(177 days)
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.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).