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The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.

A digital image capture, storage, and review system for echocardiography.

The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.

Here's a breakdown of the acceptance criteria and study information for the Camtronics Echocardiography System (K992259), based on the provided document:

This 510(k) submission states that performance data and conclusions from clinical/non-clinical test data were "Not required for determination of substantial equivalence for this class of device." This means that a specific study to prove the device meets acceptance criteria, as a primary submission requirement, was not conducted or submitted. The FDA's determination of substantial equivalence was based on a comparison to a predicate device, not on specific performance testing against pre-defined acceptance criteria.

However, based on the principle of substantial equivalence, the implicit acceptance criteria for the Camtronics Echocardiography System are its ability to function comparably to its predicate device, the MPACS "EchoLINK" (K980060), for the intended use of digital image transport and archival in echocardiography.

Below is a table summarizing the implicit "acceptance criteria" (based on predicate device specifications) and the reported performance of the Camtronics device, as well as the information directly asked for regarding a study, even if it wasn't explicitly required for this submission.

Acceptance Criteria and Reported Device Performance

Study Information (Based on K992259 Document)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. The document explicitly states: "Performance data: Not required for determination of substantial equivalence for this class of device." Therefore, no specific test set was used for a performance study.
   • Data Provenance: Not applicable. No test data was required or provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No test set was used, and thus no ground truth was established by experts for a performance study.

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

   • Not applicable. No test set was used.

4. 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 MRMC comparative effectiveness study was done. This device is an image transport and archive system, not an AI-assisted diagnostic tool.

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

   • No standalone performance study was done.

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

   • Not applicable. As no performance study was conducted, no ground truth was established.

7. The sample size for the training set:

   • Not applicable. This device is an image management system and does not rely on machine learning or require a training set in the conventional sense.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

Summary regarding performance studies for K992259:

The FDA determined that for the Camtronics Echocardiography System, "Performance data: Not required for determination of substantial equivalence for this class of device." The clearance was based on substantial equivalence to a legally marketed predicate device (MPACS "EchoLINK" K980060) due to comparable intended use and technological characteristics, features, specifications, materials, and modes of operation. No new safety or effectiveness issues were raised. Therefore, the information typically requested about a study to prove acceptance criteria, including test sets, ground truth, experts, and adjudication, is not applicable to this particular 510(k) submission.

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