(25 days)
The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing bodv fluid.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic. Adult Cephalic. Trans-rectal. 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 B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Freehand 3D mode, Dual mode, Dual live mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. 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 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text describes a 510(k) premarket notification for the Samsung Medison HS40 Diagnostic Ultrasound System. This document asserts substantial equivalence to a predicate device rather than presenting a study demonstrating acceptance criteria being met for a novel device. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new device is not applicable or not provided in this specific filing.
However, based on the provided text, I can infer and extract some relevant information.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating "substantial equivalence" to a legally marketed predicate device (HS50/HS60 Diagnostic Ultrasound System, K170493) in terms of safety, effectiveness, and functionality. The "reported device performance" is the assertion that the HS40 meets these criteria by having equivalent or similar functionality and adherence to safety standards.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (HS40) |
|---|---|
| Safety: Compliance with applicable medical device safety standards. | Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA UD 3-2004. |
| Effectiveness: Similar intended uses and clinical applications. | Supports all clinical applications of the predicate device: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. |
| Functionality: Similar technological characteristics and modes of operation. | Possesses all key features and modes of operation (e.g., B-mode, M-mode, PW Spectral Doppler, Color Doppler, Tissue Harmonic Imaging, 3D/4D imaging) present in the predicate device (HS50/HS60). No new functionality compared to the predicate. |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HS40, did not require clinical studies to support substantial equivalence." This indicates that there was no specific test set of patient data used for clinical evaluation of the HS40's performance against defined acceptance criteria because clinical studies were not required for this type of submission (510(k) for an ultrasound system). The equivalence is largely based on technical specifications and adherence to standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set requiring expert ground truth was performed for the HS40 in this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was performed for the HS40 in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The filing explicitly states that no clinical studies were required or performed. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted for this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a diagnostic ultrasound system, not an AI-powered diagnostic algorithm in the typical sense that would undergo standalone performance evaluation. The device's performance is tied to its imaging capabilities, which are considered substantially equivalent to the predicate.
7. Type of Ground Truth Used
Not applicable, as no clinical studies with ground truth were conducted for this submission. The "ground truth" in a 510(k) context for an ultrasound system like this is primarily its adherence to safety standards and demonstration of equivalent technical and functional characteristics to a predicate, not clinical diagnostic accuracy against a reference standard.
8. Sample Size for the Training Set
Not applicable. This document describes a general-purpose diagnostic ultrasound system that acquires images, not an AI/ML algorithm that is trained on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm for this device.
§ 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.