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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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The Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.

The Vital Sync™ System displayed parameters are listed on the following pages.

WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring.

The Vital Sync™ System is being extended to offer additional device compatibility and parameter display.

The design features of the subject Vital Sync™ System are substantially equivalent to the design features of the predicate Vital Sync™ system.

Below is an analysis of the provided text regarding the Vital Sync™ System, Model 5000:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described is focused on the device's technical functionality, specifically "driver validation and regression testing." The provenance of any data used for these technical tests is not mentioned (e.g., country of origin, retrospective/prospective).

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

Not applicable. The ground truth for this device's performance was established through technical validation and regression testing against the predicate device's expected behavior, not through expert review of patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no adjudication method described as the testing was technical validation and regression testing, not a clinical study requiring expert consensus.

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. The device is a physiological parameter display and recording system, not an AI-assisted diagnostic tool.

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

Yes, in a sense, a standalone performance assessment was conducted for the device's core functionality. The "driver validation and regression testing" evaluated the device's ability to accurately receive and display data from compatible bedside devices. This testing would have assessed the algorithm's performance in managing and presenting data, independent of human interpretation of the displayed parameters.

7. The Type of Ground Truth Used

The ground truth used was the expected and validated behavior of the predicate Vital Sync™ System. The new device's performance in terms of data integrity and accurate display was compared against this established baseline. This is a form of technical validation against a known, established standard (the predicate device's functionality).

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device clearance process for an update to an existing system, not the development of a machine learning or AI algorithm that would require a "training set."

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

Not applicable, as there was no training set mentioned or implied for this device.

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The 840 Ventilator System with Expanded NeoMode Option provides continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option, is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg and for use in a wide variety of clinical conditions.

The 840 Ventilator System with Expanded NeoMode Option is intended for use in hospitals and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The PB 840 Ventilator is a dual-microprocessor-based, touch-screen controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult patients (with expanded NeoMode Option) or infant to adult patients (with no Option) who require either invasive ventilation or non-invasive ventilation.

The 840 Ventilator Expanded Neomode Option includes the software enhancements that lower the ideal body weight (IBW) from 0.5kg to 0.3kg and provides the user an option to lower the tidal volume to 2mL. The ventilator determines values for operational variables and allowable settings based on breathing circuit type and IBW. The software controls prevent inadvertent mismatching of patient size and breathing circuit type.

The 840 Ventilator Expanded Neomode Option is available as an integrated part of the 840 Ventilator or as separate software upgrade kit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 840 Ventilator System with Expanded NeoMode Option:

It's important to note that this document is a 510(k) summary for a ventilator, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI device studies (like MRMC, number of experts for ground truth, sample sizes for test/training sets in the context of image analysis or similar AI tasks) are not applicable here. The "device" in this context is a medical hardware and software system, and the "study" refers to engineering verification and validation testing, not clinical trials in the way AI diagnostics are evaluated.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to a medical device modification, not an AI study)

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

   • The document does not specify a sample size for the test set in terms of patient data or clinical cases. The testing described is primarily engineering verification and validation of software and hardware performance against specifications. These tests would involve various simulations, bench testing, and potentially some animal or human user testing, but not a "test set" in the sense of a dataset for an AI algorithm.
   • Data provenance: Not applicable in the context of a typical "AI study." The context here is product development and regulatory submission for a physical medical device with software components.

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

   • This is not applicable for this type of device submission. Ground truth for a ventilator's performance is established by engineering specifications, regulatory standards (like FDA guidances for ventilators), and physiological principles, not by expert consensus on a test set of data points in the same way it would be for an AI diagnostic. The "experts" would be the engineers and compliance officers designing and testing the device, ensuring it meets these established criteria.

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

   • This is not applicable. Adjudication methods like 2+1 are typically used in clinical studies or for establishing ground truth from multiple human readers in an AI development context. For a ventilator, performance is objectively measured against predefined engineering and regulatory specifications.

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, an MRMC comparative effectiveness study was not done. This type of study is specific to AI systems that assist human readers (e.g., radiologists interpreting images). The 840 Ventilator is a life-support device, and its expanded NeoMode option is a software enhancement to its functionality, not an AI-assisted diagnostic tool.

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

   • The device's core functionality is a "standalone" system in that it delivers ventilation based on its internal algorithms and control systems. However, this is not an "AI algorithm only" in the sense of an AI diagnostic that might be compared to human performance. The ventilator's performance was validated, which inherently evaluates its "standalone" function in delivering breaths.

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

   • The "ground truth" for this device's performance is based on engineering specifications, established physiological parameters for ventilation, and regulatory guidance documents (e.g., "FDA Draft Reviewer Guidance for Ventilators"). These define the acceptable ranges and accuracy for breath delivery, tidal volume, and other operational variables.

7. The sample size for the training set:

   • This is not applicable as the document describes a software upgrade for an existing medical device, not the development of a machine learning model where a "training set" would be used to teach an algorithm. The software was developed and then validated against specifications.

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

   • Not applicable for the reasons stated above.

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The 840 Ventilator System with Leak Compensation Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions.

The 840 Ventilator System with Leak Compensation Options is intended for a wide range of patients ranging from neonate to adult (V- 5-2500 mL with NeoMode) or from infant to adult (V-25-2500 mL).

The 840 Ventilator System with Leak Compensation is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The Leak Compensation Option enables the 840 Ventilator System to automatically detect and characterize gas flow that leaves the breathing circuit through air leak(s) and does not return to the 840's exhalation valve for inclusion in the displayed exhaled spirometry. LC does not makeup for lost delivered volume but does add the necessary additional flow into the breathing circuit to optimize breath triggering and cycling functions as well as maintain the set PEEP, and display clinically valuable leak-related parameters for consideration by the clinician. The Leak Compensation feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).

Here's an analysis of the provided 510(k) summary regarding the Puritan-Bennett 840 Ventilator System with Leak Compensation Option, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which is a high-level overview. It generally does not contain the granular detail of a full study report (like sample sizes for specific tests, expert qualifications, or adjudication methods). Therefore, for several points, the answer will be that the information is not provided in this summary.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table with specific, quantitative acceptance criteria (e.g., "leak compensation accuracy must be within X%"). Instead, it states that the device "passed all tests" against its stated performance specifications and applicable guidance.

Study Details

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 for Test Set: Not specified in this 510(k) summary. The document mentions "functional testing," "testing confirms," and "all software is tested," implying internal verification and validation activities, but does not quantify the sample sizes for these tests (e.g., number of test cases, number of ventilation cycles simulated).
• Data Provenance: Not specified. The testing described appears to be internal engineering and software verification/validation, not a clinical study with patient data.

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)

• Number of Experts & Qualifications: Not applicable/Not specified. The testing described focuses on functional performance and software compliance, not diagnostic accuracy against expert-established ground truth. These types of tests are typically conducted by engineers and quality assurance personnel against predefined performance specifications.

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

• Adjudication Method: Not applicable/Not specified. Adjudication methods are typically used in clinical studies or studies where multiple human readers interpret data, and their decisions need to be reconciled to establish a ground truth. This document describes functional and software testing.

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

• MRMC Study Done: No, an MRMC comparative effectiveness study was not described in this 510(k) summary.
• Effect Size of Human Improvement: Not applicable, as no MRMC study was described. The device is a ventilator with a leak compensation feature, not an AI-assisted diagnostic tool that humans interpret.

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

• Standalone Performance: Yes, in essence, the "functional testing" and "software testing" described represent the standalone performance of the device's leak compensation algorithm and system. The ventilator itself operates automatically based on its algorithms to detect and compensate for leaks. The summary states: "Functional testing confirms that the 840 Ventilator with Leak Compensation Ventilator is capable of meeting its stated performance specifications." This refers to the device's performance without direct human intervention in the leak compensation process itself.

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

• Type of Ground Truth: For the functional and software testing, the "ground truth" would be the engineering specifications and design requirements for the leak compensation function, as well as the applicable regulatory standards and guidance documents (e.g., "Draft Reviewer Guidance for Ventilators"). The device was tested against these predefined performance targets.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This device is a mechanical ventilator with control algorithms, not a machine learning or AI system that requires a "training set" in the conventional sense of supervised learning. Its algorithms are developed through engineering design, mathematical modeling, and control theory rather than statistical training on a dataset.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of machine learning. The algorithms were designed and verified against established principles of fluid dynamics, respiratory physiology, and control system engineering, coupled with internal performance specifications and regulatory guidance.

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The PB 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:

• Positive Pressure ventilation
• Assist/Control, SIMV, or CPAP modes of ventilation
• Breath types including Volume, Pressure Control and Pressure Support.
  The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

The PB 540 Ventilator gas delivery system is composed of a flow generator capable of supplying a sufficient range of flows and pressures that is then controlled by a three-way valve enabling piloting of the expiration valve. The flow generator is a low-inertia micro-turbine driven by a brushless electric motor and the valve is a proportional electronically driven valve.
These two actuators are controlled according to specific control algorithms by a microprocessor receiving information from the pressure and flow sensors built into the ventilator.

The provided 510(k) summary for the PB 540 Ventilator does not describe an AI/ML device or a study involving acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it's for a traditional medical device (a ventilator) and discusses performance in terms of functional testing and compliance with regulatory guidelines.

Therefore, the requested information elements related to AI device performance evaluation (such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable to this document.

Here's an interpretation based on the information available:

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

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

• The document does not specify sample sizes for any "test sets" in the context of diagnostic performance. The testing described is functional and compliance-based for a physical device, not an AI model.

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 as this is not an AI/ML diagnostic device and no "ground truth" in this context was established. Performance was assessed against predefined functional and regulatory standards.

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

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is not an algorithm-only device. The "standalone" performance implied refers to the ventilator itself meeting its functional specifications.

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

• The concept of "ground truth" as used in AI/ML performance evaluation is not relevant here. The "truth" for this device's performance is its ability to meet engineering specifications, functional requirements, and regulatory standards.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The Legendair XL2 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:
. Positive Pressure ventilation
Assist/Control, SIMV, or CPAP modes of ventilation .
Breath types including Volume, Pressure Control and Pressure Support. ◆
The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

The LEGENDAIR® XL2 ventilator is composed of an airflow generator capable of supplying a range of flow rates and pressures and a valve enabling piloting of the expiration valve. The operation of the device is based on a self-adapting drive system governed by a closed loop flow generator. The speed of the flow generator (turbine) is servo-controlled to the patient pressure signal or the inspired flow signal.
The ventilation modes available are:

• -Pressure Support Ventilation
• . Pressure Support Ventilation with Back Up Rate
• CPAP mode -
• Pressure Controlled Ventilation ﮯ
• Pressure Assisted Controlled Ventilation -
• Volume Controlled Ventilation -
• Volume Assisted Controlled Ventilation -
• Synchronous Intermittent Mandatory Ventilation with either volume or pressure ﮮ targeted mandatory breaths

The provided text does not contain acceptance criteria or study details in the format typically used for AI/ML device submissions. This document is a 510(k) summary for a ventilator, a type of electro-mechanical medical device, not an AI/ML diagnostic or predictive tool.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's an analysis based on the information available and how it relates to the questions, with an explanation of why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on "substantial equivalence" to predicate devices rather than specific quantitative performance metrics against predefined acceptance criteria for an AI/ML model.

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

• Not Applicable. This is not an AI/ML device where a "test set" of data samples (e.g., images, patient records) is used to evaluate an algorithm's performance. The "testing" referred to for this ventilator would involve engineering and functional tests on the physical device itself.

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

• Not Applicable. See point 2. Ground truth in the context of an AI/ML device is typically established by medical experts reviewing data, which is not relevant here.

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

• Not Applicable. See point 2.

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. An MRMC study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This is a ventilator, not a diagnostic AI tool.

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

• Not Applicable. This device is a ventilator, not an algorithm, so the concept of standalone performance does not apply in the AI/ML sense. Its "performance" is inherent to its mechanical and software operation.

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

• Not Applicable. The "ground truth" for a ventilator would be its adherence to specified operational parameters (e.g., delivered pressure, flow rates, alarms functioning correctly) validated through engineering tests against known standards, not expert consensus on medical data or pathology. The document explicitly states "compliance with external electrical and mechanical safety standards" and "detailed comparison of performance modes, ranges of operation."

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a "training set" of data to learn patterns. The ventilator's operation is based on coded logic and physical engineering, not machine learning.

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

• Not Applicable. See point 8.

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The Nellcor® DuraMax® reusable oximetry sensor is indicated when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing 40 kg or more.

The DuraMax is a reusable sensor, sized appropriately to fit the digit of a pediatric or adult patient weighing 40 kg or more.

The DuraMax sensor consists of an internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold.

The DuraMax sensor plug contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including Advanced Signal Evaluation, Intention and data set revision, and sensor model. The DuraMax sensor is compatible with Nellcor and other monitors incorporating either Nellcor R-Cal or OxiMAX (DigiCal) oximetry technology.

Nellcor® DuraMax® Reusable Oximetry Sensor

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

The submission does not explicitly state quantitative acceptance criteria in a table format. However, it indicates adherence to the ISO 9919:2005 standard and states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." The implicit acceptance criterion, therefore, is conformance to the accuracy and precision specifications outlined in ISO 9919:2005 for pulse oximeters. The submission concludes that the device meets these requirements.

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

The submission states that "Human... tests were performed to support the determination of substantial equivalence" and that "Human oxygenation evaluations were conducted." However, the document does not specify:

• The exact sample size used for the human test set.
• The country of origin of the data.
• Whether the study 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)

This information is not provided in the submission. The submission mentions "Human oxygenation evaluations," which implies direct physiological measurements rather than expert review of data. In the context of pulse oximetry, the "ground truth" for oxygen saturation is typically established through co-oximetry measurements of arterial blood samples. Expert review for ground truth establishment is not typically the primary method for this type of device.

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

This information is not provided in the submission. Given that the ground truth for oxygen saturation is usually established by direct or highly accurate indirect physiological measurements (e.g., co-oximetry), a multi-reader adjudication method would not be applicable in the traditional sense for the device's primary function.

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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The DuraMax® sensor is an oximetry sensor, not an AI-powered diagnostic device that assists human readers in case interpretation.

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

The device itself is a passive sensor that provides data (oxygen saturation and pulse rate) to an oximeter; it does not contain a standalone "algorithm" in the sense of an AI-driven component. The "Advanced Signal Evaluation" and "Intention and data set revision" are mentioned as information carried by the sensor's memory chip, indicating internal processing logic for signal quality, but this is part of the integrated system and not a standalone algorithm evaluated independently for diagnostic performance.

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

For oxygen saturation measurements, the ground truth is typically established using arterial co-oximetry, where arterial blood samples are analyzed to determine actual oxygen saturation (SaO2). The submission states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," which strongly implies comparison against a gold standard for oxygen saturation, most commonly co-oximetry.

8. The sample size for the training set

The submission does not mention a distinct "training set" for the device, as it is a hardware sensor rather than a machine learning model that requires training. The development and verification process for such a device would involve design, bench testing, and human testing for performance validation.

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

As there is no mention of a "training set" in the context of a machine learning model, this question is not applicable. The ground truth for performance validation (the human oxygenation evaluations) would have been established through methods like co-oximetry as described in point 7.

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The Nellcor OxiMax N-600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor OxiMax N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in bospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only

The OxiMax N-600x Pulse Oximeter is a modification OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors and Cables. The N-600x is 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 N-600x Pulse Oximeter displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The N-600x can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively by an internal 6V rechargeable sealed lead-acid battery. The OxiMax N-600x Pulse Oximeter is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

The provided text is a 510(k) Summary for the Nellcor OxiMax N-600x Pulse Oximeter and primarily describes the device, its intended use, and its technological characteristics. It mentions that clinical and non-clinical tests were performed but does not provide specific details about acceptance criteria, the results of those tests, or the study design.

Therefore, many of the requested details cannot be extracted from this document, specifically:

• Acceptance Criteria and Reported Performance Table: Not provided.
• Sample size for the test set and data provenance: Not provided. The document states "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards," which implies prospective human subject research, but no details on size or origin.
• Number of experts and qualifications for ground truth: Not provided.
• Adjudication method: Not provided.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not explicitly stated or detailed, although the device itself is a standalone algorithm within the oximeter.
• Type of ground truth used: Not provided.
• Sample size for the training set: Not provided, as the document doesn't explicitly discuss an "AI" or machine learning training phase in the modern sense. The "algorithm" mentioned is for processing signals from the sensor.
• How ground truth for the training set was established: Not provided.

Summary of available information:

The document broadly states that:

• "Clinical and non-clinical tests were performed to support the determination of substantial equivalence."
• "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards."
• "The technological characteristics of the OxiMax N-600x Pulse Oximetry System and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices."

This indicates that studies were conducted to show substantial equivalence to a predicate device, rather than to meet specific performance acceptance criteria for a novel technology in the way AI/ML devices might. The FDA's letter (K060576) confirms that the device was deemed substantially equivalent based on the submitted information.

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The Nellcor® OxiMax® NeoMAX adhesive forchead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).

The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient.

The OxiMax NeoMAX sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data. Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax NeoMAX sensor is compatible with OxiMAX monitors.

The provided text describes the OxiMax NeoMAX Adhesive Forehead Reflectance Oximetry Sensor, but it does not contain a table of acceptance criteria or detailed results from a study proving the device meets specific criteria. The document states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," but it does not present these specifications or the results in detail.

Therefore, many of the requested items cannot be answered directly from the provided text.

Here is what can be extracted based on the input:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The text mentions "accuracy and precision specifications" were confirmed, but the specific values for these specifications are not given.
• Reported Device Performance: Not explicitly stated in the provided text. The document indicates that testing was performed and concluded that "The technological characteristics of the OxiMax NeoMAX sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device." However, the actual performance metrics (e.g., accuracy, bias, standard deviation of SaO2 readings) are not provided.

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

• Sample Size for Test Set: Not specified. The document only states "Human oxygenation evaluations were conducted."
• Data Provenance: Not specified (e.g., country of origin, 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/Not specified. This device is an oximeter sensor, and ground truth for oxygen saturation measurements is typically established through arterial blood gas analysis, not expert consensus on images. The document does not describe how ground truth was established.

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

• Not applicable/Not specified. Adjudication methods are typically used in studies involving expert interpretation of data (e.g., images), which is not the primary form of evaluation for an oximeter sensor.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an oximeter sensor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

• This device is a sensor. Its "performance" inherently refers to its ability to accurately measure oxygen saturation and pulse rate. The evaluation would be of the sensor's direct measurement capabilities, which is analogous to a standalone performance evaluation in the context of a medical device's fundamental function. The document states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a direct measurement efficacy study.

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

• Not explicitly stated, but for oxygen saturation measurements, the common gold standard (ground truth) is arterial blood gas analysis. It is highly probable this method was used, though not specified in the text.

8. The sample size for the training set

• Not applicable/Not specified. This device is a sensor; it does not involve a "training set" in the context of machine learning algorithms.

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

• Not applicable. This device does not involve a training set.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device and mentions that human and bench tests were performed to confirm accuracy and precision. However, it lacks the detailed quantitative data, sample sizes, and ground truth methodologies that would be necessary to fully answer many of the questions regarding acceptance criteria and study particulars.

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The Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use.

Nellcor OxiMax Pulse Oximetry Sensors, models MAX-AL, MAX-AL, MAX-P, MAX-I and MAX-FAST are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor pulse oximeter. Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

These OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation including sensor model, Advanced Signal Evaluation, and data set revision. The memory chip is also cable of storing including in-sensor data when connected to an OxiMax-capable monitor, and lot code.

Here's a breakdown of the acceptance criteria and study information for the Nellcor OxiMax Pulse Oximetry Sensors, based on the provided text:

Nellcor OxiMax Pulse Oximetry Sensors: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided text is a 510(k) summary, which often provides a high-level overview. Detailed performance data and specific acceptance criteria (e.g., ARMS values for SpO2 accuracy) are typically found in the full 510(k) submission, not always in the public summary. The summary confirms that studies were performed to support accuracy specifications, but doesn't report the specific numerical values of these specifications or the device's performance against them.

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "Clinical tests were performed" and "Clinical studies were conducted" but does not specify the number of subjects or data points in the test set.
• Data Provenance: Not explicitly stated. The document confirms that clinical studies were conducted, implying human subject data collection, but does not specify the country of origin or whether it was retrospective or prospective. Given the context of a 510(k) submission for new sensors, it is highly probable these were prospective clinical studies conducted specifically for this submission.

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 given text. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the device's readings to arterial blood gas (ABG) measurements or co-oximetry, not usually by human expert consensus on the device's output itself. Therefore, the concept of "experts establishing ground truth for the test set" in the context of reader evaluation isn't directly applicable here. The experts involved would more likely be the clinicians performing the ABG measurements or managing the study, and their qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided in the given text. Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret data (e.g., medical images) to establish a consensus ground truth. For pulse oximetry, the direct comparison to ABG/co-oximetry as a reference standard eliminates the need for such adjudication of the device's output.

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

• No, an MRMC comparative effectiveness study was not done as described in the provided text. MRMC studies are designed to assess the impact of an AI algorithm on human reader performance, usually in diagnostic tasks involving interpretation of visual data. Pulse oximetry is a direct measurement device; its performance is evaluated against a reference standard (like ABG), not by how it assists human readers in interpreting its output.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was done. The entire premise of pulse oximetry testing for regulatory approval is to establish the accuracy of the device's (algorithm's) measurements of SpO2 and pulse rate against a
  reference standard (typically arterial blood gas/co-oximetry). The statement "Clinical tests were performed to support accuracy specifications for SpO2 performance" directly refers to evaluating the device's intrinsic measurement capabilities. The device processes electrical information "by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude," indicating a standalone algorithmic evaluation.

7. Type of Ground Truth Used

• The type of ground truth used is physiological reference data, specifically arterial blood oxygen saturation (SaO2) and heart rate measurements, likely obtained through arterial blood gas (ABG) analysis or co-oximetry. While not explicitly named, this is the universally accepted gold standard for determining the accuracy of pulse oximeters. The text states "Clinical tests were performed to support accuracy specifications for SpO2 performance," which implies comparison to a highly accurate and independent measure of arterial oxygen saturation.

8. Sample Size for the Training Set

• This information is not provided in the given text. For pulse oximetry devices, "training set" doesn't apply in the same way it would for a machine learning model that learns from large datasets. Instead, the device's algorithm is developed and refined based on engineering principles, physiological models, and data collected during R&D. If the "data set revision" mentioned in the memory chip refers to an internal algorithm update, the data used for its development (not necessarily a distinct "training set" in the ML sense) is not specified. The summary focuses on the clinical validation of the device's performance.

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

• This information is not applicable/provided in the traditional sense of a "training set" for a machine learning model. The pulse oximetry algorithm relies on empirical relationships between light absorption and blood oxygenation. The ground truth for developing and refining such an algorithm would have been established through extensive physiological studies, often involving human subjects under controlled desaturation protocols, where arterial blood samples (co-oximetry) provide the reference standard. However, the summary does not detail the specific methods or data used during the initial algorithm development or "training." It focuses on the validation of the final device.

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