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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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