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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 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 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 Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis results, and construct a report for physician use.

The Spacelabs Pathfinder SL Holter Analyzer is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

Spacelabs Pathfinder SL Holter Analyzer (Pathfinder SL) is a software-only ECG analysis system for recording and analyzing up to 24 hours of 12 lead EGC or seven days of continuous 3 lead ambulatory ECG. Pathfinder SL is designed to operate on a Microsoft Windows® based personal computer (PC) platform, and contains provisions for networking. Pathfinder SL is compatible with Windows XP, Vista, or Windows 7 32-bit (ensure the latest service packs installed) operating systems.

Pathfinder SL is used in conjunction with Spacelabs Healthcare's Sentinel Cardiology Information Management System (Sentinel), and is sold only for use with Sentinel.

In conjunction with Sentinel, Pathfinder SL can acquire data from Spacelabs Holter recorders, analyze up to 12 channels of ECG data, providing classification, editing, and reporting of arrhythmia, ST segment, heart rate variability and pacer performance, and allows the operator to construct a report for physicians to use within their diagnosis of patients. Pathfinder SL is compatible with Lifecard CF, Lifecard 12, evo and Aria Holter Recorders.

ECG from pre-existing stored analyses created with the previous Spacelabs Healthcare Impresario or Pathfinder Holter analyzer systems can be analyzed from scratch using Pathfinder SL.

Pathfinder SL should be used by an operator trained in electrocardiography. A qualified medical practitioner should make any diagnosis.

Acceptance Criteria and Device Performance Study for Spacelabs Pathfinder SL Holter Analyzer

This analysis is based on the provided 510(k) Premarket Notification summary for the Spacelabs Pathfinder SL Holter Analyzer (K110001).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not explicitly state the sample size used for the performance test set.

• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "[acquiring] data from Spacelabs Holter recorders."

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

The 510(k) summary does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications. The device is intended to "allow the operator to view and edit the ECG and the analysis results, and construct a report for physician use," and that "A qualified medical practitioner should make any diagnosis." This implies human review, but the details of ground truth establishment for the test set are not provided.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe the adjudication method used for the test set.

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

The 510(k) summary does not mention or provide details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with or without AI assistance is reported. The device is a "software-only ECG analysis system" used in conjunction with human operators and physicians for diagnosis.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm. The "Performance Testing" section states, "The Pathfinder SL was tested for performance in accordance with internal requirements and the applicable portions of the following Standards," and "Test results indicated that the Pathfinder SL complies with its predetermined specification and with the applicable Standards." This implies testing of the algorithm's performance independent of human-in-the-loop improvements, demonstrating its ability to detect arrhythmias and analyze ECG data.

7. Type of Ground Truth Used

The type of ground truth used for the performance testing is not explicitly stated beyond adherence to internal specifications and external standards (IEC 60601-2-47, ANSI/AAMI EC57, ANSI/AAMI EC38). These standards typically involve databases with expert-annotated arrhythmias or synthesized signals with known characteristics. However, the specific methodology for establishing ground truth as applied to this device's test set is not detailed.

8. Sample Size for the Training Set

The 510(k) summary does not state the sample size for the training set. It primarily focuses on the device's performance against established standards and internal specifications after development.

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

The 510(k) summary does not describe how the ground truth for the training set was established. As this is a 510(k) submission, the emphasis is on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, rather than the developmental details of a novel algorithm's training process.

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The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

The device is intended for use only by a suitably qualified physician.

an anesthesia workstation that contains all the pneumatic circuitry, controls, monitoring, ancillaries and storage required to control, distribute and mix medical gases and anesthetic agents in order to deliver them to a patient system. It is capable of delivering oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The Spacelabs BleaseSirius is the latest generation product in a family of anesthesia workstations. The same breathing circuits used with the predicate device, the Blease Frontline Sirius 2000, 3000 cleared by FDA in 510(k) premarket notification K051629, are used with the Spacelabs BleaseSirius.

This document describes the 510(k) Premarket Notification for the Spacelabs BleaseSirius Anesthesia Workstation. Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The provided text does not contain a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it describes general compliance with predetermined specifications and applicable standards for various types of testing.

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

The document does not specify the sample size used for any of the tests (Electrical Safety, EMC, Performance, or Software). It also does not provide information on the data provenance, such as the country of origin or whether the studies were retrospective or prospective.

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 is an anesthesia workstation, not an AI or diagnostic imaging device that typically requires expert-established ground truth for its performance evaluation (e.g., in terms of sensitivity/specificity). The compliance is based on engineering and safety standards. Therefore, information about experts establishing ground truth for a test set is not applicable and not present in the document.

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

As the evaluation is based on compliance with predetermined specifications and standards for an anesthesia workstation, an adjudication method for a test set (as typically seen in AI or diagnostic studies) is not applicable and not mentioned in the document.

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 such study was conducted or is mentioned. The device is an anesthesia workstation, 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

This refers to the performance of an algorithm without human intervention. Since the device is an anesthesia workstation and not an AI algorithm, this concept is not applicable. The device's "performance" is its ability to operate according to its specifications and standards, which is assessed through various engineering and safety tests.

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

The "ground truth" for this medical device's safety and performance is established by predetermined specifications and applicable international and national standards (e.g., for electrical safety, EMC, and general performance). This is a technical and engineering-based "ground truth" rather than a clinical one derived from patient outcomes or expert consensus on diagnoses.

8. The sample size for the training set

This device is a hardware/software system, not a machine learning model that requires a "training set." Therefore, this information is not applicable and not provided.

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

As there is no training set for an AI model, this question is not applicable.

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The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor (Model 90217A) 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 measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Model 90217A allows the use of an automated or manual inflation system, and utilizes the oscillometric NIBP measurement method. The pressure sensor signal is amplified, digitized by an analog to digital converter (ADC), and supplied to a microprocessor which has control of the pump and vent valve. Measurements are made during the stepwise deflation of the cuff. The Model 90217A NIBP and HR algorithms are identical to that of the predicate. Additionally, the NIBP patient cuffs used with the Model 90217A are the same as those used with the predicate. A block diagram of the Model 90217A is presented in Figure 2.

The Model 90217A is powered by three (3) "AA" alkaline or rechargeable NiCad batteries; there is no capability to connect the Model 90217A to AC mains power. A lithium battery is used to provide backup power for the Model 90217A memory. Both battery types need to be periodically replaced.

The Model 90217A is carried in a pouch that is strapped and/or belted to the side of the patient. NIPB and HR measurements are taken using a blood pressure cuff attached to the patients arm. This information is recorded in the monitor, and can be transferred over a modem link, or by direct connection, between the Model 90217A and one of the ABP analysis systems.

The provided text describes the Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor and its 510(k) premarket notification. However, it does not contain the specific details required to fully address all components of your request, particularly regarding acceptance criteria, the study design (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies.

The document indicates that "Performance Testing" was conducted in accordance with applicable standards and that the device "complies with its predetermined specification." This implies that acceptance criteria were met, but the specific criteria and the detailed performance results are not provided in the summary.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Information Missing: The document states that performance testing was done and that the device "complies with its predetermined specification." However, it does not provide a table specifying the acceptance criteria (e.g., accuracy, precision targets) or the detailed reported device performance against these criteria.

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

Information Missing: The document states that "Performance Testing" was conducted, but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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

Information Missing: This device is a blood pressure monitor, and the ground truth for blood pressure measurements is typically established by another, often invasive or highly calibrated, measurement method, not usually by "experts" in the sense of image interpretation. The document does not specify how ground truth was established for performance testing, nor does it mention any experts involved in defining ground truth.

4. Adjudication Method for the Test Set

Information Missing: As there is no mention of "experts" or a consensus process for ground truth establishment for a blood pressure monitor, an adjudication method is not applicable and is not mentioned.

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

No: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human interpretation is a primary component. The device is an automated blood pressure monitor.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes (Implied): The device is an "Ambulatory Blood Pressure (ABP) Monitor" that "takes non-invasive blood pressure (NIBP) and heart rate (HR) measurements" and records them. It utilizes "oscillometric NIBP measurement method" and its "NIBP and HR algorithms are identical to that of the predicate." This description strongly suggests that the device operates in a standalone manner, with the algorithm performing the measurements without human intervention during the measurement process. The "Performance Testing" mentioned would assess this standalone performance.

7. Type of Ground Truth Used

Information Missing (Specifics): While not explicitly stated, for a non-invasive blood pressure measurement device, the implied ground truth for performance testing would typically be simultaneous measurements from a highly accurate reference standard, such as an intra-arterial blood pressure monitor or another highly validated non-invasive reference device. The document does not explicitly state the specific type of ground truth used.

8. Sample Size for the Training Set

Information Missing: The document states that the "NIBP and HR algorithms are identical to that of the predicate." This suggests that the algorithms themselves might not have undergone new "training" for this specific device, but rather are adopted from the predicate. If any new training was done, the sample size for the training set is not mentioned.

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

Information Missing: Given the statement that the algorithms are identical to the predicate, detailed information on how ground truth was established for the original training of those algorithms (if applicable) is not provided. If new training was performed for this device, then the method for establishing ground truth for the training set is not mentioned.

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