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The 3M™ Littmann® Electronic Stethoscope, Model 4100, is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds of the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.

The 3M™ Littmann® Electronic Stethoscope, Model 4100 is a healthcare device that picks sounds of the heart, arteries, veins, lung and other internal organs, electronically amplifies, filters, and transfers them to the user's ears via an active speaker and passive sound tubes.

The Model 4100 provides three filter frequency modes for auscultation: Bell (20-200 Hz), Diaphragm (100-500 Hz) and "Extended Range" (20-1000 Hz), This stethoscope provides amplification and includes features that permit it to record and store sounds on each of its six soundtracks. The recordings of the heart, lung, and other body sounds can be up to eight seconds in length on each soundtrack. The Model 4100 can play back the recordings at normal or half speed.

The Model 4100 has an infrared data transmission port that permits the recorded sounds to be transferred to another Model 4100 or to a Littmann Electronic Stethoscope Model 4000. The sounds may also be transferred to an IBMcompatible personal computer (PC) equipped with an infrared port and Windows 98/2000/XP, or to a hand-held device (i.e. a Pocket PC with Operating System 2002/2003 or Palm Pilot with Operating System 4/5).

The Model 4100 includes a liquid crystal display (LCD) on the chestpiece that displays the following information:

• Heart Rate
• Volume Level
• Track Number
• Record and Playback
• Speed of Playback (Half Speed or Normal)
• Transmit and Receive Mode
• Filter Frequency Mode
• Low-battery Indicator

The Model 4100 incorporates embedded software. The embedded software controls all of the various features found in the Model 4100 stethoscope, such as volume control, frequency mode selection, LCD display, record and playback, and the infrared data transfer. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope; DSP produces the bell, diaphragm, and "extended range" frequency response modes that are used to listen to heart, lung, and other body sounds.

The Model 4100 does not incorporate any off-the-shelf (OTS) software.

The Model 4100 operates on two (2) AAA alkaline batteries.

Device modifications that are the subject of this submission include a substitution of the microphone and minor changes to software and circuits to accommodate the change. The design and materials used for the chestpiece diaphragm were also modified to accommodate this change.

The provided text is a 510(k) premarket notification for the 3M™ Littmann® Electronic Stethoscope, Model 4100. This is a submission for a medical device that demonstrates substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested categories (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of document. The document focuses on demonstrating that the new device (Model 4100) is substantially equivalent to an existing legally marketed device (Model 4000) based on features, intended use, and materials.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit "acceptance criteria" with quantitative performance metrics in the way one might expect for an AI/CADe device. Instead, the "acceptance criteria" here is essentially demonstrating "substantial equivalence" to the predicate device (Model 4000) for regulatory approval. The reported "performance" is a comparison of features.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not applicable. This document is a regulatory submission demonstrating substantial equivalence, not a clinical trial with a test set of patient data.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth from experts is not a component of this type of regulatory submission. The assessment relies on a comparison to a previously cleared predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There is no test set or adjudication process described.

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

• Not applicable. This is not an AI/CADe device comparison study. The device is an electronic stethoscope, not an AI enhancement for human readers.

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

• Not applicable. This device is not an algorithm for standalone performance assessment. It is a diagnostic tool used by a human.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. The basis for approval is "substantial equivalence" to a predicate device, not correlation with a "ground truth" established through clinical data. The "truth" is that the predicate device is already legally marketed and considered safe and effective for its indicated use.

8. The Sample Size for the Training Set

• Not applicable. This document does not describe a machine learning model or a training set. The device incorporates "embedded software" with "digital signal processing," but the training of a model is not discussed.

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

• Not applicable, as there's no mention of a ground truth for a training set in this document.

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