(29 days)
The eKuore Pro Series is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro Series is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
eKuore Pro Series is formed by eKuore Pro Series device and eKuore Pro App.
The eKuore Pro Series device introduce three different models:
- . eKuore Pro, the basic version of the stethoscope.
- eKuore Pro Amplified, that has a higher sound amplification designed for . people with hearing problems
The main purpose of eKuore Pro Series device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges. eKuore Pro and eKuore Pro Amplified creates a WLAN access point, to which the client is able to connect via Wi-Fi with smartphones and tablets, to send the data acquired during auscultation to the eKuore Pro App.
The design of eKuore Pro Series lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
The main purpose of the eKuore Pro Series App is to get the acoustic signals from the eKuore Pro Series WLAN access point. Once the device is turn on, a new Wi-Fi signal could be detected by the smartphone/tablet, the signal name contains the last 6 digits of the serial number of the device for its identification.
After the connection, the eKuore Pro App displays the acoustic signal as a phonogram in real time, in the monitor screen there is a record button. When it is pressed the recording start, there is defined a record maximum duration of 30 seconds, it could be changed on the App configuration to 60. 90 or 120 seconds. To stop the record the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet, each recording is stored named with the date and time of the moment of the record.
eKuore Pro App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Pro App lets the user share the records.
Furthermore, eKuore Pro App has a tutorial to help the user and one "About App" screen where access to support is available.
The provided text describes the eKuore Pro Series device, an electronic stethoscope, and its substantial equivalence to a predicate device (3M Littmann Electronic Stethoscope Model 3200, K083903) for FDA clearance. The document lists the general acceptance criteria of regulatory compliance and some performance characteristics but does not contain specific numerical acceptance criteria or detailed study results for the eKuore Pro Series device's performance.
Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numerical values for the eKuore Pro Series, nor can I provide details on sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or ground truth for the eKuore Pro Series itself, as this information is not present.
However, based on the information available, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance:
The document primarily focuses on demonstrating substantial equivalence to the predicate device. The acceptance criteria described are mainly regulatory and general performance comparisons rather than specific quantitative thresholds.
| Acceptance Criteria Category | Specific Criteria (from predicate comparison) | eKuore Pro Series Performance (as stated in document) |
|---|---|---|
| Regulatory Class | Class II | Class II (Identical to predicate device) |
| Classification Name | Electronic Stethoscope | Electronic Stethoscope (Identical to predicate device) |
| Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 (Identical to predicate device) |
| Product Code | DQD | DQD (Identical to predicate device) |
| Indications for Use | Detection and amplification of sounds. | |
| Use on all persons for physical assessment. | Detection and amplification of sounds. | |
| Use on pediatric and adult patients for physical assessment/diagnostic decision support. (Similar to predicate device) | ||
| Principles of Operation | Device picks up, filters, amplifies, and sends sounds to user via earbuds/Bluetooth. | Device picks up, filters, amplifies, and sends sounds to user via earbuds/WiFi (Similar to predicate device) |
| Clinical Conditions | Human body sounds related | Human body sounds related (Identical to predicate device) |
| Use | Electronic stethoscope | Electronic stethoscope (Identical to predicate device) |
| Prescription/O.T.C. | Prescription use | Prescription use (Identical to predicate device) |
| Intended for Direct Connection to Patient | Yes | Yes (Identical to predicate device) |
| Use Environment | Clinical settings | Clinical settings (Identical to predicate device) |
| Cleaning & Maintenance | Cleaning between each patient use. | Cleaning between each patient use. (Identical to predicate device) |
| Sound Track Transfer Function | Yes | Yes (Identical to predicate device) |
| Wireless Data Transmission | Audio | Audio (Identical to predicate device) |
| Signal Input Method | Sound waves collected via Transducer. | Sound waves collected via Transducer. (Identical to predicate device) |
| Biological Equivalence (Body material) | ABS | ABS (Identical to predicate device) |
| Biological Equivalence (Contact with human tissues) | Chestpiece in contact with patients' skin. | Chestpiece in contact with patients' skin. (Identical to predicate device) |
| Sterility | Not intended to be sterilized | Not intended to be sterilized (Identical to predicate device) |
| Performance Requirements (Temperature Range) | -30°C to 40°C | 0°C to +40°C (Similar to predicate device) |
| Performance Requirements (Humidity Range) | 15% to 93% | 15% to 93% (Similar to predicate device) |
| Acoustic Performance | Not explicitly stated numerical criteria for predicate. | "Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting in all devices with similar acoustic characteristics." |
| Electrical Safety & EMC | Compliance with AAMI ANSI ES 60601-1:2005+A1:2012 and IEC 60601-1-2 Edition 4: 2014-02 | Successfully completed. |
| Software Life Cycle | Compliance with IEC 62304:2015 | Successfully completed. |
| Usability | Compliance with AAMI ANSI IEC 62366:2007 | Successfully met. |
| Risk Management | Compliance with ISO 14971:2007 | Identification, evaluation, and control of potential hazards performed. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided text. The document mentions "An acoustic performance comparison between eKuore Pro Series and 3M Littmann electronic stethoscope model 3200 has been performed" but does not detail the sample size (e.g., number of recordings, number of patients).
- Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the use of experts for establishing ground truth in the context of the acoustic performance comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No MRMC study is described. The device is an electronic stethoscope that filters and transfers sounds, not an AI-assisted diagnostic tool in the sense of offering interpretations or classifications that would involve human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device functions as an electronic stethoscope, amplifying and transferring sounds. Its primary performance claim is related to acoustic characteristics and signal acquisition, which would likely be evaluated in a "standalone" fashion (device output compared to a reference signal or predicate device output). The statement "Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting in all devices with similar acoustic characteristics" suggests a standalone evaluation, but specific metrics and methodology are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the acoustic performance comparison, the "ground truth" would likely be a reference acoustic signal or the performance of the predicate device. However, the exact nature of this "ground truth" (e.g., gold standard recordings, simulated sounds with known characteristics) is not specified.
8. The sample size for the training set:
- Not applicable/Not specified. The document does not describe machine learning or AI components that would require a "training set" in the conventional sense for image or signal classification. The device appears to be a signal processing and transmission tool.
9. How the ground truth for the training set was established:
- Not applicable/Not specified as there is no apparent training set mentioned.
§ 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.