(221 days)
The use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).
CardioDirect is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram based on a standard personal computer. It can also be used for a stress test if purchased with the proper interfaces. CardioDirect, when used as an electrocardiograph, has a special interface unit between the external connections (ECG electrodes, treadmill and blood-pressure device) and the computer. It permits either manual or automatic interpretation of electrocardiograms.
The provided 510(k) summary for the CardioDirect device does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the study proving the device meets those criteria. The summary explicitly states that clinical tests were not necessary because the CardioDirect uses the same technology as the predicate device.
Therefore, the device's equivalence was established through non-clinical tests (AAMI EC11, validation tests, ISO 60601-1, ISO 60601-1-2) compared to a predicate device, rather than a standalone clinical study with specific acceptance criteria as you've outlined.
Below is a breakdown of the information that can be extracted or deduced from the provided document, along with explanations for the missing information.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria related to clinical performance are listed in the provided document. The primary acceptance criteria were likely related to compliance with AAMI EC11 tests, general validation tests, ISO 60601-1, and ISO 60601-1-2 for electrical safety and performance, as the device was deemed "equivalent in safety and efficacy to the legally marketed predicate devices." | The device was found to be "equivalent in safety and efficacy to the legally marketed predicate devices" based on compliance with AAMI EC11 tests, general validation tests, and ISO 60601-1, ISO 60601-1-2. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The summary explicitly states, "Clinical tests are not necessary since CardioDirect uses the same technology as the predicate device." Therefore, there was no clinical test set for performance evaluation in the way typically required for new clinical claims. The evaluation was based on demonstrating equivalence to predicate devices through technical standards compliance.
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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: As no clinical test set requiring ground truth establishment was conducted for the CardioDirect device itself, this information is not available.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical test set.
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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
- No: The document does not mention any MRMC study. This device is an electrocardiograph with automatic interpretation, but the clearance was based on equivalence to predicate devices, not on a human-AI comparative effectiveness study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No (in the context of clinical performance): While the device has "automatic interpretation," its standalone clinical performance (algorithm only) was not evaluated through a separate study for this 510(k) clearance. The clearance was based on technical standards and equivalence.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: No clinical test set for performance evaluation.
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The sample size for the training set
- Not Applicable / Not Provided: As "clinical tests are not necessary," and the device uses existing technology, there is no mention of a new training set or its size for the CardioDirect device in this submission. The "automatic interpretation" likely relies on algorithms common to the predicate devices, which would have been developed and validated previously.
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How the ground truth for the training set was established
- Not Applicable / Not Provided: For the same reasons as #7, this information is not available in the provided summary.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).