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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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