(119 days)
The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.
The SonoBook Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. 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 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 echo data and to display B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) the image Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
This document describes the SonoBook Series Diagnostic Ultrasound System and compares it to a predicate device (Q Series Diagnostic Ultrasound System K150851) to demonstrate substantial equivalence for FDA 510(k) clearance.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense, as this is a submission for a general diagnostic ultrasound system rather than an AI-enabled diagnostic algorithm. Instead, it demonstrates compliance with relevant medical device safety and performance standards and compares its features to a predicate device.
The "acceptance criteria" here implicitly refer to meeting established safety standards and having comparable functionality to the predicate device. "Reported device performance" is indicated by the system's features and compliance.
| Acceptance Criteria (Implicit) | Reported Device Performance (SonoBook Series) |
|---|---|
| Compliance with Safety Standards (Electrical, Mechanical, Thermal, EMC) | IEC 60601-1: 2005, IEC 60601-1-2: 2007, IEC 60601-2-37: 2007 (Passed all laboratory tests for safety) |
| Compliance with Acoustic Output Standards | NEMA UD 2-2004, NEMA UD3: 2004 (Derated ISPTA: 720mW/cm² max, TIS/TIB/TIC: 6.0 max, MI: 1.9 max, Derated ISPPA: 190 W/cm² max - Same as predicate device) |
| Biocompatibility | ISO 10993-1:2009 (Compliant) |
| Indications for Use | Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology (Consistent with predicate device) |
| Design (Software, Probes, Playback, Archiving) | Based on embedded WINDOWS OS, Autocorrelation for color processing, FFT for pulse/CW Doppler, supports Linear, Curve, Phase array and Volume probes, Cine playback, Image file archive (Consistent with predicate device) |
| Operation Controls (TGC, Depth Range, B Dynamic Range, Gain, Focus, B Steer, B Persistence, ROI, Color/PW Filters, Color Baseline, Color Maps, PW Sample Volume, PW Angle Correction, Baseline, Cine Control, Doppler Auto Trace, Freeze Control) | Largely similar to predicate device. Some differences in value ranges or steps (e.g., B Dynamic range: 60-165 dB (vs 30-180 dB of predicate), Color Wall Filter: 4 steps (vs 8), Color Baseline: 7 steps (vs 16), Color Maps: 11 maps (vs 21), PW sweeping speed: 3 steps (vs 6), PW Wall Filter: 4 steps (vs 7), PW sample volume: 1-8mm (vs 0.5-30mm), PW angle correction: -80 |
| Display Modes | B, 2B, 4B, B/M, M, TDI, 3D/4D, CW, B/BC, B+Color M, B+PW/CW, B+CFM, B+PDI/DPD, B+CFM+PW/CW, B+PDI/DPD+PW (Consistent with predicate device) |
| Display Annotations | Logo, Hospital Name, Exam date/time, Acoustic Power, Mechanical Index, Tissue thermal index, Patient info (ID, name, gender, age), Probe model, ECG icon, Operator, TGC Curve, Focus position, Thumbnail, Imaging parameters, Dynamic Trackball indices (Consistent with predicate device) |
| Display Monitor | 15" high-resolution color LCD monitor (Consistent with predicate device) |
| Measurements | 2D mode: Depth, Distance, Area (Ellipse, Trace, Spline, Trace Length), Volume (Distance, Ellipse, Ellipse + Distance), Distance Ratio, Area Ratio, IMT, Volume Flow. M mode: Distance, Time, Heart Rate, Velocity. Doppler mode: D Velocity, Time, Heart Rate, Acceleration, D Trace, S/D, Volume Flow. (Some differences in specific items compared to predicate, but the basic clinical items are included and meet clinical use without new risk.) |
| Transducer Types & Connectors | Convex Array, Phased Array, Linear Array, Volume probe, 1 port (Predicate had 2 ports, but deemed SE as both comply with IEC60601-1) |
| Power Supply | Voltage: 100-240V~, Frequency: 50-60Hz, Power Consumption: 300VA Max (Consistent with predicate device) |
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." (Section 7). The submission relies on non-clinical tests (lab tests) and comparison to a legally marketed predicate device. Therefore, there is no test set in the sense of patient data for evaluating diagnostic performance.
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 and no specific "ground truth" for a test set of patient data was established for diagnostic performance. The ground truth for functional and safety validation would be the compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical testing was performed.
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 is a submission for a general diagnostic ultrasound system, not an AI-enabled diagnostic algorithm, and no clinical effectiveness studies of this nature were performed or required.
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, not an AI algorithm intended for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission is implicitly defined by the adherence to recognized international and national consensus standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37), acoustic output (NEMA UD 2-2004, NEMA UD3:2004), and biocompatibility (ISO 10993-1). The comparison is primarily against the performance and features of the predicate device (Q Series Diagnostic Ultrasound System K150851).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device that requires a training set of data.
§ 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.