(191 days)
The Hippocrat is an electronically amplified device intended for use in projecting the sounds associated with the heart and other internal organs. The Hippocrat records, stores, plays back, and electronically transmits these sounds.
The Hippocrat 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, arteries, and veins and other internal organs. Significant components include a control unit, installation software; and power supply/charger. The user must supply a personal computer with a Microsoft Windows 98, NT 4.0, 2000, or XP operating system, CD-ROM drive, and Infrared Port. The stored sounds can be transmitted via e-mail.
The provided text is a 510(k) summary and associated FDA correspondence for the Hippocrat Model DR300 Electronic Stethoscope. It explicitly states that no clinical testing information was submitted for the purpose of demonstrating substantial equivalence. Therefore, there is no study described that proves the device meets any acceptance criteria, nor are there any acceptance criteria listed in terms of device performance metrics.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
No acceptance criteria or reported device performance for clinical outcomes are provided in the document. The submission focused on demonstrating substantial equivalence to predicate devices (Meditron Electronic Stethoscope, 3M Littmann Electronic Stethoscope - Model 4000) based on intended use and technological characteristics, without requiring clinical performance data.
Study Information (Not Applicable - No Clinical Study Performed)
Since no clinical study was performed or submitted, the following points are not applicable:
- Sample size used for the test set and the data provenance: N/A
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
- Adjudication method for the test set: N/A
- 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: N/A
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A
- The sample size for the training set: N/A
- How the ground truth for the training set was established: N/A
Nonclinical Testing
The document mentions nonclinical testing:
- Brief Description of Nonclinical Testing: "The specifications for the environmental and electromagnetic compatibility (EMC) testing of the Hippocrat reference appropriate international standards. All product specifications were met."
This indicates that engineering and regulatory compliance testing (environmental, EMC) was performed and passed, but these are not clinical performance measures against acceptance criteria directly related to diagnostic accuracy or effectiveness in patient care, which is typically what "acceptance criteria" for device performance refers to in a clinical context.
§ 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.