Search Results

The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The system is intended for use by appropriately trained staff and should not be used by untrained users.

The Vital Signs device is indicated for use on subjects 12 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The subject device is the next generation device of the predicate (K211906).

Vital Signs is a software-only medical device (SaMD) that provides retrospective monitoring of non-contact pulse rate and respiratory rate data derived from video, without the need for contact devices to be attached to the patient or bed.

The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy rooms within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient spot heart rate and respiratory rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis.

Improvements to the device compared to the predicate are as follows:
• 24 hour trends
• Expansion of intended population from 18 years and older → 12 years and older
• Widened respiratory rate range from 8-31 bpm → 8-39 bpm

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for the Oxehealth Vital Signs Device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document specifies the acceptance criteria as "designed accuracy targets" and concludes that "all of the different subgroups were within the stated performance metrics... for both the MAD and 95% CI." The "MAD" here refers to Mean Absolute Difference, which is equivalent to Mean Absolute Error (MAE) in this context.

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

• Sample Size: 30 subjects
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involved subjects performing "a variety of activities reflecting real-world behavior, under a variety of environmental conditions similar to those expected in the intended environment," suggesting a prospective clinical validation study.

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

• Number of Experts: One physician for manual annotation of the capnogram output.
• Qualifications: "physician blinded to both device outputs." Further specific qualifications (e.g., years of experience, specialization) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "manually-annotated by a physician blinded to both device outputs." This indicates a single expert review for the primary ground truth, not a multi-reader consensus process like 2+1 or 3+1.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided document. The study focuses on comparing the device's measurements against gold-standard reference devices, not on human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described clinical performance study clearly evaluates the standalone performance of the Vital Signs device (algorithm only, as it's a SaMD) by comparing its output directly against reference devices (FDA-cleared finger pulse oximeter for heart rate and capnogram for respiratory rate). Human-in-the-loop performance is not part of this evaluation.

7. Type of Ground Truth Used

• Ground Truth:
  • Pulse Rate: FDA-cleared finger pulse oximeter. This is a gold standard reference device.
  • Respiratory Rate: Capnogram, "manually-annotated by a physician blinded to both device outputs." This is described as "the accepted gold standard for respiratory rate validation."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided document. The document describes the device as "the next generation device of the predicate (K211906)" and states, "The subject device algorithm is identical to the predicate device. It uses the same methods of Vital sign detection and the same Machine Learning techniques as the predicate device (K211906)." This suggests that any training would have been conducted for the predicate device, or for a prior version of the algorithm, but details are not given here.

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

• Ground Truth for Training Set: Not specified in the provided document. As mentioned above, the algorithm is stated to be identical to the predicate, with no details on its training provided in this 510(k) summary.

Ask a specific question about this device

The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics (including neonates). The device is intended for use by trained healthcare professionals in hospital environments. Parameters include: NIBP, SpO2, PR (pulse rate), TEMP. The F3000 Quick Temp module is not intended for neonates. The device is not intended for MRI environments.

The iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics.

The provided documentation describes the FDA 510(k) clearance for the Edan Instruments Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and software verification/validation, rather than detailing a clinical study with specific acceptance criteria for AI/algorithm performance.

Therefore, many of the requested details regarding acceptance criteria, sample size, expert involvement, and ground truth establishment for a study proving device performance in an AI/algorithm context are not applicable or not provided in this specific FDA clearance document. The device is a vital signs monitor, not explicitly described as incorporating AI for diagnosis or interpretation that would necessitate an MRMC study or detailed ground truth establishment in the context of AI performance.

The document states "Clinical data: Not applicable," further confirming the absence of a clinical study for this clearance.

Here's a breakdown based on the information available in the document:

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

The document refers to compliance with consensus standards for device performance, where the "acceptance criteria" are implied by adherence to these standards and the "reported device performance" is that the device "meets its accuracy specification and meet relevant consensus standards." Specific numerical acceptance criteria are mentioned for the measurement accuracy of SpO2, PR, and NIBP, and various temperature modules.

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

• The document explicitly states "Clinical data: Not applicable." The "test set" for performance was conducted through "Non-clinical data" including "Electrical safety and electromagnetic compatibility (EMC)" and "Performance testing-Bench."
• No specific sample sizes (e.g., number of patients/measurements) for "bench" testing are provided.
• Data provenance (e.g., country of origin, retrospective/prospective) is not applicable given no clinical study.

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

• Not applicable as no clinical ground truth or expert-adjudicated test set was used. Device performance was assessed against established engineering and safety standards.

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

• Not applicable as no clinical test set requiring adjudication was used.

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 MRMC study was performed as this device is a vital signs monitor, not an AI-assisted diagnostic device requiring human reader improvement assessment. Clinical data was deemed "Not applicable."

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

• The performance assessment focused on the device's ability to accurately measure vital signs according to specifications and consensus standards (e.g., IEC 80601-2-30 for NIBP, ISO 80601-2-56 for temperature, ISO 80601-2-61 for pulse oximetry). This is essentially a "standalone" performance evaluation of the measurement algorithms within the device against physical standards, but not in the context of an AI-driven diagnostic algorithm.

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

• For the non-clinical performance testing, the "ground truth" would be the reference measurements from calibrated and traceable sources, as specified by the relevant international standards (e.g., simulated physiological signals/conditions, calibrated temperature sources, etc.).

8. The sample size for the training set:

• Not applicable. This document describes the clearance of a vital signs monitor, not an AI/machine learning algorithm requiring a separate training set.

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

• Not applicable, as no AI training set is described.

Ask a specific question about this device

Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatric patients in hospitals, community hospitals and medical facilities. Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients.

The proposed device Vital Signs Monitor MD2000C is a device powered by internal electrical power source and external electrical power source. The MD2000C is used in hospital,community hospitals and medical facilities. It can measure and record functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult and pediatric patients. Its accessories include SpO2 probe, NIBP cuff for adult, NIBP cuff for pediatric, and power adapter. It has data storage,display,alarm.

Here's a breakdown of the acceptance criteria and study information for the Vital Signs Monitor MD2000C based on the provided text:

Acceptance Criteria and Device Performance

The direct acceptance criteria for the Vital Signs Monitor MD2000C are not explicitly stated as a separate table within the document in terms of specific performance targets for NIBP, SpO2, and PR beyond accuracy ranges. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MD2000B and MD300M for SpO2, and Multi-parameters health Examination System for NIBP).

The performance data available relates to the MD300M (for SpO2) and Multi-parameters health Examination System (for NIBP), which the new device MD2000C claims to be identical to in those modules.

Table of Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:

Note: The "Implied Acceptance Criteria" are based on the performance of the predicate devices which the new device is seeking equivalence to. The direct acceptance criteria for the specific device are not explicitly listed in a regulatory numerical format but are demonstrated through equivalence to these predicate performances.

Study Information:

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

• SpO2 Accuracy Study (MD300M):
  • Sample Size: 12 healthy adult volunteer subjects (6 females, 6 males)
  • Demographics: Ages 21-43 years, 47-82 kg, 155-185 cm, with a representative range of pigmentation.
  • Data Provenance: Conducted in Yue Bei People's Hospital. Prospective study. Country of origin not explicitly stated but implied to be China (as the manufacturer is Beijing Choice Electronic Technology Co., Ltd.)
• NIBP Accuracy Study (Multi-parameters health Examination System):
  • Sample Size: 85 subjects (35 child subjects aged 3-12 years, 50 adult subjects)
  • Data Provenance: Conducted in PLA Rocket Force Characteristic Medical Center. Prospective study. Country of origin not explicitly stated but implied to be China.

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

• The document does not specify the number or qualifications of experts used to establish ground truth for either the SpO2 or NIBP studies.
  • For SpO2, ground truth is typically established using a co-oximeter in controlled desaturation studies (e.g., fractional oxyhemoglobin measurement compared to pulse oximeter readings).
  • For NIBP, ground truth is typically established simultaneously with a reference auscultatory or invasive blood pressure measurement taken by qualified personnel.

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

• The document does not provide details on any adjudication methods used for the test sets. The studies appear to be direct performance comparisons against a reference standard rather than assessments requiring multiple human interpretations.

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 MRMC study was performed. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation tool for human readers. It provides physiological parameters directly.

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

• Yes, standalone performance was evaluated. The studies described for SpO2 and NIBP accuracy directly measure the device's performance against a reference standard, without human interpretation of the device's output influencing the accuracy metrics. The device itself is designed to provide direct physiological measurements.

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

• SpO2: The ground truth for SpO2 accuracy studies is typically established by fractional oxyhemoglobin measurement using a co-oximeter during controlled hypoxia conditions. This is considered the reference standard for pulse oximetry.
• NIBP: The ground truth for NIBP accuracy studies is established by simultaneous measurements using a reference auscultatory method (e.g., mercury sphygmomanometer with stethoscope by trained observer) or an invasive arterial line, compared to the device's oscillometric readings.

8. The sample size for the training set:

• The document does not specify sample sizes for training sets. It describes the device's performance through validation studies (test sets) for specific modules that were adopted from previously cleared devices. It's implied that the algorithms within these modules were developed and potentially trained using proprietary datasets not detailed in this 510(k) summary.

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

• The document does not specify how ground truth was established for any potential training sets. This information would typically be part of the internal development process for the SpO2 and NIBP algorithms, which predates this 510(k) application (as the modules are reused from previously cleared devices).

Ask a specific question about this device

The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8A Vital Signs Monitors are not intended for helicopter transport, hospital ambulance, or home use.

The subject VS series Vital Signs Monitors includes three monitors:

• VS 9 Vital Signs Monitor
• VS 8 Vital Signs Monitor
• VS 8A Vital Signs Monitor

The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., LTD VS Series Vital Signs Monitors. It describes the device, its intended use, comparison to predicate devices, and the performance data submitted to demonstrate substantial equivalence.

However, the provided document does not describe an AI/ML software device or a study validating its performance. The "Product Code: MWI, CCK, DQA, DXN, FLL" and "Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)" indicate traditional vital signs monitors. The 'software verification and validation testing' mentioned refers to general software engineering practices for medical devices, not specific performance criteria for an AI/ML algorithm.

Therefore, I cannot provide the requested information because the document does not contain details about:

• Acceptance criteria for an AI/ML algorithm.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets used for AI/ML validation.
• Ground truth establishment methods for AI/ML datasets.
• MRMC studies for AI/ML.
• Standalone performance for AI/ML algorithms.
• Training set details for AI/ML.

The document discusses validation for a physical medical device (vital signs monitor) including:

• Biocompatibility Testing: For NIBP cuffs due to an ink change.
• Software Verification and Validation Testing: General software V&V for the device's embedded software, not an AI/ML algorithm.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with relevant standards.
• Bench Testing: Functional and system level testing to validate device performance.
• Clinical Data: NIBP measurement accuracy validated according to ISO 81060-2:2018 in neonate, infant, child, and adult populations.

If you have a document describing an AI/ML medical device, please provide that, and I will be able to answer your questions.

Ask a specific question about this device

The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users.

The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

The provided document is a 510(k) summary for the Oxehealth Vital Signs device, specifically for a modification to a previously cleared version. The core of the submission revolves around demonstrating substantial equivalence to the predicate device, meaning the new modification does not raise new questions of safety or effectiveness.

Therefore, the study proving the device meets acceptance criteria largely refers to the studies performed for the original predicate device (Oxehealth Vital Signs version 1.30.0, classified in DEN200019), as the modifications discussed in this 510(k) submission do not affect the fundamental principles of operation or performance in measuring pulse rate and estimated breathing rate.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the performance criteria that were established for the predicate device and are considered unchanged for the modified device.

Note: The document explicitly states "No change" for performance regarding the modified device compared to the predicate, implying that the acceptance criteria and the performance demonstrated by the predicate are carried over.

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

The document refers to the clinical evidence provided and reviewed in the original DEN200019 submission. It states: "As that clinical evidence is still applicable now, no new clinical evidence is required".

Therefore, the specific sample sizes and data provenance for the test set are not detailed in this 510(k) summary, but would be found in the documentation for DEN200019. The summary only confirms that such data was provided for the predicate device and is considered sufficient for the modified device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details about the number and qualifications of experts directly for this 510(k) summary. This information would have been part of the original DEN200019 submission, where the clinical evidence was initially reviewed.

4. Adjudication Method for the Test Set

The document does not provide details about the adjudication method used for the test set. This information would have been part of the original DEN200019 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device's function is explained as "software assessing video footage from a fixed-installation solution for use within single occupancy rooms" to produce "spot check measurements." It's generally intended as a non-contact monitor, not as an AI-assistance tool for human interpretation in the sense of a diagnostic imaging study. The focus is on the device's ability to provide accurate measurements directly, not on enhancing human interpretation of complex data.

The validation testing demonstrated that "the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates." This implies a comparison against ground truth measurements, not a human-AI team performance study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, based on the description, the "Performance Data" section indicates that "As the modified Oxehealth Vital Signs device is solely software, performance testing is demonstrated through software validation." The prior validation (from DEN200019) compared the device's output to "clinically accurate patient-contacting relevant comparator device." This strongly suggests a standalone performance evaluation where the algorithm's output is directly compared to a reference standard, without human intervention in the measurement process.

7. The Type of Ground Truth Used

The document states: "The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner."

This indicates that the ground truth was established using measurements from "clinically accurate patient-contacting relevant comparator device(s)". This would imply standard, validated medical devices (e.g., pulse oximeters, capnographs, or other physiological monitoring equipment) used as the reference standard for pulse and breathing rates.

8. The Sample Size for the Training Set

The document does not provide details on the training set sample size. The focus of this 510(k) is on the substantial equivalence of a modified device to a predicate device, and it states that the modifications "do not affect the algorithm or the functionality of the software." This implies that the core algorithm, which would have been trained based on a training set, remains unchanged from the predicate version. Information on the training set would have been part of the initial submission for the predicate device (DEN200019).

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

Similar to point 8, the document does not provide details on how ground truth for the training set was established. This information would have been part of the original DEN200019 submission. The current submission reiterates that the original clinical evidence, which included comparison to "clinically accurate patient-contacting relevant comparator device," is still applicable.

Ask a specific question about this device

The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics. The device is intended for use by trained healthcare professionals in hospital environments.

Parameters include: NIBP, SpO2, PR (pulse rate), TEMP.

The F3000 Quick TEMP module is not intended for neonates.

The device is not intended for MRI environments.

The iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults, pediatrics and neonates.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the Vital Signs Monitor (iM3s, iM3As, iM3Bs, iHM3s).

Please note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily presents performance specifications and shows that the new device meets those, often by referencing existing standards or previous clearances. It does not typically include detailed experimental setups for clinical or performance studies in the way a research paper would. Therefore, some information requested (like sample size for training sets, specific adjudication methods, MRMC studies, or detailed ground truth establishment for training data) is not present in this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's specifications and compliance with relevant ISO/IEC standards. The "Reported Device Performance" for the subject device is stated as meeting these same specifications.

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

• Sample Size for Test Set: Not specified in the document. The performance is validated through "functional and system level testing" and compliance with standards, not a clinical trial with a specified patient sample size for device comparison.
• Data Provenance: The studies are described as "non-clinical data" and "bench testing." No country of origin is mentioned for patient data, as no clinical studies with human subjects are detailed. The nature of the testing implies it's retrospective, based on existing standards and validation procedures, rather than prospective clinical data.

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

• This information is not provided in the document. The "ground truth" for these performance tests would typically be established by highly calibrated reference instruments or simulated physiological signals according to the requirements of the cited ISO/IEC standards, rather than expert human interpretation in a clinical context.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. As no clinical studies with human subjects or interpretation tasks are described, there is no need for an adjudication method. The assessment is against technical specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical data: Not applicable." The focus is on the device's standalone performance against engineering and international standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the performance reported is essentially standalone. The "bench testing" and "software verification and validation testing" assess the device's accuracy and functionality in isolation, without an explicit human-in-the-loop component for interpreting outputs in the context of the device's core physiological measurements (NIBP, SpO2, PR, TEMP).

7. The Type of Ground Truth Used

• The ground truth for the performance testing is based on:
  • Reference measurements from calibrated equipment: For parameters like SpO2, NIBP, and TEMP, the "ground truth" would be simulated physiological signals or measurements from highly accurate, traceable reference devices as mandated by the respective ISO/IEC standards.
  • Compliance with international standards: The device is tested against the specific requirements and accuracy tolerances defined in standards such as IEC 80601-2-30 (NIBP), ISO 80601-2-56 (thermometers), and ISO 80601-2-61 (pulse oximeters).

8. The Sample Size for the Training Set

• This information is not provided and is not applicable in the context of this device and document. This device is a vital signs monitor, not typically an AI/machine learning diagnostic device that relies on "training sets" in the conventional sense of machine learning algorithms. Its parameters are measured directly through hardware and firmware, validated against physical standards.

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

• This information is not provided and is not applicable as there is no "training set" for an AI algorithm described for this device. The device's fundamental operational principles are based on established physiological measurement techniques, not on learning from a dataset.

Ask a specific question about this device

The monitor is intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments.

Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.

The monitor is not intended for MRI environments. TEMP module is not intended for neonates.

The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP).
• For the Monitor mode, the user can do continuous measurement, monitoring, alarming and manager patient data.
• For the Spot mode, also call spot check mode, the user can measure parameters quickly without creating a patient within the instrument workflow.
• The Round mode is designed to support hospital staff when doing ward rounds. The Round mode is similar as Spot mode. The difference between Round mode and Spot mode is that for one ward round, the iM3 can additionally store one ward round record automatically (the latest measurement) or manually (user can choose the measure results).

iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately.

The iM3can connect with EDAN's MFM-CMS Central Monitoring System to display the iM3 data on a remote work station. The MFM-CMS system received FDA 510(k) clearance on June 21, 2013(K120727)

The provided text is a 510(k) summary for the Edan Instruments iM3 Vital Signs Monitor, seeking FDA clearance based on substantial equivalence to predicate devices. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

The document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm being developed or tested against a ground truth for diagnostic or prognostic performance. Instead, it discusses the performance as it relates to comparison with a predicate device and compliance with established medical device standards.

Therefore, many of the requested details related to AI/ML validation studies (like sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training/test sets) are not applicable to this document as it describes a traditional vital signs monitor seeking 510(k) clearance, not an AI/ML diagnostic or prognostic device.

However, based on the provided text, I can infer and extract information relevant to the device's functional performance criteria and what was demonstrated:

Acceptance Criteria and Reported Device Performance (Inferred from comparison to predicate and standard compliance):

The "acceptance criteria" here are implicitly defined by the performance specifications of the predicate devices and relevant IEC/ISO standards for vital signs monitors. The reported device performance is presented as being "similar" to the predicate and compliant with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• This document does not specify a "test set" in the context of an AI/ML model, but rather refers to performance validation against established standards.
• The comparison data presented in the tables are physical performance specifications of the device modules, not patient data from a clinical trial in the AI/ML sense. Actual human testing for NIBP, SpO2, and TEMP accuracy would have been done to meet the standards (e.g., ISO 81060-2:2013 for NIBP, ISO 80601-2-61: 2011 for SpO2, ISO 80601-2-56 for TEMP), but the specifics (sample sizes, provenance) are not detailed in this summary. These physical performance tests are typically done in controlled lab settings or with human subjects as required by the specific standard.

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 requiring expert consensus on image interpretation or similar. The "ground truth" for vital signs monitoring validation is typically measured physiological parameters from reference devices.

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.

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

• Not applicable. The device directly measures physiological parameters. Its performance is inherent to its sensors and processing, and the accuracy claims are against reference measurements, not an independent algorithm being evaluated.

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

• The ground truth for the performance claims would be highly accurate reference measurements from precisely calibrated medical devices or established physiological measurement techniques (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2, highly accurate thermometers for TEMP). The document states compliance with relevant ISO/IEC standards which dictate the methods for determining accuracy, including the reference methods.

8. The sample size for the training set:

• Not applicable. This is a vital signs monitor, not a machine learning algorithm that requires a "training set" for its core function.

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

• Not applicable.

Ask a specific question about this device

The vital signs monitor is intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

This vital signs monitor is used to monitor vital signals for use in hospital environments including out-patient department, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. And it is applicable for adult, pediatric and neonatal patients.

The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

The following lists the detailed features of the subject device.

• LCD/LED display
• SpO2, Pulse Rate NIBPCO2 and TEMP measurement
• Infrared ear temp or fast temp module for Temp measurement
• Nellcor or Masimo or BLT SpO2 module
• Display numeric and waveform information simultaneously .
• Nurse call feature
• . Built-in Lithium-ion Battery
• Suitable for adult, pediatric and neonate patients .
• Visual and audible alarm

The document describes a 510(k) premarket notification for the V6 Vital Signs Monitor. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of AI/ML devices.

Therefore, many of the requested categories for acceptance criteria and study details for an AI-powered device are not applicable to this submission. This document describes a traditional medical device (vital signs monitor) which is evaluated based on its compliance with established electrical safety, EMC, and performance standards for each physiological parameter.

Here's an analysis based on the provided document, highlighting applicable information and noting where information for AI/ML performance would typically be found but isn't present here:

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

The document provides a comparison of the proposed device (Vital Signs Monitor V6) and its predicate devices, especially regarding technical specifications and compliance with standards. It does not present specific "accepted criteria" in terms of performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/ML diagnostic or assistive device. Instead, it demonstrates compliance with recognized medical device standards and equivalence to a predicate.

For the newly added F3000 Temperature Module, a "Clinical Electronic Thermometers testing" was conducted pursuant to guidance. The table below focuses on the reported accuracy of the temperature measurement, which can be interpreted as a performance metric for that specific function.

Note: The "acceptance criteria" here are largely derived from the predicate device's performance or standard requirements that both devices are expected to meet. For NIBP, SpO2, and CO2, the document only states that compliance with relevant IEC standards (IEC80601-2-30 for NIBP, IEC80601-2-61 for pulse oximeter) was demonstrated, but does not provide specific accuracy ranges within the provided text.

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 states: "No clinical study is included in this submission." This implies that for the substantial equivalence claim, the manufacturer relied on non-clinical testing and comparison to the predicate device, rather than a clinical study with a dedicated test set on human subjects to evaluate performance like sensitivity or specificity. For the temperature module, it mentions "Clinical Electronic Thermometers testing" but does not detail sample size or data provenance.

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. There is no clinical study data presented for expert-established ground truth.

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

Not applicable. There is no clinical study data presented requiring adjudication.

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

Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers.

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

The device is a standalone vital signs monitor. Its "performance" is evaluated by its ability to accurately measure physiological parameters and comply with relevant international standards. The non-clinical tests mentioned demonstrate the device's standalone performance in meeting design specifications and standard requirements.

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

For the non-clinical tests and equivalence claims of the vital signs monitor, the "ground truth" would be established by:

• Reference instruments and calibration standards for objective measurements (e.g., for SpO2, NIBP, temperature).
• Compliance with the technical requirements and performance specifications outlined in international standards (e.g., IEC 60601 series, IEC80601 series).

For the temperature module, "Clinical Electronic Thermometers testing" likely involved comparison to highly accurate reference thermometers in a controlled clinical setting, but specific details are not provided.

8. The sample size for the training set

Not applicable. This device does not appear to involve an AI/ML algorithm that would require a "training set" in the conventional sense for a diagnostic product. Its functionality is based on established hardware and software algorithms for physiological parameter measurement rather than machine learning on a dataset.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Ask a specific question about this device

The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, noninvasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

The Vital Signs Patch (VSP in short) system is designed to monitor selected vital signs of patients in a clinical environment. The VSP system is comprised of the following components: Physical Patch, Brain - VSP Transmitter, Gateway mobile device, Clinical Backend. The Patch is attached to the patient's chest. The Brain plugs into a cradle on the Patch and is connected to the Patch with a 16-pin connector. The Brain receives the power from the Pattery; the data from the sensors are transmitted using the 16-pin connector. The Gateway includes a dedicated, medical SW application (also known as the Gateway application) designed by LifeWatch Technologies. The Brain transmits data to the Gateway application using the RF component. The patient can manually trigger an event by the pressing a button on the Brain. In addition, the Brain contains a 32MB Flash memory chip that can store 6-10 hours of data in case of communication failure with the Gateway. All data received from the Brain is recorded and stored on the Gateway. In addition, the Gateway can be used to view vital sign signals received from the Brain and to transmit the data to a Monitoring Center via the internet by the Wi-Fi network. The VSP is not intended for use on patients with life threatening arrhythmias; hence it is not intended for patients in the ICU. The internal LifeWatch Technologies Ltd. Part Number of the Vital Signs Patch system is CG-1101B; this model serves also as the predicate device (cleared in K132407) for this Special submission.

The provided document is a 510(k) summary for the Vital Signs Patch (VSP) system, which is a modified version of a previously cleared device. It details product information and the modifications made, but it does not contain detailed information about specific acceptance criteria, study methodologies, or performance metrics in a quantitative way.

The document states:
"The 510(k) summarizes the testing that was performed, the acceptance criteria and the results of the testing."
However, this summary itself does NOT provide those details. It explicitly mentions that the full 510(k) contains this information, but this extract does not. Therefore, I cannot construct a table of acceptance criteria and reported device performance from the given text.

Based on the information provided in the extract, here's what can be inferred or stated about the requested points:

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

   • Not provided in the extract. The document states that the full 510(k) summarizes this, but the extract itself only mentions that testing was performed, acceptance criteria were met, and results did not raise new safety or effectiveness issues.

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

   • Not provided in the extract. The document mentions "design verification and validation testing of the modified device have been performed" but gives no details on sample size, data type, or origin.

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 provided in the extract. The nature of the device (vital signs monitor) suggests that ground truth would likely come from standard, calibrated medical equipment rather than expert human interpretation in the same way an AI diagnostic tool might, but this is not explicitly stated.

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

   • Not provided in the extract.

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/Not provided. This device is a vital signs monitor, not an AI-assisted diagnostic imaging tool for human readers. No mention of human readers or AI assistance in interpretation is present.

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

   • Not explicitly stated, but implied. The device is a "continuous, non-invasive monitoring" system for various vital signs. Its primary function is to measure and record these signs. Its performance would inherently be a "standalone" measurement against a gold standard (e.g., how accurately it measures heart rate compared to an ECG machine), rather than an algorithm assisting human interpretation. However, specific details of such standalone performance or the reference standard against which it was compared are not in this excerpt.

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

   • Not explicitly stated. For vital signs, the ground truth would typically be established by established, gold-standard medical measurement devices (e.g., a clinically validated ECG for heart rate, a separate temperature probe for temperature, a hospital-grade oximeter for SpO2). The document mentions "performance specifications," implying comparison to such standards, but doesn't detail them.

8. The sample size for the training set:

   • Not provided in the extract. The document primarily concerns modifications to an existing cleared device ("Special 510(k)"), so extensive new training data might not have been central to this specific submission, but this is speculation.

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

   • Not provided in the extract.

Ask a specific question about this device

The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

The Vital Signs Patch (VSP) system is designed to monitor vital signs of patients. The internal LifeWatch Technologies Ltd. (LWT in short) Part Number of the VSP is CG-1101B. The VSP system consists of the following components: Vital Signs Patch, VSP transmitter ("Brain"), Gateway, Clinical Backend.

Here's a breakdown of the acceptance criteria and study information for the Vital Signs Patch system, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that the device was subjected to extensive verification/validation testing to ensure it meets all functional and performance requirements and is fit for its intended use. The performance details are primarily linked to the adherence to voluntary performance standards and a specific clinical trial for SpO2.

Here's an attempt to infer and summarize based on the provided text, linking performance to the mentioned standards:

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

• Sample Size for Test Set: The document explicitly mentions a "Clinical trial of the SPO2 function." However, it does not specify the sample size for this clinical trial or for any other performance test.
• Data Provenance: The document does not specify the country of origin of the data. It also does not specify if the studies were retrospective or prospective, although "Clinical trial of the SpO2 function" typically implies a prospective study.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the tests, including the SpO2 clinical trial.

4. Adjudication Method

The document does not specify any adjudication methods (e.g., 2+1, 3+1, none) used for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with or without AI assistance. The device is for monitoring vital signs, not for assisting human interpretation of complex medical images or data that would typically involve a MRMC study.

6. Standalone Performance Study

The document indicates that studies were performed on the device's functional and performance requirements. The Arrhythmia Detection Algorithm Performance Validation and the Clinical trial of the SPO2 function suggest standalone performance evaluations of these specific features, focusing on the algorithm's accuracy in detecting arrhythmias and the SpO2 sensor's performance against a reference. While not explicitly termed "standalone performance study," the objective of these tests, especially against recognized standards, inherently assesses the algorithm/device performance without constant human intervention in data collection during the measurement phase. The device then presents data to a human for diagnosis.

7. Type of Ground Truth Used

• For SpO2: A "Clinical trial" was conducted. In such trials for pulse oximetry, the ground truth is typically established by comparing the device's readings against arterial blood gas (ABG) measurements from a co-oximeter, which is considered the gold standard for SpO2. This is implied by the nature of such a clinical trial conforming to ISO 80601-2-61.
• For ECG/Arrhythmia Detection: The ground truth for algorithm performance validation against standards like ANSI/AAMI/ISO EC57 often involves using truth-labeled ECG databases (e.g., MIT-BIH Arrhythmia Database) or synchronously recorded and extensively reviewed ECGs by expert cardiologists.
• For other vital signs (HR, Respiration, Temperature): Ground truth would typically be established by comparing the device's readings against established reference methods or calibrated medical devices known for their accuracy.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for any of the algorithms or features.

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

The document does not provide any information on how the ground truth for the training set was established.

Ask a specific question about this device