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The Audicor™ Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians.

The Audicor Upgrade System is an add-on device designed to work with the following electrocardiographs:
GE Mac 8
GE Mac Vu
GE Mac 5000
Philips Pagewriter XL

The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data.
The device is intended for use only under the direct supervision of a physician, and is for use on adults (≥ 18 years).

The Audicor Upgrade System is a pocket PC with proprietary software that can be used with several models of existing electrocardiographs to allow clinicians access to the COR (correlated audioelectric cardiography) report including graphical display of MI and LVH conditions as well as display of heart sound waveforms and identification of S3 and S4 heart sounds.

The provided document is a 510(k) summary for the Audicor™ Upgrade System. It describes the device's intended use and substantial equivalence to a predicate device, but does not contain information about specific acceptance criteria or a detailed study proving the device meets said criteria beyond compliance with performance standards.

Instead, the document states: "The Audicor Upgrade System was tested to the applicable requirements of the performance standards, and shown to comply. Laboratory and bench testing indicates compliance to the standard. Based on the results of the engineering/design level tests, it is concluded that the Audicor Upgrade System performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy."

Therefore, I cannot populate most of the requested fields as the detailed study information is not present in the provided text.

Here is what can be inferred or explicitly stated from the document:

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

Study Information (Based on the provided text):

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

  • Not specified. The document only mentions "Laboratory and bench testing" and "engineering/design level tests."

• 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 specified.

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

  • Not specified.

• 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:

  • A formal MRMC study is not described. The device's interpretation features are intended "for consideration by physicians" and are "only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data." This implies a human-in-the-loop scenario, but no specific study quantifying human improvement with AI assistance is detailed.

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

  • The document implies that the device's interpretations are not standalone, as they require "physician overread." No standalone performance metrics are provided.

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

  • Not specified.

• 8. The sample size for the training set:

  • Not specified. The document does not describe the development or training of any algorithms, only testing for compliance and equivalence.

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

  • Not specified.

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