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This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediativ patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.

This AP-10 Pulse Oximeter is wrist-worn. It measures the SPO2 physiological parameter, and the measurement results are displayed and stored. The data can be transferred to a phone or PC via a USB connection or via Bluetooth. The AP-10 Pulse Oximeter measures SPO2 and Pulse Rate simultaneously. The device can store up to 500 hours of SPO2 and Pulse rate data.

The Shenzhen Creative Industry Co., Ltd. Pulse Oximeter, AP-10, underwent a clinical study to establish its accuracy for measuring oxygen saturation (SpO2). The study was conducted in accordance with Annex EE of ISO 80601-2-61:2018 (or 2011, as listed in the provided text).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the AP-10's reported performance for SpO2 and Pulse Rate accuracy meets the ISO 80601-2-61 standard's requirements, which are the acceptance criteria.

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

The document states that clinical testing was conducted. However, it does not explicitly mention the sample size for the test set or the country of origin. It refers to the "Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011." This guideline typically involves healthy volunteers studied under controlled hypoxia conditions. Therefore, the data would be prospective.

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

The provided text does not contain information regarding the number of experts or their qualifications used to establish ground truth for the test set. For pulse oximetry, the "ground truth" for SpO2 is usually established via a co-oximeter measuring arterial blood gas (PaO2), overseen by medical professionals, but this detail is not present in the document.

4. Adjudication Method

The document does not specify an adjudication method. For pulse oximetry studies, adjudication typically refers to how reference SpO2 values are determined from blood samples, which doesn't usually involve multiple human readers in the same way imaging studies might.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The AP-10 is a direct measurement device (pulse oximeter), so this type of study is not applicable.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was conducted. The "Reported Device Performance" in the table above reflects the algorithm's accuracy in measuring SpO2 and pulse rate as a standalone device. The clinical study mentioned in "Clinical: Clinical testing was conducted per Annex EE Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011" specifically evaluates the device's intrinsic accuracy.

7. Type of Ground Truth Used

The type of ground truth used, though not explicitly stated as "co-oximetry," is implied by the reference to Annex EE of ISO 80601-2-61. This standard's Annex EE describes a method where arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples is considered the ground truth against which the pulse oximeter's SpO2 readings are compared.

8. Sample Size for the Training Set

The document does not provide any information about the sample size for the training set. It refers to non-clinical and clinical testing for the current device's performance validation, but not to machine learning model training data. Given that pulse oximeters primarily rely on established biophysical principles (light absorption at different wavelengths by oxygenated and deoxygenated hemoglobin) rather than complex machine learning models directly trained on vast datasets in the same way an AI diagnostic tool might, the concept of a "training set" for the core physiological measurement might not be directly applicable or detailed in this type of submission.

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

As with the previous point, the document does not provide information on how ground truth for a training set (if one was used for specific algorithm development within the device) was established. The focus of the submission is on the device's adherence to established performance standards for pulse oximetry.

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This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, pulse rate (PR), noninvasive blood pressure (NIBP), functional oxygen saturation (SpOz), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

There are three versions of the K serial Patient Monitor, K10, K12 and K15. The primary difference is physical dimension and display TFT size; all other specifications remain unchanged. All versions have the same indications for use.

This document, a 510(k) summary for the Shenzhen Creative Industry Co., Ltd. Patient Monitor, Models K10, K12, and K15, primarily focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Creative Industry UP-7000 Patient Monitor, K123711) rather than detailing the specific acceptance criteria and study proving performance for a novel AI/software device.

Therefore, much of the requested information regarding AI device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training) is not applicable or present in this document. This document describes a traditional medical device (patient monitor) and its components, and the "study" referred to is non-clinical and clinical testing to ensure compliance with relevant performance standards for vital sign monitoring.

However, I can extract the information that is applicable based on the provided text, particularly focusing on the performance criteria for the integrated vital sign modules.

Here's an analysis based on the provided text:

Device: Patient Monitor, Models K10, K12, K15

Indications for Use: Monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients, including ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), and end-tidal CO2 concentration (EtCO2). Applicable for use in hospitals and clinical institutions, operation by qualified professionals only.

Study Type: This is a 510(k) submission seeking substantial equivalence to a predicate device. The "studies" involve non-clinical (safety and performance) and clinical (NIBP validation) testing against recognized standards rather than a comparative effectiveness study of a novel AI algorithm's diagnostic performance.

1. Table of acceptance criteria and the reported device performance:

The document lists performance specifications for each physiological parameter module, often directly comparing them to the predicate device. The acceptance criteria are implicitly that the devices meet or are substantially equivalent to the established performance requirements of the predicate device and relevant industry standards.

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The Handheld Pulse Oximeter is intended for measuring the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active continuous monitoring.

This SP-20 Handheld Pulse Oximeter is an integrated product with a modular design. It simultaneously measures physiological parameters by integrated modules and corresponding accessories. The measurement results are displayed, stored and transferred by the central processing unit. The SP-20 Handheld Pulse links with the compatible 510(k) cleared IR Ear thermometer Device (option). Since the SP-20 receives data from the 510(k) cleared IR Ear thermometer and no data is transmitted to the thermometer, it does not affect the operations or accuracy of the linked IR Ear thermometer Device.

Here's an analysis of the acceptance criteria and study information for the Shenzhen Creative Industry Co., Ltd. Handheld Pulse Oximeter, SP-20 based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices and adherence to various safety and performance standards rather than explicitly stating numerical acceptance criteria for SpO2 and Pulse Rate accuracy with corresponding numerical performance results. However, it does state compliance with the general requirements of the standards.

Based on the information, the primary performance standard for the pulse oximeter function is:

Important Note for SpO2 and Pulse Rate: While ISO 80601-2-61 covers the particular requirements for pulse oximeter equipment, the document does not explicitly state the specific accuracy (e.g., Arms value) or bias results for SpO2 or Pulse Rate as acceptance criteria or reported performance results. It only states general compliance with the standard. Typically, pulse oximeter standards define specific accuracy requirements (e.g., Arms ≤ 3% for SpO2 between 70-100%). It's implied that the device meets these within the standard, but the specific numbers are not provided in this summary.

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

• Sample Size: Twelve (12) subjects.
• Data Provenance: The subjects consisted of volunteers (3 women and 9 men) with no known illnesses and no anemia. They represented a mixture of ethnic backgrounds with skin colors ranging from light to dark, and ages from 22 to 38. A total of 24 samples were obtained per subject.
• Study Type: This appears to be a prospective clinical testing for performance validation. The location of the test is not explicitly stated as a country, but it says "Data was recorded by Bickler-Ye Lab and provided for analysis," which might hint at a US-based lab given Dr. Jeffrey Bickler's affiliation with UCSF.

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

The document does not mention the use of experts to establish ground truth for the clinical testing in the traditional sense of consensus reading for diagnostic imaging. Instead, for pulse oximetry, the "ground truth" for oxygen saturation is typically established through direct arterial blood gas analysis, a recognized clinical standard. However, this document does not explicitly state how ground truth for SpO2 was established in the clinical test. It states "Testing validated the submitted device was effective in determining SPO2."

4. Adjudication Method for the Test Set

Not applicable in the context of this pulse oximeter performance testing. Adjudication methods like "2+1" or "3+1" are typically used in studies where human readers are interpreting images or data and their disagreements need to be resolved. For pulse oximetry, the comparison is usually against a physiological standard (e.g., co-oximetry).

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

No. An MRMC study was not done. The study described is a clinical validation of the device's accuracy in measuring SpO2 and pulse rate, not a comparative effectiveness study involving human readers with and without AI assistance.

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

Yes, the described "Clinical testing" focuses on the device's performance in measuring SpO2. This is a standalone performance test of the device (algorithm/sensor system) without human interpretation in the loop. The device directly provides numerical readings (SpO2, Pulse Rate).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the method for establishing ground truth for SpO2 in the clinical trial. For pulse oximeters, the accepted gold standard for SpO2 is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from an arterial blood sample. While the document mentions "Testing validated the submitted device was effective in determining SPO2," it doesn't detail the comparison method.

8. The Sample Size for the Training Set

No information about a training set is provided. This device is a pulse oximeter, not an AI/ML-driven diagnostic algorithm that typically requires a separate training set. Its principle of operation is based on optoelectronics and signal processing, which doesn't usually involve a "training phase" in the same way an AI model does.

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

Not applicable, as a training set for an AI/ML algorithm is not relevant to this type of device based on the provided information.

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The All-in-One Health Monitor PC-303 is a device designed for spot-checking measuring of the patient's physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP);

Additionally, the device is available to communicate with the compatible Blood Glucose Monitoring System and ECG monitor to make the measurement.

This device is applicable for Adult and Pediatic (age>3 years old) use in clinical institutions and has no conditions or factors of contraindication.

The All-in-One Health Monitor, PC-303 is mobile modular designed patient monitor. It monitors the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.

Additionally, the device is also capable to link and communicate with the compatible Blood Glucose Meter and ECG monitor to make the measurement.

This device system measure the patient's physical parameters with variety modules. It takes digital signals from NIBP, SpO2, Temperature module through COM ports, and receives ECG data, blood glucose data from compatible legally marketed ECG Monitor or BLOOD GLUCOSE MONITORING Device. The software to process the data, then display parameters on the screen and storage some useful information.

This device is applicable for use in clinical institutions and has no conditions or factors of contraindication.

The provided document describes the All-in-One Health Monitor, PC-303, and its substantial equivalence to a predicate device (UP-7000 Patient Monitor, K123711). The acceptance criteria are primarily based on meeting relevant international standards for medical electrical equipment and specific performance characteristics in comparison to the predicate device.

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

The acceptance criteria are not explicitly stated as distinct numerical targets in a single table within the document but are inferred from the comparison with the predicate device and the adherence to recognized international standards. The "reported device performance" is the claim of compliance with these standards and the equivalent performance to the predicate.

2. Sample size used for the test set and the data provenance

The document states that "Clinical testing was performed for the NIBP functions and are submitted as part of this submission." However, it does not specify the sample size used for this clinical testing or the data provenance (e.g., country of origin, retrospective/prospective).

For biocompatibility testing, the "In Vitro Cytotoxicity Test" used L929 mouse fibroblast cells, and the "Tests for irritation and skin sensitization" used guinea pigs. These are standard biological test methods, not human clinical sample sizes.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for any of the performance or clinical studies.

4. Adjudication method for the test set

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

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 device is a patient monitor with built-in and external measurement capabilities for physiological parameters (SpO2, NIBP, TEMP, Blood Glucose, ECG). It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable and was not reported.

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

The device is a medical instrument that provides physiological measurements. Its performance is inherent in its measurement capabilities and adherence to performance standards. The "standalone" performance is essentially its ability to accurately measure the parameters as specified, which is verified through testing against standards and comparison to a predicate device. The document mentions "Performance testing was performed to ensure that all of the device operated within specified parameters independently and with all other functions of the device operating." This indicates standalone performance testing of its direct measurement capabilities.

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

The ground truth for the measurements would typically be established by highly accurate reference instruments or established clinical methods, as dictated by the specific IEC/ISO/ASTM standards (e.g., for NIBP, a reference sphygmomanometer; for SpO2, a co-oximeter with induced hypoxia studies; for temperature, a reference thermometer). The document implies adherence to these standards for validation rather than explicitly stating ground truth derivation methods for each measurement. For NIBP, the reference to "clinical testing" would imply comparison to a clinically accepted gold standard.

8. The sample size for the training set

This device is a physiological monitor, not an AI/machine learning device that typically requires a "training set" in the context of algorithm development. Therefore, the concept of a training set sample size does not apply here.

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

As the device does not employ a machine learning algorithm requiring a "training set," this question is not applicable.

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The Pulse Oximeters are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display.

These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are used by adult and pediatric patients. These devices are recommended for use on the index fingers of 1.0 - 2.2 cm thick.

A blood-oxygen saturation reading indicates the percentage of hemoglobin molecules in the arterial blood which are saturated with oxygen. The reading may be referred to as SaO2. Readings vary from 0 to 100%. Normal readings in a healthy adult, however, range from 94% to 100%. The term SpO2 means the SaO2 measurement determined by pulse oximetry. In its most common (transmissive) application mode, a sensor device is placed on a thin part of the patient's body. The device passes two wavelengths of light through the body part to a photodetector. It measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbances due to the pulsing arterial blood alone, excluding venous blood, skin, bone, muscle and fat. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Oximeter. The device can measure SpO2 and body pulse simultaneously.

The PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD-1W; POD-60NW-1 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in a home and clinical environment. The index finger is the recommended site. It is intended for spot-checking adult and pediatric patients on fingers between 1.0 -2.2 cm thick.

This oximeter has a wireless data transmission function. The user can transmit the SPO2 and pulse rate data to a computer through the wireless communication module.

This document, a 510(k) summary for various Pulse Oximeter models from Shenzhen Creative Industry Co., Ltd., primarily asserts substantial equivalence to predicate devices and focuses on mechanical, electrical, and biocompatibility testing. It does not describe a study to prove the device meets acceptance criteria for its core function (SpO2 and pulse rate measurement) beyond a "Bench Test of SpO2 and Pulse Rate" which references accuracy ranges using a simulator.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not available in this document. The document explicitly states: "In that the measuring device in the electro-circuit module, cushion rubber, emitter and receiver are the same as predicate devices, we concluded that this will not affect the device performance. No new clinical validation needed." This implies reliance on the predicate device's clinical validation.

Here's an analysis of the provided information based on your requests:

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

Based on the document, the "performance" for SpO2 and Pulse Rate is presented as a target accuracy range tested using a simulator.

Note: The document only provides the tested accuracy range with the simulator, not explicit acceptance criteria from an independent study. The wording "we conducted additional verification to show it complies with the requirement" implies these ranges are the requirements, but they are presented as results from a bench test with a simulator, not from a clinical study on human subjects.

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 available in the provided document for the SpO2 and pulse rate accuracy claims. The document states a "Bench Test of SpO2 and Pulse Rate" was performed using an "SpO2 simulator method (simulator model: Index 2 series)". This is a laboratory test, not a clinical study on a human test set. Therefore, there is no information on human sample size, data provenance, or retrospective/prospective nature.

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

This information is not available. Since the primary claims for SpO2 and pulse rate accuracy were validated using a simulator, there were no human experts involved in establishing ground truth for a clinical test set.

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

This information is not available. As there was no clinical test set involving human subjects to establish ground truth, an adjudication method for such a test set is not applicable.

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 the device described. This document pertains to a pulse oximeter, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human "readers" or interpretation in the way an MRMC study evaluates.

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

Yes, in the context of a pulse oximeter, its performance is inherently standalone. The "Bench Test of SpO2 and Pulse Rate" using a simulator can be considered a standalone performance evaluation of the device's measurement capabilities.

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

For the "Bench Test of SpO2 and Pulse Rate," the ground truth was based on the output of an SpO2 simulator (Index 2 series). This is a synthetic ground truth, not derived from biological sources like expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not available and likely not applicable in the traditional sense of machine learning. The device is a hardware-based measurement instrument, and while it contains embedded software/firmware, the document does not describe it as an AI/ML device that requires a "training set." The performance relies on the physics of pulse oximetry and the calibration of its components.

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

This information is not available and not applicable. As explained above, the device is not described as an AI/ML device that typically uses a training set with established ground truth.

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This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, end-tidal CO2 concentration, respiration rate, body temperature, and so on, it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

UP-7000 Patient Monitor is a modular designed patient monitor. It monitors the patient's Electrocardiograph (ECG), respiratory rate (RR) and bo dy temperature (TEMP) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method. It can detect the blood oxygen saturation (SpO₂) and pulse rate (PR) non-invasively by the photoelectric method. Finally, it can extend CO2 monitor which measures the End-tidal Carbon dioxide, Inspired CO2 and Respiratory Rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating, the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The alarm activates if the monitored parameters go over the specified limits, alerting the medical professional.

Acceptance Criteria and Device Performance for Patient Monitor, Model UP-7000

This submission for the Patient Monitor, Model UP-7000, primarily focuses on demonstrating substantial equivalence to predicate devices through adherence to recognized performance and safety standards. The provided documentation does not detail specific, quantitative acceptance criteria for device performance parameters like accuracy, sensitivity, or specificity, nor does it present detailed study results proving a device meets such criteria to the level often seen for diagnostic AI/ML devices. Instead, the submission relies on compliance with established international and medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size used for any performance testing or the provenance of any data (e.g., country of origin, retrospective or prospective). The submission largely relies on the declaration of compliance with recognized performance and safety standards, rather than presenting a detailed clinical study with a specific test set.

3. Number of Experts and Their Qualifications for Ground Truth

The provided document does not mention the use of experts to establish ground truth for a test set. This type of submission, pertaining to a patient monitor (a hardware device measuring physiological parameters), typically relies on established calibration standards and validated reference measurement systems for performance testing, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method

Given the nature of the device and the absence of expert involvement in establishing ground truth, there is no mention of an adjudication method in the provided document.

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

No MRMC comparative effectiveness study was done as described in the provided summary. This type of study would be relevant for devices that assist human readers in making diagnostic interpretations, which is not the primary function of this patient monitor.

6. Standalone (Algorithm Only) Performance Study

The device itself is a standalone patient monitor that directly measures physiological parameters. Therefore, the "standalone performance" is essentially the device's ability to accurately measure these parameters. The submission indicates that "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This implies that the device's performance was evaluated independently against these standards. However, no specific detailed results of such a standalone study (e.g., accuracy metrics for each parameter) are provided in the summary.

7. Type of Ground Truth Used

The ground truth used for testing this patient monitor would generally be based on:

• Reference standard measurements: Comparison against highly accurate and calibrated reference devices or methods for each physiological parameter (e.g., a calibrated ECG simulator for ECG and heart rate testing, a reference oximeter for SpO2, a known pressure source for NIBP, calibrated gas mixtures for CO2).
• Biocompatibility testing: Laboratory assays for cytotoxicity, irritation, and hypersensitivity.
• Electrical and mechanical safety testing: Verification against defined thresholds and criteria in the relevant IEC standards.

The summary states that "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device." These standards implicitly define the required ground truth and evaluation methods.

8. Sample Size for the Training Set

This device is a hardware patient monitor that measures physiological parameters, not an AI/ML device that requires a "training set" in the conventional sense of machine learning. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant to this submission and no sample size for training is provided.

9. How Ground Truth for the Training Set Was Established

As explained above, this device does not typically utilize a "training set" in the context of AI/ML. The "ground truth" for its development and validation would have been established through engineering design, component validation, and testing against physical standards and known physiological inputs, in accordance with the cited international electrical and medical device standards.

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The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic. The index finger is the recommended site. It is intended for spotchecking adult and pediatric patients on fingers between 1.0 -2.2 . cm thick. This oximeter has the function of wireless data transmission. The user can effectively transmit the data to computer through the wireless communication module.

The provided 510(k) summary for the PC-60NW Fingertip Oximeter does not contain the detailed study information typically requested for acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device (PC-60 Fingertip Oximeter K063641) based on meeting relevant standards and general performance rather than presenting a specific clinical or technical study with detailed performance metrics against predefined acceptance criteria.

The document states: "The Model PC-60 Fingertip Oximeter substantially has been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market." It also mentions "Testing performed to Electrical Safety IEC 60601-1-1:1988, EMC Requirements IEC 60601-1-2, Biocompatibility IEC 10993-1, SPO2 Basic Safety and performance ISO 9919:2005, Basic Electrical safety and performance for Pulse Oximeters, ISO 80610-2-61 and pertinent FDA quidance documents, complied with the specific requirements for safety and performance."

Therefore, much of the requested information regarding detailed study design, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness is not explicitly available in this 510(k) summary. The summary focuses on compliance with established standards rather than a specific performance study with a standalone acceptance criteria table.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance results. Instead, it states that the device "complied with the specific requirements for safety and performance" according to various standards (IEC 60601-1-1, IEC 60601-1-2, IEC 10993-1, ISO 9919:2005, ISO 80610-2-61) and FDA guidance documents. These standards typically define the acceptance criteria for pulse oximeters, such as accuracy limits for SpO2 and pulse rate under various conditions. Without access to the full submission or the specific standards, the exact numerical acceptance criteria and detailed performance against them cannot be precisely tabulated from this summary.

Inferred Performance (based on compliance with standards):

• Pulse Oximetry Accuracy (SpO2): Expected to meet the accuracy requirements specified in ISO 9919:2005 and ISO 80610-2-61 for pulse oximeters, which typically outline a range of accuracy (e.g., ±2% or ±3% for SpO2 values between 70-100%).
• Pulse Rate Accuracy: Expected to meet the accuracy requirements specified in the relevant standards.
• Electrical Safety, EMC, Biocompatibility: Complies with the specified IEC standards.

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

The 510(k) summary does not specify a sample size for a test set (e.g., a specific number of patients or recordings used for performance evaluation). It mentions "system V & V plan" and "production equivalent units" but does not elaborate on the details of human subject testing or data provenance for performance validation.

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

This information is not provided in the 510(k) summary. The summary refers to compliance with standards, which might imply the use of reference devices or ground truth established by methodologies recognized within those standards, but it doesn't detail expert involvement.

4. Adjudication Method for the Test Set:

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. This type of study is more common for diagnostic imaging AI systems where human interpretation is a key component. For a pulse oximeter, the focus is on the device's direct measurement accuracy, not on human interpretation or improvement with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance assessment (algorithm only without human-in-the-loop performance) was implicitly done. The statement "The Model PC-60 Fingertip Oximeter substantially has been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market" indicates that the device's performance characteristics (SpO2 and pulse rate measurement) were evaluated independently against specified requirements. However, the details of this evaluation (e.g., number of subjects, conditions tested, specific accuracy results) are not elaborated in the summary.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. For pulse oximeters, the typical ground truth for SpO2 accuracy studies involves co-oximetry measurements from arterial blood samples (gold standard for oxygen saturation) compared to the oximeter readings under induced hypoxia conditions in healthy volunteers. While not stated, it is highly probable that expert consensus, pathology, or outcomes data were not directly used for establishing SpO2 ground truth; rather, a reference co-oximeter would be the expected ground truth method to which the device's measurements are compared.

8. Sample Size for the Training Set:

This information is not provided in the 510(k) summary. For a device like a pulse oximeter, "training set" is generally not applicable in the sense of machine learning algorithms that learn from data. The device's algorithms are typically based on well-established physiological models and empirical calibration, not a "training set" in the modern AI sense.

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

As "training set" is not applicable in the typical AI sense, this information is not provided. The calibration and empirical basis for the oximetry algorithm would have been established during the device's development using reference methods, likely involving human subject testing with co-oximetry as described in point 7.

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The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.

The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.

PC-900A vital signs monitor is a small Multi-parameter Patient Monitor, which can monitor the vital physiological parameters: Carbon Dioxide (CO2), Pulse Oxygen Saturation (SpO2), respiration and pulse rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. The specific sensors have been previously cleared by the FDA 510(k) process. (For specifics, please refer to the Description Section). After CPU analyzing and calculating, the parameters can display on the screen in a graphical way, record and/or print if necessary. The alarm will work if the parameters over the limits to take medical practitioner's attention.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Vital Signs Monitor, Model PC-900A:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria for a new clinical trial. However, it does list performance specifications and accuracy claims for the device. These can be interpreted as the functional acceptance criteria the manufacturer aims for, by comparing them to predicate devices.

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The device is an ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate. The built in speaker of the device allows for listening of the fetal heartbeat.

This Doppler tests the fetal heart rate through non-invasive ultrasonic Doppler Effect. As is known, ultrasonic wave propagating at a given frequency will be reflected when encountering an obstacle. If it is still an obstacle, the back wave will share the same frequency with the transmitted wave. Once the obstacle moves, the frequency of the back wave will be changed. The higher rate the object moves at, the bigger frequency change will take place. This is the so-called Doppler Effect. With the apparatus, the ultrasonic probe is placed on the abdomen of the pregnant woman. The ultrasonic probe can perceive the fetal heartbeat. When the transmitted wave encounters the fetal heart, the back wave will develop offset frequency. With the offset frequency, the fetal heart rate and frequency can be worked out.

The provided text from K082055 is a 510(k) summary for the PC-860 Fetal Doppler. It primarily focuses on demonstrating substantial equivalence to a predicate device and safety/performance based on standards.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for Fetal Heart Rate (FHR) detection accuracy. Instead, it broadly states that "Clinical testing was used to validate the effectiveness and accuracy of the device. Specific testing relating to Ultrasound equipment was use to verify performance to recognized standards. All test results were satisfactory."

Given this, the table below reflects what can be inferred or is directly stated:

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

The document states "Clinical testing was used to validate the effectiveness and accuracy of the device" but does not specify the sample size for this clinical testing.

The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

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

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set.

4. Adjudication Method for the Test Set

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

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or its results. The device appears to be a standalone Fetal Doppler, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance Study

The document states "Clinical testing was used to validate the effectiveness and accuracy of the device." This implies a standalone performance study was done to evaluate the device's ability to detect Fetal Heart Rate independently. However, specific performance metrics (e.g., sensitivity, specificity, accuracy against a reference) are not provided beyond the general statement of "satisfactory."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the clinical testing. Given it's a Fetal Doppler, the ground truth would typically be a reference method for FHR measurement (e.g., a cardiotocograph (CTG), a more advanced ultrasound, or expert auscultation with a stopwatch), but this is not detailed.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. Fetal Dopplers of this type typically do not involve machine learning models that require a distinct training set in the same way modern AI systems do. Their function is based on physical principles (Doppler effect) and signal processing.

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

Since a training set is not mentioned as part of the device's development or validation, there is no information on how its ground truth might have been established.

Summary of Missing Information:

This 510(k) summary is from 2009, a period before the widespread requirement for detailed AI/ML validation studies. As such, it lacks specific quantitative acceptance criteria, detailed clinical study methodologies (sample size, expert involvement, ground truth specifics), and any information relating to AI-specific study paradigms like MRMC or training sets. The submission focuses on substantial equivalence to a predicate device and adherence to general safety and performance standards for medical devices.

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The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical activities of the heart easily and conveniently. It's a single LEAD ECG measuring device for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users (age 18 or older), who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references. This Device is also not intended for recording and transmission of user's ECG signal simultaneously, and it's not recommended to use with implanted pacemaker.

PC-80 / Prince 180 Easy ECG Monitor is a handheld electrocardiograph unit which can measure, display, and store ECG data by the user. The device can calculate the average heart rate and display the heart rhythm after analysis. Furthermore, it's small, light, and easy to use. A 30-second ECG record is measured and stored in this device. The waveform data and heart rate value can be displayed on LCD screen, and those ECG data records can be reviewed.

Here's a breakdown of the acceptance criteria and study information for the PC-80 /Prince 180 Easy ECG Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its performance in detecting or interpreting ECG signals. Instead, the performance testing focuses on compliance with established medical device standards.

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

The document does not provide details on the sample size used for any clinical test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is primarily focused on engineering and quality system compliance rather than a clinical performance study.

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

The document does not mention any clinical test set involving expert review to establish ground truth for ECG interpretation. The device's intended use is for home health care and as a reference tool for doctors, not as a diagnostic tool itself.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with human review requiring adjudication is described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The submission focuses on substantial equivalence based on technical standards and device features, not on improved human reader performance with AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

The testing described is focused on the device as a whole, including its ability to measure, display, and store ECG data, and to provide average heart rate and rhythm information. There's no specific mention of a standalone algorithm performance study in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for automatically detecting specific cardiac events. The performance validation is against engineering and safety standards (IEC, AAMI).

7. The Type of Ground Truth Used

For the engineering and safety standards (IEC 60601-1, IEC 60601-1-2, AAMI EC 38) to which the device was validated, the "ground truth" would be the specifications and requirements outlined in those standards. This would involve calibrated test equipment and established protocols to verify electrical safety, EMC, and the accuracy of ECG signal acquisition and basic heart rate calculation as per the AAMI standard. There is no mention of clinical ground truth (e.g., expert consensus, pathology, or outcomes data) in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

The document does not mention a training set, which would typically be associated with AI/ML algorithm development. The device's description suggests a direct measurement and display function, with basic analysis for heart rate and rhythm, rather than a sophisticated AI-driven interpretive algorithm that would require a large training dataset.

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

Not applicable, as no training set is mentioned.

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