(142 days)
The SensiCardiac Mobi 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 SensiCardiac Mobi are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
The SensiCardiac Mobi Diagnostic Heart Murmur Application is a decision support device intended to acquire, record, and anlyze heart sounds. It is used to distinguish between normal/ physiological and pathological heart murmurs by recording the acoustic signal of the heart by means of an electronic stethoscope.
The complete system is a software application comprising Sensi Diagnostic Heart Murmur Algorithm that runs on a hosted server environment with Linux operating system, a hand held device to capture patient data, instructions for use and the electronic stethoscope that captures the acoustic heart signals. The user must provide a compatible electronic stethoscope.
SensiCardiac Mobi is a decision support software package intended to assist medical examiners in heart auscultation.
The SensiCardiac Mobi system consists of the following components:
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- The Sensi Diagnostic Heart Murmur Algorithm running within a hosted environment with TCP/IP interfaces to:
- o a hand held mobile device (iPhone 4S or later)
- o A database with patient and health worker information
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- A hand held mobile device (iPhone 4S or later) with the following uses:
- o electronic transfer of the medical device data (TCP/IP interface)
- o the electronic interfacing and conversion of the electronic stethoscope audio signal.
- o The electronic display of medical device data.
- o Capturing of basic patient information.
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- A compatible electronic stethoscope with characteristics
- o Recording Frequency Range: 20 Hz to 10,000 Hz
- o Sampling Frequency: > 4.000 Hz
- o Data Recording: Standard .wav files at resolution of 16bit, mono
- Recording Time: o minimum 10 sec, maximum 30 sec
- o Electronic stethoscope: compatible model: ThinkLabs Medical ds32a+
- Number of Sensors: o 1
The Sensi Diagnostic Heart Murmur Algorithm distinguishes between normal/ physiological and pathological heart murmurs by analyzing the acoustic heart signals captured with an electronic stethoscope. The device will record the acoustic sound of the hear at the four main auscultation positions. The acoustic heart signal is analyzed to identify heart sounds that may be present, identified sounds include S1, S2 and suspected murmurs.
The Sensi Diagnostic Heart Murmur Algorithm or the application running on the hand held mobile device does not control the medical device (electronic stethoscope) or actively monitoring the patient.
Acceptance Criteria and Device Performance
| Study Title | Acceptance Criteria (from study type) | Reported Device Performance (from study results) |
|---|---|---|
| Development of a Pediatric Cardiac Computer | ||
| Aided Auscultation Decision Support System | Not explicitly stated, but implied to demonstrate diagnostic capabilities (sensitivity/specificity). | Specificity of 94% and sensitivity of 84% (relative to golden standard - echo) |
Study Details:
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Sample size used for the test set and the data provenance:
- Test set sample size: 1568 heart sounds.
- Data provenance: Not explicitly stated but the "APCA Clinical Report" suggests a clinical setting. It's unclear if the data is retrospective or prospective, or the country of origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document only mentions "golden standard - echo" and "all patients were echoed," indicating that echocardiography results were used as the ground truth, but not the number or qualifications of experts interpreting these echoes.
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Adjudication method for the test set:
- Not specified. The ground truth was established by echocardiography, but the method for resolving discrepancies among echo interpretations (if multiple were involved) or for correlating echo findings with heart sounds is not detailed.
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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:
- No MRMC comparative effectiveness study involving human readers with and without AI assistance was reported in the provided text. The studies focused on the standalone performance of the device and its usability.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The "Development of a Pediatric Cardiac Computer Aided Auscultation Decision Support System" reports on the specificity and sensitivity of the algorithm itself, comparing its output to the "golden standard - echo."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Echocardiography (echo) was used as the "golden standard" for establishing ground truth, as mentioned in the "Development of a Pediatric Cardiac Computer Aided Auscultation Decision Support System" and the "APCA Clinical Report."
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The sample size for the training set:
- Not specified in the provided text. The document refers to validation and verification studies but does not detail the training set size for the algorithm's development.
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How the ground truth for the training set was established:
- Not specified. The document mentions the use of echocardiography as a "golden standard" for ground truth in evaluation studies, but it does not describe how ground truth was established specifically for the training data used to develop the Sensi Diagnostic Heart Murmur Algorithm.
§ 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.