(56 days)
The HS40 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HS40 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices.
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 document is a 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, novel acceptance criteria through extensive clinical studies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of an AI algorithm or an analysis of human reader improvement with AI assistance. The document explicitly states:
- "The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence." (Page 26, Section 12)
The main purpose of this submission is to demonstrate that the new HS40 system is as safe and effective as the predicate device (HS40 Diagnostic Ultrasound System K191055, and features migrated from HS50/HS60 Diagnostic Ultrasound System K192505), based on non-clinical tests and technological equivalence.
Here's a breakdown of why each requested point cannot be fully addressed by this document:
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A table of acceptance criteria and the reported device performance: This document does not present quantitative acceptance criteria for specific diagnostic performance metrics (e.g., sensitivity, specificity for a particular disease detection) that would be proven by a clinical study. Instead, it relies on demonstrating equivalence in technical specifications, safety, and functionality to a previously cleared device.
- However, it does list the clinical applications for the device and its various transducers. These implicitly represent the "performance" capabilities:
- Clinical Applications (HS40 System - Page 3): Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
- Modes of Operation (HS40 System - Page 3): B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, and various combined modes. Also mentions S-Harmonic (Harmonic Imaging), Tissue Doppler Imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging, and ElastoScan Mode.
- Added SW features (Page 25): S-Detect for Breast, 2D Follicle, LaborAssist, CrystalVue. These features, specifically S-Detect for Breast and 2D Follicle, hint at automated analysis or AI components, but no performance data for them is provided in this document.
- However, it does list the clinical applications for the device and its various transducers. These implicitly represent the "performance" capabilities:
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Sample sized used for the test set and the data provenance: Not applicable, as no clinical study or test set with patient data for diagnostic performance evaluation is detailed. The tests performed are non-clinical, related to safety and technical standards (e.g., acoustic output, electrical safety).
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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 ground truth established by experts is detailed.
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Adjudication method for the test set: Not applicable, as no clinical study requiring adjudication is detailed.
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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: Not applicable. The document does not describe an MRMC study or AI assistance for human readers. While it mentions "S-Detect for Breast" as a new software feature, which typically implies AI-driven detection, the submission does not include any performance data or comparative studies for this feature.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. No standalone algorithm performance study is described.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical study with a ground truth is detailed.
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The sample size for the training set: Not applicable. This document is a 510(k) for an ultrasound system, not an AI/ML device that would require explicit training set data for its submission. Even if the mentioned "S-Detect for Breast" feature utilizes AI, the details of its training are not part of this specific FDA submission as presented here.
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How the ground truth for the training set was established: Not applicable for the reasons stated above.
In summary of what the document DOES provide regarding device meeting acceptance criteria:
The "acceptance criteria" here are generally understood as the regulatory requirements for demonstrating substantial equivalence to a predicate device. The study proves the device meets these criteria through:
- Comparison to Predicate (Section 10, Page 25): The document argues that the HS40 is substantially equivalent to its predicate (K191055 and K192505) in:
- Intended use
- Imaging capabilities
- Technological characteristics
- Safety and effectiveness
- Specific examples include sharing imaging modes, modes of operation, and migrating certain software features and transducers from cleared devices.
- Summary of Non-Clinical Tests (Section 11, Page 26): The device has been evaluated and found to conform with applicable FDA guidance and medical device safety standards for:
- Acoustic output
- Biocompatibility
- Software function (without detailing performance metrics for diagnostic features)
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
- Specific standards cited: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004. These are the "acceptance criteria" in the context of this specific filing approach – adhering to recognized standards to ensure safety and performance equivalence.
§ 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.