(36 days)
The SonoScape S9 device 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
The SonoScape S9 Portable 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
The provided text describes a 510(k) summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on a clinical performance study with AI.
Therefore, many of the requested details about acceptance criteria driven by AI performance, sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies, are not explicitly mentioned in this type of submission.
However, I can extract information related to the device's technical specifications and the type of non-clinical testing performed to establish safety and effectiveness for substantial equivalence.
Here's a breakdown of what can and cannot be answered based on the provided document:
What can be answered (related to substantial equivalence and non-clinical testing):
- Acceptance Criteria (Indirect): The acceptance criteria are implicitly conformance to recognized safety and performance standards for diagnostic ultrasound equipment, and having technological characteristics similar to the predicate device, demonstrating equivalent capability. The "reported device performance" is the confirmation that these standards were met.
- Sample Size for Test Set: Not applicable in the context of clinical performance evaluation for AI. The testing described is laboratory-based non-clinical testing for standards compliance.
- Data Provenance: Not applicable, as no clinical test set data from patients is described. The testing is laboratory (acoustic output, electrical, thermal, mechanical safety, biocompatibility).
- Number of Experts for Ground Truth & Qualifications: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No. This is not a study involving human readers and AI assistance.
- Standalone (algorithm only) Performance: No, as there isn't an AI algorithm described that would operate in a standalone manner. The device is a diagnostic ultrasound system.
- Type of Ground Truth Used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, not clinical diagnostic accuracy.
- Sample Size for Training Set: Not applicable. This device does not inherently involve a "training set" in the context of an AI/ML algorithm.
- How Ground Truth for Training Set was Established: Not applicable.
Table of Acceptance Criteria and Reported Device Performance (based on regulatory compliance):
| Acceptance Criteria Category | Specific Criteria (Implicitly Required for Equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | Conformance to general medical electrical equipment safety standards (IEC 60601-1, IEC 60601-1-2), specific ultrasound equipment safety standards (IEC 60601-2-37), biocompatibility standards (ISO 10993-5, ISO 10993-10), and acoustic output standards (NEMA UD 2, NEMA UD3). This includes thermal, mechanical, and electrical safety. | "The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility." "Acoustic output is measured and calculated according to 'Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment'." The specific standards listed (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10, NEMA UD 2, NEMA UD3) were confirmed as met. |
| Performance/Effectiveness | Able to acquire ultrasound data and display images in specified modes (B-Mode, M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, 3D/4D), and for the intended clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Cephalic, Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal, Cardiac, OB/Gyn, Urology), demonstrating functionality substantially equivalent to the predicate. | "The SonoScape S9 Portable 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." "Its basic function is to acquire ultrasound data and display the image in B-Mode... M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D." Performance and compliance testing confirmed the device met all design specifications and was substantially equivalent to the predicate, supporting its intended use. |
| Technological Characteristics | The device's fundamental technology (digital architecture, dynamic receive focusing, exam-dependent settings, transducer compatibility and performance across specified frequency ranges and clinical uses) should be comparable to the predicate device. | The S9 "incorporates the same fundamental technology as the predicate device." "The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system." A detailed table of transducers with their types, frequency ranges, and intended uses is provided, demonstrating their claimed capabilities. |
Study Proving Device Meets Acceptance Criteria:
The study described is a series of non-clinical laboratory tests designed to demonstrate compliance with recognized consensus standards and to show that the S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to a previously cleared predicate device (SonoScape Company Limited, Diagnostic Ultrasound System, Model S6, K112602).
- Nature of the Study: This was a non-clinical validation focused on safety, electromagnetic compatibility, acoustic output, and biocompatibility, rather than a clinical performance study involving patient data and diagnostic accuracy.
- Acceptance Criteria for the Study: The implicit acceptance criteria were successfully passing all relevant tests defined by the listed international and national standards (IEC, ISO, NEMA) and demonstrating that the device's technical specifications and performance characteristics align closely enough with the predicate device to warrant substantial equivalence.
- Sample Size Used for Test Set: This is not a "test set" in the context of clinical data for AI performance. The "test set" here refers to the device and its transducers undergoing various physical and electrical tests. No specific number of "tests" or "samples" (like patient cases) is provided, as it's a conformity assessment to standards.
- Data Provenance: The data provenance is laboratory testing conducted by the manufacturer, SonoScape Company Limited, for regulatory submission to the FDA. It is not retrospective or prospective clinical data from human patients/cases.
- Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. No human expert "ground truth" for diagnostic accuracy was established in this type of testing. The "ground truth" is adherence to the technical specifications of the standards.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is for evaluating human performance, often with or without AI assistance, which is not relevant to this submission.
- Standalone (Algorithm Only) Performance: Not applicable. The device is an ultrasound system, not an AI algorithm.
- Type of Ground Truth Used: Standards conformance and engineering specifications. The "ground truth" for this submission is that the device physically performs according to established industry safety and performance benchmarks. It is not based on expert consensus, pathology, or outcomes data from patient diagnoses.
- Sample Size for the Training Set: Not applicable. This device does not describe an AI or machine learning component that would require a training set.
- How the Ground Truth for the Training Set was Established: Not applicable.
In summary, the provided document is a regulatory submission for a medical device (ultrasound system) based on substantial equivalence, which primarily relies on non-clinical testing for safety and basic performance characteristics against established standards and a predicate device. It does not describe a clinical performance study, especially not one involving AI or detailed human reader evaluation.
§ 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.