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510(k) Data Aggregation
(1025 days)
NEW REGULATION NUMBER: 21 CFR 870.2720
CLASSIFICATION: Class II
PRODUCT CODE: OWE
BACKGROUND
Code: QWE Device Type: Hyperoxia monitoring device adjunct to pulse oximetry Regulation Number: 21 CFR 870.2720
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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(30 days)
| 870.2340 | DPS |
| Patient scale | 870.2720
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines or cellular connectivity, between a patient, typically at home, and a health care professional at the authorized provider. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines or cellular connectivity to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips Telemonitoring System with eDevice BridgeD130 is a system that automatically collects and transmits medical information such as weight, blood pressure, and non-diagnostic ECG from a patient at home to a healthcare professional. The eDevice BridgeD130 is an external wireless communication device that transmits data to the backend clinical server.
The provided text describes a 510(k) premarket notification for the "M3810A Philips Telemonitoring System with eDevice BridgeD130". The primary modification is the addition of a wireless communication option (eDevice BridgeD130) to transmit data.
Based on the provided information, I can answer some of your questions, but it's important to note that this document is a 510(k) summary for a modification of an existing device. As such, the performance data presented focuses on demonstrating that the modified device maintains substantial equivalence to the predicate device, rather than providing an exhaustive de novo performance study.
Here's the breakdown of the information you requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states: "Acceptance criteria were based on the specification cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence." It does not provide a specific table with quantitative acceptance criteria and corresponding performance metrics for individual parameters (like blood pressure accuracy or ECG interpretation accuracy).
Instead, it refers to broad categories of testing and general compliance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Specifications cleared for the predicate device | Test results showed substantial equivalence |
| Specifications of the subject device (M3810A + eDevice BridgeD130) | Test results showed substantial equivalence |
| Compliance with applicable standards | Completed electrical safety testing, EMC testing, mechanical durability, safety (operator and patient), temperature/humidity and radio telemetry testing and user evaluations for consumer accuracy demonstrated compliance with applicable standards. |
| Reliability requirements and performance claims | Meets all reliability requirements and performance claims |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing focused on functional verification and validation of the hardware and software changes, not a clinical trial with a patient population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. The study described is a technical verification and validation, not a clinical study requiring expert ground truth for interpretation of physiological data in a clinical context. The device collects non-diagnostic ECG and other physiological data, which are then interpreted by a healthcare professional.
4. Adjudication Method for the Test Set
This information is not provided because the testing described is not a clinical study involving human interpretation needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes technical verification and validation, not a comparative effectiveness study involving human readers with and without AI assistance. The device is for data collection and transmission, not for automated interpretation or diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a data collection and transmission system. The "algorithm" in this context refers to the system's ability to accurately acquire and transmit data. The performance claims are related to the accuracy of the measurements and the reliability of the transmission, which are evaluated in a standalone manner (device functioning correctly) but don't involve an "algorithm" in the sense of AI for image or signal interpretation. The document states: "The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered." This clearly indicates it's not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For the instrumentation itself (weight, blood pressure, ECG signal acquisition), the "ground truth" would be established by reference standards or highly accurate laboratory equipment during calibration and functional testing. For example, blood pressure monitors are often tested against mercury sphygmomanometers, or using pressure simulators. ECG acquisition would be verified against known signal inputs. The document generally refers to "specifications," implying that performance was measured against predetermined engineering or regulatory benchmarks.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the context of this device. This is not an AI/machine learning device that learns from a training set. It is a physiological monitoring and transmission system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(5 days)
non-invasive | A&D Medical(Lifesource)Model # UA767PC | K982481 |
| 870.2720
The BL Healthcare Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, blood glucose monitor, and weight scale upon the prescription of a licensed physician or healthcare provider. The BL Healthcare Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.
The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
This system is installed by or with support from trained professionals.
This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care.
Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.
BL Healthcare Remote Care Management system serves as the communication link between FDA approved compatible devices such as Blood Pressure monitor, Blood Glucose Instrument and Weight Scale, and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center. The system enables video conferencing over broadband and a TV Interface between the Healthcare provider and the patient. The Healthcare provider may also enable video clips, automatic medication reminders and other training materials for the user to view. The TV interface provides this information on a specific TV channel and the user is informed of new updates or videoconferencing request via audio-visual indicators on the TV Interface remote.
The purpose of the system is to collect and transmit measurement information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
The provided text is a 510(k) summary for the BL Healthcare Remote Care Management system, focusing on its substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of an AI/ML device, cannot be extracted directly from this document.
The device described is a telemedicine system that acts as a communication link to transmit data from FDA-approved medical devices (blood pressure monitor, blood glucose instrument, weight scale) to healthcare providers. It also offers video conferencing and medication reminders. It is not an AI/ML diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC a study design for AI.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit acceptance criteria or a performance table in the way one would for a diagnostic or AI/ML device. The "performance" being evaluated here is the functional equivalence of the communication system to predicate telemedicine devices.
| Acceptance Criteria (Implied for communication function) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Functional Equivalence: Ability to collect and transmit medical information (weight, blood pressure, glucose) from compatible devices to a healthcare facility. | The BL Healthcare Remote Care Management system is demonstrated to be substantially equivalent in functionality to predicate telemedicine systems (e.g., M3810a Philips Telemonitoring system, Carematix Wellness system, AvidCare Series 100 Telemanagement System, Aviva Systems). |
| Data Integrity: Transmission of data without alteration from connected devices. | "The external connectivity does not alter the intended use of the devices since the devices provide connectivity to a computer serial port in that configuration." "The BL Healthcare Remote Care Management system does not alter the measurement technology of the connected devices." |
| Safety: No new risks posed by the differences between the device and predicates (e.g., broadband connection, video conferencing via TV). | "The differences pose no new risks..." |
| Compatibility: Ability to connect with FDA-approved medical devices via serial or infrared connection. | "The BL Healthcare Remote Care Management system connects externally to the FDA approved medical devices using a serial or infrared connection." |
| Intended Use Fulfillment: System effectively serves its purpose as a communication link for remote care management. | "Purpose of the system is to collect and transmit measurement information...to their healthcare provider." This is stated as being fulfilled. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission describes substantial equivalence testing for a communication system, not a clinical trial with a "test set" of patient data or samples. The "testing" referred to is functional testing, not statistical evaluation with a patient cohort.
- Data Provenance: Not applicable for the reasons above. The document does not mention data from specific countries or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to this type of device submission. The device's function is data transmission, not interpretation or diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" in the context of clinical data requiring adjudication mentioned in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC study was not done.
- Effect Size: Not applicable. This device is a data transmission system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This device is not an algorithm performing a standalone diagnostic function. It is a communication device; human interpretation is explicitly part of its intended use ("Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.").
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The concept of "ground truth" (e.g., pathology, outcomes data) is not relevant for demonstrating the substantial equivalence of a communication device for remote monitoring. The "truth" here relates to the reliable and accurate transmission of data from existing, FDA-cleared medical devices.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not employ machine learning that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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(28 days)
And Receivers Non-invasive Blood 870.1130 DXN Pressure Measurement System 870.2340 DPS Electrograph 870.2720
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit is intended to be used upon prescription by a licensed physcian or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a healthcare professional at the authorized provider which is the same intended use as previously cleared for the M3810A Interactive Health System.
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips TeleMonitoring System with M3814A SpO2 Physiological Transmitter and Receiver. The primary modification is a change to add the functionality of pulse oximetry.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the M3810A Philips TeleMonitoring System with M3814A SpO2 unit:
The provided documents, a 510(k) summary and an FDA clearance letter, offer limited but specific information on the acceptance criteria and the nature of the study performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Based on the specifications cleared for the predicate device (K992478). | "test results showed substantial equivalence" to the predicate device. |
| Verification and validation testing activities to establish performance and reliability characteristics. | Conducted a range of safety testing, including laboratory studies for biocompatibility, electrical safety, EMC testing, and radio telemetry testing. |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of clinical data, if any clinical data was used beyond laboratory testing). The focus of the provided text is on demonstrating substantial equivalence through technical and safety testing rather than a large-scale clinical performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The documents do not describe the use of experts to establish ground truth for a test set in the context of clinical performance. The testing described focuses on engineering and safety specifications.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as the testing described is primarily technical/safety verification against established specifications, not clinical performance requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study is mentioned. The submission focuses on the addition of SpO2 functionality and demonstrating substantial equivalence to a previously cleared device. The device's intended use is for automatic collection and transmission of medical information, with clinical judgment and experience required for interpretation by a healthcare professional; it's not described as an AI-powered diagnostic aid that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not directly applicable to the information provided. The device's primary function is data collection and transmission. The "algorithm" here would pertain to the accuracy of the physiological measurements (like SpO2, blood pressure) and the transmission reliability, which are addressed by the verification and validation (V&V) testing. The document states "test results showed substantial equivalence" for these aspects.
7. The Type of Ground Truth Used
For the SpO2 functionality, the "ground truth" would implicitly be established through reference standards for pulse oximetry accuracy. For other parameters like blood pressure and ECG, established medical device standards and measurement methodologies would serve as the ground truth for the V&V testing. The document highlights "biocompatibility, electrical safety testing, EMC testing and radio telemetry testing," which rely on scientific and engineering standards as their ground truth for compliance.
8. The Sample Size for the Training Set
The concept of a "training set" for an AI algorithm is not applicable here. This device, cleared in 2004, is a medical monitoring system that collects and transmits physiological data. It does not appear to employ machine learning or AI algorithms that would require a training set for model development.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI algorithm or a training set, this question is not relevant to the provided documents.
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(11 days)
|
| | 870.2720
The M3810A Philips TeleMonitoring System with M3812B TeleStation is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips TeleMonitoring System with M3812B TeleStation is intended to be used upon prescription by a licensed physcian or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a healthcare professional at the authorized provider. Apart from the convenience features added for enhanced interaction, and blood glucose meter data transmission, that is the same intended use as previously cleared for the M3810A Interactive Health System
The M3810A Philips TeleMonitoring System with M3812B TeleStation underwent verification and validation testing to establish its performance and reliability characteristics. The acceptance criteria for these tests were based on the specifications cleared for the predicate device (K993169, cleared September 22, 1999).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the testing conducted in general terms, stating that "Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, it does not provide a specific table detailing the acceptance criteria for each measured parameter (e.g., accuracy for blood pressure, ECG, weight) nor the quantitative reported device performance against those criteria.
The modifications primarily involve adding functionality for glucose meter downloads and subjective questions (automated interactions). Therefore, it can be inferred that the performance of the core physiological measurements (weight, blood pressure, non-diagnostic ECG) was expected to be equivalent to the predicate device.
| Measurement/Functionality | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|---|
| Core Physiological Measurements: | ||
| Weight | Equivalent to predicate device K993169 specifications | Substantially equivalent to predicate device |
| Blood Pressure | Equivalent to predicate device K993169 specifications | Substantially equivalent to predicate device |
| Non-diagnostic ECG | Equivalent to predicate device K993169 specifications | Substantially equivalent to predicate device |
| New Functionality: | ||
| Glucose Meter Downloads | Successful and accurate data transmission | Demonstrated to function as intended |
| Subjective Questions (Automated Interactions) | Correct operation and recording of responses | Demonstrated to function as intended |
| General Device Performance: | ||
| Biocompatibility | Met established safety standards | Passed laboratory studies |
| Electrical Safety | Met established safety standards | Passed laboratory studies |
| EMC (Electromagnetic Compatibility) | Met established safety standards | Passed laboratory studies |
| Radio Telemetry | Reliable and effective wireless communication | Passed laboratory studies |
| Consumer Accuracy (User Evaluation) | Met intended accuracy for home use | Passed user evaluations |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "laboratory studies" and "user evaluations for consumer accuracy" without specifying the sample sizes for these tests. It also does not explicitly state the data provenance (e.g., country of origin or whether data was retrospective or prospective). Given the nature of a Special 510(k) for a device modification, it's likely that a mix of prospective performance testing for new features and re-validation of existing features was conducted. The lack of detail suggests these were internal validation studies rather than a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. For a device like this, ground truth would typically involve:
- For blood pressure: Comparison against a reference standard (e.g., mercury sphygmomanometer) as read by trained clinicians.
- For weight: Comparison against a calibrated reference scale.
- For ECG: Comparison against simultaneously acquired, higher-fidelity ECGs interpreted by cardiologists or electrophysiologists (though the ECG here is "non-diagnostic").
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method. Considering the description of "laboratory studies" and "user evaluations," it's more probable that direct comparisons to reference instrumentation or expert assessments were made, rather than a multi-reader adjudication process typically associated with diagnostic image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done or reported. The modifications are related to data transmission and interaction, not advanced diagnostic interpretation requiring human-in-the-loop performance evaluation for improved diagnostic accuracy. The device is for "collect[ing] and transmit[ting] medical information," and the ECG is explicitly "non-diagnostic."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was effectively done for the device itself. The "verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device." This would include evaluating the accuracy of the measurements (weight, blood pressure) and the functionality of data transmission and automated interactions, independent of a specific human interpreter's real-time interaction influencing the primary data acquisition.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth. However, for a physiological monitoring system measuring weight, blood pressure, and non-diagnostic ECG, the ground truth would typically be:
- Reference standard measurements: Comparison of device readings against highly accurate and calibrated reference instruments (e.g., certified scales for weight, calibrated blood pressure devices for blood pressure, and potentially simultaneous recordings from clinical-grade ECG machines for basic rhythm assessment for the "non-diagnostic ECG").
- Functional verification: For the new glucose meter downloads and subjective questions, ground truth would be established by verifying that the data is accurately transmitted and recorded as intended by checking the source data against the received data.
8. The Sample Size for the Training Set:
The document does not mention a training set or its sample size. This is expected as the device is a physiological transmitter and receiver, not an AI/Machine Learning algorithm that requires a distinct training phase.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no mention of a training set, indicating this is not an AI/ML device in the context of this submission.
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