(88 days)
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.
| Performance Features | Model 3000 (New Device) | Model 4000 (Predicate Device) | Model 2000 (Predicate Device) |
|---|---|---|---|
| Frequency Response | Bell (20-200 Hz) and Diaphragm (100-500 Hz) modes. | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (20-1000 Hz) modes. | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (100-1000 Hz) modes. |
| Amplification | Up to 25 dB acoustic gain, equivalent to 18 times amplification. | Up to 25 dB acoustic gain, equivalent to 18 times amplification. | Up to 20 dB acoustic gain, equivalent to 14 times amplification. |
| Maximum Sound Level | 140 dB SPL Max | 140 dB SPL Max | 140 dB SPL Max |
| Power Source | One (1) (AAA) alkaline battery | Two (2) (AAA) alkaline batteries | One (1) (AAA) alkaline battery |
| Low Battery Indicator | Includes a low battery indicator | Includes a low battery indicator | Includes a low battery indicator |
| Displays Heart Rate | No | Yes | No |
| Record and Playback Sounds | No | Yes | No |
| Permits Data Transfer of Stored Digital Signals to and from IBM-Compatible PC and Pocket PC and Palm Pilot* | No | Yes | No |
| Volume Control | 8 Step Volume Control | 8 Step Volume Control | Continuous Variable |
| ON/OFF Switch Automatic Shut-off by Electronics | Yes | Yes | Yes |
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.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.