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The Electronic Stethoscope DS101 is intended for the detection, 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 only for medical diagnostic purposes in clinic or hospital.

The Electronic Stethoscope Omni-Steth 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 only for medical diagnostic purposes in clinic or hospital.

The proposed Electronic Stethoscopes Models DS101 and Omni-Steth detect and display the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After amplifying and filtering, the sounds are also sent to the user's ears bilaterally through the active speaker embedded at the bottom of the stethoscopes. Sound processing is conducted with the aid of a digital signal processor. Power to the device is provided by two AAA1.2V batteries. The one-hand operable user interface consists of a full-color OLED display, the Record button, arrow keys, the OK button, and a tube connector to output sounds to the headset consisting of tubes and ear tips.

The proposed devices can detect and display an acoustic based heart rate when presented with consistent heart sounds.

In addition, using a Bluetooth wireless link, the proposed stethoscopes can exchange raw audio data with external devices such as personal computers.

Note: The models DS101 and Omni-Steth are standalone devices and do not require Bluetooth data transfer to fulfill their intended use.

The differences between the proposed stethoscope models DS101 and Omni-Steth are cosmetic: specifically, the design of top housing and keyboard layout. The OLED Display information are identical.

The provided text is a 510(k) premarket notification for a medical device (electronic stethoscopes). It outlines the device's features, intended use, and comparison to predicate devices, along with performance data from non-clinical studies. However, it explicitly states that "clinical testing was deemed unnecessary" because the device's intended use, operating principle, and fundamental technology are the same as existing predicate devices.

Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria through clinical evaluation, an MRMC comparative effectiveness study, or a standalone algorithm performance study. The performance data section focuses on non-clinical evaluations like electrical safety, EMC, software verification, biocompatibility, usability, wireless coexistence, splash water, heart rate performance, and audio performance, primarily through bench testing and comparisons to predicate devices.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not present formal acceptance criteria in a tabular format, nor does it detail specific performance metrics with numerical targets and results for clinical efficacy. Instead, it states compliance with various standards and demonstrates substantial equivalence through comparative bench testing.

Based on the "Performance Data" section, here's a summary of the performance claims and the studies that support them:

2. Sample size used for the test set and the data provenance

• Usability Evaluation (Non-clinical):

  • Sample Size: 15 physicians and 15 registered nurses (Total: 30 participants)
  • Data Provenance: Conducted in San Diego, California and Saint Louis, Missouri, USA. The setting simulated clinic, out-patient clinic, and in-hospital settings.

• Heart Rate Performance Testing & Audio Performance Testing (Non-clinical):

  • These were bench tests comparing the proposed device to predicate devices (IMEDIPLUS Electronic Stethoscope DS3011A and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200). The "sample size" here refers to the number of devices tested, not human subjects or patient data. The document does not specify the number of units tested for these bench tests, or the origin of any acoustic data used for these comparisons.

• For clinical data: The document explicitly states: "There is no difference in the intended use, operating principle, and fundamental technology, in comparison to the predicate device, thus clinical testing was deemed unnecessary." Therefore, no clinical test set was used, and no related sample size or data provenance for clinical data is available.

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

• Since no clinical study was performed, there was no clinical ground truth established by experts in this submission.
• For the Usability Evaluation, 15 physicians and 15 registered nurses participated. Their role was as users of the device for the usability test, not as experts establishing a diagnostic ground truth. No specific qualifications beyond "physician" and "registered nurse" were provided.

4. Adjudication method for the test set

• Not applicable, as no clinical test set or diagnostic adjudication process was described. The usability test involved participants providing feedback, but this is not a diagnostic adjudication.

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, an MRMC comparative effectiveness study was not done. This device is an electronic stethoscope that amplifies and records sounds; it is not an AI-powered diagnostic algorithm that assists human readers in interpreting images or data. The submission focuses on the substantial equivalence of its physical and functional aspects to predicate stethoscopes.

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

• Not directly applicable in the context of an "algorithm only" performance for diagnosis. The device itself is a tool for clinicians. While it performs internal processing (e.g., heart rate detection, sound amplification/filtration), the document does not present it as a standalone diagnostic algorithm in the way AI for medical imaging would be. The performance bench tests (heart rate and audio) could be considered "standalone" in that they evaluate the device's technical output, but not a diagnostic "algorithm" in isolation from human use.

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

• No clinical ground truth (expert consensus, pathology, outcomes data) was used or established because clinical testing was deemed unnecessary.
• For the non-clinical performance tests:
  • Heart Rate Performance: Ground truth was implicitly established by comparing the device's heart rate detection to that of the already cleared predicate devices (3M 3200 and IMEDIPLUS DS3011A) in controlled bench test settings.
  • Audio Performance: Ground truth was similarly established by comparing the audio output (frequency bands) to the predicate devices in bench tests.
  • Usability: "Ground truth" for usability was successful completion of tasks and participant satisfaction, reported through feedback collected during the study.

8. The sample size for the training set

• Not applicable. This submission is for an electronic stethoscope, not a machine learning or AI model that requires a "training set" of data in the conventional sense. The device's functionality is based on established acoustic and electronic principles, not on learned patterns from a dataset.

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

• Not applicable (as per point 8).

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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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