(56 days)
The HS70A 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-reginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
The HS70A 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, 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, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical or performance studies with acceptance criteria in the way a performance study report typically would. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance metrics, and training set details) is not present in this document. The document explicitly states that clinical studies were "not applicable."
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, explicit, quantifiable acceptance criteria with corresponding device performance metrics for a specific algorithm or feature are not provided. The summary focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: The HS70A's clinical applications and modes of operation are equivalent to or expand upon those of the predicate devices.
- Technological Characteristics: The HS70A shares similar features and functionalities (e.g., imaging modes, scanhead types, frequency ranges, advanced features like 3D/4D imaging, elastography) with the predicate devices.
- Safety and EMC Compliance: The device conforms to various safety standards (UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD-2, NEMA UD-3, ISO10993-1, ISO14971).
Since this is a substantial equivalence submission for an ultrasound system, the "acceptance criteria" are implicitly met by demonstrating that the device performs as intended and is as safe and effective as the predicate devices, without introducing new questions of safety or effectiveness. No specific quantitative performance metrics comparing the subject device to a predefined threshold for a particular clinical task are mentioned.
2. Sample size 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. HS70A, did not require clinical studies to support substantial equivalence."
Therefore, there is no information provided regarding a test set sample size, data provenance, or whether data was retrospective or prospective, as no clinical studies were deemed necessary for this 510(k) submission.
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)
As stated in point 2, no clinical studies were performed, and thus, there is no information provided about experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As stated in point 2, no clinical studies were performed, and thus, there is no information provided about an adjudication method.
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
The document explicitly states: "Summary of Clinical Tests: Not applicable."
Therefore, no MRMC comparative effectiveness study was performed or reported in this submission. The device is a diagnostic ultrasound system, not an AI-powered diagnostic aide (at least not in the context implied by this question). While it lists advanced features like "S-Detect" and "ElastoScan" which could involve machine learning or advanced image processing, the submission does not frame these as AI-assisted diagnostic tools requiring MRMC studies to demonstrate human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document focuses on the ultrasound system and its transducers, which are operated by human users for diagnostic imaging. It is not an "algorithm only" device operating in a standalone capacity. The concept of "standalone performance" for an algorithm, as typically applied to AI/ML devices, is not relevant or addressed in this submission for a general diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As no clinical studies were performed or reported to assess specific diagnostic performance metrics requiring ground truth, there is no information provided regarding the type of ground truth used.
8. The sample size for the training set
The document explicitly states: "Summary of Clinical Tests: Not applicable."
Furthermore, this document describes a diagnostic ultrasound system, not an AI/ML device that would typically have a "training set" for an algorithm, at least not in the sense of a data set for a performance study. Therefore, there is no information provided regarding a training set sample size.
9. How the ground truth for the training set was established
As stated in point 8, there is no information provided regarding a training set, and therefore no information on how its ground truth might have been established.
In summary:
This 510(k) submission for the SAMSUNG MEDISON HS70A Diagnostic Ultrasound System is a demonstration of substantial equivalence to existing predicate devices. It relies on showing that the new device has similar intended uses, technological characteristics, and complies with relevant safety and performance standards. It explicitly states that no clinical studies were required or conducted for this submission. Therefore, the detailed information about acceptance criteria for particular performance metrics, test set details, expert involvement, and algorithm training specific to AI/ML device evaluations (as implied by many of your questions) is not present in this document.
§ 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.