(114 days)
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.
| Category | Acceptance Criteria (Implicit/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1:2018 | Testing demonstrated PrevisEA Device is biocompatible. |
| Electrical Safety | Conformance to safety standards (e.g., IEC60601 1-1:2005 3rd Ed.) | All testing met acceptance criteria and demonstrated safety. |
| Electromagnetic | Conformance to EMC standards (e.g., EN60601-1-2, 2007/03) | All testing met acceptance criteria and demonstrated EMC. |
| Battery Safety | Conformance to battery safety standards | All testing met acceptance criteria and demonstrated safety. |
| Auscultation Performance (Bench Testing) | Demonstrated conformity | Passed/Conforms |
| Clinical Performance | Capability in listening/capturing MH4 acoustic biomarker in vivo; validation of intended use. | Demonstrated capability of capturing MH4 while in clinical use; validated intended use. |
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.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.