(252 days)
The CK100 CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) Monitoring. The following is a listing of the most frequent indications for use:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
- Evaluation of patients for ST segment changes.
- Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
- Clinical and epidemiological research studies.
- Reporting of time and frequency domain heart rate variability.
- Reporting of QT Interval.
The CardioKey Hotter Recorder, Model CK100, is an ambulatory ECG recorder which is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Lead wire and 3) a host application.
The Sensor is a USB dongle that acquires ECG data and stores the data in nonvolatile memory. The Sensor is worn for up to 14 days and operates on one coin cell battery for the duration of the recording period. This Sensor can plug directly into a host computer's USB port for data transfer.
The female end of the lead wire cable assembly plugs onto the Sensor. The lead wire cabling on the other end of the assembly is connected to the User via two electrodes
The host application extracts user data from the Sensor and translates it to processing by a 510(k) cleared third party analysis software.
The provided text describes the CardioKey Holter Recorder, Model CK100, a medical device for ambulatory ECG monitoring. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics, ground truth establishment, or sample sizes for test and training sets.
The document states that the device "meets the requirements of following performance standards" and lists:
- ANSI/AAMI EC 38:2007 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
- IEC60601-1:1988+A1:1991+A2:1995 - Medical Electrical Equipment - Part 1: General Requirements for Safety
- IEC60601-1-2:2007 Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
These are general safety and performance standards for medical electrical equipment, not specific, quantitative acceptance criteria with corresponding device performance metrics. The document does not provide any specific "reported device performance" against quantitative acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text.
Based on the provided information, I can answer some of the other requested points:
1. A table of acceptance criteria and the reported device performance
- Not provided in the text. The document states compliance with general medical device standards (ANSI/AAMI EC 38:2007, IEC60601-1:1988, IEC60601-1-2:2007) but does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular arrhythmia detection) or corresponding reported device performance for these criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the text. No information on a specific test set, its size, or data provenance is mentioned. The "Summary of Performance Testing" refers to compliance with safety and performance standards generally, not a specific clinical or performance evaluation study.
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)
- Not applicable/Not provided. Since no specific test set and ground truth establishment are detailed, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is mentioned as there's no detailed test set described.
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
- Not applicable. This device is a Holter recorder, a data acquisition device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided/Not fully applicable. The device records ECG data and stores it for processing by a "510(k) cleared third party analysis software." The document does not describe the performance of this third-party analysis software or any standalone algorithm performance testing of the recorder itself beyond its ability to record and store data according to general standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No specific ground truth type is mentioned as there is no detailed performance study described.
8. The sample size for the training set
- Not applicable/Not provided. This device is a hardware recorder, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).