(268 days)
The IMEDIPLUS Electronic Stethoscope DS301 is intended for the detection, amplification and recording of sounds from the heart, lung, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
The IMEDIPLUS Electronic Stethoscope DS301 picks up the sounds from the heart, lung, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After detection and amplification, the sounds are transferred to the user's ears via an active speaker and passive sound tubes. It could also identify the recording number by 1-D barcode reader, indicate the sound location by intuitive keypad, and simultaneously record the sounds from different sites.
The one-hand user interface includes a full-color OLED display and an intuitive keypad at the anterior part, a barcode reader at the posterior part, a chest-piece at the superior part, a tube connector for output of sounds at the inferior part, and a recording button at the left part. Sound processing is operated with the aid of a digital signal processor.
The IMEDIPLUS Electronic Stethoscope DS301 could also exchange audio data with an external personal computing device using micro SD card. Every single audio file stored in micro SD card was labeled with the user's ID, recording number and indicated position. And the recorded audio data only can be replayed by IMEDIPLUS Electronic Stethoscope DS301, but cannot be replayed by personal computing device.
The IMEDIPLUS Electronic Stethoscope DS301 does not incorporate any off-theshelf (OTS) software.
The IMEDIPLUS Electronic Stethoscope DS301 operates on one NP-120 lithium battery with an included power management system to prolong the battery life.
The associated accessories include:
- Rechargeable Lithium-ion Battery.
- Battery charger which include adaptor and charger. ●
- Micro SD card for exchange audio data.
Here's an analysis of the acceptance criteria and study information for the IMEDIPLUS Electronic Stethoscope DS301, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain the detailed, granular level of information often found in a full clinical study report, especially regarding specific acceptance criteria and detailed statistical outcomes for each performance metric. The information below is extracted and inferred from the available text.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for each functional aspect. Instead, it relies on demonstrating substantial equivalence to the predicate device (3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200). The "performance" is generally reported as achieving substantial equivalence or compliance with relevant standards.
| Feature / Performance Metric | Acceptance Criteria (Implicitly Substantial Equivalence to Predicate) | Reported Device Performance (IMEDIPLUS DS301) |
|---|---|---|
| Biocompatibility | Low risk based on FDA #G95-1 and ISO10993-1. | Assessed as low risk; no laboratory tests performed. |
| Electrical Safety | Compliance with IEC 60601-1. | Complies with IEC 60601-1. |
| EMC | Compliance with EN 60601-1-2, CISPR 11, etc. | Complies with relevant EMC standards. |
| Software V&V | Compliance with IEC 62304, AAMI TIR45, IEC/TR80002-1. | Complies with all specified software standards. |
| Software Level of Concern | "Moderate" for minor injury. | Considered "moderate" level of concern. |
| Reliability & MTBF | Demonstrated shelf life and operating/storage conditions. | Reports demonstrate shelf life and operational conditions. |
| Battery Safety | Compliance with IEC 62133, UN38.3. | Complies with IEC 62133, UN38.3. |
| Photobiological Safety | Compliance with IEC 62471. | Complies with IEC 62471. |
| Usability | Compliance with IEC 62366, IEC 60601-1-6. | Complies with specified usability standards. |
| Heart Rate Calculation | Substantially equivalent to predicate in 30-180 bpm range. | Substantially equivalent within 30-180 bpm range. |
| Audio Performance | Substantially equivalent to predicate for audio frequency below 1 kHz. | Substantially equivalent for audio frequency below 1 kHz. |
| Clinical Evaluation (Safety & Effectiveness) | Meets basic principles of safety and effectiveness for stated indications. | Questionnaire results showed the device meets basic principles of safety and effectiveness for child, adolescent, and adult patients for heart, chest, bowel, and neck auscultation. |
2. Sample Size Used for the Test Set and Data Provenance
- Heart Rate & Audio Performance Bench Testing: The document doesn't specify a "test set" sample size for these, as these were bench tests comparing the device's output directly against the predicate or known signal inputs. It implies these were direct comparative measurements.
- Clinical Evaluation:
- Sample Size: 3 children, 3 adolescents, and 3 adults. This is a very small sample size.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given "4 testers" are involved, it's likely a prospective observational study in a clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Clinical Evaluation:
- Number of Experts: "4 testers" were used.
- Qualifications: Described as "clinically certified and qualified professionals." No further detail (e.g., specific specialty like cardiologist, years of experience) is provided.
- Bench Testing (Heart Rate & Audio): Ground truth for these technical tests would typically be established by calibrated instruments or the predicate device itself, not human experts in the same way clinical ground truth is established.
4. Adjudication Method for the Test Set
- Clinical Evaluation: Not explicitly stated. Given the small sample size and "questionnaire" mention, it's unlikely a formal adjudication process (like 2+1 reading) was used for ground truth. The "4 testers" might have individually evaluated the device for each subject, and then their feedback collected via questionnaire. It's unclear if there was any consensus building among these testers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance was not conducted or reported. This device is an electronic stethoscope that amplifies and records sounds, not an AI-assisted diagnostic tool in the typical sense for MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is less directly applicable to an electronic stethoscope. The device itself is the "algorithm" in a sense, as it processes sound.
- The bench tests for heart rate calculation and audio performance can be considered "standalone" performance evaluations as they test the device's technical specifications independently. The results for these were:
- Heart Rate Detection: Substantially equivalent to the predicate (3M™ LITTMANN® MODEL 3200) within the 30-180 bpm range.
- Audio Performance: Substantially equivalent to the predicate for audio frequencies below 1 kHz.
7. The Type of Ground Truth Used
- Bench Testing (Heart Rate & Audio): The ground truth was comparative. The performance of the IMEDIPLUS DS301 was compared to the predicate device (3M™ LITTMANN® MODEL 3200) under specified conditions, implying the predicate served as the reference standard.
- Clinical Evaluation: The ground truth was based on the subjective evaluation and professional assessment of "4 clinically certified and qualified professionals" using a questionnaire regarding the "safety and effectiveness" during auscultation. This is closer to an expert consensus/opinion rather than objective pathology or outcomes data.
8. The Sample Size for the Training Set
- The document does not mention a "training set" in the context of machine learning or AI. This device appears to be a traditional electronic stethoscope with digital signal processing, not a device that uses AI models that require specific training data. The "performance data" describes technical and clinical validations, not AI training.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned (see point 8), this question is not applicable.
§ 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.