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ZSBP-003/004/005/006/007/008 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old.

ZSBP-102/103/104/105/106/107 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old.

All measurement values can be read out and keep memory on the LCD panel for home care use.

Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at wrist or upper arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software... and so on.

The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base:

• Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
• Heart beat rate.

The provided text describes a 510(k) submission for a blood pressure monitor and does not contain detailed information about a specific study proving the device meets acceptance criteria. Instead, it refers to compliance with voluntary standards and verification/validation tests.

Here's a breakdown of what can be inferred and what is not present in the provided document, based on the requested categories:

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

The document states "Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10," which is the standard for non-invasive sphygmomanometers. This standard dictates specific accuracy requirements for blood pressure measurements.

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

This information is not provided in the document. The submission mentions "verification and validation tests" but does not detail the methodology, sample size, or data provenance of these tests.

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)

This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained technicians using a reference sphygmomanometer (e.g., mercurial manometer) in a clinical setting.

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

This information is not provided in the document.

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

This is not applicable to this device. Blood pressure monitors are standalone measurement devices and do not involve "human readers" or AI assistance in their primary function of measuring blood pressure from a patient.

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

Yes, this is the primary mode of operation for a blood pressure monitor. The device is intended to automatically measure blood pressure and heart rate using an oscillometric method. The "verification and validation tests" would assess this standalone performance against reference measurements. However, the details of these tests (e.g., specific metrics, results) are not provided.

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

The document implicitly refers to reference blood pressure measurements as the ground truth. For accuracy testing of blood pressure monitors, the established practice (as per ANSI/AAMI SP 10) involves comparing the device's readings to those obtained simultaneously from a validated reference method (e.g., a mercury sphygmomanometer) by trained observers.

8. The sample size for the training set

This information is not provided in the document. Blood pressure monitors using the oscillometric method rely on algorithms that are typically developed and refined using extensive physiological data. The size of this underlying development/training data set is not specified.

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

This information is not provided in the document. For an oscillometric blood pressure monitor, the ground truth for algorithm development would generally involve simultaneous recordings of cuff oscillations and invasive arterial pressure (or highly accurate non-invasive reference measurements) across a diverse population.

Summary of what the document does indicate regarding acceptance criteria and study:

The submission implies that the device meets acceptance criteria by:

• Stating "Compliance to applicable voluntary standards includes ANSI/AAMI, SP 10." This standard itself contains detailed acceptance criteria for non-invasive sphygmomanometers.
• Reporting that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared devices [ZSBP-001, ZSBP-002, and ZSBP-101 (K070473)]."
• The FDA's clearance (K090027) indicates that these tests were sufficient to demonstrate substantial equivalence to predicate devices, which were themselves compliant with relevant standards.

However, the document does not provide the specific numerical results of the performance tests, the sample sizes, expert qualifications, or detailed methodology of the studies conducted for this specific device (ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107). It relies on the assertion of compliance with standards and equivalence to previously cleared devices.

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The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages.

The clinical thermometer / model ZSET-XXX infrared thermometer are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use on people at all ages.

A> ZSDT-XXX Digital thermometer.
The digital clinical thermometer, models ZSDT-XXX Series, are the electronic thermometers by using a themistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control.

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, measuring circuit for the measurement of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

This system uses a 1.5V/DC AG3 or SG3 Alkaline battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically. and displays 'Low battery' in LCD display. Regarding the performance of ZSDT-XXX, it was designed and verified according to the US standard ASTM E 1112-00.

B> ZSET-XXX Infrared thermometer.
The infrared thermometer, models ZSET-XXX, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control.

From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.

This system uses a 3.0 V DC battery(2xAAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ZSET-XXX, they were designed and verified according to the US standard ASTM E 1965-2002.

Here's the breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The submission refers to compliance with specific ASTM standards rather than explicit "acceptance criteria" presented as thresholds. The device performance is implicitly demonstrated by meeting the requirements of these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Information

The document describes non-clinical tests and refers to a clinical report for one of the devices.

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

   • ZSDT-XXX Digital Thermometer: Not explicitly mentioned beyond compliance with ASTM E 1112-00. The specific test set size or data provenance for the digital thermometer is not provided in detail.
   • ZSET-XXX Infrared Thermometer: "The clinical report for the measurement accuracy comparison as required by ASTM E1965: 2002 is provided for ZSET-XXX and ST613C." The sample size, country of origin, or whether it was retrospective or prospective is not explicitly stated in this summary. ASTM E1965-2002 requires specific clinical study design, including subjects (usually febrile and non-febrile) to establish accuracy, but the details are not included here.

2. 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)

   • This information is not provided in the summary. For clinical thermometers, ground truth typically involves a highly accurate reference thermometer (e.g., a rectal or oral mercury-in-glass thermometer or a highly calibrated electronic thermometer) used by trained personnel in a controlled setting, rather than "experts" in the sense of medical specialists interpreting images.

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

   • Given the nature of a clinical thermometer's accuracy testing, an adjudication method like 2+1 or 3+1 is not applicable or mentioned. The ground truth for temperature measurement would typically be established by a single, highly accurate reference measurement.

4. 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

   • No MRMC comparative effectiveness study was done. This type of study is relevant for imaging devices where human interpretation is involved. Clinical thermometers are direct measurement devices.

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

   • The devices themselves are standalone. Their performance is assessed directly against a reference, not in a human-in-the-loop context. The summary states, "Regarding the performance of ZSDT-XXX, it was designed and verified according to the US standard ASTM E 1112-00," and "Regarding the performance of ZSET-XXX, they were designed and verified according to the US standard ASTM E 1965-2002." These standards define standalone performance requirements.

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

   • For clinical thermometers, the ground truth would be based on highly accurate reference temperature measurements (e.g., from a calibrated laboratory standard thermometer or a well-established clinical standard like a rectal mercury thermometer, as specified in the ASTM standards). The document refers to "measurement accuracy comparison as required by ASTM E1965: 2002," implying adherence to the ground truth methodologies prescribed by that standard.

7. The sample size for the training set

   • Not applicable / Not provided. These are hardware devices, not AI/machine learning algorithms that require a "training set."

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

   • Not applicable / Not provided. As mentioned above, these are not AI/machine learning algorithms requiring a training set with established ground truth in that context. The "design and verification" according to the ASTM standards implies that the engineering and calibration processes ensured the device's accuracy.

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ZSBP-001 and ZSBP-002 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old.

ZSBP-101 series of blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old.

All measurement values can be read out and keep memory on the LCD panel for home care use.

Basically two different type of blood pressure monitors are to be included in this 510(K) submission, the wrist type and upper arm type. The main intended use for these two tvpe of blood pressure monitor is as the following description:

1> ZSBP-001 and ZSBP-002 blood pressure monitor. This series of device measures automatically the human being systolic, diastolic blood pressure and heart beat rate from wrist by using the oscillometric method for the patient of ages above 18 years old.

2> ZSBP-101 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age above 18 tears old.
For all of these three blood pressure monitors, the measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician).

From the construction point of view, the non-invasive electronic blood pressure monitor was composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at upper arm or wrist, pneumatic pumping inflation and deflation system, housing, display LCD, and measuring software, and memories ....... etc.

The main operation for the non-invasive electronic blood pressure monitor is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the set pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective to time were recorded as the database of measurement. Then the following measuring results will be calculated against the measurement database, and displayed on the LCD of device:

Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
Heart beat rate.

In addition to the main blood pressure and heart beat rate measuring function, the ZSBP series of blood pressure monitor provides also the memory function for user to store the result of measurement.

The provided text is a 510(k) summary for a blood pressure monitor, not an AI/ML medical device. Therefore, much of the requested information, such as details about AI model training, test sets, ground truth establishment, and MRMC studies, is not applicable or present in this type of document.

However, I can extract the information that is relevant to the acceptance criteria and the study performed, based on the provided text.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with established voluntary standards. The document explicitly mentions:

• ANSI/AAMI SP 10-1992: This standard specifies requirements for automated sphygmomanometers.
• EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

The document states that the "representative models of ZSBP-001 and ZSBP-101 were chosen as testing samples" to demonstrate conformity with these standards.

The "reported device performance" is summarized by the conclusion that the devices "maintain the same safety and effectiveness as that of cleared devices" (the predicate devices) and that the engineering differences "do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device."

Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information (and why it's mostly not applicable here):

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

   • This information is not provided in the 510(k) summary. For a blood pressure monitor, testing would typically involve clinical validation studies (e.g., following AAMI protocols) to establish accuracy against a reference method (like auscultatory measurement by trained observers). The 510(k) summary only states "representative models... were chosen as testing samples" for standard compliance. It does not mention the number of subjects or the data provenance for these tests.

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):

   • Not applicable in this context. Blood pressure monitor validation relies on comparison to a gold standard measurement (often auscultation by trained technicians/physicians), not expert consensus on images or other subjective data. The document does not provide details on the personnel involved in the testing process or their qualifications.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where there's an element of human interpretation and potential disagreement (e.g., reading medical images). For a blood pressure monitor, the "ground truth" and device measurements are objective numerical values.

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 is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant to this device.

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

   • This device is a standalone algorithm (an oscillometric method, though not an AI algorithm) for measuring blood pressure. Its "performance" is its accuracy in measuring blood pressure compared to a reference standard, as implicitly covered by compliance with ANSI/AAMI SP 10-1992. The document confirms that "measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician)." This indicates it's intended for standalone use.

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

   • For blood pressure monitors, the gold standard (ground truth) is typically an invasive intra-arterial measurement or, more commonly in non-invasive validation, simultaneous auscultatory measurements taken by trained observers using a mercury sphygmomanometer (or an equivalent validated device). The document itself does not explicitly state the ground truth method used beyond referencing compliance with ANSI/AAMI SP 10-1992, which dictates such validation methods.

8. The sample size for the training set:

   • Not applicable. This device uses the "oscillometric method," which is a well-established signal processing technique for detecting blood pressure. It is not an AI/ML device that requires a "training set" in the modern sense.

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

   • Not applicable, as there's no AI/ML training set in this context.

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