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The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.

The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory electrocardiograph (ECG) recorder capable of providing a 3-lead recording. It is connected to the patient using a custom, disposable, single-patient only, 3-lead sensor patch that is adhesively attached to the patient's chest. The Eclipse MINI is powered by batteries that are integrated in the Eclipse Sensor Patch. These batteries are primary cells which cannot be recharged and power the recorder for up to 15 days. For an extended recording multiple Eclipse Sensor Patches may be required. The single patient event button allows the patient to indicate symptomatic episodes in the recording for correlation with the patient diary. The Eclipse MINI is fully sealed and waterproof. The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor Patch by inserting the USB connector on the sensor patch into the USB receptacle on the bottom of Eclipse MINI housing. Patient data from the Eclipse MINI is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse MINI, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921). Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

This is a 510(k) premarket notification for the Spacelabs Eclipse MINI Model 98900. A 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study for a novel device. The document primarily focuses on demonstrating that the Eclipse MINI Model 98900 is substantially equivalent to the Reynolds Medical Ltd. Lifecard CF 7-Day Holter Recorder (K011837) based on technological characteristics and performance testing in accordance with regulatory standards.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial for a new device, is not fully applicable or explicitly detailed in this 510(k) summary. The "acceptance criteria" here largely refer to meeting recognized standards for safety and performance to demonstrate substantial equivalence.

Here's an attempt to extract and interpret the information based on the provided document within the context of a 510(k) submission:

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

The document does not present a single table of "acceptance criteria" and "reported device performance" in the way one might expect for a specific clinical endpoint. Instead, the device's performance is demonstrated through compliance with various national and international standards and internal requirements, and by performing comparably to the predicate device.

The "Technology Comparison" table (page 5) lists various characteristics and indicates that the Eclipse MINI's performance is consistent with these standards and the predicate. The "Summary of Performance Testing" sections (pages 6 and 7) state that the device "complies with internal requirements, applicable Standards, and the guidance document."

Here is a summary of the broad performance areas and the reported compliance:

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

This information is not provided in a way that relates to a "test set" for a diagnostic study. The performance testing described (shelf-life, biocompatibility, software V&V, electrical safety, EMC, bench performance) are engineering and laboratory tests, not clinical studies with a patient test set in the traditional sense. Therefore, details like "sample size used for the test set" and "data provenance" (country/retrospective/prospective) are not applicable or detailed for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device, the Eclipse MINI Model 98900, is an ECG recorder and "does no cardiac analysis" itself. It is used with "Spacelabs Ambulatory ECG Analysis Software" (which would have its own clearances, e.g., K152881, K110001, K201921). As such, it is not a diagnostic algorithm that provides an output requiring ground truth established by experts. Its function is to accurately record ECG data, and its performance is assessed against technical standards for signal acquisition and safety, not diagnostic accuracy. Therefore, this information is not applicable to the device described.

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

Not applicable, as there is no diagnostic "test set" and no "ground truth" adjudicated by experts for this recording device as described in the submission.

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

Not applicable. This device is an ECG recorder and not an AI/CADe/CADx system. No MRMC study or AI assistance improvement is mentioned or relevant to the device's function.

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

Not applicable. This device is an ECG recorder, not an algorithm, and performs "no cardiac analysis."

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

Not applicable. As described in points 3, 4, 5, and 6, this device does not perform analysis that would require a ground truth for diagnostic accuracy. Its "ground truth" for performance is compliance with engineering and safety standards, and reliable recording of ECG data.

8. The sample size for the training set

Not applicable. This device is primarily hardware an embedded software for recording. It is not an AI/machine learning model that requires a training set. The software mentioned is developed through robust software development processes (as noted in the "Software" testing section) and validated against specifications, not "trained" on a data set in the ML sense.

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

Not applicable, as there is no training set for an AI/ML model for this device.

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The Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient's ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either or at home. The device does no cardiac analysis and is used with a Holter Analysis System.

The Eclipse PRO Model 98700 (Eclipse PRO) is an ambulatory electrocardiograph (ECG) recorder capable of providing a true 12-channel recording for up to 72 hours or a 3-lead recording for up to 14 days. It is connected to the patient using Eclipse PRO-specific 3, 4, or 10 lead wire cables with the recorder located in a pouch on a lanyard.

The Eclipse PRO has a large, color display which allows the user to view recorder status, configure the recorder and to view ECG lead application.

It has an internal, fast-charge, long-life, rechargeable lithium-ion battery, which is charged when connected by a cable between the USB port of a personal computer (PC) or a USB charger, and the recorder's USB-C connector.

Two (2) arrow keys on the front of the Eclipse PRO are used to navigate and select options in the recorder's menu or as a patient event button when the patient desires to indicate symptomatic episodes in the recording.

The Eclipse PRO is fully sealed and waterproof.

Patient cables are attached to the Eclipse PRO using the USB connector on the bottom of the housing and protective cable retention loop.

Patient data from the Eclipse PRO is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse PRO, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921).

Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

The Spacelabs Eclipse PRO Model 98700 is an ambulatory electrocardiograph (ECG) recorder. The provided text outlines its characteristics and the performance testing conducted to demonstrate its substantial equivalence to the predicate device, Reynolds Medical Ltd. Lifecard CF 7 Day (K011837).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly list "acceptance criteria" in a quantitative, metrics-based format for the overall device performance in recording ECGs. Instead, it focuses on demonstrating compliance with various regulatory standards and guidance documents, and technological equivalence to the predicate device. The performance testing section primarily reports that the device "complies" with these standards.

However, based on the "Technology Comparison" table, we can infer some functional acceptance criteria by comparing the proposed device against the predicate.

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

The provided document describes performance testing related to device functionality, electrical safety, EMC, software validation, and biocompatibility, but does not detail any clinical study or human subject trial for evaluating ECG recording performance. Therefore, there is no information on a "test set sample size" or "data provenance" related to patient data evaluation. The tests mentioned are primarily bench tests, engineering validations, and compliance checks against regulatory standards.

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)

As no clinical test set using patient data is described, this information is not applicable and not provided in the document. The performance evaluation focuses on technical compliance, not diagnostic accuracy requiring expert interpretation.

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

Since no clinical test set involving human interpretation of data is described, an adjudication method is not applicable and not provided.

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

The device described, Spacelabs Eclipse PRO, is a Holter recorder that "does no cardiac analysis" and is "used with a Holter Analysis System." The document explicitly states it's a recorder, not an analytical or AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study with AI assistance was performed or is relevant to this device.

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

As the device itself "does no cardiac analysis" and is a pure recorder, there is no algorithm for standalone performance to be evaluated. This question is not applicable to this device.

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

For the technical performance testing (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" used is compliance with established international standards and FDA guidance documents (e.g., ISO 10993-1, IEC 62304, IEC 60601 series). For the functional comparison, the "ground truth" for substantial equivalence is the predicate device's characteristics and specifications. There is no clinical data 'ground truth' in the context of expert diagnosis or patient outcomes.

8. The sample size for the training set

Since this is a medical device (Holter recorder) and not an AI/ML-based diagnostic algorithm, there is no concept of a "training set" as would be applicable to machine learning.

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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The Spacelabs Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists.

Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.

The Spacelabs Lifescreen PRO Analyzer is a rapid analysis software product that can be used to analyze electrocardiology (ECG) recordings of up to 30 days in duration from Spacelabs Healthcare's range of Ambulatory ECG recorders. The ECG recordings are downloaded into the Sentinel Cardiology Information Management System (Sentinel), cleared by FDA in 510(k) submission K152881, imported into Lifescreen PRO, and then analyzed.

Lifescreen PRO is designed to provide a rapid analysis of the detection and reporting of major arrhythmic events and patient reported symptomatic events including AF, Pause, VT, V-Run (>3 beats), Trigeminy and Bigeminy, SVT, SV-Run, and Bradycardia.

Individual normal, ventricular, and supraventricular beat burdens are presented as a percentage of the total beat counts.

No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events. Laboratory testing and clinical studies have shown that scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy. Following analysis, the report should be reviewed by a physician prior to initiating or changing patient treatment.

ECG data with a lot of noise, which can result from poor hook-up and/or poor-quality electrodes, can result in beat misclassification. The algorithm monitors the ECG quality throughout and will inhibit analysis during periods of noise; the inhibited analysis is clearly shown in grey. This allows the user to review the inhibited areas to ensure that significant events have not been missed.

Various tools are provided in Lifescreen PRO to allow the trained user to quickly view the full disclosure ECG, add, delete, or reclassify events and beats, or artefact periods of noisy ECG. Where more detailed analysis is required, Lifescreen PRO also has the ability to export sections of a recording up to 7 days in duration into the Sentinel Cardiology Information Management System for further analysis using the Pathfinder SL analysis system.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the format requested. While it mentions that "Test results indicated that the Lifescreen PRO complies with internal requirements, applicable Standards, and the guidance document," it does not provide the quantitative acceptance criteria, the reported device performance against those criteria, or the methodology of such a study.

However, based on the general information provided about the device's capabilities and regulatory compliance, I can infer some aspects and construct a table to illustrate the type of information that would be present if it were fully detailed.

Here's a breakdown of what can be extracted and what is missing:

The Spacelabs Lifescreen PRO Analyzer is designed for:

• Analyzing ambulatory ECG recordings.
• Detecting certain arrhythmias (AF, Pause, VT, V-Run (>3 beats), Trigeminy, Bigeminy, SVT, SV-Run, and Bradycardia).
• Allowing user review and editing of analysis results.
• Correlating symptomatic patient events.
• Constructing a report for physicians/cardiologists.
• Serving as a triage tool for assessment and export of ECG segments for more detailed analysis.

The document indicates that the device undergoes "performance testing" in accordance with internal requirements and standards like IEC 60601-2-47: 2012 (Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems). This standard would typically define performance requirements for arrhythmia detection and accuracy.

Missing Information:

• Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets for each arrhythmia).
• Reported device performance (actual values) for these criteria.
• Details of the study that generated these performance numbers (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, standalone vs. MRMC).
• Training set details.

Inferred Table of Acceptance Criteria and Reported Device Performance (Illustrative - actual values not provided in the text):

Study Details (Based on what can be inferred or what is explicitly missing):

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "Laboratory testing and clinical studies," but no details on the datasets used.

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

   • Number of Experts: Not specified.
   • Qualifications: "scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy." It also mentions "reviewed by a physician prior to initiating or changing patient treatment." However, the exact qualifications of those establishing the ground truth for a test set are not detailed.

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

   • Not specified.

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

   • The text describes the device as providing "rapid analysis" and assisting "selection and export of ECG segments for more detailed analysis." It also states, "No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events. Laboratory testing and clinical studies have shown that scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy." This implies that the device is intended to be used with human review, but it doesn't explicitly describe an MRMC comparative effectiveness study or quantify improvement with AI assistance.

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

   • The document implies that standalone performance was evaluated, as it refers to the algorithm's detection capabilities. However, it strongly emphasizes the need for human review to achieve the "highest degree of report accuracy." It does not provide specific standalone performance metrics distinct from a human-in-the-loop context.

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

   • Implicitly, the ground truth for ECG analysis and arrhythmia detection would be established by expert consensus based on manual review of ECG recordings, likely by cardiologists or trained technicians. This is suggested by phrases like "scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy" and "reviewed by a physician."

7. The sample size for the training set:

   • Not specified.

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

   • Not specified, but likely similar to the test set, involving expert review and annotation of ECG recordings.

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The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and facility information.

The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel.

The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates.

Sentinel supports importing reports from external systems and provides an HL7 interface to external systems. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment.

The Sentinel Cardiology Information Management System is not intended for patient monitoring.

The Spacelabs Healthcare Ltd. (Spacelabs) Sentinel Cardiology Information Management System (Spacelabs) is a stand-alone software product which can capture, store, access and manage electrocardiograph (ECG), ambulatory blood pressure (ABP), stress test, ergospirometry, spirometry, event and plethysmography data with Holter analyses and reports, together with the corresponding patient information. Sentinel can be used as a single stand-alone installation, or as part of a multi-user network. Sentinel may be used for recording and reviewing of ECG of adults and pediatrics in a clinical environment inside and outside of hospitals.

The provided document does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The document focuses on regulatory submission (510(k)) for the Spacelabs Sentinel Cardiology Information Management System, asserting substantial equivalence to predicate devices, and referencing general quality and safety standards for software and medical electrical equipment.

It states:

• "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standard." (Page 6)
• "Verification results indicated that Spacelabs Sentinel complies with the applicable requirements of the standard." (Page 6)
• "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standards." (Page 7)
• "The results of these activities demonstrate that Spacelabs Sentinel is as safe, as effective, and performs as well as or better than the predicate device." (Page 7)

However, it does not explicitly list what those "predetermined specifications" or "applicable standards" are in terms of performance metrics (e.g., sensitivity, specificity, accuracy for interpretations), nor does it describe specific studies with sample sizes, ground truth establishment, or expert involvement for these performance metrics.

The "Summary of Performance Testing" section primarily lists compliance with general software development standards (FDA guidance documents, IEC 62304) and electrical safety/usability standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-2-25, IEC 80601-2-30, IEC 62366). While these are important for device safety and functionality, they are not performance criteria related to the diagnostic accuracy of features like "automatic interpretation of 12-lead ECG."

Therefore, based only on the provided text, I cannot complete the table or answer all the requested questions. The document mentions "automatic interpretation of 12-lead ECG" as a feature but does not provide the performance data or details of a study to validate this interpretation.

If more detailed performance study information were available in an accompanying document, it would be needed to answer your request fully.

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The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:

• Adult
• Pediatric (1 year old and above)
  The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of:
• ECG with arrhythmia detection
• Respiration
• Non-invasive blood pressures
• Invasive blood pressures
• Body temperature
• Functional arterial oxygen saturation, and
• End tidal CO2.
  The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Spacelabs Healthcare (Spacelabs) élance Vital Signs Monitor is a family of portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG with arrhythmia detection, respiration, NIBP, temperature, SPO2, invasive blood pressure and EtCO2. Models within the Spacelabs élance family come in two different sized viewing areas (10.2" and 12.1"), two different housing colors (white and black) and offer selected monitoring features.
The Spacelabs élance Central Station software package is available for use with a customer acquired computer based on specifications provided by Spacelabs. This package allows monitoring of the élance Vital Signs Monitor at a central workstation.

The provided text is a 510(k) premarket notification summary for the Spacelabs Healthcare élance Vital Signs Monitor and élance Central Station. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo clinical acceptance criteria and conducting a dedicated study to prove that the device meets those criteria.

Therefore, much of the requested information (e.g., number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance metrics, sample sizes, and detailed ground truth establishment for a specific "study" demonstrating meeting acceptance criteria) is not present in this document because it describes a different type of regulatory submission. Clinical trial data with specific acceptance criteria and detailed performance studies are typically required for Novel Devices or those without a clear predicate.

However, based on the provided text, I can infer some aspects and present the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly alignment with recognized standards and successful completion of verification and validation testing, demonstrating that the device performs as intended and is as safe and effective as the predicate. Specific numerical performance metrics for individual parameters (e.g., accuracy for NIBP, sensitivity/specificity for arrhythmia detection) are referred to as being assessed against these standards but are not explicitly detailed in a table format with specific numerical targets.

• ANSI/AAMI EC57: 1998/(R) 2003 (Cardiac rhythm and ST-segment measurement algorithms)
• ANSI/AAMI SP10: 2002, Am1: 2003 (Sphygmomanometers)
• EN 12470-4: 2009 (Electrical thermometers)
• EN 60601-1-6: 2010 (Usability)
• EN 60601-1-8 2007, Am1: 2013, AC: 2014 (Alarm systems)
• EN 62366: 2008 (Usability engineering)
• IEC 60601-2-27: 2005 (ECG monitoring equipment)
• IEC 60601-2-30: 1999 (Non-invasive blood pressure monitoring)
• IEC 60601-2-34: 2000 (Invasive blood pressure monitoring)
• IEC 60601-2-49: 2011 (Multifunction patient monitoring equipment)
• ISO 80601-2-55: 2011 (Respiratory gas monitors)
• ISO 80601-2-61: 2011 (Pulse oximeter equipment)
• Internal requirements and procedures. | "Test results indicated that the élance VSM and élance CS comply with these Standards. Additionally, the élance VSM and élance CS were tested in accordance with internal requirements and procedures, and test results indicated that the devices comply with the predetermined requirements." |
  | Overall Equivalence| The device is "as safe, as effective, and perform as well as or better than the predicate devices." | The conclusion states that "the élance VSM and élance CS are as safe, as effective, and perform as well as or better than the predicate devices. Therefore, the élance VSM and élance CS are considered substantially equivalent to the predicate devices." |

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

The document refers to "test results" for compliance with various standards but does not specify sample sizes for these tests for each parameter. The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective in a clinical trial context. It refers to a series of bench tests against recognized standards.

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

This information is not provided in the document. For bench testing against standards, the "ground truth" often comes from reference equipment, simulated signals, or specified test conditions described within the standards themselves, rather than clinical expert consensus.

4. Adjudication Method for the Test Set

This information is not provided as it typically pertains to clinical trials requiring expert review of patient data, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A MRMC comparative effectiveness study is not mentioned or described in this document. The submission focuses on demonstrating substantial equivalence through technical characteristics and compliance with standards, not on assessing the improvement of human readers with AI assistance. The device is a monitor, not an AI diagnostic tool for human interpretation.

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

The document describes "parameter performance" testing for the élance VSM and élance CS against various standards. This testing would inherently involve evaluating the algorithms and hardware of the device itself (standalone performance) under controlled conditions to ensure they meet the criteria specified in those standards (e.g., accuracy of ECG measurement, NIBP, SpO2). However, specific metrics like sensitivity, specificity, or PPV/NPV for arrhythmia detection are not quantified in this summary, beyond stating compliance with the relevant standard (ANSI/AAMI EC57).

7. The Type of Ground Truth Used

For the performance testing mentioned, the ground truth would be based on:

• Reference Standards: The specifications and requirements outlined in the cited IEC, ANSI/AAMI, EN, and ISO standards define the acceptable performance.
• Controlled Bench Test Conditions: Specific inputs (e.g., simulated ECG waveforms, pressure cuffs with known pressures, temperature probes in calibrated environments) were used to test the device's accuracy and functionality against known values.
• Predetermined Specifications: Internal requirements and procedures of Spacelabs Healthcare.

8. The Sample Size for the Training Set

This document does not mention a training set in the context of machine learning or AI algorithm development because the device, as described, is a vital signs monitor leveraging established physiological monitoring techniques rather than a novel AI system requiring extensive machine learning training. The "software" referred to is for device operation and data processing, validated against traditional software development processes.

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

As no training set for machine learning is mentioned, this information is not applicable/provided.

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The Spacelabs Model OnTrak (9027) Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure (ABP) Monitor (Spacelabs OnTrak) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) measurements for a 24 hour, 48 hour, or longer period. These The Spacelabs OnTrak does not have any physiological alarms, but does have an audible low battery indicator. The Spacelabs OnTrak utilizes the same NIBP cuffs as the predicate device.

The provided document details the 510(k) premarket notification for the Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure Monitor. This document does not contain information about an AI-powered device, nor does it conduct a study comparing human readers with and without AI assistance. Instead, it focuses on the substantial equivalence of a new medical device to a legally marketed predicate device.

However, I can extract the acceptance criteria and performance information as presented for this device, and infer what would typically be considered "acceptance criteria" based on the standards cited for medical device performance.

Acceptance Criteria and Reported Device Performance

For a blood pressure monitor, the primary acceptance criteria revolve around accuracy of blood pressure measurement. The document refers to ISO 81060-2: 2009 for "Clinical investigation of automated measurement type," which sets the standard for blood pressure monitor accuracy. While the document doesn't explicitly list the detailed clauses of ISO 81060-2 as "acceptance criteria" tables, the "Manometer Accuracy" under the technology comparison section provides a direct performance metric.

Study Information (Based on the provided document):

1. Sample size used for the test set and the data provenance:
   The document does not explicitly state the sample size for the clinical testing (if a specific clinical test was conducted beyond meeting the standard's criteria implicitly) or for the various bench tests. It refers to "Test results" which "indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards."
   Data provenance is not mentioned. Given the regulatory nature of the submission (510(k)), it would typically be prospective clinical study data if a new clinical trial was undertaken, or extensive bench testing. The primary comparator is the predicate device, implying testing was done to show equivalence.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. For a blood pressure monitor clinical validation (as per ISO 81060-2), ground truth is typically established by trained observers using a mercury sphygmomanometer or highly accurate reference methods, often with multiple observers following a specific protocol. The qualifications would be highly trained technicians or clinicians.

3. Adjudication method for the test set:
   This information is not provided. In clinical validation studies of blood pressure monitors, an adjudication method (such as an averaged reading from two trained observers, or a third observer for discrepancy) is commonly used to establish the reference blood pressure.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No, an MRMC comparative effectiveness study was not done. This device is an Ambulatory Blood Pressure Monitor, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the performance testing described is for the standalone device. The Spacelabs OnTrak is an automated system designed to measure blood pressure independently. The "Summary of Performance Testing" for Software, Electrical Safety, EMC, and Bench performance refers to the device's inherent functionality without human intervention for the measurement process itself. The user interaction relates to operating the device (usability standard), not interpreting its output.

6. The type of ground truth used:
   For the blood pressure measurements, the ground truth for clinical validation (if detailed data were provided, which they are not) would typically be established by simultaneous measurements using a reference method, such as a mercury sphygmomanometer operated by trained personnel, per the requirements of ISO 81060-2. For other aspects like software, electrical safety, etc., the "ground truth" is adherence to the specified technical standards.

7. The sample size for the training set:
   This device does not utilize a "training set" in the context of machine learning, as it is not an AI/ML-powered device. Its operation is based on established oscillometric principles rather than learned algorithms from a dataset.

8. How the ground truth for the training set was established:
   Not applicable, as there is no "training set" for this type of device.

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The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

The Spacelabs Healthcare (Spacelabs) Telemetry Receiver, Model 96280, (ETR) is a new version of a currently marketed Spacelabs product. The Spacelabs ETR offers receipt and analysis of patient data for those patients connected to a Spacelabs Healthcare telemetry transmitter. The Spacelabs ETR provides for data communication using the TCP/IP network protocol employed in the Xhibit Central Station, Model 96102, (Xhibit) (K122146) network of hardwired and/or ETR monitored patients. Xhibit is the primary alarming device for the ETR telemetry receiver system.

This FDA 510(k) clearance document for the Spacelabs Healthcare Telemetry Receiver, Model 96280, indicates a traditional medical device (hardware and embedded software) rather than an AI/ML-driven device. As such, the information typically associated with AI/ML device studies (such as ground truth establishment involving experts, training/test set sizes for AI, MRMC studies, or standalone algorithm performance) is not available or applicable in the provided text.

The acceptance criteria and performance summary primarily revolve around compliance with established industry standards for medical electrical equipment, software development, electrical safety, electromagnetic compatibility, and performance testing for physiological monitoring.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format for specific performance metrics of the device as one might expect for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by adherence to various established medical device standards and internal requirements. The "reported device performance" is essentially that the device was tested and found to comply with these standards and its predetermined specifications.

Study Details (Based on available information)

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

   • The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. Performance testing was conducted in a bench setting based on established standards. The type or size of patient data or physiological signals used for these bench tests is not detailed (e.g., how many ECG recordings, how many simulated arrhythmia events).
   • Data provenance is not mentioned as this is a device clearance based on engineering and safety standards, not a clinical trial with patient data.

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

   • Not applicable. This is not an AI/ML diagnostic device requiring expert-adjudicated ground truth. The "ground truth" for compliance with engineering standards is the adherence to specifications as measured by laboratory testing.

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

   • Not applicable. There's no human adjudication process described for establishing ground truth as it would be for an AI/ML system.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a telemetry receiver, not an AI/ML system designed to assist human readers in interpretation. There is no mention of an MRMC study.

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

   • The device itself functions as a "standalone" physiological monitoring system, receiving and analyzing patient data. The performance tests ("Performance Testing – Bench") assess the device's inherent capabilities against technical standards. However, this is not a "standalone algorithm" in the context of an AI/ML submission where an algorithm's diagnostic performance is evaluated in isolation.

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

   • The "ground truth" for this type of device is defined by the technical specifications and requirements outlined in the referenced standards (e.g., an arrhythmia detection algorithm must correctly identify a pre-defined set of arrhythmias from test data as per the standard). This is an engineering truth rather than a clinical ground truth established by medical experts for diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.

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

   • Not applicable. See point 7.

In summary, the provided document details the FDA clearance of a traditional telemetry receiver based on its compliance with established medical device standards for electrical safety, electromagnetic compatibility, software robustness, and performance (e.g., ECG analysis, alarm systems, pulse oximetry). It does not involve AI/ML technology, and thus the specific types of studies and criteria relevant to AI/ML devices (like training/test sets, expert adjudication, MRMC studies) are not present in this submission.

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The intended use of the Spacelabs Healthcare CardioExpress (CardioExpress) is to acquire ECG signals from adult and pediatric patients using ECG electrodes. CardioExpress is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only.

The Spacelabs Healthcare (Spacelabs) CardioExpress, Models 98400-SL3-IEC, 98400-SL3-AHA, 98400-SL6-IEC, 98400-SL6-AHA, 98400-SL12-IEC, and 98400-SL12-AHA, are a series of electrocardiographs (ECGs) designed to acquire, analyze, display, and record ECG signals from ECG electrodes connected to a patient.

After been amplified, filtered and analyzed, the ECG signal waveforms and analysis results are presented on a liquid crystal diode (LCD) display, and recorded on the paper through either a thermal or USB printer. ECG data, result and patient information may be stored in the memory file. The file can be transmitted to a personal computer (PC) through either an UART or Ethernet connection.

The CardioExpress can optionally contain auto analysis software which assists in performing auto measurement and auto interpretation of data. The CardioExpress consists of two (2) basic components: (1) the signal acquisition module, and (2) the central processing unit. All models contain a rechargeable battery.

The CardioExpress series of ECG monitors are provided in three (3) primary models: CardioExpress SL-3; CardioExpress SL-6; and CardioExpress SL-12.

Here's an analysis of the acceptance criteria and study information for the Spacelabs Healthcare CardioExpress Electrocardiograph, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the Spacelabs Healthcare CardioExpress electrocardiographs (ECG) and their substantial equivalence to predicate devices. The "acceptance criteria" discussed are primarily compliance with various international standards for medical electrical equipment, including safety, usability, alarm systems, and specific requirements for ECGs. The "reported device performance" is the confirmation that the device complies with these standards and its predetermined specifications.

Table of Acceptance Criteria and Reported Device Performance

• Verification and validation per internal requirements
• FDA guidance (e.g., "The content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation," "Cybersecurity for networked medical devices") | Test results indicate that the CardioExpress complies with its predetermined specifications and the applicable standards and guidance documents. |
  | Electrical Safety Testing | IEC 60601-1: 1988, Am1: 1991, and Am2: 1995 (Medical electrical equipment. Part 1: Particular requirements for safety) | Test results indicated that CardioExpress complies with the Standard. |
  | Electromagnetic Compatibility (EMC) Testing | IEC 60601-1-2: 2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Test results indicated that CardioExpress complies with the Standards. |
  | Performance Testing (General) | - Internal requirements
• IEC 60601-1-6: 2004 (Usability)
• IEC 60601-1-8: 2003, Am1: 2006 (Alarm systems)
• IEC 60601-2-25: 1993, Am: 1999 (Particular requirements for the safety of electrocardiographs)
• IEC 60601-2-51: 2003 (Particular requirements for safety, including essential performance, of recording and analyzing single channel and multichannel electrocardiographs) | Test results indicate that CardioExpress complies with its predetermined specifications and the applicable standards. Verification and validation activities were conducted to establish the performance and safety characteristics of CardioExpress. |

Study Information

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical trial for efficacy. Therefore, many of the detailed study parameters typically found in clinical trials for new AI/ML devices might not be explicitly stated or applicable in the same way.

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

   • The document does not explicitly state a sample size for a test set in the context of a clinical performance study. The "test results" mentioned pertain to compliance with electrical, EMC, software, and general performance standards. These tests often use controlled environments and simulated data or hardware, not patient-derived datasets in a clinical sense.
   • Similarly, there is no information provided regarding data provenance (country of origin, retrospective/prospective) for any test set involving patient data. This is consistent with the nature of a 510(k) submission primarily focusing on technical and safety standards compliance.

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

   • This information is not provided. The document mentions the device includes "auto analysis software which assists in performing auto measurement and auto interpretation of data." However, it clarifies that "the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only." This suggests the device's interpretation is an aid and not a definitive diagnosis that would require extensive expert ground truth establishment in a clinical performance study for this 510(k). The regulatory submission focuses on the safety and foundational performance of the device as an electrocardiograph.

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

   • This information is not available in the provided text. Adjudication methods are typically associated with clinical performance studies where expert consensus is used to establish ground truth for a diagnostic interpretation. Since such a study for the auto-interpretation feature is not described, neither is an adjudication method.

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

   • No MRMC comparative effectiveness study is mentioned or appears to have been done for this 510(k) submission. The document states the auto-analysis software "assists" and is "offered to clinicians on an advisory basis only," indicating it's not claiming improved human reader performance through AI assistance in a comparative effectiveness study.

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

   • The document implies the auto-analysis software can function in a "standalone" computational sense (performing auto measurement and interpretation). However, it explicitly states the interpreted ECG... is only intended to be used on adult patients, and is offered to clinicians on an advisory basis only. This means that while the algorithm can generate interpretations, its intended use always involves a human clinician for final diagnosis. Therefore, a standalone clinical performance study (where the algorithm's interpretation alone dictates patient management) would not be applicable given the advisory nature of the interpretation. The testing described primarily covers the technical correctness and safety of the device's functions.

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

   • Due to the nature of the 510(k) submission focusing on technical and safety compliance of a basic ECG device, specific ground truth types (like pathology or outcomes data) for clinical interpretation accuracy are not detailed. The "ground truth" for the performance tests mentioned would be the expected output or behavior according to the specified IEC standards and internal design specifications.

7. The sample size for the training set:

   • The document does not provide a sample size for a training set. The device (an ECG machine) is designed to acquire and analyze ECG signals, and its software includes "auto analysis." This auto-analysis likely relies on well-established algorithms for ECG waveform and rhythm analysis, which may have been developed and refined over decades using large, diverse datasets. However, no specific details about "training sets" for a deep learning or complex AI model are presented in this submission.

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

   • As no training set is described, information on how its ground truth was established is not provided. If "auto analysis software" refers to rule-based or conventional signal processing algorithms, the "ground truth" for their development would be based on established cardiology principles and guidelines, rather than a prospectively labeled dataset in the modern AI sense.

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The Spacelabs Healthcare Xhibit Central Station, Model 96102 intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms. The Spacelabs Healthcare Xhibit Central Station, Model 96102 is a prescription device intended for use under the direct supervision of a licensed healthcare professional.

The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102 (Xhibit), is a new version of currently marketed Spacelabs product. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare Ultraview, Ultraview SL bedside monitor, or telemetry system. Xhibit provides for data communication using the TCP/IP network protocol employed in the Spacelabs Patient Care Management network of hardwired and/or telemetry monitored patients. Xhibit is not the primary alarming device for the Ultraview or Ultraview SL telemetry system.

The provided 510(k) summary (K122146) details the Spacelabs Healthcare Xhibit Central Station, Model 96102. The document describes various performance tests conducted to establish its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the device's clinical efficacy (e.g., arrhythmia detection accuracy). Instead, the performance testing focuses on compliance with established standards and internal requirements.

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

The document does not provide information regarding a specific "test set" in the context of clinical performance data, such as a dataset of patient physiological waveforms for evaluating alarm accuracy or arrhythmia detection. The testing described is primarily focused on engineering and software validation. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective).

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

This information is not provided. Since there's no mention of a clinical test set requiring expert ground truthing, this detail is absent.

4. Adjudication method for the test set

This information is not provided. As no clinical test set requiring ground truth is mentioned, an adjudication method is not applicable in the documented testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not described or referenced in the provided text.

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

The device is a "Central Station Remote Monitor" that displays physiological data and alarms. Its function is to facilitate human monitoring, not to operate as a standalone diagnostic algorithm. Therefore, a standalone algorithmic performance study, as typically understood for AI-based diagnostic devices, was not reported. The performance testing focuses on the system's compliance with safety and operational standards.

7. The type of ground truth used

For the engineering and software testing described, the "ground truth" would be the specifications and requirements defined by the manufacturer and the relevant national and international standards (e.g., IEC 62304, IEC 60601-1-2, IEC 60601-1-8, IEC 62366). There's no mention of clinical ground truth derived from expert consensus, pathology, or outcomes data for assessing diagnostic accuracy.

8. The sample size for the training set

This information is not provided. The document describes a traditional medical device submission, not one for an AI/ML-based device that would typically involve a separate training set. The "software development process" mentioned refers to conventional software engineering, not machine learning model training.

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

This information is not provided, as no training set for an AI/ML model is mentioned.

Summary of Device and Study Focus:

The K122146 submission for the Spacelabs Healthcare Xhibit Central Station, Model 96102, primarily focuses on demonstrating substantial equivalence to a predicate device (Philips Medical Systems Intellivue M3290A). The studies cited are primarily engineering validation and verification tests ensuring compliance with established medical device safety, software development, electromagnetic compatibility, and alarm system standards. The document does not present a clinical performance study with defined acceptance criteria for diagnostic accuracy, sensitivity, or specificity, nor does it involve clinical ground truth, expert readers, or AI/ML components requiring training and test sets in the context of this summary. The "performance testing" referenced is about the system's operational adherence to standards, not a clinical trial of its diagnostic capabilities.

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The Capno Module, 92517 (92517) is intended to provide a means of monitoring carbon dioxide and respiration rate and alert clinical personnel when the concentration moves outside of user-defined limits.

The 92517 is intended to be used with and controlled by a Spacelabs Healthcare monitors. The 92517 is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.

The Spacelabs Healthcare Capno Module, 92517 (92517) is an easy-to-use modular unit used with Spacelabs Healthcare Ultraview SL or XPREZZON monitors. The 92517 is inserted into the bay within the monitors. which is then used to control the 92517, and provide the user interface for the 92517.

The 92517 is a sidestream or mainstream analyzer intended to provide a measurement of the following parameters: carbon dioxide (CO2); and respiratory rate.

The monitor provides a number display for CO2 and respiratory rate, and a capnograph waveform. The 92517 is intended to be used primarily in the operating room environment.

The provided 510(k) summary for the Spacelabs Healthcare Capno Module, 92517, describes the device, its intended use, and technology comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria for performance metrics (like accuracy, sensitivity, specificity) or the specific results of performance testing in a tabular format as requested.

Instead, the document focuses on compliance with electrical safety, electromagnetic compatibility (EMC), general requirements for safety, alarm systems, and software development standards. It confirms that the device complies with its predetermined specifications and applicable standards, but does not present the raw performance data or detailed acceptance criteria for clinical efficacy.

Therefore, much of the requested information cannot be extracted from this document.

Here's an attempt to answer based on the available information, noting where data is missing:

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

The document states that "Test results indicated that the 92517 complies with its predetermined specification and with the applicable Standards" for various technical and safety aspects. However, specific performance acceptance criteria for parameters like CO2 measurement accuracy or respiratory rate accuracy, and the actual numerical performance results against those criteria, are not provided in the given text. The relevant sections (Summary of Performance Testing, Performance Testing) mention compliance with standards but do not detail clinical performance metrics.

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

This information is not available in the provided 510(k) summary. The document mentions "Performance Testing" and "Verification and validation activities," implying tests were conducted, but it does not specify the sample size of patients or data points, nor the provenance (country, retrospective/prospective nature) of any data used for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided 510(k) summary. The document focuses on technical and safety compliance rather than clinical study protocols involving expert review for ground truth establishment.

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

This information is not available in the provided 510(k) summary. Given the focus on technical compliance, a clinical adjudication method is unlikely to be discussed unless specific clinical trials were performed and detailed in the summary (which they are not in this case).

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

An MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. This device is a CO2 and respiratory rate monitor, not an AI diagnostic tool designed to assist human readers in interpreting images or complex data, so such a study would not be relevant in this context.

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

This device is a physical medical device (CO2 monitor) that provides measurements. Its performance is inherently "standalone" in generating these measurements, though a human interprets and acts on the displayed data. The document confirms that the device "complies with its predetermined specification and the Standards" through performance testing, which is essentially standalone validation of the device's measurement capabilities.

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

The document does not explicitly state the "ground truth" method for its performance testing related to CO2 and respiratory rate measurements. For physiological parameters like these, typically, the ground truth would be established using a highly accurate reference standard (e.g., a calibrated gas analyzer for CO2 concentration, or manual counting of respirations by a trained clinician for respiratory rate, or a verified simulator). The 510(k) summary implicitly suggests that the device's measurements were compared against accepted "standards" and "specifications."

8. The sample size for the training set

This information is not available in the provided 510(k) summary. The device is not described as involving machine learning or AI models that require a "training set" in the conventional sense. Software modifications are mentioned, but their development and validation adhere to software life cycle processes and guidance documents, not AI training methodologies.

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

As there is no mention of a "training set" in the context of machine learning, this information is not applicable and therefore not provided in the 510(k) summary.

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