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510(k) Data Aggregation
(1025 days)
The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen).
The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.
ORi is a device that provides an adjunct oximeter function that extends the monitoring resolution of hemoglobin oxygen saturation at elevated oxygen levels (e.g., due to the administration of supplemental oxygen). The feature is intended to be used in conjunction with SpO2 monitoring provided by a pulse oximeter. The ORi feature utilizes the similar principles of operation as pulse oximetry, utilizing hemoglobin wavelength absorption characteristics to determine relative blood oxygen saturation. Whereas SpO2 monitoring provides visibility to blood oxygen saturation in the transition from normoxia to hypoxia on the hemoglobin oxygen disassociation curve, ORi provides visibility to the transition from normoxia to hyperoxia.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ORi device are not explicitly laid out in a pass/fail table with specific metrics. Instead, the document discusses various performance aspects and mitigation measures for identified risks. However, we can infer some criteria from the "Risks to Health" and "Special Controls" sections, specifically focusing on the clinical performance aspect. The most direct performance claim for ORi is its ability to monitor hyperoxia.
| Acceptance Criterion (Inferred from Risks/Controls) | Reported Device Performance / Study Finding |
|---|---|
| Accuracy of hyperoxia monitoring (Clinical performance testing to evaluate accuracy) | - Adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (PaO2 100 to 250 mmHg). |
| - AUC > 0.8 in determination of PaO2 for the range 100-250mmHg when compared to SpO2. | |
| - Benefits for detection of changing PaO2 in the range of 100 to 250mmHg better than pulse oximetry alone. | |
| - The trend of ORi values is beneficial to titrate O2 delivery in surgical patients receiving supplemental O2 therapy. | |
| - Labeling mitigates the high intra- and inter-subject ORi variability with respect to PaO2. | |
| No adverse events with concomitant SpO2 monitoring | - No adverse events when the device was used with concomitant SpO2 monitoring in the operating room environment on patients receiving supplemental oxygen. |
| Demonstrated benefits for intended patient populations | - Benefit-risk profile was determined to be favorable for the intended patient populations (adults and transitional adolescents, 18 years and older under surgery with supplemental oxygen). |
| Human factors/usability testing | - Human factors/usability testing must demonstrate that the user can correctly use the device, based solely on reading the instructions for use. (No specific performance metric mentioned beyond this general statement, but it's a requirement). |
| Software verification and validation | - Software documentation for ORi was provided according to the FDA Guidance Document... The software was found to have a Moderate Level of Concern. |
| - ORi validation testing was performed to demonstrate the device software meets its performance requirements using patient data. (Specific performance details of software not quantified in this summary, but overall successful.) | |
| Biocompatibility | - Leveraged from previously cleared device (Masimo Root Monitoring System and Accessories K171121); patient contacting components are identical. (Implies it meets the criterion by proxy). |
| Reprocessing/Cleaning | - Leveraged from previously cleared device (Masimo Root Monitoring System and Accessories K171121). (Implies it meets the criterion by proxy). |
| Electromagnetic Capability & Safety | - Leveraged from a prior 510K submitted for the subject device (Masimo Root Monitoring System and Accessories K171121). (Implies it meets the criterion by proxy). |
| Compatibility with pulse oximeter devices | - Performance testing must demonstrate compatibility with pulse oximeter devices labeled to be compatible with the device. (No specific performance study mentioned for this, but it's a requirement and implies it was met). |
2. Sample Sizes Used for the Test Set and Data Provenance
The clinical studies involved a total of 206 subjects and 2330 data pairs (SpO2, SaO2) used for calculating ORi values.
- Masimo Clinical Lab Study:
- Sample Size (Subjects): 52 healthy volunteers
- Data Pairs: 939
- Provenance: Retrospective (Masimo desaturation laboratory study)
- Ground Truth: Reference PaO2 blood gas values from an ABL blood gas analyzer.
- Loma Linda University Study:
- Sample Size (Subjects): 126 hospitalized participants
- Data Pairs: 1251
- Provenance: Retrospective (Data previously collected prospectively)
- Ground Truth: ABG convenience samples obtained as part of standard of care.
- UC Davis Study:
- Sample Size (Subjects): 28 hospitalized patients
- Data Pairs: 140
- Provenance: Prospective
- Ground Truth: ABG (Arterial Blood Gas) drawn at specific time points.
Overall Data Provenance:
- Country of Origin: Not explicitly stated, but the institutions (Masimo, Loma Linda University, UC Davis) suggest United States.
- Retrospective/Prospective: Two studies were retrospective (Masimo Clinical Lab and Loma Linda), and one was prospective (UC Davis). The retrospective studies utilized data previously collected prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth. It states that:
- For the Masimo Clinical Lab study and UC Davis study, the reference PaO2 blood gas values were collected by an ABL blood gas analyzer and ABG, respectively. This implies that the ground truth for PaO2 was based on laboratory analysis of arterial blood samples, which is the gold standard, rather than expert consensus on image interpretation or clinical diagnosis.
- For the Loma Linda University study, ABG convenience samples were obtained as part of standard of care.
Therefore, the ground truth was primarily objective physiological measurement via ABG analysis, not expert interpretation.
4. Adjudication Method for the Test Set
There was no "adjudication method" in the sense of multiple experts reviewing and reaching a consensus clinical diagnosis. The ground truth was established by direct physiological measurement (Arterial Blood Gas analysis), which is considered objective and definitive for blood gas values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described for evaluating human reader improvement with AI vs. without AI assistance. The study focused on the performance of the ORi device itself in relation to PaO2, and its benefit as an "adjunct" to SpO2, implying general clinical utility rather than a direct comparison of human performance with and without ORi assistance. The statement "benefits for detection of changing PaO2 in the range of 100 to 250mmHg better than pulse oximetry alone" suggests a comparison between ORi + SpO2 vs. SpO2 alone, but not specifically quantified for human reader improvement.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed. The studies evaluated the performance of the ORi algorithm by comparing its output directly to the reference standard (PaO2 from ABG analysis). This is evidenced by:
- "ORi validation testing was performed to demonstrate the device software meets its performance requirements using patient data."
- "The pooled data demonstrated an AUC >0.8 in determination of PaO2 for the range 100-250mmHg when compared to SpO2." (This is a statistical assessment of the algorithm's output).
- "The percentage of ORi was greater than that of SpO2 for the same PaO2 values."
The device's mechanism of action and the way its output (a numeric index on a 0-1 scale) is calculated based on light absorption implies an algorithm-only function. The ORi is intended to be an adjunct to SpO2 and not a stand-alone diagnostic device, but its performance was evaluated as a standalone output (an index related to PaO2).
7. Type of Ground Truth Used
The primary type of ground truth used was Arterial Blood Gas (ABG) analysis, specifically PaO2 values. This is an objective, physiological measurement and is explicitly referred to as the "gold standard in diagnosis of hypoxemia."
8. Sample Size for the Training Set
The document does not explicitly state the sample size for a separate training set. The studies described are presented as evaluations of the device, implying they are test sets for validation. It is common for device algorithms to be developed and refined using internal datasets before these validation studies are performed, but details of such a training set are not provided here. The 206 subjects and 2330 data pairs are described as being "submitted by the sponsor for calculation of the ORi values," which might imply they were used in part for validating the final algorithm, but not necessarily for initial training.
9. How the Ground Truth for the Training Set was Established
Since a dedicated training set is not explicitly described, the method for establishing its ground truth is also not mentioned. If the validation data itself (or portions of it) was also used for initial algorithm development or parameter tuning, then the ground truth would have been established by Arterial Blood Gas (ABG) analysis as described for the test set.
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(270 days)
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and
The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.
The monitors support multiple non-invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, EEG, BIS, NMT, and gas analysis.
The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.
The monitor models MX750 and MX850 differ mainly in size. While MX750 has a 19" flat panel display, MX850 has a 22″ display.
This K221348 510(k) summary document describes the Philips IntelliVue Patient Monitor MX750 and MX850. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of compatibility with external Masimo measurement devices.
Based on the provided document, here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific acceptance criteria (e.g., accuracy, precision thresholds) for each physiological parameter measured by the IntelliVue Patient Monitors MX750 and MX850, nor does it provide detailed reported performance values for these criteria in the context of this specific 510(k) submission.
Instead, the document states:
- "Performance specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications remain unchanged" from the predicate devices.
- "performance specifications of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine remain unchanged."
This implies that the acceptance criteria and reported device performance for the core functionalities of the IntelliVue Patient Monitor MX750 and MX850 (excluding the newly added external measurements) are inherently covered by the predicate devices they are compared against. For the newly integrated Masimo modules, their performance criteria and data are derived from their own prior clearances (K162603, K123043, K171121, K172890).
Therefore, a table cannot be directly constructed from this document as it doesn't provide new, specific performance data for the current submission's acceptance criteria beyond referencing existing performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "Non-clinical Bench Tests: There were no new questions of safety or effectiveness introduced as a result of using this device."
- "Clinical Studies: The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo O3, IRMA CO2, ISA CO2 and SedLine parameters are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor."
This indicates that no new test set (clinical or otherwise) with a specific sample size was used for this 510(k) submission to evaluate the primary IntelliVue devices' performance beyond what was established for their predicates. The assessment relies on the existing validation of the predicate IntelliVue device and the individual Masimo modules.
Therefore, sample sizes for a new test set are not applicable here. The provenance of existing data would refer to the previous submissions for the predicate IntelliVue devices and the Masimo modules, which are not detailed in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no new clinical studies or test sets were conducted for this 510(k) submission to establish new performance data, there is no information provided regarding a number of experts used to establish ground truth or their qualifications. The submission asserts that the performance characteristics (and thus, the ground truth establishment) of the individual components (IntelliVue monitor and Masimo modules) remain unchanged from their prior clearances.
4. Adjudication Method for the Test Set
Since no new test set was generated for this 510(k) submission (as per point 2), no adjudication method specific to this submission's test set is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document states that "The subject devices, like the primary predicate devices, did not require clinical trials." This implies that no MRMC comparative effectiveness study was performed for this submission. The device is a patient monitor, not typically evaluated with MRMC studies in the way imaging AI algorithms are.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
The document focuses on the integration of external modules into an existing patient monitor. While the individual Masimo modules (O3, IRMA CO2, ISA CO2, SedLine) likely had standalone performance studies as part of their original clearances, this 510(k) document does not report new standalone performance studies for the integrated system or its individual components in this context. The core assertion is that the measurements are not modified, only the host monitor connection.
7. Type of Ground Truth Used
Given that no new studies were conducted, the document implicitly relies on the ground truth established during the previous clearances of the predicate IntelliVue monitors and the Masimo modules. The specific types of ground truth for these physiological parameters would typically involve:
- Reference standard measurements: Comparison against highly accurate and precise clinical instruments for parameters like ECG, SpO2, blood pressure, CO2.
- Clinical observation and expert interpretation: For conditions like arrhythmia detection (ECG) or state of brain monitoring (EEG/BIS/SedLine), ground truth might involve expert review of physiological waveforms and patient state.
- Pathology/Outcomes data: Not explicitly mentioned or typically applicable for patient monitoring as a primary ground truth.
However, this document does not detail the specific ground truth methodologies used in those prior studies.
8. Sample Size for the Training Set
The document describes a 510(k) submission for a patient monitor and the integration of external modules. This type of device relies on established algorithms for physiological parameter measurement, rather than a machine learning model that requires a distinct "training set" in the common sense of AI/ML software. Therefore, the concept of a "training set sample size" as typically used for AI/ML does not directly apply or is not detailed here. The algorithms used in the Masimo modules and the Philips monitor were developed and validated, but this process doesn't align with a "training set" in the AI/ML context.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" in the AI/ML sense is not applicable or detailed in this document for these types of patient monitoring algorithms. Therefore, information on how ground truth for a training set was established is not present. The algorithms' foundational accuracy would have been established through a combination of engineering, physiological principles, and validation against clinical reference standards, as mentioned above for "Type of Ground Truth."
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(401 days)
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are additionally intended for use in transport situations within hospital environments.
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and
The IntelliVue Patient Monitors MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis.
The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located at the patient bedside vicinity and can also be used during patient transport inside hospitals.
The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.
The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.
Here's a breakdown of the acceptance criteria and the study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided FDA 510(k) summary:
This submission is a 510(k) for modifications to an existing device, the IntelliVue Patient Monitors MX500 and MX550. The acceptance criteria and supporting studies primarily focus on demonstrating that the modifications do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an update to an existing device focusing on integrating new measurement modules (Masimo O3, IRMA CO2, ISA CO2) and updating EMC standards, the "acceptance criteria" are primarily related to meeting established performance standards for patient monitors and demonstrating that the new modules function as intended without compromising the overall device safety or efficacy. The document doesn't present specific numerical acceptance criteria for all physiological parameters of the overall monitor, but rather confirms compliance with recognized standards.
| Acceptance Criteria Category | Details/Standard Adherence | Reported Device Performance |
|---|---|---|
| General Safety and Performance | Demonstrated compliance with harmonized standards. | Passed all safety tests for demonstrated compliance with harmonized standards. |
| Software Life Cycle Processes | IEC 62304:2015 Edition 1.1 (consolidated version) - Medical device software - software life cycle processes. | Complies. Software Verification and Validation testing was conducted, and documentation was provided as recommended by FDA guidance. Software Level of Concern determined to be Major. |
| Basic Safety and Essential Performance | AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. | Complies. Electrical safety testing conducted. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 (Ed. 4.0) - Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests. | Complies. EMC testing conducted. Note: The predicate device conformed to Ed. 3; the subject device updates to Ed. 4. |
| Alarm Systems | IEC 60601-1-8:2012 (Ed. 2.1) - Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems. | Device passed tests for this standard. |
| Respiratory Gas Monitors | ISO 80601-2-55:2011 (Ed. 1) - Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors. | Device passed tests for this standard. |
| System Level Device Specifications | Bench testing for system level device specifications. | Verified through bench testing. |
| Mechanical & Electrical Specifications | Bench testing for mechanical and electrical specifications. | Verified through bench testing. |
| Packaging Integrity | Bench testing for packaging integrity. | Verified through bench testing. |
| Shelf Life | Not applicable, as devices do not contain aging components. | No shelf life specified. |
| Sterility | Not applicable, as devices are not sterile. | Sterilization not evaluated. |
| Biocompatibility | Not applicable, as devices do not have patient contact. | Biocompatibility requirements are not applicable. Legally marketed medical accessories remain unchanged, so biocompatibility aspects are not affected. |
| Functionality of Added Masimo O3 Module | Intended use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region for adults ≥40 kg and pediatrics ≥5 kg and |
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(100 days)
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.
The SmartLinx Vitals Plus Patient Monitoring System operates with the SmartLinx Medical Device Information Platform (MDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.
The proposed SmartLinx Vitals Plus Patient Monitoring System consists of the following components:
- SmartLinx Neuron Mobile Platform
- SmartLinx Vitals Plus Application
- SmartLinx Vitals Plus NIBP Monitoring Module
- Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02
- Nellcor SpO2 Oximetry Module
- Masimo uSpO2 Pulse Oximetry Cable
- Exergen TAT-5000S Temperature Scanner
- SmartLinx Early Warning Scoring System
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. Instead, it describes a "SmartLinx Vitals Plus Patient Monitoring System" which is a medical device data system that integrates various vital signs modules.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study for a new, novel device.
The "Performance Testing" section mentions adherence to FDA recognized consensus standards (Table 4), which are often general safety and performance standards for similar types of medical devices (e.g., electrical safety, electromagnetic compatibility, usability, software lifecycle, and particular requirements for specific monitoring components like non-invasive blood pressure, pulse oximetry, and respiratory gas monitors). This is a different type of "acceptance criteria" than what might be established for a novel AI/ML-based diagnostic device.
Crucially, the document explicitly states:
- "The subject of this premarket submission, SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."
Therefore, I cannot extract the specific information requested about acceptance criteria and a study proving the device meets them from this document, as there was no such clinical study performed or required for this 510(k) submission.
To directly answer your numbered points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document refers to conformance with recognized consensus standards (Table 4) rather than specific performance acceptance criteria for a novel functionality.
- Sample sized used for the test set and the data provenance: Not applicable, as no clinical study was required or performed. Performance testing involved hardware and software verification, validation, and testing against consensus standards, not a "test set" of patient data in the typical sense of an AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was required or performed that involved expert-established ground truth on patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML-based diagnostic or assistive technology that would typically undergo an MRMC study. It is a patient monitoring system integrating existing vital sign modules.
- 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 type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The device relies on the established accuracy and ground truth of its component modules (e.g., NIBP, SpO2, CO2 sensors) which are themselves regulated and have their own performance specifications.
- The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML.
- How the ground truth for the training set was established: Not applicable.
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