country of origin of the data is not explicitly stated in the provided text, but the company is based in Japan. It is not specified whether the studies were retrospective or prospective; however, clinical validation studies for medical devices are typically prospective.

3. Number and Qualifications of Experts for Ground Truth

The mechanism for establishing ground truth in clinical studies for blood pressure monitors typically involves comparison against a reference standard, often auscultation performed by trained clinicians.

• Number of Experts: Not explicitly stated, but standard practice for ANSI/AAMI SP10-1992 compliance involves multiple trained observers to mitigate inter-observer variability.
• Qualifications of Experts: Not explicitly stated. However, for blood pressure measurement validation, experts would typically be medical professionals (e.g., physicians, nurses, or trained technicians) with experience in accurate auscultatory blood pressure measurement using a mercury sphygmomanometer, often with specific training for validation studies.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described in the provided text. In a typical ANSI/AAMI SP10-1992 validation, multiple observers would take reference measurements, and the results would be averaged or reconciled to establish a robust ground truth, reducing individual observer bias.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study, which typically evaluates the improvement of human readers with AI assistance versus without AI assistance, was not indicated. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "measurement performance of the DS-181 system has been evaluated in clinical studies... and found to comply fully with the accuracy criteria established in the standard." This confirms the device's ability to accurately measure blood pressure independently of human interpretation of readings, demonstrating its standalone performance.

7. Type of Ground Truth Used

The ground truth used for the clinical validation of blood pressure monitors typically involves a reference method, such as:

• Simultaneous auscultatory measurements performed by trained observers using a mercury sphygmomanometer (or other validated reference devices), which is considered the gold standard for non-invasive blood pressure measurement.
• The ANSI/AAMI Standard SP10-1992 specifically outlines requirements for the reference method.

8. Sample Size for the Training Set

The document does not provide details about a separate "training set" in the context of machine learning. The Model DS-181 uses "fuzzy logic to regulate opening cuff pressure" and "a pressure measurement algorithm designed to detect, filter, process, and store pressure readings." While these algorithms would have been developed and refined, the text specifically focuses on the clinical studies for performance evaluation, which are typically validation studies rather than training set evaluations. If an internal training process using data was performed for the fuzzy logic or algorithms, its sample size is not disclosed.

9. How the Ground Truth for the Training Set Was Established

As noted above, details about a distinct "training set" for the fuzzy logic or algorithms are not provided. However, generally, the ground truth for developing such algorithms would be established through:

• Extensive experimental data collection, potentially involving human volunteers, alongside established reference blood pressure measurement methods.
• Data could be derived from engineering tests, simulated physiological conditions, and early human subject measurements to optimize the algorithm's performance before final clinical validation.

Ask a specific question about this device