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The Electronic Stethoscope is intended for the detection and amplification of sounds from the heart, lungs and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment for medical diagnostic purposes only.

The Mintti Electronic Stethoscope, model smartho-D2 is a healthcare device that picks up sounds of the heart, lungs and other internal organs with the use of selective frequency ranges from 10-2000Hz. After amplification and filtering, the sounds are transferred to the user's ears via an wired-connected headset.

The user interface includes a 5-button keypad and an 1.3' OLED display with a blue back-light. Sound processing is carried out with the aid of a digital signal processor.

The smartho-D2 does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product, including sound capture, digital signal processing, volume control, OLED display and Bluetooth function.

The smartho-D2 operates on a certificated rechargeable 3.7V/2000mAh lithium ion battery.

The provided document is a 510(k) summary for the "Electronic Stethoscope - smartho-D2". It outlines the device's characteristics and its comparison to a predicate device, 3M™ Littmann® Electronic Stethoscope Model 3200 (K083903), to demonstrate substantial equivalence for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in a separate table format. However, it provides a "Specific Comparison to Predicate" table which implicitly serves this purpose by comparing the proposed device's specifications to those of the predicate. The "Comment" column in this table indicates whether the characteristic is "Same" or "Different." For differences, the justification is that they "do not affect the basic design principle, usage, effectiveness and safety of the subject device." The performance testing section further supports these claims.

Here’s a table summarizing the implicit acceptance criteria based on the predicate comparison and the performance demonstrated by the proposed device:

The study that "proves" the device meets these criteria is the "Performance Testing For Substantial Equivalence Evaluation" section, which includes:

• Non-Clinical Data: Biocompatibility testing, Reprocessing (Cleaning and Disinfection) validation, Electrical safety and electromagnetic compatibility (EMC) testing, Bench Testing, Software Verification and Validation Testing, Risk Analysis, and Wireless Function Testing.
• Clinical Data: None submitted.

The overall conclusion is that "The Mintti smartho-D2 Electronic Stethoscope is Substantially Equivalent (SE) to the 3M™ Littmann® Electronic Stethoscope Model 3200 cleared by K083903." This implies that the differences observed do not raise new questions of safety or effectiveness and are addressed by the performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient data. The non-clinical testing refers to testing on the device itself and its components. For example:
  • Biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation) were conducted on the "smartho-D2 Electronic Stethoscope." The sample size refers to the number of devices or components tested, not human subjects.
  • Electrical safety and EMC testing were conducted on "the smartho-D2 Electronic Stethoscope device, consisting of all the modules and accessories."
  • Bench testing was conducted on "the smartho-D2 Electronic Stethoscope device, consisting of all the accessories."
  • The document explicitly states: "No animal or clinical testing was submitted in this 510(k)." This means there was no human or animal test set for performance on biological subjects.
• Data Provenance: Not explicitly stated for specific test data, but the submitter is Hefei Mintti Medical Technology Co., Ltd. China. Given the nature of the non-clinical testing (lab-based), the "country of origin" would likely be the location where these tests were performed, presumably China. The data would be prospective with respect to the tests conducted on the device, as they were performed to support this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• As "No animal or clinical testing was submitted in this 510(k)," there was no human or animal test set requiring experts to establish ground truth in a medical diagnostic context. The ground truth for electrical safety, biocompatibility, and functional performance (e.g., frequency response, amplification) is established by adherence to recognized international standards (e.g., ISO, IEC) and internal company specifications, with the assessment of experts in those respective engineering and scientific fields (e.g., electrical engineers, biocompatibility specialists) who perform the tests and interpret the results against the standard's criteria. Their qualifications are not detailed in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Since no human or animal clinical test set with medical diagnostic outcomes was conducted, there was no adjudication method involving multiple human readers/experts comparing device output to clinical ground truth. The "adjudication" for non-clinical tests would involve comparison of test results against predefined pass/fail criteria from international standards or design specifications.

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 was done. The device (Electronic Stethoscope - smartho-D2) is a simple electronic stethoscope for sound detection and amplification. It does not appear to incorporate AI, nor does the submission mention any AI features or claims of improving human reader performance. The device's function is to assist physicians by amplifying and filtering sounds, not to provide diagnostic interpretations or AI-assisted readings.

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

• The device is a hardware product (an electronic stethoscope) with embedded software for control and signal processing, not a standalone algorithm providing diagnostic output. Therefore, no standalone algorithm performance study was conducted in the sense of an AI algorithm making a diagnosis without human input. The "standalone" performance testing refers to the device's functional performance (e.g., amplification, frequency response) as a physical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical performance testing:
  • Biocompatibility: Ground truth is established by the pass/fail criteria specified in ISO 10993-1.
  • Reprocessing: Ground truth is established by validation results demonstrating effective cleaning and disinfection, presumably against microbial reduction criteria.
  • Electrical safety and EMC: Ground truth is established by compliance with IEC 60601 series standards' requirements.
  • Bench Testing (functionality): Ground truth is established by design specifications (e.g., 10-2000Hz operating range, 100X amplification) that the device must meet, measured against calibrated test equipment.
  • Software V&V: Ground truth is established by functional requirements and specifications that the software must fulfill, validated through testing.
  • Risk Analysis: Ground truth is adherence to ISO 14971 principles and documented mitigation of identified risks.
  • Wireless Function Testing: Ground truth is demonstrated by compliance with FDA Guidance on Wireless Technology, ensuring no adverse effect on safe and effective use.
• No clinical ground truth (expert consensus, pathology, or outcomes data from human/animal subjects) was used, as no clinical studies were submitted.

8. The sample size for the training set

• The document does not mention any "training set" as no machine learning or AI models are described for this device. The device is an electronic stethoscope that amplifies and filters sounds, not an algorithm that learns from data to make predictions or classifications.

9. How the ground truth for the training set was established

• Since there is no mention of a training set or machine learning, this question is not applicable to the information provided in the document.

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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

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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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