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PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use.

PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. The device includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, as well as a display screen and buttons. The PrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen of the patient via an adhesive wafer on the back of the device. The PrevisEA is a single-use, disposable unit, which avoids the need for cleaning and disinfection.

The PrevisEA requires no cable connections for operation of the device. Integration of the above components allow auscultation and digital capture of digestive sounds, such as MH4.

Messages are transmitted to the easy-to-read display screen on the front of the device. The PrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health in patients following major abdominal surgery, such as gastrointestinal impairment (GII).

This document, K230769, is a 510(k) premarket notification for the PrevisEA Device. It's important to note that this specific submission is for a change in wording in the device description and states that no new testing was performed for this submission as biocompatibility, electrical safety, shelf-life, and clinical testing were submitted for the original application for K211068.

Therefore, the information regarding acceptance criteria and performance study details would reside in the documentation for K211068, which is the predicate device for this submission and essentially the same device. This document explicitly states: "For this submission, the Subject and Predicate devices are the same. The Subject and Predicate devices have the same intended use/indications for Use, and there are no differences in technological characteristics between the Subject and Predicate devices."

Given the information provided in K230769, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them from this document alone. This document clearly states that no new testing was performed for this submission.

However, based on the information present, I can infer what type of information would have been in the original K211068 submission and highlight what is missing from this current document according to your request.

Here's what can be extracted/inferred from K230769 and what is missing based on your request:

General Device Information (from K230769):

• Device Name: PrevisEA Device
• Regulation Number: 21 CFR 870.1875
• Regulation Name: Stethoscope
• Regulatory Class: Class II
• Product Code: DQD
• Intended Use/Indications for Use: PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use.
• Device Description: PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. It includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, display screen, and buttons. It's a convenient, single-use, disposable unit that attaches to the abdomen via an adhesive wafer. It detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, comparing it to a predefined threshold to determine the presence of abnormal digestive health in patients following major abdominal surgery, such as gastrointestinal impairment (GII).

Addressing Your Specific Points Based on K230769 (and what's missing):

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

   • Information in K230769: This document explicitly states: "No new testing was performed for this submission. Biocompatibility, electrical safety, shelf-life, and clinical testing were submitted for the original application for K211068."
   • Missing from K230769: The actual clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for detecting abnormal digestive health) and the reported performance metrics against those criteria are not present in this document. This would have been detailed in the K211068 submission.

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

   • Missing from K230769: This information is not provided in this document. It would have been part of the clinical study report in K211068.

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):

   • Missing from K230769: This information is not provided in this document. This detail would be found in the clinical study methodology in K211068.

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

   • Missing from K230769: This information is not provided in this document. This detail would be found in the clinical study methodology in K211068.

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:

   • Information in K230769: The device "assists physicians in assessing the digestive health of patients." This implies human-in-the-loop use. However, the exact type of study (MRMC) and the effect size of human improvement are not detailed in this document. It refers to "clinical testing" in K211068.
   • Missing from K230769: Details on a specific MRMC study, if conducted, and the quantitative effect size of AI assistance are not available in this document.

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

   • Information in K230769: The device's description states it "detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health." This suggests the algorithm performs an analysis independently to reach a determination. The device then "displays information which assists physicians." This implies both a standalone algorithmic function and a human-in-the-loop assistance. However, specific standalone performance metrics (e.g., sensitivity, specificity of the algorithm itself) from a standalone study are not provided in this document.
   • Missing from K230769: Direct evidence or results from a dedicated standalone performance study are not detailed here.

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

   • Missing from K230769: The specific method for establishing ground truth (e.g., clinical diagnosis of GII based on patient outcomes, expert review of acoustic data, etc.) is not provided in this document. This would be crucial information in the K211068 clinical study.

8. The sample size for the training set:

   • Missing from K230769: This information is not provided in this document. It would have been part of the development process for the proprietary algorithm mentioned.

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

   • Missing from K230769: This information is not provided in this document. Similar to the test set ground truth, the methodology for the training set would be part of the algorithm development documentation.

In summary, K230769 is a notification about a minor change (wording in the description) to an already cleared device (K211068). It explicitly refers back to the original K211068 submission for all performance and testing details. To answer your questions comprehensively, you would need to review the K211068 documentation.

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PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use.

PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. The device includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, as well as a display screen and buttons. The PrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen of the patient via an adhesive wafer on the back of the device. The PrevisEA is a single-use, disposable unit, which avoids the need for cleaning and disinfection. The PrevisEA requires no cable connections for operation of the device. Integration of the above components allow auscultation and digital capture of digestive sounds, such as MH4. Messages are transmitted to the easy-to-read display screen on the front of the device. The PrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health in patients following intestinal surgery, such as gastrointestinal impairment (GII).

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics for the clinical effectiveness of the PrevisEA device. However, it does mention that "All testing met acceptance criteria" for electrical safety, electromagnetic compatibility, and battery safety. For clinical performance, the acceptance criteria are implicitly tied to demonstrating the device's capability in "listening/capturing the acoustic biomarker, MH4 while in clinical use" and validating its intended use in assessing digestive health.

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

• Sample Size for Test Set: 75 subjects
• Data Provenance: The study involved subjects undergoing intestinal resection surgery, which implies a clinical setting. While the specific country of origin is not explicitly stated, the FDA clearance suggests it was likely conducted in the US or under protocols acceptable to the FDA. The study is prospective as devices were applied at the completion of surgery.

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

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. The output of the PrevisEA device is "information which assists physicians in assessing the digestive health of patients," and it "quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health." The "ground truth" seems to be related to the device's ability to detect MH4 and, implicitly, its correlation with digestive health post-surgery. However, the method for establishing this ground truth (e.g., against a gold standard for "abnormal digestive health") is not detailed.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study described focuses on the device's ability to detect a specific biomarker in a clinical setting, not on comparing the performance of human readers with and without AI assistance.

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

Yes, the described "Clinical Testing - PrevisEA Optimization Trial" appears to be a standalone (algorithm only) performance study. The device itself "detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health." The study demonstrated the device's capability in "listening/capturing the acoustic biomarker, MH4 while in clinical use." There is no mention of human readers interpreting the raw sounds or the device's direct output except that the device "displays information which assists physicians." The focus is on the device's intrinsic ability to detect and quantify MH4.

7. The Type of Ground Truth Used:

The type of ground truth is indirectly a form of outcome data or physiological measurement (acoustic biomarker detection). The device specifically listens for the "MH4 acoustic biomarker" and "quantifies the number of MH4 detections." The study's objective was to demonstrate the device's capability in "listening/capturing the acoustic biomarker, MH4 while in clinical use." The implication is that the detection of MH4 itself serves as the ground truth for the device's primary function, with the ultimate goal of assisting in the assessment of digestive health. However, the direct clinical ground truth for "abnormal digestive health" against which the MH4 detection was validated is not elaborated.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for the training set. The clinical trial described (75 subjects) is presented as a validation or optimization trial, not a training set. The term "proprietary algorithm" suggests internal development, but details on its training are absent.

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

The document does not provide any information on how the ground truth for the training set was established.

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