(245 days)
The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.
Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data.
The CardioDay V2.5 system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
Patient population includes both adult and pediatric human patients.
CardioDay V2.5 provides the user arrhythmia study and Holter analysis capabilities.
Data acquired may be used for the following indications:
- · Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances,
- · Evaluation of symptoms that may be due to myocardial ischemia,
- · Detection of ECG events that alter prognosis in certain forms of heart disease.
- · Detection and analysis of pacemaker function and failure,
- · Determination of cardiac response to lifestyle,
- · Evaluation of therapeutic interventions,
- · Investigations in epidemiology and clinical trials.
Prescription Device Statement: United States federal law restricts CardioDay to sale by or on the order of a physician.
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, to download and analyze the data, 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.
The provided document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for test and training sets, expert qualifications, or adjudication methods for CardioDay V2.5.
The document states:
- "No clinical testing was performed in order to support safety or effectiveness."
- "Non-clinical testing that has been conducted includes: a. ECG performance testing according to AAMI / ANSI / IEC 60601-2-47; b. Software development life cycle according to IEC 62304; c. Risk management process according to AAMI / ANSI / ISO 14971 and IEC /TR80002-1; d. Usability engineering process according to AAMI / ANSI / IEC 62366-1 and IEC 60601-1-6; e. Security tests to fulfill FDA Guidance for cybersecurity; f. Interface tests to fulfill FDA Guidance for interoperability."
Therefore, I cannot provide the requested table or detailed information as it is not present in the given text.
Summary of what's missing from the document based on your request:
- Acceptance criteria and reported device performance table: Not provided. The document states "No clinical testing was performed."
- Sample size for test set and data provenance: No clinical test set mentioned.
- Number of experts and qualifications for ground truth: No ground truth establishment for a test set mentioned.
- Adjudication method for test set: Not applicable as no clinical test set is mentioned.
- MRMC comparative effectiveness study: Not applicable as "No clinical testing was performed."
- Standalone performance study: Not applicable as "No clinical testing was performed."
- Type of ground truth used: Not applicable as no clinical testing or ground truth is mentioned.
- Sample size for training set: Not applicable as no machine learning training set is mentioned; the device is described as "Holter Analysis Software" that "does not perform any diagnosis of data by itself."
- How ground truth for training set was established: Not applicable for the same reason as above.
§ 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).