(91 days)
The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound maging 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, Trans-esophageal(Cardiac) and peripheral vessel.
The HS50 / HS60 are 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, Combined mode, Simultaneous mode and Zoom mode. The HS50 / 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 document is a 510(k) Summary for the SAMSUNG MEDISON HS50/HS60 Diagnostic Ultrasound System. It describes the device, its intended use, and establishes substantial equivalence to predicate devices, but it does not contain acceptance criteria or study data demonstrating device performance in relation to specific clinical efficacy metrics.
The document states:
- "The proposed device HS50 / HS60 Ultrasound System, did not require clinical studies to demonstrate substantial equivalence." (Page 34, Section 12)
- The "Determination of Substantial Equivalence" section emphasizes the similarity of intended use, imaging capabilities, technological characteristics, and safety and effectiveness with predicate devices, rather than presenting de novo performance data against acceptance criteria.
Therefore, many of the requested details, particularly regarding specific performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not available in this document.
However, I can extract information related to non-clinical testing and the basis for substantial equivalence.
Here's a breakdown of what can be provided based on the input document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance data for specific clinical outcomes. Instead, it asserts equivalence to predicate devices based on technological characteristics and compliance with recognized safety standards. The "acceptance criteria" here implicitly refer to meeting the requirements of these standards.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Acoustic Output Compliance | Device conforms with applicable FDA guidance and NEMA UD 2-2004 (R2009) (Page 34, Section 11). |
| Biocompatibility | Device conforms with applicable FDA guidance and ISO10993-1:2009/(R)2013 (Page 34, Section 11). |
| Software Functionality | Device evaluated for software function (Page 34, Section 11). Adds new SW features (2D Follicle, LaborAssist) and provides similar functionality to 5D Follicle and Sono L&D in predicate devices (Page 33, Section 10). |
| Cleaning & Disinfection | Device evaluated for cleaning and disinfection effectiveness (Page 34, Section 11). |
| Thermal Safety | Device conforms with applicable FDA guidance and IEC 60601-1 (Page 34, Section 11). |
| Electrical Safety | Device conforms with applicable FDA guidance and IEC 60601-1 (Page 34, Section 11). Additionally, designed in compliance with approved electrical safety standards (Page 33, Section 10). |
| Electromagnetic Safety | Device conforms with applicable FDA guidance and IEC IEC60601-1-2: 2014(4th Edition) (Page 34, Section 11). |
| Mechanical Safety | Device evaluated for mechanical safety (Page 34, Section 11). |
| Overall Safety | Acoustic power levels are below applicable FDA limits. Manufactured with materials found to be safe. (Page 34, Section 10). |
| Essential Performance | Device conforms with IEC 60601-1 and IEC 60601-2-37 (Page 34, Section 11). |
| Risk Management | Device conforms to ISO 14971:2007 (Page 34, Section 11). |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/Not provided. The document explicitly states that clinical studies were not required to demonstrate substantial equivalence. The non-clinical testing involved various engineering and safety evaluations, not human clinical data.
- Data provenance: Not applicable. The evaluations were non-clinical (e.g., acoustic output, biocompatibility, software function, electrical/mechanical safety testing following recognized standards).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. As no clinical studies were conducted, no ground truth established by experts for clinical performance is mentioned.
4. Adjudication method for the test set:
- Not applicable/Not provided. No clinical study data requiring adjudication is mentioned.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states that clinical studies were not required. The device is a diagnostic ultrasound system, not an AI-powered reader assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a diagnostic ultrasound system. While it has some new software features (2D Follicle and LaborAssist), the document does not describe them as standalone algorithms or provide performance data for them. The focus is on the overall system's equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided for clinical performance. For non-clinical technical evaluations, the "ground truth" would be the specifications and requirements of the referenced international and FDA-recognized standards (e.g., IEC, ISO, NEMA).
8. The sample size for the training set:
- Not applicable/Not provided. The document does not describe any machine learning models or AI components that would require a "training set" in the context of clinical image analysis. The new software features mentioned are not described as requiring such training data in this submission.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As no training set is mentioned, the method for establishing its ground truth is also not mentioned.
§ 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.