(56 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 Q 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 the image B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Q Series Diagnostic Ultrasound System
1. A table of acceptance criteria and the reported device performance:
The provided text does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task. Instead, it focuses on demonstrating substantial equivalence to a predicate device (QBit Series Diagnostic Ultrasound System, K150861) by comparing technical and functional specifications. The "acceptance criteria" here implicitly refer to the device safely and effectively performing within the established parameters and indications for use, similar to the predicate device.
| Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Indications for Use: The device performs within the specified clinical applications. | Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology. (Same as predicate) |
| Design: Technical design and capabilities. | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve, Phase array and Volume probes. Cine play back capability. Image file archive. (Same as predicate) |
| Operating Controls: User interface and control parameters. | TGC 8 slider, Depth Range: 0-30 cm, 256 shades of gray, B Dynamic range control: 30-180 dB, Gain: 0-255, Focal Number: 1-4, Focus position: adjustable, B steer: available on linear transducers, B Persistence: 7 steps, ROI size/position: adjustable, Color Wall Filter settings: 8 steps, Color Baseline: 16 steps, Color Maps: 21 maps, Color Invert: on/off, PW sweeping speed: 6 steps, PW Wall Filter: 7 steps, PW sample volume: 0.5-30mm, PW angle correction: -89~89 degrees, Baseline: 8 steps, Cine control: step, play backward, play continuously, Doppler Auto Trace, Freeze control: Toggling freeze key. (All Same as predicate) |
| Safety Compliance: Adherence to relevant safety standards. | IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO 10993-1. (Same as predicate) |
| Patient Contact Materials: Biocompatibility. | Bio-compatible. (Same as predicate) |
| Operation Mode: Available imaging modes. | B, THI, M, Color M, Free Steering M mode, Color Doppler Imaging, Power Doppler Imaging/Directional PD, Pulsed Wave Doppler, Continuous Wave Doppler, TDI, Contrast Imaging, 3D/4D, Elastography, Curved Panoramic, Trapezoidal image. (Same as predicate) |
| Display Modes: Combinations of imaging modes. | B, M, PW, CW, CFM, PD/DPD, TDI, 3D/4D; B+M, B+PW, B+CFM, B+PD/DPD, B+CFM+PW/CW, B+PW+PD/DPD. (Same as predicate) |
| Display Annotations: Information shown on the display. | Logo, Hospital Name, Exam date, Exam time, Acoustic Power, Mechanical index, Tissue thermal indices, ID, Last name, First Name, Middle initial, Gender, Age, Probe model, ECG ico, Operator, TGC Curve, Focus position, Thumbnail, Imaging parameters, Dynamic Trackball indices. (Same as predicate) |
| Display Monitor: Specifications of the display. | 15" high-resolution color LCD monitor. (Same as predicate) |
| Measurements: Measurement capabilities. | 2D mode: Depth, Distance, Area (Ellipse, Trace, Spline, Trace Length, Double Distance Parallel), Volume (Distance, Ellipse, Ellipse + Distance), Distance Ratio, Area Ratio, IMT, Volume Flow, Color Velocity; M mode: Distance, Time, Slope, Heart Rate, Velocity; Doppler mode: D Velocity, Time, Heart Rate, Acceleration, D Trace, PS/ED, Volume Flow. (Same as predicate) |
| Transducer Types & Connectors: Supported transducers. | Convex Array, Phased Array, Linear Array, Volume probe. (Predicate: 4 ports; Submission device: 2 ports. Deemed Substantially Equivalent in safety as both comply with IEC60601-1, and no new risk is raised.) |
| Users / Sites: Intended usage environments. | Hospitals, clinics usage. (Same as predicate) |
| Acoustic Output: Compliance with acoustic output limits. | Track 3; MI, TIS, TIC, TIB. Derated Ispta: 720mW/cm² maximum, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max. (Same as predicate) |
| Power Requirements: Electrical specifications. | AC: 100V-240V, Frequency: 50-60Hz, Operating temperature: 10-40°C, relative humidity 30-75%, Barometric pressure: 700 to 1060 hPa. (Same as predicate) |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "No clinical testing was required." This indicates that there was no test set of patient data used for clinical performance evaluation. The substantiation of equivalence was primarily through non-clinical testing and comparison of technical specifications to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical testing with a test set and ground truth established by experts was performed or required.
4. Adjudication method for the test set:
Not applicable, as no clinical testing with a test set was performed or required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a hardware diagnostic imaging system; it does not explicitly refer to an "algorithm only" performance separate from the system's overall function. The performance is inherent to the integrated ultrasound system.
7. The type of ground truth used:
Not applicable, as no clinical testing requiring ground truth was performed. The evaluation relied on compliance with engineering standards and direct comparison of specifications to a legally marketed predicate device.
8. The sample size for the training set:
Not applicable. As this approval is for a traditional diagnostic ultrasound system and not an AI/ML-driven device, there would not typically be a "training set" in the sense of machine learning. The system's design and performance are based on established ultrasound physics and engineering principles, and its functionality is validated against industry standards and predicate devices.
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as #8.
§ 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.