(50 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdomen; Pediatric; Small Organ (breast, tests, thyroid); heart soft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.
The SonoScape SSI-1000/SSI-5000 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. The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000). These systems are designed with the latest technology, using the same quality procedures as ultrasound systems which have been available in the market for vears. 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, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes.
The SonoScape SSI-1000/SSI-5000 ultrasound system, including its transducers (2P1, L741, C344), received 510(k) clearance based on substantial equivalence to predicate devices (GE Logiq 500 - K970901, K991611, and K010329). This is a premarket notification, not a study reporting clinical performance or acceptance criteria in the typical sense of algorithm-driven AI devices. Instead, the "acceptance criteria" here refers to demonstrating that the device meets general safety and effectiveness standards, and is substantially equivalent to legally marketed predicate devices for its stated intended uses.
The provided document describes the intended use of the device and its transducers across various clinical applications and operating modes. The "proven" aspect is the FDA's determination of substantial equivalence, which is typically based on comparing technological characteristics and intended uses to previously cleared devices. There isn't a specific set of quantitative acceptance criteria listed that would be met by a clinical study in the context of an AI/ML device.
Here's a breakdown based on the information provided, recognizing that this is a traditional medical device clearance, not an AI performance study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Clearance) | Reported Device Performance |
|---|---|
| General Safety and Effectiveness | The FDA determined the SonoScape SSI-1000/SSI-5000, along with its transducers, to be substantially equivalent to legally marketed predicate devices (GE Logiq 500 - K970901, K991611, K010329). |
| Technological Characteristics Comparison | The device is an integrated preprogrammed color ultrasound imaging system with all-digital architecture, progressive dynamic receive focusing, wide-band all-digital demodulation, and native frequency digital scan converter. It supports various display modes (Single and dual 2-D, Duplex 2-D/M-mode, 2-D/Pulsed Doppler, Triplex 2-D/CD/Pulsed Doppler), measurements (Distance, area, circumference, calipers, velocity, PI, RI, Cardiac, OB, Vascular package), and specified acoustic output limits consistent with diagnostic ultrasound systems. |
| Intended Use Equivalence | The device's intended uses (Abdomen; Pediatric; Small Organ; Heart; Peripheral Vascular, Musculo-skeletal and Urology, across modes like B-Mode, M-Mode, Color-Flow Doppler, Pulsed Doppler, Power Doppler, Tissue Harmonic Image) are deemed equivalent to those of the predicate devices. |
| Compliance with Standards (Safety and EMC) | Adherence to IEC601-1 (Medical Electrical Equipment) and IEC60601-2 (Electromagnetic Compatibility) is declared. |
| Acoustic Output within Limits | Maximum Derated Ispta: 720mW/cm²; TIS/TIB/TIC: 0.1-4.0 Range; Mechanical Index: 1.9 Maximum; Derated Isppa: 190 W/cm² max. (A post-clearance special report is required to confirm these based on production line devices). |
Regarding the Absence of AI/ML Specific Information:
The provided document is a 510(k) summary from 2004 for a diagnostic ultrasound system. At this time, AI/ML in medical imaging was not a widespread or independently regulated component. Therefore, the concepts below (2 through 9) are not applicable to this document as it describes a traditional hardware and software medical device, not an AI-powered diagnostic tool. The document details the device's functional capabilities and safety/equivalence profile, not its performance on a specific diagnostic task using an AI algorithm.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (510(k) Clearance Process):
The "study" here refers to the premarket notification (510(k)) process, where the manufacturer demonstrates that their device is "substantially equivalent" to a legally marketed predicate device. This typically involves:
- Comparison of Intended Use: Showing the new device has the same intended use as a predicate.
- Comparison of Technological Characteristics: Demonstrating that the technological characteristics (e.g., display modes, measurements, operating principles, acoustic output, safety compliance) are either identical or, if different, do not raise new questions of safety and effectiveness.
- Performance Testing (Non-Clinical): For ultrasound systems, this typically includes acoustic output measurements (as explicitly mentioned, with a post-clearance report required for production units), electrical safety testing (IEC601-1), and electromagnetic compatibility (IEC60601-2). These tests confirm the device operates within established safety and performance parameters, consistent with existing technology.
The FDA's review and determination of substantial equivalence act as the "proof" that the device "meets the acceptance criteria" for market clearance under the 510(k) pathway. There are no clinical performance metrics for a diagnostic AI algorithm presented in this type of submission.
§ 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.