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The IMEDIPLUS Electronic Stethoscope DS3011A is intended for the detection, amplification and recording of sounds from the heart, lungs, 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 diagnostic purposes in clinic or hospital.

The IMEDIPLUS Electronic Stethoscope DS3011A 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. When picking up the sounds, the phonogram of sounds could simultaneously display after pushing the button 'OK' or 'REC' for recording. When you auscultate with DS3011A, the sounds are conducted simultaneously to the user's ears bilaterally by active speaker embedded at the bottom of the IMEDIPLUS Electronic Stethoscope DS3011A. At the meantime, sound processing is operated with the aid of a digital signal processor. The IMEDIPLUS Electronic Stethoscope DS3011A could identify the recording number by 1-D barcode reader, indicate the sound location by intuitive keypad, and record the sounds from different sites. The one-hand user interface includes a full-color OLED display, 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. After opening the Electronic Stethoscope DS3011A with your setting password and connection with a wireless device by Bluetooth, the IMEDIPLUS Electronic Stethoscope DS3011A could transmit digital data of recorded sounds under the operation of IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) installed in the connected device. The IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) will only operate under the user's authorization with the seething password. The IMEDIPLUS DS3011A-DM Software (IMEDIPLUS DS3011A-Datamanagement Software) installed in mobile device provides the users to connect with the IMEDIPLUS Electronic Stethoscope DS3011A, receive the recorded data of sounds, storage the data, display the phonograms, and replay the recorded audio data with the speaker of effective frequency range from 20 to 1000Hz. The IMEDIPLUS Electronic Stethoscope DS3011A could also exchange audio data with an external personal computing device by micro SD card. Every single audio file stored in the micro SD card was labeled with the user's ID, recording number and indicated position. The IMEDIPLUS Electronic Stethoscope DS3011A does not incorporate any other off-the-shelf (OTS) software. The recorded audio data only can be replayed by the IMEDIPLUS Electronic Stethoscope DS3011A, the IMEDIPLUS Electronic Stethoscope DS301, and the IMEDIPLUS DS3011A_DM Software (DS3011A_Data Management) installed in the mobile device with the speaker of effective range from 20 to 1000Hz. The IMEDIPLUS Electronic Stethoscope DS3011A operates on one (1) NP-120 lithium battery with an included power management system to prolong the battery life.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes used for the Test Set and Data Provenance

• Clinical Evaluation:
  • Sample Size: 15 subjects (4 children, 4 adolescents, and 7 adults).
  • Data Provenance: Not explicitly stated, but given the submission is from Taiwan, it is likely the data originated from Taiwan. The study is described as a "clinical evaluation," implying it was prospectively conducted.
• Bench Testing (Heart Rate Detection & Audio Performance):
  • Sample Size: Not specified for the number of measurements, but the comparison involves three devices: IMEDIPLUS Electronic Stethoscope DS3011A, 3M 3200, and IMEDIPLUS Electronic Stethoscope DS301.
  • Data Provenance: Retrospective comparison against established predicate and reference devices.

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

• Clinical Evaluation:
  • Number of Experts: 4 clinical doctors.
  • Qualifications: Described as "clinically certified and qualified professionals." No further details on their specific specialties or years of experience are provided in this document.

4. Adjudication Method for the Test Set

• Clinical Evaluation: The text mentions "statistical analysis of the questionnaire" and that the medical equipment can meet the "basic principles of safety and effectiveness." It implies that the experts assessed the device's performance based on their clinical judgment of safety and effectiveness, likely through the questionnaire. It does not explicitly state a formal adjudication method like "2+1" or "3+1" for discrepancies.

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

• No, a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study as typically understood for diagnostic accuracy (e.g., comparing human readers with and without AI assistance on a case set) was not explicitly described.
• The clinical evaluation involved 4 clinicians using the device on 15 subjects, but the objective was to confirm safety and effectiveness, not to measure an improvement in human reader performance with AI assistance.
• The comparison studies were primarily bench tests against predicate/reference devices for specific technical functionalities (heart rate detection, audio performance), not human reader performance.

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

• Yes, for certain aspects. The "Bench Testing" for Heart Rate Detection and Audio Performance appears to be standalone algorithm performance, as it compares the DS3011A's objective measures against those of predicate and reference devices, without involving human interpretation or decision-making beyond operating the device for measurement.

7. The Type of Ground Truth Used

• Clinical Evaluation: The ground truth was established through the "clinical evaluation" conducted by "4 clinical doctors." This suggests a form of expert consensus/clinical judgment on the device's safety and effectiveness during actual use or simulated use. It's not explicitly tied to pathology or outcomes data from the subjects in this summary.
• Bench Testing (Heart Rate & Audio): The ground truth for these tests would be the established performance characteristics or specifications of the predicate and reference devices (3M 3200 and IMEDIPLUS DS301), and objective measurement standards for heart rate and audio frequency.

8. The Sample Size for the Training Set

• The document describes the device itself and its performance, but does not mention any AI or machine learning components that would require a "training set." The device is an electronic stethoscope that amplifies, records, and processes sounds, not an AI diagnostic tool that learns from data. Therefore, the concept of a training set is not applicable here.

9. How the Ground Truth for the Training Set was Established

• As there's no mention of AI/ML components requiring a training set, this question is not applicable to the provided information.

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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.

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.

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