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Mecun SpO2 sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. The sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

Mecun SpO2 Sensor consists of a connector, cable and patient sensor terminal. The optical components of sensor contain a LED emitter and a LED detector assembled into the non-woven housing. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

The provided document describes the Mecun SpO2 sensor and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (02), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements.

The bedside monitoring systems require both a core unit and an input unit. The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices.

The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display
• CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav

The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav
• CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display

The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

Here is an analysis of the acceptance criteria and supporting study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device rather than defining specific performance-based acceptance criteria for novel claims. The acceptance criteria are implicitly derived from the predicate device's specifications and compliance with recognized standards. Therefore, the "reported device performance" is essentially a statement of "identical" or "below" (meaning lower capacity/resolution but deemed not to affect safety/effectiveness) compared to the predicate.

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The Reusable and Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. The sensors are intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

The proposed device, Reusable and Disposable SpO2 sensors are the accessory of the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), and it is used to attach the patient's finger and measure oxygenation of blood from detecting the infrared-light and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation values and heart rate conditions.

The Reusable and Disposable SpO2 sensors consist of compatible connectors, cable, and patient sensor terminal. And the optical components of sensor are designed to a light emitting diode and a light detector. Red and Infrared lights are shone through the terminal tissues. Then parts of the emitting lights are absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. The light detector detects the light volume transmitted through the tissues on the basis of blood pulse, then the microprocessor calculates a value for the oxygen saturation by measuring the absorbance of the wave peak and the wave trough. The saturation values are determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

This document describes a 510(k) premarket notification for reusable and disposable SpO2 sensors. It details performance data, including biocompatibility, electrical safety, EMC, and clinical studies. However, the document does NOT contain information about AI/ML models or their performance, nor does it specify acceptance criteria for such models, or the details of ground truth establishment by experts for AI/ML development.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML, as the provided text pertains to a standard medical device (SpO2 sensor) without any indication of AI components.

To answer your question accurately, I would need a document that describes the performance of an AI-powered medical device.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI.

The proposed Monitor B40V3 is still a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2.1 (K133576) and now complies with IEC60601-1 3rd edition and RoHS (Restriction of Hazardous Substances) requirements, enabled time synchronization in HL7(Health Level 7) network environment, verified compatibility with CARESCAPE Central Station (K133882) and supported OAC (Optional Activation Codes) tool used in manufacturing and service for product license control. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to interface with following optional extension modules: E-MiniC module (K052582), Airway Gas Option Module (N-CAiO) (K133576), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and Entropy module. Comparing with E-Entropy module version (E-ENTROPY-00) (K061907) supported in predicate device, the proposed Monitor B40V3 supports improved E-Entropy module version (E-ENTROPY-01) (K150298). As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to be compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) with spirometry function disabled. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 still includes features and subsystems that are optional or configurable. The proposed Monitor B40V3 will continue interfacing to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes the GE Medical Systems China Co., Ltd. Monitor B40 (K151063), a multi-parameter patient monitor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of analytical or clinical performance.

Instead, the document focuses on:

• Substantial Equivalence: Demonstrating that the Monitor B40 (V3) is substantially equivalent to its predicate device (Monitor B40V2.1, K133576).
• Design Changes and Rationale: Explaining minor design modifications (e.g., compliance with IEC60601-1 3rd edition, RoHS compliance, time synchronization, compatibility updates, component upgrades due to end-of-life parts) and asserting that these changes do not impact the device's ability to obtain patient measurements or its safety/effectiveness.
• Compliance with Standards: Listing numerous voluntary and international standards the device and its applications comply with (e.g., IEC 60601-1, IEC 62304, ISO 80601-2-56).
• Quality Assurance Measures: Detailing the development process, including risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety).

Therefore, many of the requested points cannot be extracted from the provided text. The document explicitly states: "The subject of this premarket submission. The proposed Monitor B40V3 did not require clinical studies to support substantial equivalence." This indicates that detailed performance metrics from a dedicated clinical study for this specific device (B40V3) are not present in this submission.

Here is what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly listed as quantitative performance metrics for a specific function (e.g., arrhythmia detection sensitivity/specificity, NIBP accuracy). Instead, acceptance criteria implicitly refer to compliance with the listed international standards and demonstrating substantial equivalence to the predicate device, implying that its performance is at least as good as the predicate.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for any of the monitored parameters (ECG, SpO2, NIBP, etc.) for the Monitor B40V3 itself. The document claims "no changes to the parameter measuring principle" and that "all related risks were re-evaluated and found to be unchanged," implying performance is comparable to the predicate device.

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

• Not provided. The document does not describe specific test sets for analytical or clinical performance of the device's monitoring functions. It mentions "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," and "Safety testing" as part of quality assurance, but no details on size, provenance, or type of data are given.

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/Not provided. Since no specific clinical or analytical performance study with a 'test set' requiring expert ground truth is described, this information is absent. The submission focuses on technical compliance and substantial equivalence rather than de novo performance validation.

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

• Not applicable/Not provided. As no performance study with a test set requiring 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/Not provided. This device is a physiological monitor, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or described.

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

• Not explicitly described as a standalone performance study. The device itself functions in a "standalone" mode as a monitor, and its algorithms (e.g., ECG EKPRO V12, NIBP) operate without human intervention in their core function. However, no specific "standalone study" with performance metrics for these algorithms is described in this document for the B40V3. The document states that the Monitor B40 can be a stand-alone monitor or interfaced to other devices.

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

• Not applicable/Not provided. For a physiological monitor, ground truth would typically be established against highly accurate reference devices or established clinical standards. However, since no specific clinical performance study is detailed, the method for establishing ground truth for performance metrics is not mentioned. Compliance testing for standards (e.g., IEC, ISO) would rely on defined test methodologies and reference values.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a "training set" for AI or machine learning algorithms within this submission. The device uses established algorithms for physiological parameter monitoring.

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

• Not applicable/Not provided. As there is no mention of a training set.

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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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The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

The Nellcor Portable SpO2 Patient Monitoring System is a modification of the OxiMax NPB-40 and N-600X Pulse Oximetry Systems. It is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using Nellcor pulse oximetry sensors with OxiMAX technology, and the oximetry sensor cable. The monitor displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Nellcor Portable Sp02 Patient Monitoring System is powered by four AA batteries.

This document is a 510(k) summary for the Nellcor Portable SpO2 Patient Monitoring System (K141542). It claims substantial equivalence to two predicate devices: OxiMAX NPB-40 Pulse Oximeter (K051352) and N-600X Pulse Oximeter (K123581).

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics for the Nellcor Portable SpO2 Patient Monitoring System itself. Instead, it relies on the established performance of its predicate devices and states that its performance is equivalent.

However, it does mention adherence to standards, which imply certain performance expectations:

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

The document leverages clinical data from the predicate devices (K060576 and K123581). Since these studies are not detailed within this document, the specific sample sizes for their test sets and data provenance (e.g., country of origin, retrospective/prospective) are not directly provided in this K141542 summary.

The current device (K141542) underwent non-clinical/bench testing. For the pulse rate accuracy test during motion, it refers to using a "functional tester" and "simulated motion," which implies a test set of situations/scenarios rather than human subjects. The details of this test set are not specified (e.g., number of different motion patterns, duration).

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

This information is not provided in the K141542 summary. As the device relies on clinical data from predicate devices, details about how ground truth was established in those earlier studies (K060576 and K123581) would be necessary for a full answer. For the non-clinical testing of K141542, ground truth would likely be based on calibrated equipment for measurements like pulse rate.

4. Adjudication Method for the Test Set:

This information is not provided in the K141542 summary.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done, nor is it applicable in this context. This device is a pulse oximeter, which directly measures physiological parameters (SpO2 and pulse rate) and presents them to a user. It is not an AI-assisted diagnostic imaging or interpretation tool where human readers would improve with AI assistance.

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

The performance discussed is inherently "standalone" in the sense that it refers to the device's ability to accurately measure SpO2 and pulse rate. The "oximetry performance verification" and "pulse rate accuracy during motion" tests evaluate the device's technical capabilities directly, without requiring human interpretation as part of the core measurement process.

7. The Type of Ground Truth Used:

For the clinical data referenced from K060576 and K123581, the ground truth for SpO2 measurements in pulse oximetry studies typically involves arterial blood gas analysis (co-oximetry) as the gold standard for measuring actual arterial oxygen saturation. For pulse rate, an ECG often serves as the reference.

For the non-clinical testing of K141542, particularly for pulse rate accuracy during motion, the "functional tester" would likely have a precisely controlled and known output for pulse rate, serving as the instrument-based ground truth.

8. The Sample Size for the Training Set:

This document is for a medical device (pulse oximeter) that performs direct physiological measurements, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would refer to its design, engineering, and calibration processes. Therefore, the concept of a "training set sample size" as typically understood for AI is not applicable.

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

As mentioned above, the concept of a "training set" as it applies to AI/ML is not relevant for this specific device. The device's performance is based on its underlying technology and algorithms, which are developed and validated against established physiological principles and measurement standards.

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The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX Sensors and Cables is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospital-type facilities, intra hospital transport, and home environments.

The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.

For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software: The Nellcor Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpOz) and pulse rate of adult, pediatric, and neonatal patients during both no motion conditions and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hosport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in aifflow through the upper airway and into the lungs.

The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

The Nellcor Bedside SpOz Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.

The OxiMAX family of pulse oximeters (including the N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring System) provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate.

The N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside Sp02 Patient Monitoring System are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMAX pulse oximetry sensors and the DOC-10 cable.

The Nellcor Bedside Respiratory Patient Monitoring System, Bedside SpO₂ Patient Monitoring System and the OxiMAX N-600X Pulse Oximetry System, the Nell-1 family of pulse oximeters, are technologically identical. They have the same oximetry PCBA and software.

Here's a breakdown of the acceptance criteria and study details for the Covidien pulse oximeters, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here is for the pulse oximeter's accuracy in measuring SpO2 (functional oxygen saturation of arterial hemoglobin) and pulse rate under both no-motion and motion conditions. The study implicitly aims to demonstrate that the device's accuracy remains within acceptable clinical ranges despite motion. The specific numerical acceptance criteria (e.g., standard deviation or RMS error) are not explicitly stated in the provided text as a table of criteria values. However, the study results confirm that the device was "validated for accuracy."

Study Details

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

   • Test Set Sample Size: The exact number of healthy adult volunteers for the invasive hypoxia study is not specified, but the study was conducted on "healthy, well-perfused adults."
   • Data Provenance: The study was a prospective, induced hypoxia study conducted by Covidien. The country of origin of the data is not specified, but the device manufacturer (Covidien) has addresses in Boulder, CO (USA) and Galway, IRELAND. The study description implies it was performed under medical supervision.

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

   • The document does not mention the use of human experts to establish ground truth for this medical device study. Instead, the ground truth was established by objective medical measurements:
     • SpO2 ground truth: SaO2 values from a CO-Oximeter (a laboratory instrument).
     • Pulse Rate ground truth: ECG values.

3. Adjudication method for the test set:

   • No adjudication method (like 2+1 or 3+1 consensus) was used, as the ground truth was established by direct instrumental measurements (CO-Oximeter and ECG) rather than subjective expert interpretation.

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, as this is a pulse oximetry device, not an AI-assisted diagnostic imaging or interpretation tool. The study focuses on the device's accuracy against objective measurements, not human reader performance.

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

   • Yes, the primary study detailed is essentially a standalone performance evaluation of the pulse oximeter's algorithm. The device measures SpO2 and pulse rate independently and then these measurements are compared to the ground truth from the CO-Oximeter and ECG. Human interpretation is not part of the measurement process being tested.

6. The type of ground truth used:

   • Objective Instrumental Measurements:
     • For SpO2: SaO2 values obtained from a laboratory CO-Oximeter.
     • For Pulse Rate: ECG values.

7. The sample size for the training set:

   • This document describes a clinical validation study for a medical device trying to expand its indications for use. It does not mention a "training set" in the context of machine learning, as this is not an AI/ML device that requires explicit training data for its core functionality. The device's algorithms for SpO2 and pulse rate measurement would have been developed and refined during its initial design process, but the details of that development (including any "training" data for the algorithms themselves) are not part of this 510(k) submission summary. The "training" in this context would implicitly refer to the data used during the initial development and validation of the N-600X and Nell-1 family of oximeters prior to this specific K-K123581 submission.

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

   • Not applicable, as this submission does not detail a machine learning model's training process. The ground truth for the validation study was established using a CO-Oximeter for SpO2 and ECG for pulse rate, as mentioned above.

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For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software:

The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO₂) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

The Covidien Nellcor Bedside Respiratory Patient Monitoring System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of a range of compatible Nellcor OxiMax oxygen transducers (sensors). The Bedside Respiratory Patient Monitoring System displays digital values of SpO2 and pulse and respiratory rate. Pulse amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (from 80VAC to 264VAC) or alternatively by an integral sealed 7.2V, 83W/hr rechargeable lithium-ion battery. The Nellcor OxiMax Bedside Respiratory Patient Monitoring System is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, and intra-hospital transport.

The provided 510(k) summary for the Covidien Nellcor Bedside Respiratory Patient Monitoring System primarily establishes substantial equivalence to predicate devices and focuses on the integration of existing respiration rate software. It does not present a new study with specific acceptance criteria and detailed performance data for this device.

Instead, the summary states:

• "The Bedside Respiratory Patient Monitoring System features the same performance characteristics as the predicate K083325, N-600x Pulse Oximeter with Oximax SPD Alert."
• "performance data to demonstrate saturation and pulse rate accuracy, and SPD are unchanged and the associated information provided in K060576 and K083325 are applicable to the device subject of this submission."
• "Integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate based upon oximetry ohotoplethysmography data, therefore performance data to respiration rate are unchanged and the associated information provided in K111933 are applicable to the device subject of this submission."

Therefore, the detailed acceptance criteria and study information you requested would reside within the referenced predicate device submissions (K060576, K083325, and K111933), not in this document. This submission relies on the previously established performance of its components.

However, I can extract the information provided about the overall performance testing and what was confirmed by this submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission does not present new, specific acceptance criteria for a novel study, but rather refers to predicate devices, the table below reflects the general scope of verification mentioned. Specific quantitative acceptance criteria and reported numerical performance values for parameters like SpO2 accuracy, pulse rate accuracy, and respiration rate accuracy are not provided in this document but would be found in the predicate 510(k)s.

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

This document describes "Bench Testing" and "Usability / Human Factors" studies.

• Bench Testing: No sample sizes are specified for 20-point COPs or Low Perfusion tests in this document. The data provenance is implied to be laboratory/bench testing.
• Usability / Human Factors: No sample size is specified. The study was "simulated operating environments."
• Clinical Performance (SpO2, Pulse Rate, Respiration Rate): No new test set sample sizes or data provenance are stated for these parameters, as the submission relies on the data from predicate devices K060576, K083325, and K111933.

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

This information is not provided in the current document, as it refers to predicate device data for clinical performance. For the usability studies, the "users" involved are noted, but their qualifications are not specified nor is there mention of experts establishing a ground truth in the context of human factors.

4. Adjudication Method

This information is not provided in the current document.

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

This information is not provided, and given the nature of the device (a monitoring system for physiological parameters), an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant in the traditional sense. The AI (algorithm) here is for parameter calculation, not diagnostic image interpretation.

6. Standalone Performance Study

The submission states that "integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate." This implies that the performance data for the algorithm (standalone) for respiration rate was established in the K111933 submission and is referenced here as unchanged. Similarly, SpO2 and pulse rate algorithms would have standalone performance established in K060576 and K083325.
This document describes "Bench Testing" which included "20-point COPs and Low Perfusion Pulse Rate and Saturation Accuracy tests," which are forms of standalone performance evaluation against a known standard.

7. Type of Ground Truth Used

• For SpO2 and Pulse Rate: Historically, pulse oximeter accuracy studies (like those in K060576, K083325) use arterial blood gas (ABG) analysis as the gold standard for oxygen saturation (SaO2), along with ECG-derived heart rate for pulse rate.
• For Respiration Rate: The K111933 submission would have detailed the ground truth for respiration rate, which typically involves manual counting by experts from capnography, impedance pneumography, or direct observation/audio recording.
• For Bench Testing: Controlled laboratory standards and reference measurements are used as ground truth (e.g., precise oxygen mixtures for CO-oximetry, simulated pulse signals).

8. Sample Size for the Training Set

This information is not provided in the current document, as the core algorithms and their training (if any neural networks were involved, which is not explicitly stated but implied by "software algorithm") were developed prior to this submission and are referenced via predicate devices.

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

This information is not provided in the current document, for the same reasons as point 8.

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The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside and outside of the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients. The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The Philips IntelliVue Patient Monitors family comprises the multiparameter patient monitor series: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, and MX800. Each monitor consists of a display unit including built-in or separate central processing unit (CPU) and physiological measurement modules. All monitors share the same architecture of CPU units and exactly the same software is executed on each monitor. The monitors measure physiological parameters such as: Sp02, pulse, ECG, arrhythmia, ST, QT, respiration, invasive and noninvasive blood pressure, temperature, CO2, spirometry, C.O., CCO, tcp02/ tcpCO2, S02, Sv02, Scv02, EEG, and BIS. They generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to the central station. IntelliVue series MP2, X2, MP5, MP5T, MP5SC, MP20, and MP30 are robust, portable, lightweight, compact in size and modular in design patient monitors with interfaces to dedicated external measurement devices. Models MP2, X2, MP5, MP5T, and MP5SC also incorporate multiple built-in physiological measurements. IntelliVue series MP40, MP50, MP60, MP70, MX600, MX700, and MX800 are patient monitors with built-in central processing unit, flat panel display and interfaces to dedicated external measurement devices. Models MX600, MX700, and MX800 have widescreen displays. IntelliVue series MP80 and MP90 are patient monitors with flat panel display and central processing unit as separate components. They have interfaces to dedicated external measurement devices.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:

Acceptance Criteria and Device Performance Study for Philips IntelliVue Patient Monitors (Software Revision J.04)

Overview:
The submission describes a software modification to existing Philips IntelliVue Patient Monitors (MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700, and MX800) to introduce a new SpO2 intelligent alarm delay feature called 'Smart Alarm Delay'. The study aims to demonstrate that this modified device is as safe and effective as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a quantitative table of acceptance criteria with corresponding performance metrics for the 'Smart Alarm Delay' feature in the format often seen for diagnostic devices (e.g., sensitivity, specificity, accuracy). However, the "Summary of V&V activities" section outlines the general performance goals and outcomes.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not specify the exact number of individuals (test persons) involved in the clinical evaluation. It refers to "two user groups - one consisting of physicians and one consisting of nurses" and later "the vast majority of test persons." This suggests a qualitative assessment rather than a statistically powered performance study.
• Data Provenance: Not explicitly stated, but clinical evaluation of user understanding implies prospective testing with healthcare professionals. The country of origin for this specific clinical evaluation is not mentioned.

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

• The "clinical evaluation" appears to focus on user comprehension and acceptance, not on establishing a traditional clinical "ground truth" for diagnostic accuracy.
• Number of Experts: Two user groups were formed: "one consisting of physicians and one consisting of nurses." The exact number of individuals within each group is not provided.
• Qualifications of Experts:
  • Physicians
  • Nurses
  • No specific years of experience or subspecialty are mentioned.

4. Adjudication Method for the Test Set

Not applicable. The clinical evaluation described is a qualitative assessment of user understanding and perception, not a diagnostic accuracy study requiring adjudication of results.

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

No. The document describes a software modification to an existing patient monitor to add an intelligent alarm delay feature. The "clinical evaluation" focused on user understanding and acceptance of this feature, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, not in the traditional sense of a standalone diagnostic algorithm performance study. The modification is an alarm delay feature within an existing monitoring system. The document states:

• "The new 'Smart Alarm Delay' feature is isolated from the SpO2 measurement algorithm, i.e. signal acquisition and numeric processing."
• "The devices hardware and all accessories including, but not limited to the SpO2 sensors remain completely unchanged."
• "The modification does not affect device performance in general and device accuracy in particular."
• Performance aspects covered by ISO 9919 from prior V&V are considered still valid.

This indicates that the fundamental SpO2 measurement accuracy itself was not re-evaluated as a standalone algorithm performance, as the algorithm for SpO2 measurement remained unchanged. The focus was on the alarm delay logic and its user-facing implications.

7. Type of Ground Truth Used

For the "clinical evaluation" regarding the 'Smart Alarm Delay' feature, the "ground truth" appears to be user understanding and subjective opinion as gathered directly from physicians and nurses. For the core SpO2 measurement, the ground truth and performance validation are based on prior verification and validation activities conducted according to ISO 9919 for the predicate device, which are deemed still valid.

8. Sample Size for the Training Set

Not applicable. This submission is for a software modification adding an alarm delay feature, not a machine learning or AI algorithm that requires a dedicated training set for model development. The 'Smart Alarm Delay' is described as being "based on the same fundamental principle" as the predicate's 'SatSeconds' alarm management technique, implying a rule-based or empirically derived logic rather than a learned model.

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

Not applicable, as no training set for a machine learning model was described or used.

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The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.

The Fukuda Denshi model LX-7230KM/7230N is a patient worn Transmitter that transmits physiological data such as ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate from a patient to a Fukuda Denshi Central Monitor. The front LCD display information such as ECG, heart rate, respirogram, respiration rate, SpO2, plethysmograph, pulse rate, pulse amplitude level, battery level, and the conditions of the ECG electrodes and SpO2 sensor. For the SpO2 measurement, the LX-7230N utilizes Nellcor SpO2 module technology (K060576) and the LX-7230KM utilizes Konica-Minolta SpO2 module technology (K053419). Both transmitters can only be used as an interface device of the previously cleared Fukuda Denshi Central Monitor (K970585, K000746, K020084) utilizing the central telemetry receiver (K980728). Both transmitters utilize digital FSK (frequency shift keying) technology and operate in the WMTS 608 to 614 MHz transmission frequencies. One or two channel ECG waveforms are selectable with lead selection available using the two buttons (Enter and down arrow) on the front panel. (In case of using a 3-electrode lead cable or a 5-electrode chest lead cable). Both transmitters are battery powered using 2 AA alkaline batteries with available continuous operation for 6 days (LX-7230KM) or 3 days (LX-7230N). The LX-7230KM/7230N is small and lightweight at 190 grams including batteries. The physical dimensions of the device are 72 mm (W) x 98 mm (H) x 24.8(D) mm.

This is a summary of the acceptance criteria and study information based on the provided text.

This submission describes a telemetry transmitter (Fukuda Denshi Model LX-7230KM/7230N) which is an interface device that transmits physiological data (ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate) from a patient to a central monitor. The core technology (ECG and Respiration measurement) is the same as the predicate device (LX-5630, [K033711](https://510k.innolitics.com/search/K033711)). The SpO2 measurement function integrates OEM modules from Konica Minolta (PULSOX-300/300i, [K053419](https://510k.innolitics.com/search/K053419)) and Nellcor (N-600x Pulse Oximeter, [K060576](https://510k.innolitics.com/search/K060576)), without modification to these modules or their sensors. The submission focuses on demonstrating substantial equivalence to the predicate device and the previously cleared OEM SpO₂ modules rather than presenting new clinical study data with specific performance metrics.

Acceptance Criteria and Device Performance

The provided document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the Fukuda Denshi Model LX-7230KM/7230N Transmitter. Instead, the claim for substantial equivalence is based on the device incorporating identical fundamental technology for ECG and Respiration measurement as a predicate device and utilizing pre-cleared, unmodified SpO₂ modules whose performance has already been established and accepted by the FDA.

The "reported device performance" indicated is that the device "demonstrates that this device is as safe and effective as and performs as well as the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711." This implies that the device meets the performance standards already established for the predicate device and the incorporated OEM SpO₂ modules.

Study Details

The provided text describes a 510(k) submission seeking substantial equivalence for a medical device by demonstrating that its core technology is the same as a predicate device and that its SpO2 components are pre-cleared, unmodified OEM modules. Therefore, the "study" described is not a new clinical trial with specific performance endpoints, but rather a set of tests to confirm the new device's functionality and safety consistent with its predicate and incorporated components.

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

   • Test Set Sample Size: Not explicitly stated as a patient-based sample size. The document mentions "extensive safety, environmental and performance testing" and "various performance tests." For the SpO2 modules, it states they were "host tested at the previously noted OEM engineering test facility."
   • Data Provenance: Not specified in terms of country of origin or whether it was retrospective or prospective. The testing appears to be internal validation ("laboratory testing, validation and risk Analysis") and OEM engineering testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The submission relies on technical equivalence to established, cleared devices and modules rather than new ground truth establishment by experts for a new dataset.

3. Adjudication method for the test set: Not applicable. There is no mention of an adjudication process for expert consensus on a test set.

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: Not applicable. This device is a telemetry transmitter and does not involve AI or human interpretation of medical images or data requiring an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed as a "standalone" performance study in the context of an algorithm. The device itself is a standalone transmitter. Its performance is demonstrated through its hardware and software functionality as an interface for physiological data, relying on the established performance of its component parts (ECG/Respiration from predicate, SpO2 from OEM modules).

6. The type of ground truth used: The "ground truth" for this submission is based on the performance established for:

   • The predicate device (Fukuda Denshi model LX-5630 Transmitter, K033711) for ECG and Respiration measurement.
   • The pre-cleared OEM SpO₂ modules (Konica Minolta "Pulsox-300/300i" K053419 and Nellcor "OxiMax N-600x Pulse Oximeter" K060576).
     The ground truth is implicit in the regulatory clearance of these prior devices and modules.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that would typically involve a "training set" for an algorithm. The device's functionality uses established physiological measurement technologies.

8. 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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