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The UV Radiation Treatment System models YK-6000A-T, YK-6000B, andYK-6000B-T, are intended for use under the direction of a physician, for the treatment of vitilizo, psoriasis, and eczema. The devices are intended for treatment of these conditions on Fitzpatrick Skin Types (I-VI).

The proposed device, UV Radiation Treatment System is a portable medical device that consists of tubes, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment. It has four models: YK-6000A,YK-6000A-T,YK-6000B,YK-6000B-T,in which the model YK-6000A and YK-6000A-T emit UVA light and the model YK-6000B and YK-6000B-T emit UVB light.

This product has the features are as follows:

A. Use Philips special UV lamp as light source, with high stability and long service life:

B. Small bulk, lightweight, operation simply, patients can take with themselves;

C. There is glisten board inner radiation unit, which can raise radiant efficiency.

The UV Radiation Treatment System only can be used in Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician.

The provided document is a 510(k) summary for a UV Radiation Treatment System and specifies that no clinical study was performed to prove the device meets acceptance criteria. The submission relies solely on non-clinical (lab bench) testing and comparison to a predicate device. Therefore, many of the requested sections (2-5, 7-9) cannot be answered with information from this document because there was no study involving patient data, ground truth, or expert review.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics against a defined standard (e.g., sensitivity, specificity for an AI device). Instead, it presents a comparison of the proposed device's characteristics against a predicate device, focusing on substantial equivalence. The "performance" is demonstrated through compliance with various safety and electrical standards via non-clinical bench testing.

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

• No test set was used. As explicitly stated in Section 8.0, "No clinical study is included in this submission." The evaluation for substantial equivalence was based on non-clinical bench testing and comparison to a predicate device.

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. No clinical study was performed, and therefore no ground truth needed to be established by experts for a test set.

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

• Not applicable. No clinical study was performed.

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 UV radiation treatment system, not an AI diagnostic or assistance tool. No MRMC study was performed.

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

• Not applicable. This device is a physical UV treatment system, not an algorithm.

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

• Not applicable. No clinical study involving patient data and ground truth was conducted. The "ground truth" for the non-clinical tests would be the established performance specifications and regulatory standards (e.g., measured electrical safety, biocompatibility results).

8. The sample size for the training set

• Not applicable. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm.

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

• Not applicable. There is no training set for this device.

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The Arm blood pressure monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.

The proposed device, Arm Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven both battery and AC power supply. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy. The measuring method for the Arm Blood Pressure Monitor is oscillation mensuration. And all values can be read out in one LCD panel. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data.The blood pressure storing 2x99 set memory value, each measurement it will automatically stored. When it stored 2x99 set memory value, the old value will be covered by the new one. It can show the latest 3 times average value. User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result: User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure, diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.

This document is a 510(k) Premarket Notification from Xuzhou Yongkang Electronic Science Technology Co., Ltd. for their Arm Blood Pressure Monitor (Model YK-BPA1). It aims to demonstrate substantial equivalence to a legally marketed predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Arm Blood Pressure Monitor are primarily derived from the ISO 81060-2:2013 standard for clinical validation of automated non-invasive sphygmomanometers.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 150 subjects.
• Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. It is implied to be a prospective study ("relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement").

3. Number of Experts and Qualifications for Ground Truth

• The document does not explicitly state the number of experts or their specific qualifications. It mentions that "Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device." This implies trained personnel were involved in taking the reference measurements, but their number and specific qualifications (beyond being "qualified") are not detailed.

4. Adjudication Method for Test Set

• The document does not specify a formal adjudication method (like 2+1 or 3+1). The ground truth was established through Auscultation using a qualified calibrated mercurial sphygmomanometer, which is a direct measurement method rather than a subjective interpretation requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the accuracy of an automated blood pressure monitor against a gold standard, not on how it assists human readers.

6. Standalone (Algorithm Only) Performance

• Yes, the performance study effectively evaluates the standalone performance of the Arm Blood Pressure Monitor. The study validates the accuracy of the device's automated measurements against a clinical gold standard (auscultation).

7. Type of Ground Truth Used

• Clinical Measurements / Expert Consensus (Implicit): The ground truth was established through auscultation using a qualified, calibrated mercurial sphygmomanometer. This involves direct physiological measurement, performed by what are assumed to be trained and qualified personnel (implicitly, experts in taking blood pressure measurements via auscultation).

8. Sample Size for Training Set

• The document does not provide information on the sample size for a training set. This is a medical device validation, and the provided clinical data is for performance testing, not for training an AI/ML algorithm. The device described appears to be a traditional automated blood pressure monitor, not an AI-driven one.

9. How Ground Truth for Training Set was Established

• Not applicable. The document describes the validation of a standard automated blood pressure monitor, not an AI/ML-driven device that requires a training set with established ground truth.

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The Infrared thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

The Infrared thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use. The Infrared thermometer has the following features

1. 1 second measure the temperature.
2. Sensor measurement technology.
3. Automatically power-off, if left idle for 60 seconds.
4. One-key measurement.
5. Prompt for fever.
6. Stores 12 sets recent measurement data for your data contrast.
7. Safety by infrared measuring.

YK-IRT1 is divided into System initialization module, Temperature Signal sample module, AD (Analog signal/Digital signal) sample process module, Beyond the threshold process module,Key processing module, Power Manage module,User Interface module.

The provided text describes the acceptance criteria and a clinical study conducted to demonstrate the safety and effectiveness of the YK-IRT1 Infrared Thermometer.

Here's the breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

The clinical study was performed according to ASTM E1965-98, Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature. The acceptance criteria are implicitly defined by the values specified in this standard for clinical accuracy and repeatability. The reported device performance is presented as clinical standard deviation, mean absolute deviation, and clinical repeatability for different age groups.

Note: The exact numerical acceptance criteria from ASTM E1965-98 are not explicitly stated in the provided text, but the conclusion states that the device "all conform to the values specified in ASTM E1965-98."

Details of the Study Proving Acceptance Criteria

1. Sample size used for the test set and the data provenance:

   • Sample Size: 161 subjects in total, divided into three age groups (at least 30 subjects per group), as determined by referring to Term X2.3.1 of the Appendix to ASTM E1965-98.
   • Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective, but clinical trials are generally prospective. The comparison to other thermometers (oral mercury-in-glass thermometer, Braun PRO 6000 ear thermometer, TVT-200 forehead thermometer) suggests a controlled clinical setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The ground truth was established by comparing the YK-IRT1 readings to a "calibrated oral mercury-in-glass thermometer used in the hospital." The document does not specify the number or qualifications of medical professionals involved in taking these measurements.

3. Adjudication method for the test set:

   • The document implies a direct comparison method where the YK-IRT1's measurements are compared against the ground truth established by the oral mercury thermometer. It also compares the ear temperature results to a Braun PRO 6000 ear thermometer and forehead temperature results to a TVT-200 forehead thermometer of the control group. There is no mention of an adjudication process involving multiple human readers for the test set results.

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. This is a study for an infrared thermometer, not an AI-assisted diagnostic device. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable.

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

   • Yes, implicitly. The clinical trial directly assessed the device's accuracy and repeatability by comparing its readings to a reference standard (calibrated oral mercury-in-glass thermometer) on human subjects. The device, being an infrared thermometer, operates as a standalone measurement tool.

6. The type of ground truth used:

   • Expert Consensus/Reference Standard: Calibrated oral mercury-in-glass thermometer used in the hospital. This serves as the reference standard for body temperature measurement.

7. The sample size for the training set:

   • The document describes a clinical trial (test set) but does not mention a separate "training set" for the device, as it is a measuring instrument, not a learning algorithm (like AI/ML). The device's design and calibration would be based on engineering principles and potentially internal testing, not a distinct training set in the AI sense.

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

   • Not applicable, as there is no mention of a "training set" in the context of an AI/ML device. The device's inherent accuracy and performance are developed through its engineering design and manufacturing processes, with its clinical performance validated against a reference standard in the described clinical trial.

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The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home. The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.

The proposed device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. The Wrist Type Blood Pressure Monitor can automatically complete the inflation, deflation and measurement of systolic and diastolic blood pressure as well as the pulse rate of adult person. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data; User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result; User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure. diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.

The provided document is a 510(k) premarket notification for a Wrist Type Blood Pressure Monitor (K162616). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving stand-alone safety and effectiveness through extensive, detailed clinical trials with the rigor typically seen for novel devices.

Therefore, the information available is primarily related to demonstrating equivalence to the predicate device, particularly regarding adherence to relevant performance standards for blood pressure monitors. It does not contain the granular detail about acceptance criteria, test set characteristics, expert qualifications, or multi-reader studies that would be present in a submission for a novel AI device with complex image analysis or diagnostic capabilities.

Here's an attempt to extract and interpret the information based on the provided document, addressing the requested points. Please note that many points cannot be fully answered due to the nature and scope of this 510(k) submission for a blood pressure monitor.

Acceptance Criteria and Device Performance (as demonstrated for a blood pressure monitor)

The primary acceptance criteria for a blood pressure monitor, as indicated by compliance with ISO 81060-2:2013, relate to the accuracy of blood pressure measurements.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Table 2 shows a general "BP Accuracy: ±3 mmHg" which typically refers to the device's inherent precision, not the clinical validation results against a gold standard as per ISO 81060-2. The clinical conclusion on page 6 is more relevant for the acceptance criteria. |
| Pulse Rate (PR) Accuracy (not explicitly detailed in acceptance criteria, but measured) | PR Range: 40-199 bpm (Table 2) |
| Non-Clinical Test Compliance | IEC 60601-1:2012 (General safety)
IEC 60601-1-2:2007 (EMC)
ISO 80601-2-30:2013 (Specific for automated non-invasive sphygmomanometers)
ISO 10993-5:2009 (Biocompatibility - cytotoxicity)
ISO 10993-10:2010 (Biocompatibility - irritation/sensitization) (Page 5-6) |
| Substantial Equivalence to Predicate Device | Demonstrated through comparative tables for product code, regulation, class, intended use, application site, patient population, measurement items, principle, main components, BP/PR ranges, operation/storage conditions, data storage, performance standard, cuff size, power supply, voltage, electrical safety, EMC, biocompatibility, labeling, and software level of concern. (Pages 6-8) |

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

• Sample Size: "There were 150 subjects been selected to participate in the trial." (Page 6)
• Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. It can be inferred that it was likely conducted in China, given the manufacturer's and submission correspondent's locations.
• Retrospective or Prospective: Not explicitly stated, but clinical validation studies for device accuracy are typically prospective to ensure controlled measurement conditions per the standard.

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

• The ground truth was established by "Auscultation... with the qualified calibrated mercurial sphygmomanometer used as control group." (Page 6).
• The document does not specify the number or qualifications of the individuals (experts or clinicians) who performed the auscultation measurements. For ISO 81060-2:2013, typically two independent observers (clinicians trained in auscultation) are required to take measurements.

4. Adjudication Method for the Test Set

• Not explicitly described. For ISO 81060-2:2013, the standard dictates how the reference measurements are obtained and compared, often involving simultaneous auscultation by multiple observers. An explicit adjudication method beyond this standard protocol is not mentioned.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools (e.g., in radiology) where human-in-the-loop performance is being evaluated. This device is a standalone measurement device (blood pressure monitor), not an AI-assisted diagnostic tool.

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

• Yes, the primary clinical validation was a standalone performance test of the device's accuracy. The device (Wrist Type Blood Pressure Monitor, YK-BPW1) operated autonomously to measure blood pressure, and its readings were compared against the established gold standard (auscultation). This is inherent to the type of device.

7. The Type of Ground Truth Used

• Clinical Measurements via Auscultation: The ground truth was established by human auscultation using a qualified calibrated mercurial sphygmomanometer (a medical standard for manual BP measurement). This represents expert consensus/clinical gold standard.

8. The Sample Size for the Training Set

• This document describes a clinical validation study and non-clinical tests for a medical device (blood pressure monitor), not a machine learning or AI algorithm in the sense of needing a distinct "training set." The device's underlying algorithm is pre-programmed based on known oscillometric principles. Therefore, there is no explicit "training set" sample size mentioned or implied for this type of device submission.

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

• As there is no "training set" in the context of an AI algorithm being trained, this question is not applicable to the information provided for this blood pressure monitor. The device's design and internal algorithms are based on established biometric measurement principles.

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The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,

The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;

The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.

The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.

The provided document is a 510(k) premarket notification for a medical device, specifically a Fingertip Pulse Oximeter (Model YK-81C). While it describes the device, its intended use, and a clinical study for SpO2 accuracy, it does not present a formal table of "acceptance criteria" for the device's performance in the typical sense of a pre-defined set of metrics that must be met. Instead, it describes compliance with recognized standards and presents the results of a specific performance test.

Here's an attempt to extract and synthesize the information based on your request, with an understanding that the document isn't structured around explicit "acceptance criteria" in a table format but rather demonstrates compliance and performance results.

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with the relevant ISO standard for pulse oximeters regarding SpO2 accuracy.

Note on Acceptance Criteria: The document does not explicitly state an "acceptance criteria" value for the SpO2 accuracy (Arms) that the device must be less than or equal to. However, the study was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 "Procedure for invasive laboratory testing on healthy volunteers." This standard outlines the methodology for evaluating pulse oximeter accuracy, and the resulting Arms value is used to demonstrate performance. Typically, a lower Arms value indicates better accuracy, and regulatory bodies often have an expectation around this value based on the standard. For many pulse oximeters, an Arms value of 3.0% or less in the 70-100% range is often considered acceptable for regulatory clearance. The reported 2.53% falls within typical acceptable ranges.

II. Study Details

1. Sample Size used for the Test Set and Data Provenance:

   • Sample Size: 12 healthy adult volunteer subjects.
   • Data Provenance: The study was conducted in a laboratory setting (likely in China, given the manufacturer's location, though not explicitly stated for the study site). It was a prospective study involving induced hypoxia.

2. Number of Experts used to establish the Ground Truth for the Test Set and the Qualifications of those Experts:

   • The document does not specify the number of experts used to establish ground truth or their qualifications.
   • The ground truth was established by arterial blood CO-Oximetry, a laboratory analytical method, not by human expert assessment.

3. Adjudication Method for the Test Set:

   • Not applicable / None directly stated. The ground truth (SaO2) was determined by an objective lab measurement (CO-Oximetry) of arterial blood samples, not by expert consensus or adjudication. The device's SpO2 readings were compared to these objective measurements.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was NOT done. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. For a pulse oximeter, the primary evaluation is device accuracy against a physiological reference.

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

   • Yes, in essence. The clinical trial evaluated the device's SpO2 accuracy performance by comparing its readings directly to arterial blood CO-Oximetry. While a human applies the device, the performance metric (Arms) is a direct measure of the device's algorithmic output against the physiological reference.

6. The Type of Ground Truth Used:

   • Outcomes Data / Physiological Standard (Arterial Blood CO-Oximetry): The ground truth for SpO2 accuracy was established by analyzing arterial blood samples using a reference CO-Oximeter, which provides functional SaO2. This is considered the gold standard for SpO2 accuracy assessment in pulse oximetry.

7. The Sample Size for the Training Set:

   • Not applicable / Not stated in the context of this document. This document describes a 510(k) submission for a finished medical device. The clinical study described is a validation study (test set) for the device's accuracy, not a study for training an AI model. Pulse oximeters typically rely on well-established physiological principles and calibrations, not 'training data' in the machine learning sense, although their internal algorithms are developed and refined using extensive data. The document focuses on proving the device's performance against a standard after its design and internal algorithms are finalized.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As mentioned in point 7, there's no "training set" described in the context of this 510(k) document. The device's internal algorithms would have been developed and calibrated by the manufacturer, likely using proprietary methods and data, but this information is not part of the regulatory submission's clinical performance evaluation.

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