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The 3MTM Littmann® TeleSteth Online Auscultation System is intended to provide and control the real time data transfer of body sounds between two 3M Littmann Electronic Stethoscopes Model 3200 over a data network. Patient body sounds may be remotely evaluated in real-time or in store-and-forward mode. The 3M Littmann TeleSteth Online Auscultation System can be used on any person undergoing a physical assessment.

The 3MTM Littmann® TeleSteth Online Auscultation System, used together with the 3MTM Littmann® Model 3200 Electronic Stethoscope (K083903), allows healthcare professionals to share heart, lung and other body sounds with colleagues located across the globe using the internet or a private data network. When operational, 3MTM Littmann® TeleSteth Online Auscultation System software is physically located on a data network server and on each clients PC (see Figure 1 below). Functionally, software that is located on a clients PC establishes a wireless (Bluetooth) communications connection with a 3MTM Littmann® Model 3200 electronic stethoscope on one side and the designated network server (internet or private data network) on the other. When connected in such a way the 3MTM Littmann® Model 3200 electronic stethoscope can transmit heart, lung, and other body sounds through the clients PC to the server using secured and encrypted digital communications. Data sent to the server in such a way can then be sent on to a remotely located client PC where it can be listened to in real time (data streaming mode) by a second 3MTM Littmann® Model 3200 Electronic Stethoscope, or the sound data may be stored on the server database where it can be retrieved and listened to at a later point in time (store and forward mode).

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) Premarket Notification for the 3M Littmann TeleSteth Online Auscultation System, primarily focusing on establishing substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving the device meets the criteria. The document explicitly states: "Information provided in this 510(k) submission shows that the 3M™ Littmann® TeleSteth Online Auscultation System is substantially equivalent in terms of intended use, composition, physical properties and technological characteristics compared to the predicate device, the 3M™ Littmann® Scope-to-Scope Software System (K101834). There are no new questions of safety or effectiveness." This indicates that the approval was based on equivalence, not on independent performance studies with detailed acceptance criteria.

To address the specific points of your request based on the absence of this information in the provided text:

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

• Acceptance Criteria: Not provided in the document.
• Reported Device Performance: Not provided in the document.

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

• Not provided in the document. No specific test set or study data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no test set or ground truth establishment process is described.

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

• Not applicable as no test set or adjudication process is 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. The device is a system for transferring body sounds, not an AI diagnostic tool that assists human readers. No MRMC study is mentioned.

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

• Not applicable as the device is a communication system, not a standalone diagnostic algorithm.

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

• Not applicable as no studies involving ground truth are described.

8. The sample size for the training set:

• Not applicable as no training set or machine learning components are mentioned for this device.

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

• Not applicable as no training set or ground truth establishment process is described.

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The 3M™ Littmann® Scope to-Scope Software System is intended to provide and control the real time data transfer of body sounds between two 3M™ Littmann® Electronic Stethoscopes, Model 3200 over a data network. It can be used on any person undergoing a physical assessment.

The 3M™ Littmann® Scope-to-Scope Software System consists of software on a CD working with two 3M Littmann® Model 3200 Electronic Stethoscopes (cleared under K083903), such that when the software program is installed onto a PC, the software provides and controls real time data transfer of body sounds between two 3M Littmann® Model 3200 Electronic Stethoscopes over a data network. The sound captured by the stethoscope at the Patient site can be heard equivalently at both the Patient and Consulting sites through the Model 3200 headsets. The Scope to Scope Software System can be used on any person underqoing a physical assessment. thereby enabling health care professionals in remote clinics to obtain a second opinion from clinicians in a different location. Both sites' Model 3200 electronic stethoscopes are connected to Microsoft Windowsbased PC's via a Bluetooth wireless link. The two PC's are then connected to each other over a TCP/IP data network. The software allows for the Consulting site to control the Patient site's filter settings remotely when connected. The software also provides for the ability to facilitate verbal communication usinq the stethoscope's 'talk-through' feature that utilizes an expanded frequency range to better capture voice audio. This allows the Consultant to provide verbal cues and/or directions to the Patient site.

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) Premarket Notification for the 3M™ Littmann® Scope-to-Scope Software System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with quantitative acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document primarily describes the device, its intended use, and its classification, and confirms its substantial equivalence to a predicate device for regulatory approval.

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The 3M™ Littmann® Electronic Stethoscope, Model 3200 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from 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 3200 is a healthcare device that picks up sounds of the heart, arteries, veins, lungs and other internal organs with the use of selective frequency ranges. After amplification and filtering, the sounds are transferred to the user's ears via an active speaker and passive sound tubes. The Model 3200 can also exchange audio data with a personal computing device (PC) using wireless Bluetooth link. The user interface includes a 5-button keypad and an LCD display. Sound processing is carried out with the aid of a digital signal processor. The Model 3200 does not incorporate any off-the-shelf (OTS) software. The Model 3200 operates on one (1) AA alkaline, lithium, or NiMH battery.

The provided text describes the 3M™ Littmann® Electronic Stethoscope, Model 3200, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically understood for AI/ML-driven devices.

The submission is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than establishing novel performance metrics or conducting clinical trials for performance acceptance as might be seen for entirely new technologies or AI models.

Therefore, many of the requested sections below cannot be filled with the provided information.

Description of Device and Comparison

The 3M™ Littmann® Electronic Stethoscope, Model 3200, is a healthcare device designed to pick up, amplify, and filter sounds from internal organs (heart, arteries, veins, lungs, etc.) using selective frequency ranges. It transfers these sounds to the user's ears via an active speaker and passive sound tubes. A key technological characteristic noted is its ability to exchange audio data wirelessly with a personal computing device via Bluetooth. The device uses a 5-button keypad and an LCD display for its user interface and carries out sound processing with a digital signal processor. It does not incorporate off-the-shelf (OTS) software.

The submission demonstrates "substantial equivalence" to two predicate devices: the 3M™ Littmann® Electronic Stethoscope, Model 3000 (cleared under K050159), and the 3M™ Littmann® Electronic Stethoscope, Model 4100 (cleared under K051790). This equivalence is based on "intended use, indications for use, composition, physical properties and technological characteristics." The document explicitly states that "There are no new questions of safety or effectiveness."

Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence to predicate devices, specific, quantifiable performance acceptance criteria and a detailed report of the device's performance against these criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) are not provided in the given text. The substantial equivalence argument implies that the new device performs at least as well as the predicate devices for its intended use.

Study Details (Based on the provided text, many fields cannot be filled)

Given that this is a 510(k) for an electronic stethoscope and not a diagnostic AI/ML device, the typical "study" involves demonstrating functional equivalence and safety rather than diagnostic performance metrics like those for an AI algorithm. Therefore, the following information is largely not applicable or not present in the provided text.

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

   • Not applicable / not provided. The submission does not detail a "test set" in the context of an AI/ML algorithm's diagnostic performance study. The evaluation likely involved engineering verification and validation testing to ensure functional requirements were met and that the device performed similarly to its predicates.

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

   • Not applicable / not provided. Ground truth, in the context of diagnostic accuracy for an AI/ML model, is not relevant here. The device amplifies sounds for human interpretation.

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

   • Not applicable / not provided.

4. 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 / not provided. This device is a tool for human clinicians; it does not intrinsically involve AI assistance for "human readers" in a comparative effectiveness study as would be done for an AI diagnostic model.

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

   • Not applicable / not provided. This is an electronic stethoscope, designed for human-in-the-loop use. It does not operate as a standalone diagnostic algorithm.

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

   • Not applicable / not provided. The device's "ground truth" performance would be about its ability to accurately capture and amplify physiological sounds, which is a functional test, not a diagnostic accuracy test against a clinical outcome.

7. The sample size for the training set:

   • Not applicable / not provided. This device does not use an AI/ML training set in the conventional sense.

8. How the ground truth for the training set was established:

   • Not applicable / not provided.

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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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The 3M™ Littmann® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from 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 3000 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 3000 provides two filter frequency modes for auscultation: Bell (20-200 Hz) and Diaphraqm (100-500 Hz). The Model 3000 incorporates embedded software. The embedded software controls all of the various features found in the Model 3000 stethoscope, such as volume control and frequency mode selection. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope: DSP produces the bell and diaphragm frequency response modes that are used to listen to heart, lung, and other body sounds. The Model 3000 does not incorporate any off-the-shelf (OTS) software. The Model 3000 operates on one (1) AAA alkaline battery.

The provided document is a 510(k) Premarket Notification Summary for the 3M™ Littmann® Electronic Stethoscope, Model 3000. It details modifications made to the device's embedded software and asserts its substantial equivalence to a predicate device.

However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the way a typical AI/ML medical device submission would. This is because the submission is for a classic medical device (electronic stethoscope) where the focus is on functional equivalence and safety rather than a diagnostic performance study with statistical endpoints.

Specifically, for the questions asked, the submission does not contain the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information on standalone (algorithm only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Analysis of the Provided Text:

The relevant section for performance and equivalence is "6. Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device." It states:

"The Model 3000 as modified in this special pre-market notification submission is composed of the same or substantially equivalent materials, has the same performance features, same intended use, same indications for use, and same labeling as the Model 3000 predicate device cleared under K041934."

This statement indicates that the manufacturer is demonstrating equivalence based on the device having the same performance features as its predicate, rather than presenting new performance data against specific acceptance criteria. The modifications were to embedded software, and the submission explicitly states: "The modifications included in this submission do not affect the device's intended use or indications for use, performance features, labeling or claims."

Therefore, the "study" proving the device meets acceptance criteria, in this context, is the demonstration of substantial equivalence to the predicate device by asserting that the modifications made do not alter its performance features, intended use, indications for use, or labeling. No specific quantitative performance study with a test set, ground truth, or expert review is mentioned because it's not relevant to this type of submission for this particular device modification.

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The 3M™ Littmann ® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of 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 3000 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 3000 provides two filter frequency modes for auscultation: Bell (20-200 Hz) and Diaphragm (100-500 Hz). The Model 3000 incorporates embedded software. The embedded software controls all of the various features found in the Model 3000 stethoscope, such as volume control and frequency mode selection. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope; DSP produces the bell and diaphragm frequency response modes that are used to listen to heart, lung, and other body sounds. The Model 3000 does not incorporate any off-the-shelf (OTS) software. The Model 3000 operates on one (1) AAA alkaline battery.

The provided text describes the 3M™ Littmann® Electronic Stethoscope, Model 3000, and its submission for 510(k) clearance. The document focuses on establishing substantial equivalence to predicate devices (Model 4000 and Model 2000) rather than providing detailed acceptance criteria and a study to prove they are met.

Therefore, many of the requested details cannot be extracted directly from the given text.

Here's an analysis based on the information available:

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

The document does not explicitly state "acceptance criteria." Instead, it provides a "Comparison of Performance Features" with predicate devices to demonstrate substantial equivalence. These performance features act as de-facto criteria for the new device based on the predicate devices' established performance.

Study Proving Device Meets Acceptance Criteria:

The provided document does not describe a formal clinical study or a specific test report detailing how the Model 3000's performance was rigorously measured against predefined acceptance criteria. Instead, it relies on a comparative analysis with predicate devices to establish substantial equivalence based on similar design and performance features. The underlying assumption is that because the predicate devices were cleared, and the new device is "substantially equivalent" in its relevant performance aspects, it also meets the necessary safety and effectiveness requirements.

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

Not applicable. No specific test set or clinical study is described. The comparison is based on the device's inherent design and specifications relative to the predicate devices.

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

Not applicable. Expert-established ground truth for a test set is not mentioned as part of this 510(k) submission, which focuses on substantial equivalence to existing devices.

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

Not applicable. No test set or human adjudication method is 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 device is an electronic stethoscope, not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm that performs standalone analysis. It is a tool for human practitioners.

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

Not applicable. The submission relies on a comparison of device specifications and intended use against predicate devices, not on a ground truth for diagnostic accuracy. The "truth" in this context is established by the functional parameters matching or being acceptably similar to those of a previously cleared device.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set is mentioned.

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The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended range mode amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode, where some lung and heart sounds may occur, as well as providing low frequency response at a slightly reduced level compared to the bell mode.

The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended range mode amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode, where some lung and heart sounds may occur, as well as providing low frequency response at a slightly reduced level compared to the bell mode.

This 510(k) submission for the 3M Littmann™ Electronic Stethoscope does not provide the detailed acceptance criteria and study data in the format requested. The document describes non-clinical testing for frequency response and gain to establish substantial equivalence to a predicate device, but it does not specify quantitative acceptance criteria or report performance against such criteria in a structured manner.

Here's an breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit table of acceptance criteria or quantitative performance metrics against these criteria is provided in the document. The submission focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing.

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

The document describes non-clinical testing using a "computerized audio analysis system" and a "transducer." This indicates a laboratory setup, not a clinical test set with patient data. Therefore, there's no information about:

• Sample size: Not applicable as it's not a clinical test involving a "test set" of patient data.
• Data provenance: Not applicable. The testing is described as lab-based.

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

Since this was a non-clinical, lab-based test for frequency response and gain, there were no human "experts" establishing ground truth in the clinical sense (e.g., radiologists interpreting images). The ground truth for the frequency response test would be the known input frequencies and amplitudes generated by the swept frequency oscillator.

4. Adjudication Method for the Test Set:

Not applicable. There was no human interpretation or adjudication involved, as it was a non-clinical, instrumental test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The testing described is non-clinical, focusing on the device's physical properties (frequency response and gain) compared to a predicate device. It does not involve human readers using the device with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

The device itself is an electronic stethoscope, designed to be used by a human healthcare professional. The "non-clinical testing" described is effectively a standalone performance test of the device's technical specifications (frequency response and gain) in a controlled lab environment. However, the document doesn't present it as an "algorithm only" study in the modern sense of AI device evaluation. It's a characterization of the physical device.

7. Type of Ground Truth Used:

The ground truth for the non-clinical testing was the known, controlled audio frequencies and amplitudes generated by the "frequency oscillator" and presented to the stethoscope via a transducer. This is objective, physical measurement data, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

Not applicable. This device is an electronic stethoscope, not an AI/ML algorithm that requires a "training set" in the context of machine learning model development. The document describes a physical product.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary of what is available from the provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the 3M Littmann™ Electronic Stethoscope to a predicate electronic stethoscope through non-clinical testing of its physical characteristics (frequency response and gain).

• Acceptance Criteria (Implicit): The implicit acceptance criteria were that the frequency response and gain of the new device should be "substantially equivalent" to the predicate, with intentional differences designed for improvement (e.g., improved bell mode, reduced noise in diaphragm mode, reduced masking in extended range mode).
• Study: A non-clinical study using a computerized audio analysis system.
  • A frequency oscillator swept frequencies from 10 to 5000 Hz.
  • The stethoscope was placed on a transducer receiving these frequencies.
  • A calibrated microphone in the eartip measured the stethoscope's response.
  • The computer recorded and stored this response.
  • This was performed for each of the three frequency response modes.
• Conclusion: The manufacturer concluded that the device performs "as well as, and in many cases substantially better than the predicate electronic stethoscope" based on these measurements, justifying the intentional design differences.

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