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The Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

The Oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult patients in the home and hospital. The oximeter features a small size, low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. Principle of the oximeter as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and infrared zones. Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor. The four models (JZK-301, JZK-303, JZK-305, and JZK-307) have the same intended use, working principle, characteristic, and conformance standards, only in appearance have some different (appearance design, dimension, and weight).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Please note that the acceptance criteria for SpO2 and Pulse Rate accuracy are directly stated as the target performance matching the predicate device. The narrative details how this performance was verified. Other criteria are related to compliance with recognized standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 12 subjects (healthy, non-smoking, light-to-dark-skinned adults).
• Data Provenance: The study was a prospective clinical hypoxia accuracy testing conducted during induced hypoxia studies in an independent research laboratory. The country of origin is not explicitly stated, but the manufacturing and submission details point to China.

3. Number of Experts and Qualifications for Ground Truth

• The document implies the use of a CO-oximeter as the control device to establish the ground truth for arterial hemoglobin oxygen (SaO2) values from blood samples. While clinical experts are involved in conducting the study and collecting samples, the direct measurement of SaO2 by a CO-oximeter serves as the objective ground truth, rather than expert interpretation.
• The qualifications of individuals operating the CO-oximeter or collecting blood samples are not specified in this summary but are implicit in conducting a clinical study according to ISO 80601-2-61.

4. Adjudication Method for the Test Set

• The ground truth for SpO2 and Pulse Rate accuracy was established by comparing the device's readings against arterial hemoglobin oxygen (SaO2) values determined from blood samples with a CO-oximeter. This is an objective measurement rather than a subjective expert adjudication process.
• The analysis of the data included Bland and Altman statistics and assessing outliers. This indicates a statistical method for evaluating agreement rather than a consensus-based adjudication from multiple human readers. Therefore, an adjudication method like 2+1 or 3+1 is not applicable here as it's not based on expert interpretation of images or other subjective data.

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

• No, an MRMC comparative effectiveness study was not done.
• This study focused on the accuracy of the device itself against a reference standard (CO-oximeter), not on how human readers perform with or without AI assistance. The device is an oximeter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The entire clinical study described is about the standalone performance of the Oximeter device, without human-in-the-loop assistance for interpretation. The device itself produces the SpO2 and PR readings.

7. Type of Ground Truth Used

• The ground truth for SpO2 and Pulse Rate accuracy was outcomes data / objective measurement: arterial hemoglobin oxygen (SaO2) values determined from blood samples using a CO-oximeter.

8. Sample Size for the Training Set

• Not applicable / Not specified. This device is a pulse oximeter, which operates on established opto-electronic principles (Lambert Beer Law, Photoelectric Oxyhemoglobin Inspection Technology) rather than a machine learning or AI algorithm that typically requires a distinct training set. The clinical study performed is a validation (test set) study.

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

• Not applicable / Not specified. As there is no explicit training set mentioned for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission. The device's operational principles are physics-based, not data-driven in the sense of AI training.

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The Infrared forehead thermometer (Models JZK-602, JZK-603) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

Infrared forehead thermometers (includes model JZK-602, JZK-602, JZK-603) are intended to measure the body temperature through receiving infrared energy radiation via the forehead for people of all ages. These thermometers have the capability to measure temperature via body mode or object mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:

1. The device is intended to be reusable for home use and clinical use.
2. The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, LCD display.
3. Switching of temperature unit between °C and °F.
4. The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
5. Buzzer on or off to set the prompt tone on or off.
6. Prompt tone function and backlights function.
7. The prompt limit setting function.
8. Low battery indication, and auto power-off.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text for the Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603):

Device: Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 200 subjects were evaluated in the clinical study.
  • 50 newborns (0 to 3 months)
  • 50 infants (older than 3 months up to 1 year)
  • 50 children (older than 1 year and younger than 5 years)
  • 50 adults (older than 5 years old)
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It merely describes the study design and its findings. It was a clinical investigation, implying a prospective data collection, rather than retrospective.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study. It refers to a "randomization, simple blind homologous control, pairing design of clinical investigation" that evaluated the device against the requirements of ASTM E1965-98 (Reapproved 2016). This standard itself defines the acceptable reference methods for temperature measurement (e.g., oral, rectal, axillary, tympanic) and their accuracy, which would serve as the defacto "ground truth" rather than direct expert consensus reading of the device's output.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method in the traditional sense of multiple reviewers resolving discrepancies, as might be found in imaging studies. Given it's a thermometer study comparing to a reference method, the "ground truth" is likely established by the reference thermometer measurements as per ASTM E1965-98, negating the need for complex expert adjudication of device readings. The study design is described as "randomization, simple blind homologous control, pairing design."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic AI tools where human readers interpret medical images with and without AI assistance to measure improvement in diagnostic performance. For a temperature measurement device, the objective is to accurately measure temperature against a reference standard, not to assist human interpretation of complex data. Therefore, an MRMC study is not applicable here.

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

Yes, the primary performance evaluation appears to be a standalone (algorithm only) assessment. The device's accuracy and performance criteria (measurement range, accuracy, response time) are tested directly against performance standards (ISO 80601-2-56, ASTM E1965-98) and in a clinical study where its readings are compared to a reference method, without explicit human interpretation being part of the primary performance metric beyond using the device as intended. The "human-in-the-loop" here is the user taking the temperature, but the device's measurement itself is the standalone output being validated.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was based on reference temperature measurements as required by the ASTM E1965-98 (Reapproved 2016) standard. This typically involves using highly accurate reference thermometers (e.g., direct contact electronic thermometers, mercury-in-glass thermometers at a core body site) as the "true" temperature against which the infrared forehead thermometer's readings are compared.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. This is a medical device, not an AI/ML diagnostic algorithm in the sense of requiring separate training datasets. While internal calibration or factory data might be used in manufacturing, it's not a "training set" in the context of deep learning models.

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

As this is a physical measurement device (infrared thermometer) and not a machine learning model requiring a distinct training phase with annotated data, the concept of a "training set" and its ground truth establishment in the AI/ML sense does not apply. The device's internal algorithms are likely based on physical principles of infrared detection and calibrated during manufacturing, rather than "trained" on a dataset of patient temperatures.

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This Upper Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.

The Upper Arm Blood Pressure Monitor, including ZK-B869, ZK-B869, ZK-B872 and ZK-B876, can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 32cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and arm cuff. The ZK-B868 is powered by 4 AA dry batteries (DC 6V), other models are powered by 4 AAA dry batteries (DC 6V). The device has a memory function that automatically stores some sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function. The four models have the same intended use, working principle, measuring range, accuracy, cuff, conformance standard; only in appearance and power supply have some difference.

This document describes the 510(k) summary for the "Upper Arm Blood Pressure Monitor" (Models: ZK-B868, ZK-B869, ZK-B872, ZK-B876) by ShenZhen ZhengKang Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to blood pressure measurement accuracy.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

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

The document mentions compliance with the standard ISO 81060-2 (Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type). This standard sets widely accepted accuracy criteria for blood pressure monitors.

While the document doesn't explicitly present a table of acceptance criteria and reported performance in a single table, it states the device "passed" the performance testing according to ISO 81060-2.

The Accuracy section within the comparison table (page 5) lists the following for the targeted device, which are the inherent performance characteristics the device aims to meet:

These values are consistent with the requirements of ISO 81060-2. The statement that the performance testing was "performed to, and passed" these standards implies that the device achieved these accuracies within the limits defined by ISO 81060-2.

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

The document does not provide details on the sample size used for the clinical validation according to ISO 81060-2. It also does not specify the country of origin of the data, nor whether the study was retrospective or prospective.

ISO 81060-2 typically requires a prospective study with a specific number of subjects (usually 85 subjects with specific blood pressure ranges) for clinical validation. However, these specific details are not present in this summary.

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)

For a blood pressure monitor, the "ground truth" (or reference measurement) is typically established by trained observers (often physicians or nurses) using a standardized auscultatory method, with the accuracy verified against a mercury sphygmomanometer or highly accurate validated electronic device.

The document does not specify the number of experts or their specific qualifications used to establish the ground truth for the clinical validation. ISO 81060-2 mandates specific procedures for reference measurements, involving two trained observers, but these details are not stated here.

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

The document does not describe any adjudication method for the test set. For clinical validation of blood pressure monitors, the ISO 81060-2 standard outlines a specific methodology for collecting simultaneous reference measurements from two trained observers, and if there are significant discrepancies, a third observer might be involved. However, this level of detail is not present in the provided text.

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 section is not applicable to this device. The device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant.

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

The device is inherently a "standalone" automated measurement system. Its performance, as validated against ISO 81060-2, represents its algorithm-only performance in measuring blood pressure and pulse rate. The study is a standalone performance evaluation.

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

The ground truth for blood pressure measurement is established through:

• Simultaneous auscultatory measurements by trained observers using a reference sphygmomanometer (mercury or a highly accurate validated electronic device). This is the standard method prescribed by ISO 81060-2.

While the document doesn't explicitly state "auscultatory measurements," the reference to ISO 81060-2 implies this methodology for ground truth establishment.

8. The sample size for the training set

This device is a hardware product with embedded software/firmware for an established measurement principle (oscillometric). It is not an AI/ML device that undergoes "training" in the typical sense of a deep learning model. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant here, and no information on a training set size is provided.

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

As explained above, there is no "training set" in the AI/ML context for this type of device. The accuracy of the device is assessed through clinical validation against established ground truth measurements from human observers, as per ISO 81060-2, not "trained" on a dataset.

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