(69 days)
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging 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, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
This SonoScape P20 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 does not contain information about acceptance criteria or specific studies that prove the device meets these criteria in the typical sense of a clinical trial evaluating diagnostic performance (e.g., sensitivity, specificity, accuracy).
Instead, the document is a 510(k) summary for a SonoScape P20 series Digital Color Doppler Ultrasound System, focusing on demonstrating substantial equivalence to a predicate device (SonoScape P50 Digital Color Doppler Ultrasound System K170999).
The "studies" described are primarily non-clinical tests to ensure safety and performance according to established standards, rather than clinical efficacy or diagnostic accuracy studies.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for imaging performance (like sensitivity or specificity) for clinical applications. Instead, it states that the device was evaluated for its ability to meet design specifications and relevant safety and performance standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:2005+A1:2012 (General safety) | The P20 system met all design specifications and conformed to this standard. |
| Compliance with IEC 60601-1-2:2007 (EMC) | The P20 system met all design specifications and conformed to this standard. |
| Compliance with IEC 60601-2-37:2007 (Ultrasound safety) | The P20 system met all design specifications and conformed to this standard. |
| Compliance with ISO 10993-5:2009 (In vitro cytotoxicity) | The P20 system met all design specifications and conformed to this standard. |
| Compliance with ISO 10993-10:2010 (Irritation & skin sensitization) | The P20 system met all design specifications and conformed to this standard. |
| Compliance with AIUM/NEMA UD 2:2004 (R2009) (Acoustic output measurement) | The P20 system met all design specifications and conformed to this standard. |
| Compliance with AIUM/NEMA UD 3:2004 (R2009) (Real-time acoustic output display) | The P20 system met all design specifications and conformed to this standard. |
| Functional Equivalence to Predicate Device (SonoScape P50 K170999) | The P20 Series has the same intended use and comparable basic and key technical features (design, operation controls, display modes, operation modes, measurement items, Cine Loop, Operating and Storage Condition) as the predicate device. New probes and biopsy brackets were compared to and found to be similar or previously cleared with other predicate devices. This demonstrates substantial equivalence in safety and effectiveness for diagnostic ultrasound imaging and fluid flow analysis. No specific performance metrics (e.g., image quality ratings, diagnostic accuracy) are provided in a quantitative format for clinical applications. |
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 states: "No clinical testing was required." The "test set" in this context refers to the non-clinical evaluations to confirm adherence to engineering and safety standards. There is no mention of a patient-based test set or its provenance.
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 testing was performed to establish diagnostic ground truth. The "ground truth" for the non-clinical tests would be the specifications of the standards (e.g., a certain level of electrical safety, a specific acoustic output).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing was performed requiring adjudication of diagnostic findings.
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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" or reference was the technical specifications of the device and the requirements of the referenced international and national standards (e.g., IEC 60601-1, ISO 10993-5, AIUM/NEMA UD 2).
8. The sample size for the training set
Not applicable. This document describes a traditional medical device (ultrasound system), not a machine learning algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set was used in the context of machine learning. The "truth" for device design and verification is established through engineering principles and compliance with recognized standards.
§ 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.