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CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to judge their current cardiac functionality such as patients who have recently received pacemakers.

CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.

This document describes the CardioDay® 2.4 Holter evaluation software.

No acceptance criteria or study demonstrating device performance for CardioDay® 2.4 is provided within the given text.

The submission is a 510(k) summary for CardioDay® 2.4, which states it is substantially equivalent to CardioDay® 2.0 (K070280).

Here's what can be extracted from the provided text:

• No information is provided for the following:
  • Table of acceptance criteria and reported device performance.
  • Sample size used for the test set.
  • Data provenance for the test set.
  • Number of experts used to establish ground truth for the test set and their qualifications.
  • Adjudication method for the test set.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human readers improvement with/without AI. This device does not perform diagnosis, so an AI/human comparison is not applicable in this context.
  • Whether a standalone (algorithm only) performance study was done.
  • Type of ground truth used.
  • Sample size for the training set.
  • How the ground truth for the training set was established.

Key Findings from the 510(k) Summary:

• Device Name: CardioDay® version 2.4
• Predicate Device: CardioDay® 2.0 (K070280)
• Device Function: Software package for trained physicians/healthcare professionals to download, analyze, review, and print reports from long-term continuous electrocardiographic (ECG) recordings. It does not perform any diagnosis by itself but displays ECG morphologies and associated calculated graphs (heart rate trends, RR variability, statistical values).
• Changes from Predicate: Incremental changes in workflow, renaming of menu entries for usability, support for more Holter ECG recorders, and an identical FDA-approved TWA (T-Wave Alternance) algorithm (K032513) were implemented.
• Non-Clinical Testing: ECG performance testing according to AAMI / ANSI / EC 38 and software development life cycle according to AAMI / ANSI / IEC 62304 were conducted. These tests "did not demonstrate that CardioDay® 2.4 brought up any issues of safety or effectiveness."
• Clinical Testing: "No clinical testing was performed in order to support safety or effectiveness."
• Conclusion: The device is considered substantially equivalent to its predicate device with regard to intended use, indications for use, and operating principle. The changes "do not raise any new questions of safety and effectiveness."

In summary, the provided document does not contain an acceptance criteria table or a study proving the device meets specific performance criteria. Instead, it relies on substantial equivalence to a predicate device and non-clinical testing to demonstrate safety and effectiveness.

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CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.

CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.

The provided document describes a Special 510(k) notification for the CardioDay® software, which is a Holter ECG device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (CardioDay® Version 1.9.5, K051471) rather than presenting a performance study with specific acceptance criteria that would typically involve numerical metrics like sensitivity, specificity, or accuracy for an AI/algorithm-driven device.

The "acceptance criteria" in this context are primarily related to the functional equivalence of the new version (CardioDay® Version 2.0) to the predicate device and compliance with relevant medical device standards. The study proving this effectively involves comparing the technical and functional characteristics of the new device to the predicate.

Here's an analysis based on the provided text, addressing your specific points:

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

Since this is a Special 510(k) for a software update rather than a new device with novel AI algorithms, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity) but rather as functional and technical equivalence to the predicate device and compliance with standards. The "reported device performance" is the demonstration that these equivalences and compliances are met.

Below is a summary table based on the document's comparison of the new device (CardioDay® Version 2.0) to the legally marketed predicate (CardioDay® Version 1.9.5). The acceptance criterion implicitly embedded in this type of submission is "maintains all predicate functionalities" and "introduces no new safety or effectiveness concerns."

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 explicitly states: "Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness." This implies there was no formal "test set" of patient data used in the sense of a clinical trial or performance evaluation for the software's diagnostic capabilities. The evaluation was primarily based on a comparison of technical and functional specifications and compliance with standards. Therefore, information on sample size, data provenance, retrospective/prospective nature is not applicable or not provided in this 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)

Since clinical testing was not performed and no patient data test set was used for diagnostic performance evaluation, there were no experts used to establish ground truth for a test set. The submission focuses on software verification and validation, ensuring that the software functions as intended and is equivalent to the predicate device.

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

As no clinical test set was utilized for evaluating diagnostic performance, no adjudication method was applied to a test set.

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 MRMC comparative effectiveness study was done. The CardioDay® software, as described, "does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected." It is a tool for physicians to review and analyze Holter ECG data, not an AI diagnostic algorithm that assists human readers in making a diagnosis from scratch.

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

The software is explicitly stated to be a tool for physicians and "does not perform any diagnosis of data by itself." Therefore, a standalone performance evaluation (algorithm only) designed to establish diagnostic accuracy was not performed nor would it be appropriate for a device with this stated functionality. Its performance is tied to its role as a display and analysis tool for human interpretation.

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

Given that no clinical performance study was conducted, there was no ground truth established for diagnostic accuracy. The "ground truth" for this submission revolves around the software's functional correctness and compliance with its own specifications and relevant standards.

8. The sample size for the training set

The document does not describe any machine learning or AI models requiring a "training set." Therefore, information on the sample size for a training set is not applicable or not provided.

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

As there is no mention of a training set for machine learning/AI, this point is not applicable. The "ground truth" for the software's development likely refers to software requirements specifications, design documents, and medical device standards against which its functionality was verified.

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CardioDay" is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports.

This device is available only upon the order of a physician or other licensed medical professional and not intended for any ambulatory or home applications.

Federal law restricts CardioDay® to use on order of a physician.

CardioDay is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.

WARNING:
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values.

CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.

CardioDay® is a software package which is delivered on CD.

The provided document is a 510(k) summary for CardioDay®, a Holter ECG software. The submission aims to establish substantial equivalence to a predicate device, Holter for Windows®. The document focuses on comparing the new device against the predicate in terms of various characteristics and functionality, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not explicitly available in the provided text. The document primarily makes a claim of substantial equivalence based on comparison rather than a standalone performance study with defined criteria.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a formal table of device performance metrics against such criteria. Instead, equivalence is established through qualitative comparisons of features and functionalities with the predicate device. The performance is implied to be equivalent to the predicate.

Below is a summary of the comparative analysis, which serves as the basis for claiming "performance":

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

The document mentions that "The impact of all parameters, especially those specified above, is evaluated with the help of the data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT) and performance evaluations." This indicates that public domain databases (AHA and MIT-BIH Arrhythmia Database are commonly used for Holter analysis algorithm validation) were used for performance evaluations. However, the specific sample size used from these databases for the test set, or details on data provenance (e.g., country of origin, retrospective/prospective) are not specified in this summary.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for any test set derived from the AHA or MIT databases. These databases typically come with expert-verified annotations, but this fact is not explicitly stated in relation to this device's validation.

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

The document does not describe any specific adjudication method used for a test set.

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 does not mention any MRMC study or any study evaluating the improvement of human readers with or without AI assistance. The device is described as a software for trained professionals to review, edit, and print data, explicitly stating that it "does not perform any diagnosis of data by itself." This implies it's an analysis and presentation tool, not an AI-powered diagnostic aid designed to directly assist human readers in improving their diagnostic accuracy.

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

The document notes that performance evaluations used "data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT)." This implies that the algorithms within CardioDay® were tested against these reference databases, which constitutes a form of standalone performance evaluation. However, specific metrics, methodology, and results are not provided in this summary. The output of the device (ECG morphologies, graphs, statistical values) is then reviewed and edited by human users.

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

Given the mention of AHA and MIT databases, the ground truth for the algorithm evaluation would typically be expert annotations/consensus provided with these publicly available arrhythmia databases.

8. The sample size for the training set

The document does not provide any information about the sample size used for a training set. As a rule-based or conventional signal processing software (not explicitly stated as AI/machine learning), it might not have a "training set" in the modern sense. If it did employ machine learning, this detail is omitted.

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

Not applicable, as no training set information is provided. If the algorithms were trained, the ground truth would likely be derived from expert annotations, similar to the test set ground truth.

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