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The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.

It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.

Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.

The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).

The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.

The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.

The mainstream gas analyzers are characterized by the following features:

• Low system integration complexity
• Low power consumption
• Fast startup time
• Low weight

The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.

Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.

However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.

1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):

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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 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 SERVO-U ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-n ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-U/n Ventilator System is available in two models, SERVO-U and SERVOn. The SERVO-U/n Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The SERVO-U/n Ventilator System is built on the same architecture as the cleared predicate device SERVO-i Ventilator System (K123149). The ventilation modes in the SERVO-U/n Ventilator System are identical to the ventilation modes in the cleared predicate device, even though the standard configurations of available modes and optional modes differ between the devices i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-i Ventilator System (K123149).

The ventilator delivers controlled or supported breaths to the patient, with constant flow. constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration.

NAVA (Neurally Adiusted Ventilatory Assist) is a supported mode for SERVO-U/n that uses the Edi signal as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off of supported breaths. NAVA is available in invasive and non-invasive modes. These ventilation modes are identical in the SERVO-U/n Ventilation system and the cleared predicate device SERVO-i Ventilator System (K123149). Furthermore, the included hardware parts Edi module and Edi catheters are also identical to the ones used for the cleared predicate device SERVO-i Ventilator System (K123149).

SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). In the cleared predicate device SERVO-i Ventilator System (K123149) the corresponding nebulizer function is available as an optional module.

Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The CO2 monitoring option is updated with Capnostat 5 and the Y sensor is based on a new technology and measuring function compared to the corresponding options for the cleared predicate device SERVO-i Ventilator System (K123149).

The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond preset or default limits and produce alarm recordings. The alarm handling is very similar to the one used in the cleared predicate device SERVO-i Ventilator System (K123149), except the possibility to set alarm off for leakage related alarms in Neonatal Patient category when leakage compensation is activated. Additionally, an Inspiratory tidal volume (VT) too high alarm has been added in the neonatal patient category and three alarms have been removed in the Non-invasive modes.

The system contains provisions for battery modules to supply the system in the case of mains power failure or during in-hospital transport. The batteries are identical to the one used for the cleared predicate device SERVO-i Ventilator System (K123149).

System parts:
The SERVO-U/n Ventilator System consists of the following parts:

• User interface, where all user interactions are performed.
• Patient unit with all connections to the patient, to power and gases.
• Mobile cart, on wheels, for using the ventilator on either the left or the right side of the patient.

This document describes the premarket notification (510(k)) for the SERVO-U and SERVO-n Ventilator System. It largely focuses on demonstrating substantial equivalence to a predicate device (SERVO-i Ventilator System, K123149) rather than presenting a study to prove acceptance criteria for novel device performance. Therefore, the information typically requested regarding acceptance criteria and a proving study for a new AI/ML device is not fully available in this document.

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

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

The document doesn't present a formal table of acceptance criteria with reported performance in the way one might expect for a new device claiming specific performance metrics. Instead, "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device and compliance with relevant standards. The "reported device performance" is mainly a statement that the device performs "within its specifications and within the limits of the applied product performance standards."

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

• Sample size for test set: Not explicitly stated as a single "test set" in the context of typical AI/ML evaluation. The design verification and validation activities involved various types of testing (code review, unit tests, integration tests, system tests, Free User Testing, regression testing, biocompatibility testing, usability testing, and an animal study). The number of test cases or "samples" for each of these activities is not quantified.
• Data provenance: Not directly applicable in the sense of a clinical dataset. The testing conducted was primarily non-clinical (engineering verification, lab testing, animal study).
  • Animal study: Done to evaluate the performance of the Y sensor algorithm at different degrees of humidity and leakage and its effect on tidal volume measurements. Provenance (e.g., country) is not specified.

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):

This information is not provided. The ground truth for the verification and validation activities would largely be established by engineering specifications, regulatory standards, and expert review within the company. For "Free User Testing" and "usability validation," the "experts" would be representative users (healthcare providers), but their number and specific qualifications are not detailed.

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

Not applicable in the context of this 510(k) submission. Adjudication methods are typically relevant for human review of clinical data, especially in studies involving subjective assessments of images or patient outcomes. The testing described here is primarily technical and performance-based.

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 MRMC comparative effectiveness study was done. This device is a ventilator, not an AI-powered diagnostic or assistive tool for human readers.

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

The device itself is a standalone medical device (a ventilator). The "performance" described is of the device's various functions and components, rather than the performance of an isolated algorithm. The document emphasizes the integration of hardware and software.

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

The "ground truth" for the various verification and validation activities would primarily consist of:

• Engineering specifications and design input requirements: For system tests, unit tests, integration tests, and code reviews.
• Applicable product standards: For compliance testing.
• Predefined performance ranges and accuracy limits: For sensor evaluations (e.g., Y sensor in animal study, CO2 analyzer).
• Simulated physiological conditions: Used in lab testing.
• User expectations and safety requirements: For usability and risk analysis.

8. The sample size for the training set:

Not applicable. This document describes a medical device (ventilator), not an AI/ML system that undergoes "training" in the conventional sense.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder.

The DS-8100N/8100M provides monitoring of ECG (Up to 7lead), heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, and parameters in combination of invasive blood pressure (IBP) (max. 2ch.), temperature (max. 4ch.), and cardiac output (max. 1ch.) using the multiparameter connector. In addition, the DS-8100M provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The DS-8100N for SpO2 measurement utilizes a technology of an OxiMax N-600x Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) # K060576. The DS-8100M for SpO2, SpCO, SpMet, and SpHb measurement utilizes a technology of a Masimo RADICAL 7 Pulse CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K110028. All parameter connectors are on the front panel and are labeled on the left side of the main unit. By connecting the optional CO2 Gas Unit (HCP-800/HCP-810) or Gas Unit I/F (HPD-800/HPD-810) to the AUX Connector on the rear side of the main unit, it provides monitoring of carbon dioxide concentration (CO2) The CO2 Gas Unit (HCP-800/HCP-810) that utilizes Oridion Medical 1987 Ltd. technology "Microstream"" and previously cleared under 510(k) #K094012. The Gas Unit I/F (HPD-800/HPD-810) allows to connect the Capnostat 5 Mainstream CO2 Sensor, 510(k) #K042601, manufactured by Respironics Novametrix, LLC. to the main unit with serial communication protocol for CO2 monitoring.

The DS-8100N/8100M is a self-contained monitor, which includes a 10.2 inch TFT color LCD display which can display up to 14 waveforms and up to 14 numeric displays. The user interfaces, the touch screen panel, is located on the front of the main unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. And there are five (5) fixed keys (Alarm Silence, NIBP Start/Stop, Home, Menu, and Prev. Disp.) and Jog Dial on the right side of the front of the main unit. The infrared remote-control command is also available (optional). By attaching the optional Recorder Unit (HR-800) or Recorder/Expansion Port Unit (HR-811), a dot matrix thermal printer, on the bottom of rear of the main unit, it provides hard copy recordings of all monitored parameters and can print up to three (3) waveforms simultaneously. In addition, the Recorder/Expansion Port Unit (HR-811) contains the Analog Output Connector that outputs the ECG and BP waveforms, including the ORS SYNC output signal, VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor. By attaching the Expansion Port Unit (CU-810) on the bottom of rear of the main unit, it provides the VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor or connects to the laser printer as general LAN.

Additional standard features include DS-LAN connection, which is a proprietary network system based on an Ethernet LAN (#K970585), through a built in Ethernet LAN, and a wireless connection using the optional telemetry transmitting module (Model: HLX-801) and a wireless bidirectional communication using the optional Bidirectional Wireless Communication Module (Model: HTC-702) allow remote monitoring when combined with Fukuda Denshi Central Station Monitors. An option battery operation allows a patient to continue to be monitored during intra-hospital transport.

The DS-8100N/8100M is small and lightweight at 3.5 kg. The physical dimensions of the device are 300 mm (W) x 265 mm (H) x 75 mm (D).

The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is a multi-parameter patient monitor. The provided document doesn't detail specific acceptance criteria and the associated study results for each parameter within the device. Instead, it offers a general statement that the device has undergone "extensive safety, environmental and performance testing" to ensure all functional and performance specifications are met. It also states that OEM engineering test facilities confirmed the performance and functional specifications for their supplied modules.

The conclusion asserts that the device is "as safe and effective and performs as well as the legally marketed predicate devices" based on "laboratory testing, validation, and risk analysis." This implies a comparative study against predicate devices and adherence to various safety and performance standards, rather than proving performance against predefined quantitative acceptance criteria with specific metrics.

Here's a breakdown of the available information based on your request, even though specific quantitative acceptance criteria are not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated in the provided text for each parameter (ECG, NIBP, SpO2, etc.), a table cannot be fully constructed with precise numbers. The document generally states that "all functional and performance specifications were met."

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "various performance tests" and "OEM engineering test facility" testing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily technical and performance-based against established standards and predicate device performance, not reliant on expert clinical interpretation for ground truth.

4. Adjudication Method

The document does not describe any adjudication method. This is typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is a patient monitor, and its evaluation would generally focus on the accuracy of its physiological measurements against reference standards, rather than the improvement of human reader performance with AI assistance. The document focuses on performance specifications and equivalency to predicate devices.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was implicitly done for various parameters (e.g., SpO2, CO2, ECG performance) by testing against relevant standards (e.g., ANSI/AAMI EC13 for ECG, ISO 9919 for pulse oximeters). The document states: "Final testing for the device included various performance test for the device designed to insure that all functional and performance specifications were met." This refers to the device's ability to accurately measure and display physiological data.

7. Type of Ground Truth Used

The ground truth for the performance testing appears to be based on:

• Reference standards/simulators: This is typical for physiological monitors, where the device's measurements are compared against highly accurate reference instruments or simulated physiological signals.
• Performance of predicate devices/OEM modules: The document explicitly states the device utilizes technologies "incorporated into previously cleared devices and OEM manufactured module" and that performance was confirmed by OEM test facilities. This implies comparison against the established performance of those components.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is likely because the device is a patient monitor that measures physiological parameters, not an AI/ML device that requires a large dataset for training a diagnostic algorithm. The algorithms for signal processing and measurement in patient monitors are typically deterministic or based on established physiological models, not machine learning that would involve a "training set."

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned (as the device is not described as using machine learning that requires one), the document does not describe how ground truth for a training set was established.

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NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only . The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.

NTID Vital Signs Monitor provides:

• SpO2 monitoring
• Pulse rate (PR) monitoring
• End tidal carbon dioxide (EtCO2) monitoring
• Respiration rate (RR) monitoring
• CO2 and SpO2 waveform display
• Audible and visual physiological and technical alarms
• Trend graph and trend table review
• Alarm event records review
• History data storage
• Rechargeable batteries
• External power supply and charger
  The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals.
  The product is composed of monitor, SpO2 sensor, Mainstream/Sidestream CO2 sensor, charging base, USB Adapter and PC software.

Here's a breakdown of the acceptance criteria and the study details for the NT1D Vital Signs Monitor, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific accuracy criteria for SpO2, Pulse Rate, and EtCO2.

Note: For SpO2 accuracy per decade (70-80%, 80-90%, 90-100%), the NT1D also reports +/- 2%, aligning with its overall 70-100% accuracy claim. The predicate devices did not specify accuracy in these discrete ranges.

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

• SpO2 Module (Clinical Trial for T400A sensor):

  • Sample Size: Ten healthy volunteers.
  • Data Provenance: Prospective, from the Hypoxia Research Laboratory, University of California, San Francisco, USA.

• CO2 Module: The document states that the CO2 module has already obtained 510(k) numbers (K042601 for Capnostat 5 CO2 Sensor and K053174 for LoFlo C5 CO2 Sensor). This implies that the performance of the CO2 module within the NT1D is based on the previously established performance and clearance of these predicate CO2 sensors. Therefore, a new specific clinical test set for the CO2 module with the NT1D is not detailed, as its equivalence is established through the cleared components.

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

The document describes an invasive laboratory test for SpO2 accuracy. For such tests, the "ground truth" for oxygen saturation is typically established using a co-oximeter on arterial blood samples, which is considered the gold standard.

• The study was conducted in a "Hypoxia Research Laboratory."
• While the document doesn't explicitly state the number or qualifications of clinicians involved in sample collection or co-oximeter operation, such laboratory tests are generally performed by trained medical and/or laboratory professionals with expertise in invasive blood gas analysis and co-oximetry, ensuring the accurate establishment of the ground truth. The mention of "co-oximeter sample value" confirms this method.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for these types of clinical performance tests.

• For the SpO2 accuracy study, the performance is assessed by comparing the device readings against the co-oximeter reference values obtained from arterial blood samples. There isn't a subjective interpretation by multiple experts that would require an adjudication method like 2+1 or 3+1. The process is a direct comparison of quantitative measurements.

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 MRMC study was done. This device is a vital signs monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data alongside an AI. The evaluation focuses on the device's accuracy in measuring physiological parameters (SpO2, PR, EtCO2, RR).

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

• Yes, a standalone performance evaluation was done. The clinical trial for the SpO2 module (with the T400A sensor) and the reliance on previously cleared CO2 modules represent standalone performance evaluations. The device's measurement outputs are directly compared to a reference standard (co-oximeter for SpO2, and the previously established accuracy of the predicate CO2 sensors). Human interaction is for device operation and data collection, not for interpretation that influences the device's core measurement output.

7. The Type of Ground Truth Used

• For SpO2: Invasive laboratory testing (in vivo) using co-oximetry on arterial blood samples, which is considered the gold standard for SpO2 measurement.
• For CO2: Ground truth for the CO2 sensors (Capnostat 5 and LoFlo C5) would have been established during their initial 510(k) clearances, likely through comparison to reference gas analyzers or other established methods for CO2 measurement in controlled environments.

8. The Sample Size for the Training Set

• The document does not specify a training set size because this device is a vital signs monitor based on established spectrophotometry (SpO2) and infrared absorption (CO2) principles, not a machine learning or AI-driven algorithm that typically requires a large training dataset. The "training" for such devices is inherent in their physics-based design and calibration.

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

• As mentioned above, there is no explicit "training set" in the context of machine learning. The device's design and calibration are based on fundamental scientific principles and established measurement techniques.
  • For SpO2, the underlying principles of differential light absorption by oxyhemoglobin and deoxyhemoglobin are well-understood and form the basis of the device's algorithms. Calibration would involve using known oxygen concentrations.
  • For CO2, the principle of infrared absorption by CO2 molecules is used. Calibration would involve using gas mixtures with known CO2 concentrations.

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The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric a nd neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

The YM6000 patient monitor is to monitor electrocardiography (ECG), Arrhythmia, ST segment, heart rate (HR), pulse rate, noninyasive blood pressure (systolic, diastolic and mean arterial pressures); functional arterial oxyge n saturation, invasive b lood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate in patients in general hospital and alternate ca re facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The YM6000 patient monitor is a lightweight and compact device (341 × 305 × 172 (mm) (W × H × D) and 5.5 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

The provided text is a 510(k) summary for a patient monitor. It focuses on establishing substantial equivalence to predicate devices rather than presenting detailed performance studies with specific acceptance criteria and detailed study results in the format requested.

Therefore, many of the requested categories cannot be directly extracted from the provided text. The document primarily describes the device, its intended use, and argues for its equivalence based on shared modules and compliance with industry standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance values in a quantifiable manner for each parameter. Instead, it states that various modules (ECG, NIBP, SpO2, Respiration, Thermometry, Capnography) used in the YM6000 are identical to those in predicate devices and comply with relevant standards (AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34). For example, it says: "all devices comply with the AAMI performance standard SP-10 & IEC60601-2-30 and have same measurement technology" for NIBP.

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 explicitly stated in the document. The text mentions "The Mediana patient monitor, Model YM6000 substantially have been tested in accordance with the system V & V plan (#P AA00-00005) and summary included with the submission using production equivalent units prior to release to market." This indicates testing was performed, but details about sample size, data type (retrospective/prospective), or origin are not provided.

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)

This information is not provided. The document focuses on technical equivalence and compliance with standards rather than human-expert-based ground truth establishment.

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

This information is not provided.

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 an AI-powered device, but a physiological patient monitor. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

The device is a patient monitor. Its performance is inherent to its functional modules, which operate "standalone" in recording physiological parameters. The document primarily focuses on the technical specifications and standards compliance of these modules.

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

The "ground truth" for a patient monitor like the YM6000 would generally be based on:

• Reference measurement devices/standards: For parameters like NIBP, SpO2, ECG, etc., the accuracy is typically verified against highly accurate reference devices or simulated signals that meet specific industry standards.
• Compliance with performance standards: The document frequently refers to compliance with standards like AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34. These standards define the acceptable range of error and performance characteristics.

The document does not explicitly state "expert consensus," "pathology," or "outcomes data" as ground truth methods for the device's fundamental physiological measurements.

8. The sample size for the training set

This information is not provided. For a patient monitor, there isn't typically a "training set" in the machine learning sense. The device's algorithms for physiological parameter measurement are developed based on established physiological principles and signal processing, and then validated against a range of inputs/patients.

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

As there's no mention of a "training set" in the AI/machine learning context, this question is not applicable. The ground truth for developing and testing the device's measurement algorithms would be based on established medical and engineering principles, known physiological ranges, and comparison with highly accurate reference equipment under controlled conditions.

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The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring:

• Electrocardiography (ECG)
• Heart rate (HR)
• Noninvasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Pulse rate (PR)
• Respiration rate (RR)
• Temperature (Temp)
• Arrhythmia/ST segment (M30 only)
• Capnography (M30 only)
  Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
  Note: The medically skilled and trained user can be clinicians like doctors and nurses who know to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.

The Mediana Lucon M-series (M20, M30) patient monitor is a lightweight and compact device (250 × 210 × 170 (mm) and 3.2 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

• Electrocardiography (ECG)
• Heart rate (HR)
• Noninvasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Pulse rate (PR)
• Respiration rate (RR)
• Temperature (Temp)
• Arrhythmia/ST segment (M30 only)
• Capnography (M30 only)

The provided text does not contain specific acceptance criteria with numerical performance targets or a detailed study demonstrating that the device meets these criteria. Instead, it focuses on establishing substantial equivalence to predicate devices for a patient monitor (Mediana Lucon M-series M20, M30).

However, based on the information provided, we can infer the approach used to demonstrate performance and substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance specifications of the predicate devices. The document repeatedly states that the Mediana Lucon M-series has "identical" or "similar" specifications and uses "identical technology" or "same technology" as the predicate devices. It also mentions compliance with relevant performance standards.

• ECG and heart rate specifications are identical to Omron HBP-2070.
• ECG measurement performance is similar to Philips SureSigns VM6.
• Uses identical technology as predicate devices. |
  | Noninvasive Blood Pressure (NIBP) | - NIBP module (M3200) is identical to that in Omron HBP-2070.
• NIBP specifications are identical to Omron HBP-2070.
• Complies with AAMI performance standard SP-10 & IEC60601-2-30.
• Uses same technology as predicate devices (Omron HBP-2070 and Philips SureSigns VM6). |
  | Functional Arterial Oxygen Saturation (SpO2) | - SpO2 module (NELL-3) is used in Spacelabs mCARE 300, 91220 and Omron HBP-2070.
• SpO2 specifications are identical to Omron HBP-2070 and Spacelabs 91220.
• Complies with performance standard ISO9919. |
  | Respiration Rate (RR) | - Algorithm of Impedance measurement is identical to Omron HBP-2070.
• Respiration specification is identical to Omron HBP-2070.
• Respiration measurement (Thoracic Impedance) for Lucon M-series and Spacelabs 91220 are from the same ECG module (designed and manufactured by Mediana). |
  | Capnography (EtCO2) | - Algorithm of Airway Measurement has identical performance to Spacelabs 91220.
• Airway Measurement is from Capnography module (Philips Respironics Inc.).
• Operation theory of Airway Measurement in Welch Allyn Propaq Encore 200 series is same as Lucon M-series (M30 only) and Spacelabs 91220.
• Uses Capnostat 5 and Lo Flo C5 modules (already FDA registered: K042601, K053174) which are identical to modules used in Spacelabs 91220.
• Minor differences in Capnography specification between Lucon M-series (M30 only) and identified predicate devices; all three devices have identical technology and operation theory for Capnography. |
  | Temperature (Temp) | - Thermometry MDT-1 module is identical to that in Omron HBP-2070 and Spacelabs 91220.
• Temperature measurement technology is equivalent to Omron HBP-2070 and Spacelab 91220.
• Uses YSI 400 and 700 probes/probe covers, identical to predicate devices. |
  | Pulse Rate (PR) | - Derived from NIBP channel (M3200 module), identical to Omron HBP-2070.
• Derived from SpO2 channel (NELL-3 module), identical to Omron HBP-2070 and Spacelabs 91220. |
  | General Device Functionality | - Internal power source (rechargeable lead acid battery and AC power) is similar to predicate devices.
• Overall safety and effectiveness, and compliance with appropriate medical device standards, stated to be substantially equivalent to predicate devices. |

Study Details:

The submission highlights a "Summary of Performance Testing" but provides very limited details about the actual studies conducted to prove the device meets acceptance criteria.

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

   • The document states that the device "substantially have been tested... with the system V & V plan (#MDR-YW071202-02) and summary included with the submission using production equivalent units prior to release to market."
   • No specific sample size for a test set is mentioned.
   • No information on data provenance (e.g., country of origin, retrospective or prospective) is provided. The testing seems to be internal verification and validation (V&V) against design specifications and predicate device performance.

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

   • Not applicable/Not mentioned. The testing described involves technical performance characteristics, not clinical interpretation that would require expert ground truth.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Given the nature of the technical performance testing described, an adjudication method like 2+1 or 3+1 would not be relevant.

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 MRMC study was done. This device is a patient monitor, not an AI-assisted diagnostic tool.

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

   • Yes, implicitly. The "Performance Testing" refers to the device's technical specifications and how it performs in measuring various physiological parameters. This would be standalone performance of the device's modules and algorithms. The core argument for substantial equivalence relies on the identical/similar technology and specifications to the predicate devices, which suggests an evaluation of the device's intrinsic measurement capabilities.

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

   • The ground truth for this type of device would typically be reference standards or highly accurate measurement equipment used to validate the accuracy and precision of each physiological parameter (ECG, NIBP, SpO2, Temp, RR, EtCO2). For example, NIBP accuracy might be validated against an invasive arterial line or a calibrated simulator. The document also mentions compliance with specific performance standards (e.g., AAMI SP-10, IEC60601-2-30, ISO9919), which define test methods and acceptance criteria.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to use a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physiological measurement technologies, often implemented as modules from reputable manufacturers (Omron, Nellcor, Philips Respironics).

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

   • Not applicable/Not mentioned. As there's no mention of a traditional training set for an AI algorithm, this question is not relevant. The performance is validated against established medical device standards and the performance of predicate devices.

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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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Use of the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N20), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7000 Series Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000 Series Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. An optional Battery Pack operation allows the DS-7210/7210M to be used to monitor patients during intra-hospital transport. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder.

The DS-7000 Series Patient Monitor allows for the monitoring of ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, temperature, invasive blood pressure (IBP), and cardiac output. This subject modified DS-7000 Series Patient Monitor extended the NIBP measurement target populations from adult and pediatric to adult. pediatric, and neonatal and the DS-7210/7210M of the DS-7000 Series includes ECG 12 Lead monitoring.

The DS-7000/7000M of the DS-7000 Series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG), which utilizes Criticare Systems technology (K012059), by using the option Multigas Unit (MGU-701/MGU-702) . And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 6 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. No new functions for the options are being added and are not the subject of this submission for the DS-7000/7000M.

This subject modified DS-7210/7210M of the DS-7000 series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), which utilizes Oridion Medical 1987 Ltd. technology "Microstream"" (K060065), by using the option CO2 measurement unit (MGU-722). Or, by using the option Mainstream CO2 interface Unit (MGU-721), the Capnostat 5 Mainstream CO2 Sensor (K042601) manufactured by Respironics Novametrix, LLC. is allowed to connect to the DS-7210/7210M with serial communication protocol for CO2 monitoring. And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 5 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored.

For the SpO2 measurement monitoring, the DS-7000 utilizes Nellcor technology (K021090) and the DS-7000M utilizes Masimo one (K033296). No new functions for SpO2 measurement are being added and are not the subject of this submission. This subject modified DS-7210/7210M has the same feature.

The DS-7000 Series Patient Monitor is a self contained monitor which includes a 12.1 inch TFT color LCD display which can display up to 12 (for DS-7000/7000M) or 14 (for DS-7210/7210M) waveforms and up to 20 (for DS-7000/7000M) or 16 (for DS-7210/7210M) numeric displays. Input operation is performed by the touch screen panel, 5 fixed keys (only DS-7000/7000M), or infrared remote-control command (optional). Additional standard features of the DS-7000 Series Patient Monitor include the DS-LAN II connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously, and an alarm indicator feature on the top of device that alerts to alarm conditions.

The DS-7000/7000M of the DS-7000 Series is small and lightweight at 9.0 kg. The physical dimensions of the device are 324mm (W) x 260mm (H) x 179mm (D). The option Multigas Unit (MGU-701/MGU-702) weight is 1.8 kg. The physical dimensions of the device are 248mm (W) x 138mm (H) x 82mm (D). No weight and physical dimensions are being changed and are not the subject of this submission for the DS-7000/7000M.

The subject modified DS-7210/7210M weight is 9.9 kg. The physical dimensions of the device are 310mm (W) x 351mm (H) x 245mm (D). The option CO2 measurement Unit (MGU-722) weight is 260g and Mainstream CO2 interface unit (MGU-721) weight is 200g. The both physical dimensions of the device are 141.5mm (W) x 41mm (H) x 79mm (D).

For the DS-7000 Series option Unit (HU-71/HU-72/HU-73) weight is 180g. The physical dimensions of the device are 37mm (W) x 99 mm (H) x 90 mm (D). No weight and physical dimensions are being changed and are not the subject of this submission.

The provided text describes the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance in the format requested.

The document primarily focuses on:

• Description of the device: Its features, monitored parameters, and intended use.
• Predicate device comparison: Stating that it incorporates identical technology and is substantially equivalent.
• Safety and environmental testing: Mentioning compliance with various general and individual safety standards, and EMC standards.
• Conclusion: Reiterating that it's as safe and effective as predicate devices based on laboratory testing, validation, and risk analysis.

However, it lacks the specific quantitative data, sample sizes, ground truth establishment methods, or expert qualifications that would be detailed in a robust clinical or performance study report.

Therefore, I cannot populate the requested table and answer many of the specific questions directly from the provided text.

Here's a breakdown of what can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Answers to Specific Questions:

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

• Sample size: Not specified. The document only mentions "various performance tests" and "final testing."
• Data provenance: Not specified. The text indicates "laboratory testing" and testing at an "OEM engineering test facility." This suggests internal testing, but no details on patient data, if any, are provided. It does not mention if the data was retrospective or prospective.

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. The document describes compliance with technical standards and performance specifications, not diagnostic accuracy requiring expert ground truth in a clinical setting.

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

• Not applicable. This type of adjudication is typically for subjective assessments or discrepancy resolution in clinical studies, which is not described here.

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 device is a patient monitor, not an AI-assisted diagnostic tool. The submission focuses on device safety and performance as a monitoring system.

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

• Not applicable in the context of an "algorithm only" study. The performance testing mentioned is for the integrated patient monitor system.

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

• For a patient monitor, the "ground truth" for performance testing typically refers to validated reference standards or simulated physiological signals that mimic real patient data with known values (e.g., a calibrated simulator for vital signs, or direct physical measurement for electrical safety parameters). The document does not explicitly state the specific type of ground truth used, but it would be based on these established engineering and physiological reference systems.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would have a separate "training set."

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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