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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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