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Truly Automatic Arm Blood Pressure Monitor, Models DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 are a series 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 devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected. Over-The-Counter Use

Truly Automatic Arm Blood Pressure Monitor DB series, Models DB33, DB81, DB83, DB85, DB91, DB92, DB93 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AA alkaline batteries. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

Here's a breakdown of the acceptance criteria and study details for the Truly Automatic Arm Blood Pressure Monitor, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 90 subjects.
• Data Provenance: The study was a clinical study conducted with subjects in a hospital setting. It includes 15 hypertensive patients, implying a mixture of normotensive and hypertensive individuals. The location (country) of the study is not explicitly stated, but the submitter is based in China. The study appears to be a prospective clinical study, as indicated by the "Subjects" and "Method" sections.

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

• Number of Experts: Two doctors.
• Qualifications of Experts: Not explicitly stated beyond "doctors." However, given they were using a standard mercury sphygmomanometer and performing "simultaneous and blinded blood pressure determinations," it can be inferred they are trained medical professionals capable of accurately measuring blood pressure.

4. Adjudication Method for the Test Set

• The method described is "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies a form of independent double reading, where both doctors recorded their measurements without knowledge of the device's reading or each other's readings, and then these independent readings were compared against device readings and among themselves. It is not a typical 2+1 or 3+1 adjudication as seen in AI studies, but rather a direct comparison of independent expert measurements.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This study focused on the accuracy of the device against a reference method and between human observers, not on how human readers' performance improved with AI assistance.

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

• Yes, this was effectively a standalone performance study. The device's measurements were compared directly against the reference standard (mercury sphygmomanometer readings by experts) and the agreement between experts themselves, without any human-in-the-loop interaction or AI assistance for the expert readings.

7. Type of Ground Truth Used

• Expert Consensus / Reference Standard: The ground truth for blood pressure measurements was established by two doctors using a "standard mercury sphygmomanometer" as a "reference standard." This represents an expert-determined reference standard, often considered the gold standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" or "training data" for the device's algorithm. For traditional medical devices like blood pressure monitors, the underlying oscillometric algorithm would typically be developed and validated during the device's design phase using various physiological models and potentially earlier clinical data, but this specific 510(k) summary focuses on the clinical validation of the final device rather than the algorithm's development.

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

• As no training set is explicitly mentioned in this summary, the method for establishing its ground truth is also not provided. The information provided pertains solely to the clinical validation of the completed device.

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Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 are a series devices 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 wrist.

The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Truly Automatic Wrist Blood Pressure Monitor DW series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 135 and 220 mm, includes the inflatable bladder and nylon shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by two AAA alkaline batteries.

The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The Truly Automatic Wrist Blood Pressure Monitor (Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903) conducted a clinical study to demonstrate its accuracy in measuring systolic and diastolic blood pressure.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size (Test Set): 90 subjects, including 15 hypertensive patients.
• Data Provenance: The document does not explicitly state the country of origin, but the submitter's address is in Guangdong Province, China, suggesting the study was likely conducted there. The study appears to be prospective, as it involved actively recruiting subjects and performing blood pressure determinations.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Two doctors.
• Qualifications of Experts: The document does not specify their exact qualifications (e.g., "radiologist with 10 years of experience"). It only mentions they are "two doctors" who performed simultaneous and blinded blood pressure determinations.

4. Adjudication Method

The adjudication method used was paired, simultaneous, and blinded reference measurements by two observers against the test device. This implies a 2-reader, 1-device comparison method:
* The two observers ("doctors") simultaneously and independently measured blood pressure using a standard mercury sphygmomanometer (the reference standard).
* The agreement between these two observers also had its own acceptance criteria (95% within ±10mmHg, 85% within ±5mmHg).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted as described for AI-assisted human readers. The study focused on the standalone accuracy of the device itself compared to a reference standard with human observers. There is no mention of a scenario where human readers' performance was compared with and without AI assistance from this device.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The entire clinical study described is a demonstration of the device's accuracy in measuring blood pressure and pulse rate (algorithm only/standalone without human-in-the-loop performance, beyond interacting with the device itself) compared to a reference standard.

7. Type of Ground Truth Used

The ground truth used was expert consensus / reference standard comparison using a standard mercury sphygmomanometer. The "between-observer agreement" criteria also implies the ground truth for the reference measurements themselves was established by agreement between the two doctors.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This is typical for a traditional medical device (like a blood pressure monitor) which relies on established physical principles (oscillometric method) and calibration rather than machine learning models that require distinct training data.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" for an AI/machine learning model is mentioned, this information is not applicable to this device's development as described. The device's measurement algorithm ("oscillometric method") is a well-established technique that would have been developed and validated through general engineering and physiological principles rather than a distinct machine learning training phase.

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Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M are a series devices 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 devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA alkaline batteries.

The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

Unfortunately, the provided document K091434 for the Truly Automatic Arm Blood Pressure Monitor does not contain the specific details required to answer your questions about acceptance criteria and the study proving the device meets them.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed technical report of performance testing against explicit acceptance criteria.

Here's what is (and isn't) present in the document regarding your questions:

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

• What's in the document: The summary provides "Accuracy Pressure: ± 3mmHg" and "Accuracy Pulse: ± 5%" under "Table 1" and "Table 2" when comparing to predicate devices. This represents the claimed accuracy, which would likely be the acceptance criteria, but no formal study data proving this performance is presented within this document.
• What's missing: The document does not present a table explicitly laying out acceptance criteria from a validation study alongside the performance results from that study. It merely lists the stated accuracy specifications as a comparison point during the substantial equivalence argument.

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

• Missing: This information is not present in the 510(k) summary. It does not describe any clinical or performance test setup, subject numbers, or data origin.

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)

• Missing: This information is not present. The device is a non-invasive blood pressure monitor, and its ground truth typically relies on a reference measurement method (like a mercury sphygmomanometer with auscultation), not necessarily "experts" in the context of image interpretation. However, the exact reference method and its application details are not provided.

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

• Missing: This information is not applicable and not present. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a blood pressure monitor, reconciliation would be against the reference standard.

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

• Missing: Not applicable and not present. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that human readers would use.

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

• What's in the document: The device itself is a "standalone" automatic blood pressure monitor, meaning its measurement is solely algorithmic without human intervention in the measurement process (though a human operates the device). The document states it uses the "oscillometric method" and an "electronic pressure sensor."
• What's missing: While the device operates standalone, the document doesn't explicitly describe a "standalone performance study" in the context of comparing its algorithm-only performance against a human or a different standard. It just states its general operating principle.

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

• Missing: The document does not explicitly state the ground truth method used for any performance testing. For blood pressure monitors, the ground truth is typically obtained from simultaneous measurements using a validated reference method (e.g., a mercury sphygmomanometer with a trained observer using auscultation), adhering to standards like ANSI/AAMI SP10. This is implied to be the basis for claiming "Accuracy Pressure: ± 3mmHg," but the details are not provided.

8. The sample size for the training set

• Missing: Training sets specifically for an algorithm are not mentioned. The "oscillometric method" is described as a "well-known technique in the market." If there were any machine learning components, a training set would be relevant, but this document does not provide such details.

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

• Missing: As no training set is described, this information is also absent.

In summary, the K091434 submission is a 510(k) summary focused on establishing substantial equivalence based on technical similarities and stated performance specifications, rather than detailing the full performance study data against explicit acceptance criteria. To find the information you're looking for, you would typically need to review the full 510(k) submission and its accompanying test reports, which are not included in this summary document.

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Truly Automatic Wrist Blood Pressure Monitor ,Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 wrist.

The devices features include irregular pulse rhythm detection during measurement. and display a warning signal with the reading once the irregular heartbeat is detected.

Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

Truly Automatic Wrist Blood Pressure Monitor DW series are single-mounted devices of the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to wrist circumfernan approximately between 135 and 220 mm, includes the inflatable bladder and nylon shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by two AAA alkaline batteries.

The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Truly Automatic Wrist Blood Pressure Monitor DW series:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the accuracy acceptance criteria for both pressure and pulse rate measurements.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the measurement methods are "No change, all same" as the predicate devices, implying that their performance is expected to be similar.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any tests performed specifically for this device. Blood pressure monitor studies typically compare device readings against reference measurements taken by trained professionals using a mercury sphygmomanometer, but this specific information is absent.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Blood pressure monitors are typically assessed for agreement with a gold standard, not for their impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The listed "Accuracy Pressure" and "Accuracy Pulse" of ±3 mmHg and ±5% respectively are standalone performance metrics of the device's algorithm and hardware, without human intervention in the measurement process itself, beyond initiation. The document states that the calibration and measurement algorithms are the same ("No change, all same") as the predicate device K014141, which itself would have undergone standalone performance testing to meet its accuracy claims.

7. Type of Ground Truth Used

The document inherently refers to the auscultatory method as the ground truth. It states, "Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer." While not explicitly detailed for this specific device's testing, the standard for validating oscillometric blood pressure monitors involves comparing their readings against those obtained by trained observers using a mercury sphygmomanometer (auscultatory method).

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for a training set. This is typical for oscillometric blood pressure monitors, which often rely on well-established algorithms that may have been developed and validated over many years, rather than requiring re-training on new data for each new device model. The document states the measurement algorithm is "No change, all same" as the predicate.

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

The document does not provide any information on how the ground truth for a training set was established. Given that the measurement algorithm is stated as "No change, all same" as the predicate device (Digibio Digital Blood Pressure Monitor, Model D11), it implies that the core algorithm was previously established and validated with a ground truth likely derived from the auscultatory method. The only detail provided is on the irregular heartbeat detection algorithm, where it refers to a "Software validation report I-5. Algorithm description 4. Determination method of irregular heartbeat," which would presumably detail its development and validation, but this report is not included.

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