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The device is intended to be used by health care professionals in the field of echocardiography. The device is capable of transferring ultrasound images over long distances as digital files. It is used to transmit echocardiograms over the Internet for the purpose of interpretation of echocardiograms at a remote location. It is anticipated that it will be used when echocardiograms must be performed in a location where no interpreting cardiologist is present, and will facilitate prompt interpretation of echocardiograms. It should be particularly useful in rural areas of the United States.

Echoencoder is a combined software-hardware system that is composed of three parts: 1) a system for conversion of analog echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; 2) a system for conversion of digital echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; and 3) an optional Server based database system for tracking of interpretations of the video so obtained.

The system for analog video conversion is composed of a Macintosh computer equipped with the echoencoder software, and a video cassette recording device equipped with a video digitizer. The cassette recorder is interfaced with the computer via a firewire cable. The operator inserts a video cassette into the video cassette recorder, and uses the software program to convert the video into a Quicktime movie, perform MPEG-4 based video compression to compress the file by approximately 50:1, and transfer the file to a server where it can be subsequently reviewed by a Cardiologist.

The system for digital video conversion is also composed of a Macintosh computer equipped with the echoencoder software, and is interfaced with a health care provider's network server. The operator selects the file to be converted, generally in DICOM format, and the software subsequently converts the video into a Quicktime movie, performs MPEG-4 based video compression to compress the file by approximately 25:1, and transfers the file to a server where it can be subsequently reviewed by a Cardiologist.

The server based database product is, by the customer's option, interfaced with the above described Echoencoder system. This system that is based on the software product Filemaker Pro, and allows for electronic report generation and review.

The provided text describes a 510(k) submission for the "Echoencoder" device but does not contain acceptance criteria or a study proving the device meets specific performance criteria.

The document focuses on demonstrating substantial equivalence to predicate devices (Tel-Echo System K990052 and EchoLINK K980060) based on intended use and technological characteristics, rather than a performance study with defined acceptance criteria.

Therefore, many of the requested sections regarding performance studies, sample sizes, expert ground truth, and adjudication methods cannot be extracted from this document.

Here's an attempt to answer the questions based on the available information, noting the missing data:

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

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

• Sample Size for Test Set: Not applicable. No performance study with a test set is described.
• Data Provenance: Not applicable.

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)

• Not applicable. No performance study with ground truth established by experts is described.

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

• Not applicable. No performance study with a test set requiring adjudication is described.

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 MRMC comparative effectiveness study is mentioned. The device is a "conversion and transfer software system," not an AI-assisted diagnostic tool.

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

• The document implies a standalone function of the software in converting and transferring files, but it doesn't describe a formal standalone performance study with defined metrics. The focus is on the technical capability of conversion and transfer.

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

• Not applicable. No performance study requiring ground truth is described.

8. The sample size for the training set

• Not applicable. The device is not a machine learning or AI-based system that typically requires a training set in the context of diagnostic accuracy. It's a data conversion and transfer system.

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

• Not applicable. As above, this is not a machine learning device.

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