Search Results

The Ultrasonic Fetal Doppler (Model M520, M521, M523) is intended to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an "Ultrasonic Fetal Doppler." This document primarily focuses on regulatory approval and does not contain specific information about the acceptance criteria, study details, or performance metrics of the device as typically found in clinical validation studies.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document states the device's intended use: "to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation." However, it does not provide the technical validation data that would be used to establish equivalence and meet performance criteria.

Ask a specific question about this device

The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the of adult by using the arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.

Not Found

This document is a 510(k) clearance letter from the FDA for a Blood Pressure Monitor. It does NOT contain information about an AI/ML medical device, nor does it describe an acceptance criteria study with the requested details.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set information.

The provided text focuses on the regulatory clearance process for a standard medical device (blood pressure monitor), detailing regulations, marketing provisions, and administrative contact information.

Ask a specific question about this device

This device is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.

The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic noninvasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric technique. The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The subject device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.

The proposed blood pressure monitor includes two models, which are W05, W1101L. All models contain the same software, measurement principle and NIBP algorithm. The main differences are product appearance, specification of pump and specification of the battery. W05 is alkaline battery driven device and W1101L is lithium battery driven device.

Here's a breakdown of the acceptance criteria and the study details for the Shenzhen Jamr Technology Co., Ltd. Wrist Type Blood Pressure Monitor (W05, W1101L):

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 95 patients.
• Data Provenance: The document does not explicitly state the country of origin. The study was a clinical investigation performed to verify accuracy according to ISO 81060-2:2018, which is a standard for clinical investigation of intermittent automated measurement type for non-invasive sphygmomanometers. It describes patients with "adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site." It is a prospective clinical test, as new measurements were taken for the study.

3. Number of Experts and Qualifications for Ground Truth:

• The document implies that the ground truth was established by the standard auscultation method, which is performed by trained medical professionals. However, the exact number of experts and their specific qualifications (e.g., number of years of experience) used to establish the ground truth for this particular test set are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set:

• The document states, "Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2 Third edition 2018-11." This indicates a direct comparison approach, but no specific adjudication method (like 2+1 or 3+1 for resolving discrepancies) is mentioned.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by humans.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The clinical test summarized in the document directly evaluates the device's accuracy in measuring blood pressure and pulse rate against a reference standard (auscultation) without human-in-the-loop assistance. The device's measurement principle is described as "oscillometric technique," which is an automated process.

7. Type of Ground Truth Used:

• Expert consensus (indirectly through a standard method): The ground truth was established using the standard auscultation method. This method relies on the auditory interpretation of Korotkoff sounds by trained human observers, which can be considered an expert-derived ground truth.

8. Sample Size for the Training Set:

• The document does not provide information about a separate training set or its sample size. Blood pressure monitors typically rely on established algorithms for oscillometric measurements, rather than machine learning models that require a distinct training set in the same way an AI diagnostic tool would.

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

• As a training set is not explicitly mentioned or implied for this type of device (a traditional blood pressure monitor using an oscillometric algorithm), the document does not explain how ground truth for a training set was established.

Ask a specific question about this device

The Upper Arm Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.

The proposed device, Upper Arm Type Blood Pressure Monitor, is a battery or AC adaptor driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use. The proposed blood pressure monitor includes 2 models, which are F1701T, F1701TA. All models follow the same software, measurement principle and NIBP algorithm. The main difference is the deflation valve.

The provided text describes the clinical testing performed for the Upper Arm Type Blood Pressure Monitor (models F1701T and F1701TA) to verify its accuracy according to ISO 81060-2:2018.

Here's an organized breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

(The document states "The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device F1701T in the group of 90 adult subjects...")

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

• Sample Size: 90 adult subjects (60 male and 30 female)
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation" or "clinical testing," which typically implies prospective data collection for the purpose of the study.

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. For blood pressure monitor accuracy studies per ISO 81060-2, the ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, not a panel of experts. The text mentions "designate individual(s)" performed the activities, but their number or qualifications aren't specified beyond being "trained."

4. Adjudication Method for the Test Set

This information is not explicitly detailed in the given text. For ISO 81060-2 studies, ground truth measurements are usually obtained simultaneously from a reference device by trained observers, and discrepancies typically require a pre-defined adjudication protocol (e.g., repeating measurements, or a third observer if two disagree beyond a certain threshold). However, the specific method used here (e.g., 2+1, 3+1, none) is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone accuracy of the device against a reference method, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The clinical study evaluated the accuracy of the device (F1701T) in measuring blood pressure and pulse rate, which is an assessment of the algorithm's performance without human interpretation or intervention in the measurement process itself. The "human-in-the-loop" in such a context would typically refer to a human reading and interpreting the oscillometric waveform, which is not how automated devices operate. The device itself performs the measurement and provides the reading.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison with a reference standard (human-obtained measurements from a reference sphygmomanometer) as required by ISO 81060-2 for non-invasive sphygmomanometers. While the document doesn't explicitly state "reference sphygmomanometer," this is the standard practice for clinical validation against the ISO 81060-2 standard.

8. The Sample Size for the Training Set

The document does not provide information about the sample size for any training set. Blood pressure monitors using oscillometric techniques typically use pre-established algorithms derived from engineering principles and validation against reference methods, rather than machine learning models that require a separate, large training set in the typical sense.

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

Since no specific training set or machine learning approach is mentioned, the document does not describe how ground truth for a training set was established. The overall accuracy of the device's measurement algorithm would have been developed and validated through extensive engineering and prior testing, ultimately leading to the clinical validation study described.

Ask a specific question about this device

The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.

The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel. The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Blood Pressure Monitor (Models C02 and F01)
Manufacturer: Shenzhen Jamr Technology Co., Ltd.
Predicate Device: Full Automatic (NIBP) Blood Pressure Monitor HL858CL (K190507)

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for the clinical performance of the blood pressure monitor are derived from the ISO 81060-2 standard.

Note: The document explicitly states that the device passes various other non-clinical standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-11, IEC 80601-2-30, ISO 81060-1, IEC 62304, ISO 14971, IEC 62366-1) which imply acceptance criteria for electrical safety, EMC, performance, software, usability, and risk management, but specific quantitative acceptance values for these are not detailed in this summary.

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

• Sample Size for Test Set: 90 patients (42 males and 48 females)
• Data Provenance: Not explicitly stated, but the submission is from a Chinese company (Shenzhen Jamr Technology Co., Ltd.) and refers to a "Clinical Test report" and "clinical investigation," implying this data was collected during a clinical study to support this particular device. It is most likely prospective data collected for the purpose of regulatory submission. The location of the actual clinical trial is not specified.

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

The document states that the "Standard auscultation method was used as the reference blood pressure monitor measuring in the arm according to the sequence in ISO 81060-2."

• Number of Experts: Not explicitly stated. The ISO 81060-2 standard typically requires measurements by multiple trained observers (usually at least two trained observers taking simultaneous or sequential measurements) to establish the reference values using the auscultatory method. However, the specific number of experts involved in this particular study is not detailed in the provided summary.
• Qualifications of Experts: Not explicitly stated, but implies individuals trained in the auscultatory method of blood pressure measurement, as per the ISO 81060-2 standard.

4. Adjudication Method for the Test Set

The adjudication method is implicitly that of the ISO 81060-2 standard for assessing blood pressure devices using the auscultatory method. This standard typically involves comparisons between the automated device and a reference measurement obtained by trained observers using a sphygmomanometer and stethoscope. While the document doesn't explicitly state an "adjudication method" in terms of resolving discrepancies between multiple expert readings, the ISO 81060-2 protocol itself serves as the framework for establishing the reference values against which the device is compared. It generally involves the average of readings from multiple observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study is a standalone clinical validation of the device's accuracy against a standard reference method (auscultation), not a comparison of human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone clinical validation (algorithm only) was done. The study evaluated the accuracy of the Blood Pressure Monitor (an automated device) against the reference auscultation method. This evaluates the device's inherent performance.

7. The Type of Ground Truth Used

The type of ground truth used is expert consensus/clinical reference measurement established by the standard auscultation method. This is considered the gold standard for non-invasive blood pressure measurement in such validation studies.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set. This is a clinical validation study for a medical device's accuracy, not a machine learning algorithm that typically requires a distinct training set. The device itself (Blood Pressure Monitor) is a hardware device with an embedded algorithm; the summary focuses on the validation of the device rather than the development of the algorithm.

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

As no training set is mentioned or implied for this type of device validation, this information is not applicable.

Ask a specific question about this device