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510(k) Data Aggregation
(61 days)
Model CH-311B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
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This document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report. Therefore, it does not contain the detailed information requested about acceptance criteria, study methodology, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The letter confirms that the device, Model CH-311B Blood Pressure Monitor, is substantially equivalent to legally marketed predicate devices and can be marketed for over-the-counter use for oscillometric measurement of systolic and diastolic blood pressure and pulse for checking personal health conditions at home. While it mentions the device meets general controls provisions and potentially additional controls for Class II devices, it does not provide the specific performance data or the study details to prove this.
To answer your request, one would typically need access to the actual 510(k) submission or a separate study report for the device.
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(82 days)
Model CH-432 Blood Pressure Meter intended use is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Citizen Watch Company's Blood Pressure Meter, Model CH-432.
This letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework and responsibilities of the manufacturer. It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, you would typically need to refer to the full 510(k) submission document or a summary thereof, which often includes details of performance testing and comparison to predicate devices, but these specifics are not present in the provided FDA letter.
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(161 days)
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(154 days)
The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.
The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers are noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's upper arm. The units are contained in a hard plastic housing that contains a user interface panel, microprocessor and air pump and is connected by tubing to an adjustable arm cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD"). The user interface panel for the CH-481 has an additional switch to control the memory function, while the user interface panel for the CH-491 has additional switches to control the clock and memory functions.
The device measures blood pressure through the use of an automatically-inflating arm cuff. The cuff automatically deflates during blood pressure measurement. Model CH-471 has a memory function that displays the last blood pressure readout when the system is turned on. Model CH-481 has a memory function that allows the user to retain seven (7) prior blood pressure measurements. Model CH-491 has a memory function that allows the user to retain thirty (30) prior blood pressure measurements and also includes an LCD display that shows blood pressure measurement in a graph format.
The provided text is a 510(k) summary for the Citizen Watch Company's CH-491, CH-481, and CH-471 Blood Pressure Meters. While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain information about acceptance criteria or specific study data to prove the device meets those criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent detailed questions about a study. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting a detailed performance study against predefined acceptance criteria.
The document indicates that Citizen "determined that these changes have no influence on the correct measuring and the accuracy of systolic and diastolic blood pressure" compared to the predicate device (CH-401). However, it does not provide the underlying data or studies to support this determination.
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(207 days)
The Citizen CH-601A and CH-601B digital wrist sphygmomanometers are intended to be used for the oscillometric measurement of systolic blood pressure and pulse. They are intended to be sold over-the-counter.
The Citizen Ch-601A and CH-601B digital wrist sphygmomanometers are small handheld noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's left wrist. The units are contained in a hard plastic housing that contains a user interface panel and an adjustable wrist cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse. The device measures blood pressure through the use of an automatically-inflating wrist cuff. The cuff automatically deflates during blood pressure measurement. The only difference between the CH-601A and the CH-601B is that the CH-601B has a memory function which displays the last blood pressure readout (but not the last pulse) when the system is turned on.
Here's an analysis of the provided text to extract the acceptance criteria and details of the study proving the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Citizen CH-601A/B) |
|---|---|---|
| Blood Pressure Range | 0 to 280 mm Hg | 0 to 280 mm Hg |
| Blood Pressure Accuracy | Greater of ± 3 mm Hg or ± 2% of reading | Greater of ± 3 mm Hg or ± 2% of the reading |
| Pulse Measurement Range | 40 to 200 pulses/minute | 40 to 200 pulses/minute |
| Pulse Measurement Accuracy | ± 5% of the measured pulse frequency | ± 5% of the measured pulse frequency |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Citizen submitted laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device." However, it does not specify the sample size used for this test set nor the provenance (e.g., country of origin, retrospective/prospective nature) of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. Blood pressure measurements are typically compared against a standard reference method (e.g., auscultatory method with a trained observer), but this detail is absent.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not mentioned. The document focuses on the device's standalone accuracy compared to a predicate device.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The document states, "Citizen submitted laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device." This indicates that the device's performance (accuracy for blood pressure and pulse) was directly measured and compared against the stated accuracy of the predicate device (Omron HEM-605).
7. Type of Ground Truth Used:
The document implies the ground truth for blood pressure and pulse accuracy was established through laboratory testing, likely by comparing the device's readings against a validated reference method (though the specific method is not detailed). It's not explicitly stated as expert consensus, pathology, or outcomes data. Given the nature of blood pressure measurement devices, the ground truth would typically be derived from a validated method of direct physiological measurement.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. This type of device (oscillometric sphygmomanometer) typically relies on established algorithms for signal processing and does not usually involve a "training set" in the machine learning sense for its core function.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned for this device, information on how its ground truth was established is not applicable and therefore not provided in the document.
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(550 days)
The Citizen CH-502A and CH-502B finger sphygmomanometers are intended to be used for the oscillometric measurement of systolic and diastolic blood pressure and pulse.
The Citizen CH-502A and CH-502B finger sphygmomanometers are small hand-held noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's index finger. The units are contained in a hard plastic housing that contains a user interface panel and a finger cuff size adjuster slide. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse.
The provided 510(k) summary for the Citizen CH-502A and CH-502B Digital Finger Sphygmomanometers does not contain the detailed acceptance criteria and study data typically requested for a comprehensive evaluation. This document is a summary of the device's characteristics and its substantial equivalence to a predicate device, rather than a full study report.
However, based on the information provided, we can infer some details and highlight what is missing.
Inferred Information from the 510(k) Summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Citizen CH-502A/B) |
|---|---|---|
| Blood Pressure Accuracy | ± 3 mm Hg or ± 2% of the reading (the greater of) | ± 3 mm Hg or ± 2% of the reading (the greater of) |
| Systolic/Diastolic Range | 0-280 mm Hg | 0-280 mm Hg |
| Pulse Measurement Range | 40-200 pulses/minute | 40-200 pulses/minute |
| Pulse Measurement Accuracy | ± 5% of the measured pulse frequency | ± 5% of the measured pulse frequency |
Note: These "acceptance criteria" are inferred directly from the performance specifications of the predicate device (Omron HEM-815F) which the Citizen devices claim to be substantially equivalent to. The summary states: "Both devices have a blood pressure measurement accuracy of the greater of ± 3mm Hg or ± 2% of the reading. The pulse measurement range of the Citizen devices and the Omron predicate are also the same... The accuracy of the pulse measurements for both the Citizen sphygmomanometers and the Omron predicate device are ± 5% of the measured pulse frequency." This implies that the Citizen devices are expected to meet these same performance standards to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document is a 510(k) summary, which often summarizes testing without providing explicit sample sizes for clinical validation.
- Data Provenance: Not explicitly stated. Given the manufacturer's location (Japan) and the submission date (1995), it's likely the testing data would be from Japan, but this is not confirmed. It is also not stated if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: For a blood pressure monitor, the "ground truth" is typically established by comparative measurements against a recognized standard method (e.g., auscultation by trained observers using a mercury sphygmomanometer) rather than expert consensus on images or diagnoses. The summary does not provide details on how the accuracy was assessed in a clinical study.
4. Adjudication method for the test set
- Not Applicable / Not Provided: As the ground truth would be objectively measured blood pressure readings, there wouldn't typically be an adjudication process involving multiple experts as seen in diagnostic imaging studies. The summary does not provide any details on adjudication.
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: This device is a standalone blood pressure monitor, not an AI-powered diagnostic tool intended to assist human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes (Implied): The performance specifications provided (blood pressure accuracy, pulse accuracy) represent the standalone performance of the device without human interpretation or intervention beyond proper application. The device is designed to automatically measure and display these values. However, the study details of this standalone performance are not provided.
7. The type of ground truth used
- Inferred based on industry standards: For blood pressure monitors, the ground truth is typically a reference measurement from a validated standard method, such as auscultation by trained observers using a mercury sphygmomanometer, often following protocols like those established by the AAMI (Association for the Advancement of Medical Instrumentation) or BHS (British Hypertension Society). The summary does not explicitly state this, but it is the standard for proving accuracy.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not described as utilizing machine learning or AI that would require a separate "training set" in the modern sense. Its design is based on oscillometric principles and microcomputer control, which typically involve fixed algorithms, not learning models.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no explicit training set, this question is not applicable.
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