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The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.

The Automatic Arm Electronic Blood Pressure Monitor, including LBP70C and LBP70D, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult patient with arm circumference ranging from 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches) by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure. The subject device consists of the PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries and optional accessory AC adapter. The two models have same intended use, working principle, measuring range, accuracy, cuff, component and appearance. They are only different in power supply. Model LBP70C is powered by 4 AA alkaline batteries or AC adapter, while model LBP70D is powered by rechargeable lithium-polymer battery or AC adapter. The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.

The provided text describes the acceptance criteria and a clinical study conducted for the Automatic Arm Electronic Blood Pressure Monitor (K210435).

1. Table of Acceptance Criteria and Reported Device Performance

Note on Measurement Range: While the table indicates $\pm 3$ mmHg accuracy for blood pressure, the full ISO 81060-2 standard typically defines acceptance based on the mean difference and standard deviation of differences between the device and reference measurements. The text states "the results showed the accuracy of the subject device is within acceptable scope specified in ISO 81060-2," implying these statistical criteria were met.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 85 patients (46 males, 39 females).
• Data Provenance: The document does not explicitly state the country of origin. The study was conducted as a "clinical study," which implies it was a prospective collection of data for the purpose of validating the device.

3. Number of Experts and Qualifications for Ground Truth

• The document implies the use of a manual Mercury Sphygmomanometer as a reference sphygmomanometer. This suggests that human operators (who would be skilled in using such a device) were involved in generating the reference measurements.
• Number of Experts: Not explicitly stated. For ISO 81060-2, a minimum of two trained observers are typically required, but the document does not specify this detail.
• Qualifications of Experts: Not explicitly stated. For a standard like ISO 81060-2, trained observers are required, typically with experience in auscultatory blood pressure measurement using a mercury sphygmomanometer.

4. Adjudication Method for Test Set

The document states, "Same arm sequential method was adopted during the clinical study." This method involves taking measurements on the same arm sequentially using both the test device and the reference device. There is no mention of an adjudication process (e.g., 2+1, 3+1) for discrepancies, as the ground truth is established by the direct measurements from the reference standard. If multiple human observers were used, the ISO standard would typically dictate an averaging or specific agreement criteria, but this is not detailed here.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study focuses on validating the accuracy of the automated blood pressure monitor against a reference standard, not on comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

The study directly assesses the performance of the Automatic Arm Electronic Blood Pressure Monitor, which is a standalone device. While it contains "intelligent" components (Automatic Arm Electronic Blood Pressure Monitor, Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.), the intent of the clinical study is to validate the accuracy of the device itself (algorithm + hardware) in producing blood pressure measurements. Therefore, the reported performance is effectively the standalone performance of the device without explicit human-in-the-loop assistance for the measurement process (beyond the human placing the cuff).

7. Type of Ground Truth Used

The ground truth was established using measurements from a manual Mercury Sphygmomanometer. This is considered a reference standard for blood pressure measurement in clinical validation studies as per ISO 81060-2.

8. Sample Size for Training Set

The document does not provide any information regarding the training set size or how the device's algorithms were developed. The information provided pertains solely to the clinical validation (test set).

9. How Ground Truth for Training Set Was Established

As no information about a training set is provided, no details on how its ground truth was established can be given. The document focuses on the validation of the finished device.

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The Fingertip pulse oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospital-type facilities, and homecare.

Fingertip pulse oximeter, LOX100A, LOX100B, LOX100C, LOX100D, mainly include of signal acquisition module, signal processing module, prompt module, detector, and emitter LED, display and user interface module, power supply module, the device is used to measure the patient's blood oxygen saturation (SpO2) and pulse rate (PR). The device is mainly composed of main board PCB, lamp panel PCB, sensor, OLED screen, button, silicone gel pad and enclosure.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Fingertip pulse oximeter:

Device: Fingertip pulse oximeter (Model LOX100A, LOX100B, LOX100C, LOX100D) by Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the comparison of the subject device against a predicate device (K161560) and adherence to relevant standards. The "Acceptance Criteria" are implied by the requirements of these standards and the equivalence to the predicate, with "Reported Device Performance" reflecting the subject device's demonstrated capabilities.

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

• Test Set Sample Size: 12 healthy adult volunteer subjects.
• Data Provenance: Retrospective (implied, as the study results are presented as completed data for review), conducted on healthy adult volunteers. The document does not explicitly state the country of origin, but given the company's location (Shenzhen, China) and common regulatory practices, it's likely the study was conducted there or in a region with compatible regulatory/ethical standards.

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

The document states that arterial blood samples were analyzed on a "reference co-oximeter" to provide the functional SaO2 for comparison. This implies an objective, instrumental ground truth, not one established by human experts. Therefore, the "number of experts" for ground truth establishment is not applicable in this context. The co-oximeter itself serves as the gold standard.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established objectively by a co-oximeter, not through human expert consensus requiring adjudication.

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

No. An MRMC study was not described. The study focused on the device's standalone accuracy against a measured physiological ground truth (co-oximetry), not on evaluating human reader performance with or without AI assistance. This device (a pulse oximeter) is a direct measurement device, not an AI diagnostic aid that assists human interpretation.

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

Yes. The clinical study described is a standalone performance test of the device, where the Fingertip pulse oximeter's SpO2 readings were directly compared to arterial blood co-oximeter readings. There's no human "in the loop" for interpreting the device's output influencing the accuracy validation.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was outcomes data in the form of arterial blood co-oximetry readings (functional SaO2). This is considered a highly objective, gold-standard method for determining true arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For a pulse oximeter, the core measurement principle is based on pre-established physiological principles (Lambert-Beer law, absorption characteristics of oxygenated/deoxygenated hemoglobin), not on machine learning models that require distinct training and test sets in the same way. The device's calibration and algorithm development would have utilized extensive physiological data, but this is distinct from a "training set" for a new AI algorithm.

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

Given that this is a pulse oximeter and not an AI-driven diagnostic image analysis tool, the concept of a "training set" with ground truth in the typical machine learning sense is not applicable here. The device's underlying algorithm relies on the physical properties of light absorption by blood components, which were established through fundamental scientific research over many decades. The device is calibrated and validated against established standards (like ISO 80601-2-61) and objective physiological measurements (like CO-oximetry) rather than "training" an AI model.

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The Infrared Forehead Thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of degree C or degree F. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:

Device: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to compliance with performance standards rather than explicitly listing acceptance criteria with numeric targets for all aspects. However, based on the discussions and the standards invoked, we can infer some key performance criteria.

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

• Sample Size (Clinical Study): The clinical study involved "four age groups: 0 up to 3 months, 3 months up to 1 year, older than 1 year and younger than 5 years and older than 5 years". The exact number of subjects within each group or total subjects is not specified in this document.
• Data Provenance: Not explicitly stated (e.g., country of origin). However, the sponsor is Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. from Shenzhen, Guangdong, China. It is highly probable the data originates from China.
• Retrospective or Prospective: Not explicitly stated, but clinical comparison studies are generally prospective. The text "A comparison study and clinical repeatability testing was performed" suggests a prospective collection of data for this study.

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

The document states that a clinical comparison study was performed "to compare the Infrared Forehead Thermometer with Mercury thermometer." This implies the Mercury thermometer served as the reference standard (ground truth). The text does not mention human experts establishing ground truth for individual measurements, but rather the objective measurement from a validated reference device.

4. Adjudication Method for the Test Set

Not applicable/not mentioned, as the ground truth was established by comparison to a Mercury thermometer, not by expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study described is a clinical comparison study of the device against a reference measurement tool (Mercury thermometer) for temperature measurement, not a study involving human readers interpreting results with and without AI assistance.

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

Yes, the studies described are standalone performance evaluations. The device's measurement accuracy, range, and other characteristics were tested directly against standards and a reference thermometer. The clinical study compares the device's output (algorithm only) to the Mercury thermometer.

7. The Type of Ground Truth Used

The primary ground truth for the clinical study was the measurement obtained from a Mercury thermometer. This serves as a widely accepted clinical standard for body temperature measurement.

8. The Sample Size for the Training Set

The document does not mention a distinct "training set" in the context of device development or performance testing for regulatory submission. It refers to a "software" and indicates it was developed, documented, and validated according to IEC 62304 and FDA guidance. This suggests the software development process involved appropriate internal testing, but no specific "training set" for an AI/ML algorithm is detailed, given this is primarily a hardware device with embedded control software.

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

Not applicable/not mentioned, as no explicit training set for an AI/ML model for temperature measurement is described. The control software likely operates based on physical principles and calibration rather than a trained AI model.

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