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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 an electronic auscultatory device intended to acquire, record, and analyze heart sounds.

The complete system is a CD comprising software and instructions for use with an included USB transceiver for connection with a PC and capable of wireless communication with a Bluetooth-enabled electronic stethoscope.

Here's an analysis of the acceptance criteria and study information for the Zargis Acoustic Cardioscan (ZAC), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K083309) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance metrics for a novel technology. Therefore, specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding numerical performance results are not explicitly stated in this document.

The document broadly states: "non-clinical performance testing has been conducted to demonstrate the performance of the modified ZAC device and that it meets its intended use." and "A clinical software validation was performed to insure the performance of the enhanced software algorithm."

Based on the limited information, we can infer the implied performance goal is to "identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs." However, no specific metrics for the accuracy of this identification are provided.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "A clinical software validation was performed," but does not provide the number of cases or patients included in this validation.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The device's intended use emphasizes "physician over-read" and "consideration of all other relevant patient data," implying medical professionals are involved in the overall diagnostic process, but their role in establishing ground truth for the validation study is not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated. The document does not describe how discrepancies in ground truth or interpretation were resolved, if multiple experts were involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect Size: Therefore, no effect size of human readers improving with AI assistance is provided. The device is intended to "provide support to the physician" and is "not intended as a sole means of diagnosis," requiring "physician over-read." This implies human-in-the-loop, but a comparative study assessing its impact is not described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance Study: The document does not explicitly present standalone (algorithm-only) performance metrics such as sensitivity or specificity. While "analysis procedure will identify specific heart sounds," the performance of this identification in isolation is not separately quantified. The emphasis is on its use "in conjunction with physician over-read."

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated. Given the nature of heart sound analysis, it's highly probable that the ground truth would have been established by expert clinical assessment (e.g., cardiologists interpreting auscultation, possibly combined with other diagnostic tests like echocardiography), but this is an inference, not a direct statement from the document.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not mentioned or provided in the document.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set Establishment: Not mentioned or provided in the document.

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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 patients' heart sounds.

The product acquires and records the acoustic signals of the heart and analyzes 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 an electronic auscultatory device intended to acquire, record, and analyze heart sounds.

The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.

The provided text describes the Zargis Acoustic Cardioscan (ZAC) device and its 510(k) submission (K060197). However, it does not contain specific acceptance criteria, detailed study results, or the methodological specifics requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance details, or types of ground truth used to define criteria or evaluate performance).

The documentation states that:

• "non-clinical performance testing has been conducted to demonstrate the performance of the ZAC device and that it meets its intended use."
• "A comprehensive list of verification and validation testing was performed..."
• "Software verification... was performed at the module and system level."
• "The integrated ZAC system was further evaluated to verify the graphic user interface software and the ZAC system as an integrated product."
• "Validation of the ZAC was performed to ensure that the ZAC device consistently fulfills its intended use and the needs of the user. A clinical software validation was performed to insure the performance of the enhanced software algorithm."

Despite these statements, the document does not elaborate on the specific metrics, thresholds, or outcomes of these tests that would constitute 'acceptance criteria' or 'reported device performance' in a measurable way. It largely focuses on substantial equivalence to a predicate device (K031517, K042128) based on design, technological characteristics, indications for use, and a general assertion of performance testing.

Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.

Here's what can be extracted and what cannot:

Acceptance Criteria and Reported Device Performance

Detailed Study Information

1. Sample size used for the test set and the data provenance: Not specified in the provided text.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
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: Not specified in the provided text. The device is intended to "provide support to the physician" and "is not intended as a sole means of diagnosis," implying an AI-assisted workflow, but no MRMC study or effect size is reported.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The phrase "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" suggests that standalone performance, if evaluated, was not considered sufficient for clinical use. No specific standalone performance metrics are provided.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified in the provided text. It only mentions "identif[ying] specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs." How the "presence" of these sounds was definitively established for validation is not detailed.
7. The sample size for the training set: Not specified in the provided text.
8. How the ground truth for the training set was established: Not specified in the provided text.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence and general safety/performance rather than providing detailed clinical study results with specific quantitative metrics and methodologies.

Ask a specific question about this device

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.

Ask a specific question about this device

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 an electronic auscultatory device intended to acquire, record, and analyze heart sounds. Heart sounds identified are S1, S2 and suspected murmurs.

The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.

The provided text describes the Zargis Acoustic Cardioscan (ZAC) and its 510(k) summary, but it does not contain the specific details required to answer all parts of your request comprehensively. The document focuses on showing substantial equivalence to predicate devices and general validation, rather than an in-depth clinical study with detailed performance metrics and ground truth establishment.

However, based on the available information, here's what can be extracted and what remains unknown:

Acceptance Criteria and Study Details for Zargis Acoustic Cardioscan (ZAC)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for specific performance metrics (e.g., sensitivity, specificity for murmur detection) or report precise numerical device performance results against such criteria. It generally states that "non-clinical performance testing has been conducted to demonstrate the performance of the ZAC device and that it meets its intended use" and that "A clinical software validation was performed to insure the performance of the heart sound detection algorithm."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document mentions "A clinical software validation was performed," but does not specify the number of cases or the origin (country, retrospective/prospective) of the data used for this validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. While the device's output "is only significant when used in conjunction with physician over-read," the number and qualifications of experts involved in establishing ground truth for the validation set are not detailed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The document states the device "is intended to provide support to the physician" and "is not intended as a sole means of diagnosis," implying a human-in-the-loop scenario. However, a formal MRMC study demonstrating improvement with AI assistance is not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document states, "A clinical software validation was performed to insure the performance of the heart sound detection algorithm." This implies a standalone evaluation of the algorithm's performance in identifying heart sounds (S1, S2, suspected murmurs). However, no specific performance metrics from this standalone evaluation are reported.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for its "clinical software validation." Given the nature of heart sound analysis, it is highly likely that ground truth would have been established by a panel of expert cardiologists or auscultation specialists, potentially using a combination of clinical assessment, echocardiography, or other diagnostic information, but this is an inference, not directly stated.

8. The Sample Size for the Training Set

This information is not provided in the document. The document mentions "software verification was performed," but does not detail the size or nature of any training data used for the algorithm's development.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document.

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