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The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.

The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.

The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor 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 and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.

The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.

The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).

The provided document is a 510(k) summary for a "Multi-parameter detector." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, along with non-clinical and clinical testing performed. However, it does not provide the detailed acceptance criteria and "study that proves the device meets the acceptance criteria" in the format requested, particularly for an AI/algorithm-based device study.

The document primarily focuses on demonstrating substantial equivalence based on performance standards for traditional medical devices (blood pressure, SpO2, temperature, body composition) rather than the rigorous evaluation of a new AI/ML-driven diagnostic or assistive technology.

Here's a breakdown of what can be extracted and what is missing based on your prompt:

Extracted Information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance standards and reports whether the device met them, rather than a direct "acceptance criteria" table with specific quantitative thresholds and exact results for each parameter alongside performance metrics like sensitivity/specificity for an AI.

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

• NIBP: 119 subjects.
• TEMP: 105 subjects.
• SpO2: 10 healthy subjects (aged 22-40, Fitzpatrick 2-6), but this was for the integrated FDA cleared device (K170047), not a new test for this submission's SpO2 component.
• Data Provenance: The NIBP and TEMP clinical studies were described as "single-center, randomized, self-controlled clinical trial[s]" conducted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. This implies prospective data, likely from China given the company's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not explicitly stated in the document.
• For NIBP and TEMP, the ground truth was established by comparison with "registered mercury thermometer and desktop sphygmomanometer." This implies these are the "gold standard" reference devices, not human experts.

4. Adjudication Method for the Test Set:

• Not applicable/Not stated. The ground truth was based on direct measurements from reference devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

• No. This type of study is typical for AI/ML diagnostic tools assisting human readers (e.g., radiologists). The device in question is a multi-parameter measurement device, not an AI diagnostic tool requiring human reader studies to demonstrate assistance.

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

• Yes, in spirit. The performance metrics (accuracy, standard deviation) for NIBP, TEMP, and SpO2 are reported for the device itself compared to reference standards, indicating standalone performance. The document describes the device directly measuring these parameters.

7. The Type of Ground Truth Used:

• Reference device measurements.
  • NIBP: "desktop sphygmomanometer"
  • TEMP: "registered mercury thermometer"
  • SpO2/PR: Data from a previously cleared device (K170047, K063641) presumably validated against arterial blood gas or CO-oximetry as typical for oximetry.
  • No pathology or outcomes data mentioned

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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 Capnograph and Oximeter 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 Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.

This device is used to monitor up to four physiological parameters for the patient at the same time: End tidal CO2 concentration (EtCO2), Respiration Rate (RR), functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The monitor can be purchased having functions with two or more of the parameters mentioned above, but the manual can be used for the device in any configuration.

The Capno-H uses an infrared absorption method to measure in a sidestream or Mainstream mode. The measurement parameters are EtCO2, InsCO2 and Respiration Rate. InsCO₂, also called FiO₂ is the fraction of oxygen in the volume being measured. The CO2 response time is Sidestream:

The provided text describes the acceptance criteria and study for the CMI Health Inc. Capnograph and Oximeter, Model Capno-H (K170820).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are primarily based on equivalence to a predicate device (Shenzhen Creative Industry Co., Ltd, Vital Signs Monitor, Model PC-900A, K093016) and compliance with various international standards. The document explicitly states: "All of the pre-determined acceptance criteria were met."

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

The document does not specify human clinical trials or a "test set" in the context of diagnostic accuracy for the entire device. The performance data for SpO2 and CO2 accuracy are stated as ranges and thresholds without detailing specific patient data used for testing.

• SpO2 module: The document states that the Capno-H uses the "PC-60 SpO2 module cleared in K063641" and that "the sensors were clinically validated and intended to be used in K063641." This implies that the clinical validation for SpO2 accuracy was conducted as part of the K063641 submission, not for the current device directly. The provenance of that original SpO2 clinical validation data (K063641) is not provided in this document.
• CO2 module: The CO2 accuracy is presented as fixed ranges (e.g., ±2mmHg for 0-40mmHg). It mentions compliance with ISO 80601-2-55 (which governs respiratory gas monitors) and that the CO2 module (CapnoCore) uses the non-dispersive infrared gas (NDIR) technology. However, no specific details about a clinical test set (sample size, provenance) for CO2 accuracy are provided in this document for either the Capno-H or its CapnoCore module.
• Type of Study: The primary "study" described is a comparison to a predicate device and compliance with established performance and safety standards. This is a bench and engineering testing-based assessment rather than a typical clinical study with a specified "test set" of patients.

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

Not applicable. The document does not describe a clinical study where experts established ground truth for a test set. The accuracy claims are numerical specifications that are likely verified through device calibration and bench testing against known gas concentrations or established reference devices/methods for SpO2.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication is described.

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 an oximeter and capnograph, not an AI-powered diagnostic imaging device involving human readers or interpretation of complex medical cases.

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

This device appears to be a standalone measurement device. Its performance specifications (e.g., SpO2 accuracy, EtCO2 accuracy) are inherently "standalone" in that they describe the device's direct measurement capability, without an AI component or complex human-in-the-loop interaction in its core function of displaying vital signs. The device is intended for "regular supervision of clinical personnel," but this refers to its clinical use, not the intrinsic performance validation of the measurement algorithms.

7. The Type of Ground Truth Used

The ground truth for the performance specifications (EtCO2, SpO2, Pulse Rate, Respiration Rate) would have been established using:

• Reference Standards/Known Concentrations: For CO2 accuracy, gas mixtures with precisely known CO2 concentrations would be used in bench testing.
• Reference Oximeters/Co-oximeters: For SpO2 accuracy, reference co-oximeters are typically used (e.g., during induced hypoxia studies) to establish arterial oxygen saturation (SaO2) values for comparison. The document clearly refers to "clinically validated" sensors in the SpO2 module (from K063641), implying such studies occurred for that module.
• Controlled Measurements: For pulse rate and respiration rate, comparison with ECG or manual counts, or simulated physiological signals, would likely be the ground truth.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical device, not an AI/machine learning algorithm that requires a "training set." The device's algorithms for calculating SpO2, CO2, etc., are based on established physiological principles and signal processing, not on training data in the AI sense.

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

Not applicable, as there is no "training set" for an AI algorithm.

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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 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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