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The Zargis Acoustic Cardioscan, (ZAC), is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.

The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs.

The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

The ZAC is a computer-assisted auscultatory device, intended to provide support to the target users in the evaluation of heart sounds and murmurs. The product will acquire and record the acoustic signal of the heart, over appropriate regions of the chest, and then analyze these signals. The analysis procedure will evaluate sounds of the heart and aid healthcare providers in identifying murmurs. Results are presented to the user in near real-time.

As a complete system, the ZAC consists of an electronic stethoscope, a laptop computer. software, and a printer.

The provided text describes a Special 510(k) Premarket Notification for a revised Zargis Acoustic Cardioscan (ZAC) system. However, it does not contain acceptance criteria for a study, nor does it present the results of a study proving the device meets specific acceptance criteria.

The document focuses on the changes made to a previously cleared device and argues for substantial equivalence based on these changes not affecting the core method of operation, data acquisition, processing, or existing data analysis. It also discusses safety information and compliance with performance standards in a general sense, but no specific performance metrics or thresholds are provided.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance, nor can I provide details about the study that proves the device meets these criteria. The document explicitly states: "The proposed revisions, included as part of this submission, do not affect the current method of operation, data acquisition, processing, or existing data analysis in any way." This suggests that a new comprehensive performance study with acceptance criteria was not deemed necessary for this specific 510(k) submission, as it relates to minor display and software revisions.

To elaborate on what is available in the document regarding its performance context:

• Device Name: Zargis Acoustic Cardioscan (ZAC)
• Intended Use: To provide support to physicians in the evaluation of heart sounds in patients, by acquiring, recording, and analyzing acoustic signals of the heart to identify S1, S2, and suspected murmurs. It is not intended as a sole means of diagnosis and requires physician over-read.
• Regulatory Class: Class II
• Predicate Device: The original ZAC system, which was cleared by the FDA on May 26, 2004.
• Changes described in this 510(k):
  • Adding a graphical display of timing and energy of suspected murmurs.
  • Revising the Heart Sound Recording Display to remove "mm" label from shaded areas.
  • Changing the wording of summary reports to include heartbeat interval designation for suspected murmurs.
  • Minor software revisions (e.g., shortened analysis time, storing revision level, license expiration, security enhancements).

The key argument for this 510(k) is substantial equivalence to the previously cleared device, not new performance data against acceptance criteria. The document states "There are no changes in intended use of the product, nor any changes in technology."

In summary, the provided text does not contain the information required to answer your specific questions about acceptance criteria and a study proving their fulfillment.

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