(163 days)
Signal is an electronic device intended to support the physician in the evaluation of heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The device allows for the recording of multiple, simultaneous acoustic signals and includes a single-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files. Signal is intended for use by healthcare professionals only.
Signal™ is an electronic auscultation device intended to acquire, record, and display heart sounds and other body sounds. Signal includes a single-lead electrocardiograph to produce an ECG on the laptop monitor to enable the health care professional to synchronize the phonocardiogram with the beginning of the heart cycle. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files.
The provided text describes the Zargis Medical Corporation's Signal™ electronic stethoscope, but it does not contain the detailed information required to fill out all the columns in the requested table or answer all the specific questions about acceptance criteria and a study proving those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, technological characteristics, indications for use, and performance characteristics. It outlines general categories of testing (biocompatibility, electrical safety/EMC, software verification/validation) and states that "All product specifications were met." However, it does not provide specific quantitative acceptance criteria or the results of a study designed to demonstrate those criteria were met in the way that would typically be expected for a detailed performance study.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria and detailed reported device performance are NOT available. The document generically states that "All product specifications were met" following non-clinical performance testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified quantitatively in the document. The document only states that "All product specifications were met" and "Non-clinical performance testing has been conducted to demonstrate the performance of the Signal device and that it meets its intended use." Categories of testing mentioned include biocompatibility, electrical safety and EMC testing, and software verification and validation testing. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided document.
- Data provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective). The document only mentions "Non-clinical performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical study with expert-established ground truth is described. The testing mentioned is "non-clinical performance testing."
4. Adjudication method for the test set
- Not applicable as no clinical study with expert adjudication is described. The testing mentioned is "non-clinical performance testing."
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, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided document. The device is described as "non-interpretive" and intended to "support the physician in the evaluation," implying it's a tool for obtaining data rather than an AI for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the device itself (Signal™) was tested for its performance. However, there is no specific mention of an "algorithm only" standalone performance as would be done for an AI diagnostic algorithm detached from human use. The device is an electronic stethoscope that acquires, records, and displays sounds, and includes an ECG for synchronization; it's not described as having an interpretive algorithm that would be tested in a "standalone" fashion.
7. The type of ground truth used
- Given that the described testing is "non-clinical performance testing" for device specifications, the "ground truth" would likely refer to engineering specifications, reference standards, and established test protocols for electrical safety, biocompatibility, and software functionality, rather than clinical ground truth (e.g., pathology, expert consensus, outcomes data).
8. The sample size for the training set
- Not applicable/Not specified. The document describes a medical device (electronic stethoscope), not an AI algorithm that would typically require a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified. As above, this document describes device testing, not AI algorithm training.
§ 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.