(73 days)
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology,
This SonoScape S60 series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 25.0 MHz. This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
The provided text is a 510(k) summary for the SonoScape S60 Series Digital Color Doppler Ultrasound System. It details the device's intended use and compares it to a predicate device, the SonoScape S45 Digital Color Doppler Ultrasound System (K160283), to assert substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device based on similar intended use and technical characteristics, and compliance with recognized safety standards.
The closest to "acceptance criteria" are the standards the device was designed and manufactured to meet, and the "reported performance" is implicitly that the device met these standards and is "substantially equivalent" to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device and standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (SonoScape S45, K160283) across various clinical applications. | Stated as "the same intended use" as the predicate device. |
| Technical Characteristics | Same as predicate device (SonoScape S45, K160283) in Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating, and Storage Condition. | Stated as "the same as the predicate device". |
| Probe Comparison | Similar probes (Curved Array, Linear Array, CW, Micro-curved Array, Phased Array) to predicate, with differences not affecting safety, effectiveness, or clinical use. | Detailed analysis asserting similarity and non-impactful differences. |
| Safety Standards | Compliance with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-2-37:2007, ISO 10993-5:2009, ISO 10993-10:2010, AIUM/NEMA UD 2:2004 (R2009), and AIUM/NEMA UD 3:2004 (R2009). | Stated as "met all design specifications" and "conformed to applicable medical device standards." |
| Biocompatibility | Compliance with ISO 10993-5:2009 and ISO 10993-10:2010. | Evaluated for biocompatibility. |
| Acoustic Output | Compliance with AIUM/NEMA UD 2:2004 (R2009) and AIUM/NEMA UD 3:2004 (R2009). | Evaluated for acoustic output. |
| Electrical, Mechanical, Thermal, EMC Safety | Compliance with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-2-37:2007. | Evaluated for these safety aspects. |
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: "No clinical testing was required." This indicates that there was no human-subject test set. The evaluation was based on non-clinical testing, primarily laboratory and phantom tests to verify design specifications and compliance with standards. The document does not provide details on the sample size for these non-clinical tests or the data provenance beyond "Laboratory tests (including Phantom tests) were conducted..."
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)
Since no clinical testing was required, no experts were used to establish ground truth for a clinical test set. The validation relies on technical specifications and adherence to standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No clinical test set was used, therefore no adjudication method for a clinical test set 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
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI or human-in-the-loop performance improvement. The device is an ultrasound system, and the submission focuses on its equivalence to a predicate device, not on augmented intelligence features.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone algorithm performance testing. The device is a diagnostic ultrasound system that requires a human operator, and its performance evaluation is based on technical and safety specifications, and comparison to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that "No clinical testing was required," there was no ground truth based on expert consensus, pathology, or outcomes data for clinical performance. The "ground truth" in this context refers to the defined specifications and industry standards for ultrasound systems, which were verified through non-clinical laboratory and phantom tests.
8. The sample size for the training set
The document does not describe any training sets or machine learning algorithms. The device is an ultrasound system and its evaluation is based on traditional medical device regulatory pathways.
9. How the ground truth for the training set was established
Not applicable, as no training set or machine learning components are 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.