(69 days)
The HL 200 ELECTRONIC STETHOSCOPE is intended for medical diagnostic purposes only. It can be used for the amplification heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
HL 200 ELECTRONIC STETHOSCOPE is a non-sterile, reusable Electronic Stethoscope . HL 200 ELECTRONIC STETHOSCOPE, equipped with built-in micro-computer chip, includes state-of-the-art amplification and filtering systems. It is ideal for picking up difficult-to-hear heart and other body sounds. The features of HL 200 ELECTRONIC STETHOSCOPE is as follows
- Providing three-mode choices for adequate requirements: heart sound mode, lung sound mode and combination mode
- Eight volumes levels provide up to 18X amplification of acoustic stethoscopes
- Electronic design with fully eliminates sound loss and resonance effects associated with traditional acoustic stethoscopes. With amplified signal, you could even hear the slight sounds much clearer than the traditional one.
- Ergonomically designed with comfortable handholding, subtle with material and touch
- Four-segments display shows the battery conditions could inform you to know the battery using state
- Auto shut-off after 3 minutes for extending battery life
Here's a breakdown of the acceptance criteria and study information for the HL 200 ELECTRONIC STETHOSCOPE, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Performance Specification | Conformance to applicable standards | Conforms to IEC 60601-1 and IEC 60601-1-2 & related requirements. | Bench Testing |
| Safety | Conformance to applicable standards | Conforms to IEC 60601-1 and IEC 60601-1-2 & related requirements. | Bench Testing |
| EMC Requirements | Conformance to applicable standards | Conforms to IEC 60601-1 and IEC 60601-1-2 & related requirements. | Bench Testing |
| Technological Characteristics | No new questions of safety or effectiveness compared to predicate. | Differences in technological characteristics do not raise any new questions of safety or effectiveness. | Bench Testing, Comparison to Predicate |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. This submission relies on substantial equivalence to a predicate device, supported by bench testing. The data provenance is also not explicitly stated as country of origin or retrospective/prospective. The description suggests testing was likely performed by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for a test set in the context of clinical performance or diagnostic accuracy. The evaluation is focused on technical and electrical safety standards.
4. Adjudication Method for the Test Set
Since there is no mention of a test set involving clinical data or expert review for diagnostic accuracy, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical standards and comparisons to a predicate's characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an electronic stethoscope, which is a hardware device for sound amplification. It is not an "algorithm only" device in the sense of AI. Its performance is inherent in its electrical and acoustic properties, which are evaluated by bench testing, not as a standalone algorithm's diagnostic accuracy. So, technically, the "standalone" performance is the bench testing, but not in the AI sense.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is adherence to electrical safety and EMC (electromagnetic compatibility) standards (IEC 60601-1 and IEC 60601-1-2), and the functional characteristics of the device as compared to a predicate electronic stethoscope. This is determined through bench testing against these established technical specifications, rather than clinical ground truth like pathology or expert consensus on diagnoses.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence models. As this is an electronic stethoscope (a hardware device), there is no training set in that context. The device's design and manufacturing processes are likely informed by engineering principles and possibly prior product development, but not by a formal "training set" like an AI model.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense for this device, the question of how its ground truth was established is not applicable. The "ground truth" in its development would relate to engineering specifications, component performance, and adherence to design requirements, verified through internal testing and quality control processes.
§ 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.