(138 days)
The doctorgram™ Stethoscope DES-I is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The doctorgram™ Stethoscope DES-I is intended for use on pediatric and adult patients. The doctorgram™ Stethoscope DES-I is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
The doctorgram™ Stethoscope DES-I (hereafter referred to as DES-I stethoscope) is a digital stethoscope device designed for use by health care professionals as well as lay users in clinical or non-clinical environments. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing or can transmit the data for telemedicine use. It also enables regular users to listen to their body sounds (lungs, heart, arteries, veins, Gastrointestinal tract, etc.) and record and share it with their physicians. It consists of two primary components: 1) The DES-I stethoscope handheld piece, a stand-alone electronic stethoscope and 2) Doctor's Ear, a mobile application that pairs with the Doctorgram Stethoscope.
The provided document is a 510(k) premarket notification for the doctorgram™ Stethoscope DES-I. It primarily focuses on demonstrating substantial equivalence to a predicate device (Eko CORE Electronic Stethoscope System).
Therefore, it does not contain the detailed acceptance criteria and study information (including sample sizes, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies) typically found in a clinical study report for a diagnostic AI device aiming to establish its own clinical performance or effectiveness against a control group.
Instead, the document relies on demonstrating that the new device has "similar overall operational and technological characteristics" to the predicate device and that performance testing showed it "functioned as intended" and has a "safety and effectiveness profile that is similar to the predicate device."
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document describes performance testing in a general sense ("bench verification, as well as software verification and validation. Electrical safety and EMC were successfully conducted, and Bluetooth SIG Qualification were obtained. The OTC use of the device was assessed in usability testing with passing results.").
However, it does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio requirements) or the actual numerical performance results of the doctorgram™ Stethoscope DES-I against those criteria. The primary performance claim is substantial equivalence to the predicate, which implies meeting general functional and safety standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any performance testing.
- Data Provenance: Not specified. The document mentions "usability testing with passing results" but offers no details about the participants or data sources.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The nature of the device (an electronic stethoscope for sound amplification, filtering, and transmission) suggests that "ground truth" might relate more to technical accuracy of sound reproduction and transmission rather than a diagnostic interpretation requiring expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as detailed clinical performance testing with "ground truth" adjudication is not 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:
- No MRMC comparative effectiveness study is mentioned. This device is an electronic stethoscope, not an AI-powered diagnostic algorithm designed to assist human readers in interpretation. Its function is to capture and transmit sounds.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the typical sense of an "algorithm-only" performance for diagnostic accuracy. The device's standalone performance would relate to its ability to amplify, filter, and transmit sounds accurately, which is covered by "bench verification" and "software verification and validation" but without specific metrics provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Based on the device type, "ground truth" for its performance testing would likely involve objective acoustic measurements and verification against known sound sources, rather than clinical diagnostic ground truth.
8. The sample size for the training set:
- Not applicable. The document does not describe any machine learning or AI algorithm development that would necessitate a "training set." The device's functionality is based on electronic amplification, filtering, and transmission, not on learning from a dataset.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set 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.