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The provided text describes the safety and efficacy of exercise testing in general and then discusses the testing procedures for the Cardio Perfect ST device and its components (Cardio Perfect MD units, recorders, and CPCOM cards). However, it does not contain specific acceptance criteria, a standalone study with performance metrics (like sensitivity, specificity, or accuracy) for the device, human-in-the-loop studies, or details about ground truth establishment for a test set.
The information provided focuses more on the design verification, production quality control, and general safety/efficacy of exercise tests from external studies rather than a specific study to prove the Cardio Perfect ST meets defined acceptance criteria.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's a breakdown of what can and cannot be extracted:
Acceptance Criteria and Study Details for K935732
Many of the requested details are not present in the provided text. The document focuses on the general safety and efficacy of exercise testing and internal quality control for the Cardio Perfect ST device, rather than a specific study demonstrating its performance against defined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided. The document describes internal testing procedures for various components but does not quantify performance metrics against specific acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a performance study. The text mentions:
- "About 10 Cardio Perfect MD units were tested for compliance with all system specifications." (Internal design verification)
- "About 450 Cardio Perfect recorders have been produced to date." (Implies these underwent production testing)
- The CPCOM cards are tested "over a period of at least an hour, usually longer" and "one CPCOM card was returned which was reported defective". (Internal quality control)
These are internal testing or production numbers, not a "test set" for a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No external "test set" with ground truth established by experts is described for the Cardio Perfect ST device's performance evaluation.
4. Adjudication Method for the Test Set
Not applicable. No external "test set" requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC study is not mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No detailed standalone performance study is described. The text mentions internal testing for compliance with system specifications and proper operation of components. While these are "standalone" in that they don't involve human interpretation of the device's output for analysis, they are quality control checks, not a clinical performance study with metrics like sensitivity/specificity.
7. The Type of Ground Truth Used
Not applicable. For the internal testing described, the "ground truth" would be the expected electrical signals from simulators or known byte patterns for the CPCOM card. This is for functional verification, not clinical ground truth.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this device is not described as using machine learning or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned.
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Summaria
CARDIO PERFECT ST 510k application K935732.
Summary and Certification. 2.
2.1. Safety and efficacy of exercise testing in general.
SIOLE)
2.1.1. Safety of the exercise test.
Rochmis and Blackburn reported a survey of the safety experience of 170000 exercise stress tests performed in 73 medical centers [9]. Sixteen documented deaths were attributed to the exercise, a mortality of less than I in 10000. Nonfatal complications that required hospitalization within 1 week after the test occurred at the rate of about 3 per 10000. A more recent survey reported 17 deaths among 712285 patients tested (1 in 40000) [6], with nonfatal ventricular fibrillation occurring at a rate of one per 7000 tests, and nonfatal myocardial infarction at a rate of one per 70000 tests.
In a report of 1377 symptom-limited exercise tests performed in 263 patients with histories of ventricular tachycardia or fibrillation, serious but nonfatal arrhythmia complications occurred during 2.3% of the tests, involving 9.1% of the patients [12]. The incidence of such complications in 8221 maximal exercise tests involving 3444 patients without histories of sustained ventricular arrhythmias performed in the same institution was 0.05%.
2.1.2. Efficacy of the exercise test.
Sensitivity and specificity of exercise testing are dependent on a number of variables. Among these are the lead system employed, the (ST) criteria used, and the incidence of CAD in the test population. In a study reported by McNeer and associates in 1978 [8] of 1472 patients, the sensitivity was 57% and the specificity 90%. Deckers [3] reports a sensitivity and specificity, respectively, of 77% and 90% in females and 74% in males, in 1988 at the Thorax Centrum in Rotterdam, the Netherlands. Simoons at the same institute attributes reports of high incidence of both false positives and false negatives in subgroups of patients largely on patient selection.
Both coronary arteriography with angiographic evaluation of left ventricular function and exercise testing can provide prognostic information in patients with CAD [2]. Gollke et al. [5] analyzed the additional prognostic value of exercise testing in 1034 patients with known CAD and normal or mildly impaired left ventricular function. In various subgroups, five-year survival was highest in patients with a better exercise tolerance. For example, in patients with double-vessel disease, five-year survival was 9512% in those with exercise tolerance greater than 110W and only 81±5% in those who performed less than 90W.
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2.2. Safety and efficacy of Cardio Perfect ST.
Unit testing.
A total of about 10 Cardio Perfect MD units were tested for compliance with all system specifications. Some of these were tested in-house as part of the design verification and testing phases of development, and some at institutions like the German TUV for testing of compliance to local and international standards like the IIC-601.
In the volume production, tests are performed to verify correct operation of each produced device.
Recorder testing
After confirming that the optical transmission section of the recorder operates properly, the devices are burnt in for 24 hours. After that, the lead connections, gain, time base etc. are measured by recording an ECG with a simulator. Measurements of these recordings are stored and compared, and the ECG is superimposed on a reference ECG on a color monitor for visual inspection.
Before the unit is sent to the client (which may be after a time of storage), four more ECGs are recorded with standard simulator settings, and compared against reference recordings.
Parameters like defibrillation overload recovery and gain drift are met by design and are not tested for each produced device.
About 450 Cardio Perfect recorders have been produced to date.
CPCOM testing
The first CPCOM tests are performed after production at the same time as testing of the recorders. This is a simple check of proper operation which lasts between one and two minutes (not exhaustive), by recording a resting ECG.
The CPCOM cards are then tested by inserting them into a PC on which special test software is running. A small device generates a pattern of bytes which are sent through the same optical connection as is utilized with the Cardio Perfect recorder. Only, the pattern is known (actually a simple counter), so the software can check every bit ff incoming information. With a standard recorder, only 5 bits in every 2-byte sample are predictable. Also, the baudrate used for testing is the maximum baudrate (460800) which the CPCOM can accommodate, which is eight times faster than needed for a standard Cardio Perfect recorder.
Through a DMA channel on the card, the testing software (a TSR) can monitor two cards in one PC at the same time while allowing the PC to be used for other purposes as well. When errors are encountered, a window pops up to report this fact. The cards are tested in this fashion over a period of at least an hour, usually longer.
To date, one CPCOM card was returned which was reported defective, but the jumper settings turned out not to match the settings the client entered in the program.
0108
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.