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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 AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score.

Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic.

The device is intended for use only under the direct supervision of a physician.

The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System analyzes and reports the following parameters: Heart rate including bradycardia and tachycardia events . Atrial fibrillation . ECG beat classification and morphology grouping with user-editing . . Heart rate variability . Snoring detection Sleep disordered breathing (apnea/hypopnea) events . Sleep disordered breathing score . Activity level - Heart sound and combined ECG/heart sound measurements - Heart rate distributions of heart sound parameters ●

The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. It primarily describes the device, its intended use, and states that it complies with certain standards. There is no information on sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Here's a breakdown of what could be extracted and what is missing, based on the input:

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

• Acceptance Criteria: Not explicitly stated in measurable terms (e.g., sensitivity, specificity thresholds). The document mentions compliance with standards (EN 60601-1, EN 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57) which likely contain performance requirements, but these are not detailed here. For the sleep disordered breathing analysis, it states it's intended "as a screening device...to determine the need for evaluation by polysomnography based on the patient's score," which implies a screening performance standard, but none is provided.
• Reported Device Performance: Not reported in quantitative terms (e.g., specific sensitivity, specificity, accuracy values for any of the detected parameters).

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Adjudication Method: Not mentioned.

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

• MRMC Study: Not mentioned. The document primarily focuses on the device's technical specifications and equivalency to predicates, not its impact on human reader performance.
• Effect Size: Not applicable as no MRMC study is reported.

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

• The document implies a standalone algorithm performance for features like sleep disordered breathing detection as it mentions "analysis and reporting" and "interpretation of the data in an integrated report for consideration by physicians," suggesting the algorithm generates an interpretation before physician review. However, specific performance metrics for this standalone functionality are not provided.

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

• Type of Ground Truth: Not explicitly stated. For sleep disordered breathing, it implies comparison to polysomnography ("screening device to determine the need for evaluation by polysomnography"), which would likely be the ground truth for that specific function, but this is not confirmed.

8. The sample size for the training set

• Sample Size: Not mentioned.

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

• Ground Truth Establishment: Not mentioned.

In summary, the provided text from the 510(k) K120462 document is a submission for a medical device modification (AUDICOR System - CPAM with SDB). It details the device's capabilities, intended use, and declares substantial equivalence to predicate devices, along with compliance with relevant safety and performance standards. However, it does not include the detailed study design, acceptance criteria, test set specifics, or performance metrics that would be necessary to populate the requested table and answer the study-related questions. Such information would typically be found in more detailed technical reports or clinical study summaries, which are not part of this "Summary of Safety and Effectiveness."

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