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Masimo Rad-97 Pulse CO-Oximeter and Accessories:

The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediativ and infant patients.

The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NiBP module is designed to measure blood pressure for patient population described in the following Table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

Masimo Radical-7 Pulse CO-Oximeter and Accessories

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

Masimo Radius-7 Pulse CO-Oximeter and Accessories:

The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoplobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitaltype facilities, home environments, and transport within healthcare facilities.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The subject of the submission is to add Respiration Rate from photoplethysmogram (designated as RRp) feature to the previously cleared Masimo Pulse Oximetry devices. The RRp feature that was previously cleared as part of MightySat fingertip pulse oximeter under K181956. RRp feature determines the patient's respiration rate by analyzing cyclic variations in photoplethysmogram (pleth) to establish respiration measurement. The devices in which the RRp feature is being added as part of this submission are the previously cleared Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, and Masimo Radius-7 Pulse CO-Oximeter.

Rad-97 Pulse CO-Oximeter: Masimo Rad-97 System and Accessories (Rad-97), is a portable monitor that features a touchscreen that provides a display and control user interface for monitored parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery. The Rad-97 comprises of technologies that enable the device to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or capnography parameters or noninvasive blood pressure (NIBP) parameters which were all previously cleared under K183697.

Radical-7 Pulse CO-Oximeter: Masimo Radical-7 and Accessories, is a pulse co-oximeter that features a touchscreen that provides a display and control user interface for monitored parameters. It can be used either as a handheld or standalone monitor. Radical-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor. The Radical-7 comprises of technologies that enable the Radical-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.

Radius-7 Pulse CO-Oximeter: Masimo Radius-7 and Accessories, is a wearable Pulse CO-Oximeter. Radius-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor via Bluetooth or WiFi. The Radius-7 comprises of technologies that enable the Radius-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.

The document provided explains the regulatory clearance of Masimo Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters with the addition of a Respiration Rate from photoplethysmogram (RRp) feature. The acceptance criteria and the studies proving the device meets these criteria are detailed below, focusing on the newly added RRp feature.

Acceptance Criteria and Device Performance

The core acceptance criterion for the RRp feature is its accuracy (ARMS) and mean error when compared to a gold-reference capnography.

Table of Acceptance Criteria and Reported Device Performance (RRp Feature):

Note: The document states the performance specification of RRp is "ARMS of ≤ 3.0RPM and mean error of 1", which is explicitly met by the reported performance.

Study Details Proving Device Meets Acceptance Criteria

1. Sample Sizes Used for the Test Set and Data Provenance:

• Prospective Clinical Study (Healthy Adults):
  • Number of Data Points: 7,751
  • Data Provenance: Not explicitly stated but implied to be from a controlled clinical setting, likely in the US (given FDA submission). It's a prospective study.
• Retrospective Clinical Validation Study (Hospitalized Adults):
  • Number of Data Points: 119,174
  • Data Provenance: Collected from hospitalized adults. Retrospective study. Country of origin not explicitly stated, but common for such studies to be multi-site or from a single clinical institution, likely in the US.
• Retrospective Clinical Validation Study (Hospitalized Pediatrics):
  • Number of Data Points: 35,390
  • Data Provenance: Collected from hospitalized pediatrics. Retrospective study. Country of origin not explicitly stated.

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

• The document does not specify the number or qualifications of experts involved in establishing the ground truth. The ground truth method relies on an FDA-cleared capnography device (Oridion Capnostream20, K060065) as the "gold-reference method." This suggests that the ground truth is derived from instrumental measurements rather than human expert interpretation of raw data.

3. Adjudication Method for the Test Set:

• Not applicable as the ground truth is established by a medical device (capnography) and not human consensus or adjudication. The comparison is between the device's RRp measurement and the capnography's measurement.

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

• No, an MRMC comparative effectiveness study was not done. The study focuses on the accuracy of the device's RRp measurement against a reference standard, not on how human readers' performance improves with or without AI assistance. The device is a monitor, not an AI-assisted diagnostic tool that requires human interpretation.

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

• Yes, the studies conducted demonstrate the standalone performance of the RRp algorithm. The device produces a directly measurable respiration rate (RRp) which is then compared to a reference standard (capnography). Human interpretation is not part of the RRp measurement process itself.

6. The Type of Ground Truth Used:

• The ground truth used is an instrumental reference standard: an FDA-cleared capnography device (Oridion Capnostream20, K060065), which is considered a "gold-reference method" for respiration rate measurement. This is a direct physiological measurement, not expert consensus or pathology.

7. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set. It mentions that the "technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956)." This implies that the RRp algorithm was likely developed and potentially trained using data before this specific submission, possibly on data sets contributing to the MightySat clearance. The presented studies are validation studies for the implementation of this existing feature on new devices.

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

• The document does not provide details on how the ground truth for the training set was established. Given that the RRp feature's technology is stated to be the same as a previously cleared predicate device (MightySat K181956), it can be inferred that the validation and potentially the training of the original algorithm would have followed similar rigorous methods, likely involving comparison to golden standards such as capnography. However, specific details for the training set's ground truth establishment are not present in this submission.

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The Masimo MightySat Rx Fingertip Pulse Oximeter is intended for hospital-type facilities, home environments, and transport.

The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of respiration rate (RRp) for adult patients.

The subject device, MightySat Rx, was previously cleared under K150314 as a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate (PR), calculation of Perfusion Index (Pi) and optional Pleth Variability Index (PVi) in adults and pediatrics. The current submission concerns the MightySat Rx's measurement of respiration rate through photoplethysmogram analysis (designated as RRp).

Like the secondary predicate (K150314), the device is a spot check pulse oximeter and does not include alarms. The device has the combined function of a pulse oximeter monitor and a reusable sensor. It includes an OLED color display, enclosed by plastic housing and powered by two alkaline AAA batteries.

The MightySat Rx also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices, such as a smartphone.

1. Acceptance Criteria and Reported Device Performance (RRp Measurement):

2. Sample Size and Data Provenance for Test Set:

• Prospective Study: 28 healthy volunteers. Data provenance is not explicitly stated but implies a controlled clinical setting, likely within the US given the FDA submission.
• Retrospective Study: 59 hospitalized subjects. Data provenance is not explicitly stated but implies a clinical setting, likely within the US.

3. Number and Qualifications of Experts for Ground Truth:

The document states that the RRp measurements were compared against "manual, clinician-scored capnograms." The number of clinicians and their specific qualifications (e.g., years of experience, specialty) are not provided in this document.

4. Adjudication Method for Test Set:

The adjudication method for establishing ground truth is not explicitly stated beyond "manual, clinician-scored capnograms." It does not mention whether multiple clinicians were used or if a specific adjudication process (e.g., 2+1, 3+1) was employed.

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

No MRMC comparative effectiveness study is mentioned for the RRp measurement. The studies described are focused on the standalone performance of the device.

6. Standalone Performance Study:

Yes, a standalone performance study was done for the RRp measurement. Two clinical tests were performed to validate the accuracy:

• A prospective analysis on 28 healthy volunteers.
• A retrospective analysis on 59 hospitalized subjects with different clinical conditions.

7. Type of Ground Truth Used:

The ground truth used for the RRp measurement was "manual, clinician-scored capnograms" obtained from a Capnostream20 device (K060065). This indicates a form of expert consensus based on instrument readings.

8. Sample Size for Training Set:

The document does not explicitly state the sample size used for the training set for the RRp algorithm. It mentions that the technology change for RRp is a "software change which utilizes the same hardware as the secondary predicate," and that "the primary predicate and subject device both rely on the technological principle of respiration-induced variations in the photoplethysmogram." This suggests that the algorithm likely learned from data that exhibits these physiological variations, but the specific training dataset size is not provided.

9. How Ground Truth for Training Set was Established:

The document does not explicitly describe how the ground truth for the training set was established. It notes that "both devices rely on the technological principle of respiration-induced variations in the photoplethysmogram," and references a scientific paper on multiparameter respiratory rate estimation. This implies that the algorithm's development (and thus its training, if applicable) was based on established physiological principles and potentially data where these variations were known or measured by other validated methods. However, the exact method for establishing ground truth for any potential training set is not detailed.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The Philips SureSigns Series Patient Monitors, SureSigns VM4, VM6, and VM8 Patient Monitors are multi-parameter patient monitors. The modifications include a new OEM CO2 module, addition of an apnea alarm, a new main board, modified front end board, alternate internal component speaker, optional bar code reader, optional RS232 serial port adaptor, several new accessories, and software enhancements. Impedance respiration is added to SureSigns VM4.

1. Acceptance Criteria and Reported Device Performance

The provided text only states that "Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence." It does not explicitly list specific acceptance criteria or quantitative performance metrics. It generally asserts that the device "meet all reliability requirements and performance claims."

2. Sample Size 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 or prospective nature of the data). It broadly mentions "system level tests, performance tests, and safety testing from hazard analysis."

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. The type of device (patient monitor) and the nature of modifications (hardware and software enhancements to existing parameters, addition of alarms) suggest that "ground truth" might be established through comparisons with reference measurement devices or established clinical standards, rather than expert consensus on image interpretation, for example.

4. Adjudication Method

The document does not mention any adjudication method.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The evaluation focuses on technical performance and equivalence to a predicate device.

6. Standalone Performance (Algorithm Only)

The device itself is a standalone patient monitor, and its performance was evaluated. However, the term "standalone" in the context of AI often implies an algorithm's performance without any human-in-the-loop. In this case, the device monitors physiological parameters and provides alarms directly, so its performance is inherently standalone in generating these outputs. The text indicates that "testing activities establish the performance, functionality, and reliability characteristics of the subject devices."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for physiological monitoring devices, the ground truth would typically be established by:

• Reference standard devices: Comparing the device's readings against highly accurate and calibrated reference instruments for each physiological parameter (e.g., a clinical-grade blood pressure cuff for NBP, a calibrated pulse oximeter for SpO2, a gas analyzer for CO2).
• Physical simulators: For certain parameters, using simulators that can generate precise physiological waveforms or values.
• Clinical standards/established norms: Ensuring basic functionality and alarm thresholds align with recognized clinical practices.

8. Sample Size for the Training Set

The document does not specify any training set sample size. This type of device (patient monitor with hardware and software modifications to existing parameters) is unlikely to have a "training set" in the sense of machine learning models requiring large datasets for training. Its development would involve engineering design, component testing, and system-level validation against specifications, not typically a data-driven training process in the modern AI sense.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

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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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