(118 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,Transectal, Transvaginal, Urology.
The QBit 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 Fusion 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.
The provided document is a 510(k) premarket notification for the CHISON Medical Imaging Co., Ltd. QBit Series Diagnostic Ultrasound System. This document asserts substantial equivalence to a predicate device and does not present an independent clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.
Instead, the document focuses on demonstrating that the QBit Series Diagnostic Ultrasound System has similar technological characteristics and performance to a legally marketed predicate device (DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System, K132341), thereby concluding that it is as safe and effective.
Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth for a de novo or novel device cannot be directly extracted from this type of regulatory submission in the typical sense. However, I can infer and extract information to the best of my ability based on the provided text, primarily from the "Comparison to Predicate Device" table.
Here's the breakdown of what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical task. Instead, it relies on demonstrating that the "Submission Device" (QBit Series) is comparable to the "Predicate Device" in terms of indications for use, design, operating controls, safety compliance, patient contact materials, operation modes, display modes, display annotations, display monitor, measurements, transducer types & connectors, acoustic output, and power requirements.
The "reported device performance" is essentially the statement that the submission device is "Same" or "Substantially Equivalent" (SE) to the predicate across these many features.
| Feature | Acceptance Criteria (Implied: "Same as Predicate") | Reported Device Performance (Submission Device) | Remark |
|---|---|---|---|
| Indications for Use | Same as Predicate | 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 |
| Design | Same as Predicate | 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 |
| Operating Controls | Equivalent to Predicate | TGC 8 slider. Depth Range: 0 to 30 cm (Predicate: 1.5 to 40 cm). 256 shades of gray. B Dynamic range control: 30-180 dB, 5/step. Gain: 0-255, 1/step (Predicate: 0-100, 1/step). 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 only), 13 steps. PW angle correction: -89~89degrees, 1/step. Baseline: 8 steps. | SE Analysis 1 (Depth Range, Gain differences considered SE) |
| Safety Compliance | Same standards as Predicate | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004, ISO 10993-1. | Same |
| Patient Contact Materials | Biocompatible | Bio-compatible | Same |
| Operation Mode | Same modes as Predicate | B, FHI, M, Color M, Free M mode, Color Doppler Imaging, Power Continuous Wave Doppler, TDI, Contrast Imaging, 3D/4D, Elastography, Curved. (Predicate lists similar modes including THI, PSH, Steering Free Xros MTM, Free Xros CM, ColorPD, Pulsed Wave Doppler, Doppler Imaging, Power Doppler Imaging/Directional PD, Pulsed Wave Doppler, Continuous Wave Doppler, TDI, UWN+Panoramic, Trapezoidal image, Contrast Imaging, 3D/4D, Elastography, iScape View). | Same |
| Display Modes | Same modes as Predicate | B,M,PW,CW,CFM,Power/Dirpower,TDI,3D/4D; B+M,B+PW,B+CFM,B+PD/DP D,B+CFM+PW/CW,B+PW+PD/DBD. (Predicate lists identical modes: B,M,PW,CW,CFM,Power/Dirpower,TDI,3D/4D; B+M,B+PW,B+CFM,B+PD/DPD, B+CFM+PW/CW,B+PW+PD/DP D) | Same |
| Display Annotations | Same as Predicate | Logo; Hospital Name; Exam date; Exam time; Acoustic Power; Mechanical thermal indes; ID, Last name, First Name, Middle initial, Gender, Age; Probe model; ECG ico; Operator; TGC Corve; Focus position; Thumbnail; Imaging parameters; Dynamic Trackball indices. | Same |
| Display Monitor | Equivalent to Predicate | 15"/ 19" high-resolution color LCD monitor (Predicate: 19" high-resolution color LCD monitor). | Same |
| Measurements | Same as Predicate | 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 |
| Transducer Types & Connectors | Same as Predicate | Convex Array, Phased Array, Linear Array, Volume probe. 4 ports. | Same |
| Acoustic Output | Same as Predicate | 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 |
| Power Requirements | Equivalent or improved relative to Predicate | AC :100V- 240V, Frequenzy: 50-60Hz, Operating temperature: 10-40° C; relative humidity 30-75%; Barometric pressure:700 to 1060 hPa. (Predicate: AC: 100-127V, or 220-240v, Frequenzy: 50/60 Hz, Operating temperature: 0-40° C; relative humidity 30-85%; Barometric pressure:700 to 1060 hPa). | SE Analysis 2 (Power supply compliance with IEC60601-1 and US voltage range) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not applicable and not provided. The submission states, "No clinical testing was required." The comparison is based on technical specifications and regulatory compliance, not on clinical performance data gathered from a test set of patient cases.
- Data Provenance: Not applicable, as no clinical test data is presented.
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 test data with expert-established ground truth is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test data requiring adjudication is presented.
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 510(k) submission for a diagnostic ultrasound system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device for which MRMC studies are typically conducted to evaluate reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a diagnostic ultrasound system, the performance of which is inherent to its image acquisition and processing capabilities, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical test data with ground truth is presented. The "ground truth" for this regulatory submission is effectively the compliance with recognized standards (e.g., IEC, NEMA, ISO) and the technical specifications of the predicate device.
8. The sample size for the training set
- Not applicable. This document pertains to the regulatory clearance of a medical device based on substantial equivalence, not the development or training of an algorithm using a dataset.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.