(88 days)
The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software earphones, and a communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner.
The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software; earphones, and communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner.
This 510(k) summary for the E-Steth Electronic Stethoscope (K011898) explicitly states that clinical study information was not submitted for the purpose of demonstrating substantial equivalence. Therefore, the device's acceptance criteria were not established through a clinical study as typically understood for AI-powered diagnostic devices.
Instead, substantial equivalence relied on:
- Nonclinical Testing: Specifications for environmental and electromagnetic compatibility (EMC) testing.
- Predicate Devices: Comparison to legally marketed electronic stethoscopes (Meditron Electronic Stethoscope and 3M Littman Electronic Stethoscope).
- Prior Certification: The product had been tested and certified by France and the European Union.
Given the information provided, it's not possible to populate a table of acceptance criteria and reported device performance derived from a clinical study for this specific device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Clinical Performance) | Reported Device Performance (as per 510(k)) |
|---|---|
| Clinical Performance: Not evaluated through a substantial equivalence clinical study. | Not applicable. Device was not validated via a specific clinical study for this 510(k). |
| Environmental & EMC: Met specifications referencing appropriate voluntary standards. | All product specifications were met. |
| Functional Equivalence: Amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs, similar to predicate devices. | The E-Steth performs these functions. |
| Safety & Effectiveness: Indications for use are consistent with legally marketed electronic stethoscopes and do not raise new issues of safety or effectiveness. | Determined to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. No clinical testing was submitted for the purpose of demonstrating substantial equivalence.
- 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. No clinical testing was submitted.
4. Adjudication method for the test set
- Not applicable. No clinical testing was submitted.
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. This device is an electronic stethoscope, not an AI-powered diagnostic tool in the sense of modern deep learning algorithms for image or signal interpretation. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is an electronic stethoscope that amplifies and records sounds for human interpretation. It is not an "algorithm" in the context of standalone AI performance. The device itself operates as a standalone unit for recording heartbeats analogically, but its ultimate use is in conjunction with a human diagnostician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No specific ground truth for diagnostic performance was established through a clinical study for this premarket notification. Substantial equivalence was based on nonclinical testing and comparison to predicate devices.
8. The sample size for the training set
- Not applicable. This device is an electronic stethoscope and does not involve AI/machine learning models that require a "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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.