(39 days)
The HS50 / HS60 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HS50 / HS60 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, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 and HS60 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 HS50 / HS60 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 is a 510(k) summary for the Samsung Medison HS50/HS60 Diagnostic Ultrasound System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly available in this document.
However, I can extract information related to the device's technical characteristics and the general safety and effectiveness assessments.
Summary of Device Features and Equivalence:
The HS50/HS60 Diagnostic Ultrasound System is a general-purpose, mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data and displays it in various modes (B, M, Color M, Anatomical, Color Doppler, Pulsed Wave (PW) Spectral Doppler, Continuous Wave (CW) Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Doppler (PD), ElastoScan, 3D/4D/XI STIC imaging, Dual, Quad, Combined, Simultaneous, and Zoom modes). It also provides measurement and analysis packages for diagnostic purposes.
The device's substantial equivalence to predicate devices (H60 (K143264), RS80A (K162094), WS80A (K153529), HM70A (K153408), and HS70A (K163691)) is claimed based on safety, effectiveness, and functionality. All systems transmit ultrasonic energy into patients, process echoes for display of anatomic structures and fluid flow, and allow for measurements and calculations.
Here's the information formatted to the best of my ability based on the provided text, acknowledging that direct "acceptance criteria" and "study results" in the sense of a new clinical claim are not present for this type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for a new clinical performance claim, as it is a 510(k) submission for substantial equivalence to existing devices. The "performance" is implicitly deemed equivalent if the device meets all safety standards and performs its intended functions similarly to the predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate Devices) | Reported Device Performance (HS50 / HS60 Ultrasound System) |
|---|---|
| Safety and Effectiveness | "The HS50 / HS60 is a general purpose, mobile, software controlled, diagnostic ultrasound system." |
| Consistent intended uses with predicate devices. | "The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Clinical applications listed are identical to those of predicate devices: 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. |
| Similar technological characteristics (modes, scanhead types, frequencies). | The comparison table on pages 22-23 explicitly states that HS50/HS60 supports all modes of operation (B-mode, M-mode, PW Spectral Doppler, CW Doppler, Color Doppler, Power Amplitude Doppler, Tissue Harmonic Imaging, 3D/4D imaging mode, Combined modes) and transducer types (linear, curved linear, endocavity, phased array, static probes) and frequency ranges (1.0 ~ 20.0 MHz) as the identified predicate devices. |
| Compliance with relevant safety standards (electrical, acoustic, biocompatibility, EMC). | "The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards." Specific standards listed include IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971, NEMA UD 2-2004, NEMA UD 3-2004. |
| Similar functionality. | The comparison table on pages 22-23 lists various functionalities (Quick Scan, ClearVision, MultiVision, Needle Mate+, Auto IMT+, Strain+, ElastoScan, Panoramic, 3D Imaging (Volume Data Acquisition), 3D Imaging Presentation, 3D Cine/4D Cine, 3D Rendering MPR, 3D XI, 3D MSV/Oblique View, 3D MXI Volume Slice/Mirror View, Volume CT, 3D MagiCut, Volume Calculation (VOCAL, XI VOCAL), XI STIC, HDVI, Realistic Vue, Ez Exam+, CEUS+, 5D NT, 5D Follicle) and marks them as present ("V") in the subject devices (HS50/HS60) and their predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size, data provenance, or details of a clinical study to report from this document.
3. 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)
Not applicable, as no clinical studies were performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were performed.
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
Not applicable. This is a 510(k) for a diagnostic ultrasound system, not an AI-based interpretation device claiming improved reader performance. The document explicitly states "Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, which is a human-operated device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies were performed for a new performance claim. The ground for substantial equivalence relies on comparison to predicate devices, which are already cleared for clinical use.
8. The sample size for the training set
Not applicable. This document is for a medical device (ultrasound system), not an AI algorithm requiring a training set in the typical sense for machine learning.
9. How the ground truth for the training set was established
Not applicable.
§ 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.