(99 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 P60 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 P60 Series Digital Color Doppler Ultrasound System. It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence to gain FDA clearance.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) as would be the case for an AI/ML software. Instead, it relies on demonstrating substantial equivalence to a predicate device (SonoScape S45 Digital Color Doppler Ultrasound System K160283) and adherence to recognized standards.
The "performance" is implicitly demonstrated through:
- Same Intended Use: The P60 Series has the same intended use as the predicate device (evaluation of Fetal, Abdominal, Pediatric, Small Organ, Cephalic, Trans-rectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal, Cardiac, Trans-esophageal Cardiac, Laparoscopic, OB/Gyn and Urology).
- Similar Technical Characteristics: Design, operation controls, display modes, operation modes, measurement items, cine loop, operating and storage conditions are stated to be the same or similar to the predicate.
- Adherence to Standards: The device meets several IEC and ISO standards related to electrical, mechanical, thermal, electromagnetic safety, biocompatibility, and acoustic output (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10, AIUM/NEMA UD 2, AIUM/NEMA UD 3).
- Probe Similarity: For new probes introduced with the P60 series, the document argues their similarity in clinical application, performance, or frequency to previously cleared probes, stating that the differences do not affect safety or effectiveness.
Acceptance Criteria (Implicit - based on Substantial Equivalence and Standards Adherence):
| Criterion Type | Specific Criteria (Implied) | Reported Performance (Implied) |
|---|---|---|
| Intended Use | The new device's intended use must be the same as the predicate device. | The SonoScape P60 Series Digital Color Doppler Ultrasound System shares the same intended use as the predicate device, SonoScape S45 (K160283). |
| Technical Equivalence | Basic and key technical features (Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Condition) must be the same or similar to the predicate device. For any differences, they must be demonstrated not to raise new questions of safety or effectiveness. | The P60 Series' basic and key technical features are identified as the same as the predicate device. New probes are considered "similar" in clinical application and performance, and the differences are claimed not to affect safety, effectiveness, or clinical use. |
| Safety and Effectiveness Standards | Compliance with relevant medical device safety, performance, and acoustic output standards. This includes electrical safety, electromagnetic compatibility, biocompatibility, and specific standards for ultrasonic equipment. | The device has been evaluated for electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility, and acoustic output. It is stated to comply 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). The acoustic output levels are consistent with the predicate. |
| Performance Data | Verification of meeting design specifications and conformance to applicable standards through laboratory tests, including phantom tests. | Laboratory tests (including Phantom tests) were conducted to verify that the P60 system met all design specifications and conformed to applicable medical device standards. |
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." Therefore, there is no test set sample size, country of origin, or information about retrospective/prospective data provenance from clinical studies described for this clearance. The "test set" for this clearance primarily consisted of engineering and performance bench testing, and comparisons to the established predicate device and standards.
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, there would have been no experts establishing ground truth in the context of reading clinical cases for a test set. Evaluation focused on engineering specifications and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used for this clearance.
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 general-purpose ultrasound system, not an AI/ML-driven diagnostic aid that would typically undergo an MRMC study to demonstrate improvement in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (ultrasound system), not an AI algorithm evaluated for standalone performance. Its "performance" is based on its ability to acquire and display quality ultrasound images according to its intended use and technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (laboratory and phantom tests), the "ground truth" would be the established engineering specifications, physical measurements, and the requirements outlined in the cited international safety and performance standards (e.g., accuracy of measurements, image quality metrics, acoustic output levels as defined by the standards).
8. The sample size for the training set
Not applicable. This document describes the clearance of an ultrasonic imaging 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, as there is no training set mentioned or implied for an AI/ML model for this device.
§ 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.