(116 days)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
The RS85 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. Color Doppler imaging. Power Doppler imaging (including Directional Power Doppler mode: S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode or as a combination of these modes. The RS85 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals. The RS85 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 the acceptance criteria and study information:
Response:
Based on the provided 510(k) summary for the SAMSUNG MEDISON RS85 Diagnostic Ultrasound System (K182932), the device's acceptance criteria are primarily related to its substantial equivalence to a predicate device, K173204 (also an RS85 Diagnostic Ultrasound System). The submission did not involve clinical studies to demonstrate substantial equivalence, but rather relied on non-clinical tests and a comparison of technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
Given that no clinical studies were performed, the "reported device performance" in the typical sense of metrics like accuracy, sensitivity, or specificity is not available for this submission. Instead, the acceptance criteria are based on equivalence to the predicate device in terms of features and conformity to relevant standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated) |
|---|---|
| Intended Use Equivalence: Same clinical applications and modes of operation as predicate. | Met: Device has the same stated Indications for Use and Modes of Operation (pages 3-26). |
| Technological Characteristics Equivalence: Similar scanhead types, frequency range, acoustic output display, modes of operation, transmit/receive channels, system characteristics, software functionality, transducers, and biopsy guides as predicate. | Met: Detailed comparison table on page 28-29 shows identical specifications and listed features between the proposed and predicate RS85 device (K173204). New features like "S-Fusion" and "MV Index" are stated to be substantially equivalent to features on other reference devices (page 31). |
| Safety and Effectiveness Equivalence: Conformity to applicable medical device safety standards. | Met: Non-clinical tests evaluated acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety, confirming compliance with standards like ISO 14971, ANSI AAMI ES60601-1, IEC60601-1-2, ISO 10993-1, and NEMA UD 2/3 (pages 31-32). |
2. Sample Size Used for the Test Set and Data Provenance
No test set of patient data (e.g., images) was used or described for performance evaluation in this 510(k) summary. The submission focuses on hardware and software equivalence to a previously cleared device. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective data) relating to clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as no test set requiring ground truth establishment by experts was used.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring adjudication was used.
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 MRMC comparative effectiveness study was done. The submission explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." (page 32). There is no mention of AI integration or assessment of human reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone performance study of an algorithm was conducted or described, as this submission is for a diagnostic ultrasound system and not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical studies with ground truth were conducted. The "ground truth" for this submission focuses on demonstrating that the device's technical specifications and intended uses are equivalent to a predicate device and that it complies with relevant safety and performance standards.
8. The Sample Size for the Training Set
Not applicable. This submission does not describe the development or training of any machine learning or AI models. It pertains to a diagnostic ultrasound system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This submission does not describe the development or training of any machine learning or AI models.
§ 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.