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The intended use of the ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

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Here's an analysis of the provided text regarding acceptance criteria and study information for the "External Counterpulsation Device with SPO2 Monitoring, Models P-ECP/T1 and P-ECP/TM":

Based on the provided document, there is no information regarding specific acceptance criteria for device performance, nor details about a study that proves the device meets such criteria.

The document is an FDA 510(k) clearance letter, which primarily states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance typically relies on demonstrating equivalence to an existing device rather than necessarily conducting new, extensive performance studies against pre-defined acceptance criteria.

Therefore, the following points will indicate "No information provided" where the requested details are not present in the document.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

No information provided. The 510(k) clearance letter does not describe a test set or data provenance for a performance 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)

No information provided. The 510(k) clearance letter does not describe a performance study involving expert assessment or ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

No information provided. The 510(k) clearance letter does not describe a performance study or adjudication method.

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

No information provided. This device is an External Counterpulsation Device, which is a therapeutic device, not an AI-assisted diagnostic device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No information provided. This is a therapeutic device, not an algorithm-based diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No information provided. The 510(k) clearance letter does not describe a performance study or the type of ground truth used.

8. The sample size for the training set

No information provided. The 510(k) clearance letter does not describe any training set or machine learning components.

9. How the ground truth for the training set was established

No information provided. The 510(k) clearance letter does not describe any training set or how ground truth was established.

Summary of Document Contents Related to Performance:

The document is an FDA 510(k) clearance letter, which confirms that the identified devices are substantially equivalent to predicate devices already on the market. This often means that the manufacturer provided data (e.g., engineering specifications, performance testing against industry standards, or comparison to the predicate device's known performance characteristics) to demonstrate that the new device performs as intended and is as safe and effective as the predicate. However, the letter itself does not contain the details of these performance studies or any specific acceptance criteria used. To find such information, one would typically need to review the full 510(k) submission itself, which is not provided here.

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