(86 days)
The HS40 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS40 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text is a 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System. It is a regulatory submission to the FDA demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML.
The document primarily focuses on:
- Indications for Use: Listing the various clinical applications and modes of operation for the ultrasound system and its different transducers.
- Device Description: Describing the HS40 as a general clinical diagnostic ultrasound system with standard imaging modes.
- Substantial Equivalence: Comparing the HS40 to existing predicate devices (e.g., HS40 (K172129), Sonoace R7 (K133505), LOGIQ S7 Expert (K160182)) based on intended use, imaging capabilities, technology, safety, and effectiveness.
- Non-Clinical Tests: Listing compliance with various safety and performance standards (e.g., IEC 60601-1, ISO 10993-1, NEMA UD 2-2004).
- Absence of Clinical Tests: Explicitly stating, under "Summary of Clinical Tests," that "The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as this document pertains to a traditional diagnostic ultrasound system and explicitly states that clinical studies were not required for its substantial equivalence determination.
To answer your request, if this were an AI/ML device and the information was present, here's how the structure of the answer would typically look, but based on the provided text, the answer to most points would be "N/A" or "Not specified in this document":
Based on the provided 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System, there is no information present regarding acceptance criteria or a study proving the device meets those criteria for an AI/ML-based device.
The document pertains to a traditional diagnostic ultrasound system and its transducers, demonstrating substantial equivalence to previously cleared devices. It explicitly states that clinical studies were not required for this submission. Therefore, most of the requested details about AI/ML device performance studies are not applicable or specified in this regulatory filing.
Here's a breakdown of the requested information based on the provided text:
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A table of acceptance criteria and the reported device performance:
- N/A. This document does not describe performance metrics or acceptance criteria for an AI/ML component. It details the cleared indications for use and operational modes of a diagnostic ultrasound system.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- N/A. No test set for an AI/ML algorithm is described. The document states "The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- N/A. No ground truth establishment for an AI/ML algorithm is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No test set for an AI/ML algorithm is described.
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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. No MRMC study is mentioned. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image analysis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This document does not describe an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No ground truth for an AI/ML algorithm is described.
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The sample size for the training set:
- N/A. No training set for an AI/ML algorithm is described.
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How the ground truth for the training set was established:
- N/A. No ground truth for an AI/ML algorithm is described.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.