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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.

Device Description

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.

AI/ML Overview

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.

Feature/Criterion	Acceptance Criteria (Implied from Predicate/Standards)	Reported Device Performance (Eclipse PRO Model 98700)
Intended Use	Records patient's ambulatory electrocardiogram; for pediatric or adult patients in clinical or home settings; does no cardiac analysis; used with Holter Analysis System.	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 a clinical setting or at home. The device does no cardiac analysis and is used with a Holter Analysis System. (Matches criteria)
Channels	1, 2, or 3 channels (Predicate)	3 or 12 channels (Meets or exceeds predicate's capability)
Leads	3, 4, and 6 leads (Predicate)	3 leads, 4 leads, and 10 IEC or AHA leads (Meets or exceeds predicate's capability)
Recording Duration	Up to 24 hours recording x channels, up to 7 days recording x channels (Predicate)	Up to 3 days recording 12 channels, up to 14 days recording 3 channels (Exceeds predicate's capability in both duration and channel options)
Data Stored	Full disclosure ECG with pacing and patient event markers, recording date and time, patient name and record number, encrypted patient record file, 8-second voice recording, recorder serial number. (Predicate)	Full disclosure ECG, with pacing and patient event markers. Recording date and time. Patient name and record number (only if permitted by user). Recorder serial number. (Matches essential data points, with reasonable variations like voice recording not present but not critical for ECG recording, and encrypted record replaced by user-permitted name/record number and internal memory data transfer method).
Pacemaker Detection	Yes	Yes (Matches criteria)
Power Source	Battery, rechargeable or disposable	Battery, rechargeable (Meets criteria)
Biocompatibility	Compliance with ISO 10993-1: 2009 for patient-contact materials.	Test results indicated that the patient-contact materials in the Eclipse PRO and accessories comply with the applicable Standard and guidance document.
Software Robustness	Designed and developed according to a robust software development process, verified and validated, compliant with FDA guidance documents (e.g., "The content of premarket submissions for software contained in medical devices," "General principles of software validation"), IEC 62304: 2015.	Test results indicate that the Eclipse PRO complies with its predetermined specifications, guidance documents and Standards.
Electrical Safety	Compliance with IEC 60601-1: 2012 and IEC 60601-1-11: 2015.	Test results indicated that the Eclipse PRO complies with the applicable Standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2: 2014.	Test results indicated that the Eclipse PRO complies with the applicable Standard.
Performance Testing – Bench	Compliance with internal requirements, IEC 60601-1-6: 2013, IEC 60601-2-47: 2012, IEC 62366-1: 2015, and inter-operability guidance.	Test results indicated that the Eclipse PRO complies with internal requirements, applicable Standards, and the guidance document.

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.