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SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727), or ﺴ
• other compatible cassette tape recorder. -
  In addition, any ISHNE compatible recording can be read by SyneScope™

EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727), or -
• other compatible cassette tape recorder. -

SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727) -

HolterReader is intended to view and print Holter reports from SyneScope™ p orts of TM and Comment The TW EasyScope™ and SyneCom™ .

SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:

• Patient symptoms such as syncope, dizziness or palpitations. .
• Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
• Function of an implanted pacemaker or defibrillator. .

SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only).

SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.

The provided document is a 510(k) summary for ELA Medical's Holter ECG analysis software and related tools (SyneScope™, EasyScope™, SyneCom™, and HolterReader). It focuses on demonstrating substantial equivalence to predicate devices rather than directly providing acceptance criteria and a study to prove performance against those criteria.

Therefore, the information requested in your prompt regarding specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, and multi-reader multi-case studies is not present in this document.

The document does mention "functional testing" and "software verification and validation testing," but it defers the details to attachments (e.g., Attachment 10.6 for software verification and validation, Attachment 10.9 for safety and performance tests according to AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards, and Attachment 10.4 for field testing). Without these attachments, a complete answer to your request cannot be provided.

Based only on the provided text, here's what can be extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The document mentions adherence to standards (AAMI/ANSI EC38:1998 & IEC 60601-2-47) and functional testing, but it does not present a table of specific quantitative acceptance criteria or device performance metrics against those criteria.

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

The document refers to "functional testing," "software verification and validation testing," and "field testing" but does not specify the sample size of any test set or the provenance of the data (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided 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

The document describes software for Holter ECG analysis and reporting, but it does not mention any MRMC comparative effectiveness study evaluating human reader improvement with or without AI assistance. This type of study is typically associated with AI-driven diagnostic aids. The device's description (Holter ECG analysis software) suggests it's an analysis tool, not necessarily an AI-assisted diagnostic system in the modern sense.

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

While the software performs automated analysis, the document emphasizes its use "under the supervision of licensed and trained practitioners." It does not present a standalone performance evaluation of the algorithm explicitly separate from human oversight. The "functional testing" and "software verification and validation" (references to attachments 10.6 and 10.9) likely cover the algorithm's performance, but the details are not included.

7. The type of ground truth used

The document refers to "functional testing" and "field validation," but it does not explicitly state the type of ground truth data used (e.g., expert consensus, pathology, outcomes data, etc.) for these evaluations. For Holter analysis, ground truth would typically come from expert cardiologist review of ECG recordings.

8. The sample size for the training set

The document does not mention a training set as this is a 510(k) for software functionality and equivalence, not explicitly for a machine learning or AI algorithm in the context of a "training set."

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

As no training set is mentioned, this information is not provided.

Summary of Studies Mentioned (without details):

The document states:

• SyneScope™, EasyScope™, SyneCom™ and HolterReader safety and performance testing: "Safety and performance tests according to the AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards." (Details in Attachment 10.9)
• SyneScope™, EasyScope™, SyneCom™ and HolterReader software verification and validation testing: "Module and functional testing for SyneScope™, EasyScope™, SyneCom™ and HolterReader software applications." (Details in Attachment 10.6)
• SyneScope™, EasyScope™, SyneCom™ and HolterReader field testing: "Field validation protocol and evaluation form completion." (Details in Attachment 10.4)

In conclusion, while the document confirms that various tests were performed to demonstrate that the device performs in a safe and effective manner and complies with relevant standards, it does not provide the specific details of acceptance criteria, quantitative performance, sample sizes, ground truth establishment, or human-in-the-loop study results you requested. These details would likely be found in the referenced attachments.

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