(61 days)
The SonoScape S45 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
This SonoScape S45 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. 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.
This document describes the SonoScape S45 Digital Color Doppler Ultrasound System and its substantial equivalence to a predicate device (SonoScape S50 Digital Color Doppler Ultrasound System K152854). The information provided focuses on the regulatory clearance process rather than specific performance metrics against defined acceptance criteria from a clinical study.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in this document in the way they would be for an AI/ML device focusing on diagnostic accuracy. The document focuses on demonstrating that the device is safe and effective as an ultrasound system and is substantially equivalent to a previously cleared device.
However, I can extract information related to the device's technical characteristics and the non-clinical tests performed.
Here's an attempt to answer your questions based on the provided text, with clarifications where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity) for a clinical application. Instead, it focuses on demonstrating compliance with recognized electrical, mechanical, and safety standards for medical ultrasound equipment. The "reported device performance" is framed in terms of meeting these engineering and safety standards and having comparable functionality to the predicate device.
| Category | Acceptance Criteria (as implied by the document) | Reported Device Performance (as implied by the document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:12005+A1:2012 (Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance). | S45 system has been designed and manufactured to meet this standard. |
| EMC | Compliance with IEC 60601-1-2:2007 (Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests). | S45 system has been designed and manufactured to meet this standard. |
| Ultrasound Specific Safety | Compliance with IEC 60601-2-37:2007 (Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment). | S45 system has been designed and manufactured to meet this standard. |
| Biocompatibility | Compliance with ISO 10993-5:2009 (Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity) and ISO 10993-10:2010 (Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization). | S45 system has been designed and manufactured to meet these standards. |
| Acoustic Output | Compliance with AIUM/NEMA UD 2:2004 (R2009) (Acoustic output measurement standard for diagnostic ultrasound equipment) and AIUM/NEMA UD 3:2004 (R2009) (Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment). | S45 system has been designed and manufactured to meet these standards; "consistent acoustic output levels" compared to predicate. |
| Design Specifications | Met all internal design specifications. | Laboratory tests (including Phantom tests) were conducted to verify that the S45 system met all design specifications. System functions and modes are comparable to predicate. |
| Intended Use | The system should be suitable for evaluation across various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Cephalic, Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal, Cardiac, Trans-esophageal Cardiac, Laparoscopic, OB/Gyn and Urology). | The S45 system has the "same intended use" as the predicate device SonoScape S50 (K152854). |
| Technical Characteristics | Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Conditions should be comparable to the predicate device. | The basic and key technical features of the S45 are the "same as the predicate device." |
| Probes | New probes should have comparable clinical application, performance, and frequency, without affecting safety, effectiveness, or clinical use compared to existing cleared probes. | One new probe (9L-A) was compared to a similar probe (L743) on the predicate device and found to have "same clinical application, similar performance or frequency," and "doesn't affect the safety, effectiveness and clinical use." All other probes are directly equivalent or similar. |
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." Therefore, there is no clinical test set, sample size, or data provenance relevant to clinical performance for this submission. The testing performed was non-clinical (laboratory and phantom tests).
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set 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
Not applicable. This device is an ultrasound system, not an AI/ML diagnostic tool meant to assist human readers in image interpretation. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm for standalone diagnostic performance. It is a diagnostic ultrasound system. The "performance" reviewed was its technical and safety compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by engineering specifications, physical phantom measurements, and compliance with the relevant international safety and performance standards for ultrasound equipment. For instance, phantom tests would use known physical properties of the phantom as ground truth.
8. The sample size for the training set
Not applicable, as the document does not describe an AI/ML algorithm with a training set. This is a conventional ultrasound system.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of an AI/ML training set in the 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.