(230 days)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
The SonoEye P1/ SonoEye P1-G/ SonoEye V1-G/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.
The Digital Color Doppler Palm Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android mobile device .
- . CHISON Ultrasound software is running as an app (Android) on the COTS device
- . The SonoEye P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G Linear array USB transducer.
The provided text is a 510(k) Summary for the CHISON Medical Technologies Co., Ltd. SonoEye P1/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study (or lack thereof) to prove the device meets these criteria, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the format of specific performance metrics with target values. Instead, it demonstrates compliance by comparing the subject device's features and safety adherence to those of legally marketed predicate devices. The "acceptance criteria" are implied to be the standards and functionalities met by the predicate devices and general medical device regulations.
The provided comparison table shows similarities in various aspects between the subject device and the predicate devices. Below is a summarized table reflecting the reported device performance as per the comparison table, where "Same" indicates alignment with predicate devices, and specific values are given where differences are noted.
Table 1: Reported Device Performance vs. Implied Acceptance Criteria (via Predicate Comparison)
| Acceptance Criteria Category (Implied by Predicate Features & Standards) | Reported Device Performance (SonoEye Digital Color Doppler Palm Ultrasound System) |
|---|---|
| Indications for Use | Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid (Same as some predicate indications, subset of others) |
| Design Fundamentals | Autocorrelation for color processing, FFT for pulse Doppler processing, Supporting Linear probe, Cine play back capability, Image file archive (Same as predicates) |
| TGC Functionality | STC (Same as predicates' TGC) |
| Depth Range | 1.0 to 9.9cm (Different from predicate ranges, but "meets clinical requirements") |
| Shades of Gray | 256 (Same as predicates) |
| Gain Control | Gain: 0-255, 1/step (Same as predicates) |
| Focus Control | Adjustable (Same as predicates) |
| ROI Adjustment | Adjustable (Same as predicates) |
| Baseline | Present (Same as predicates) |
| Cine Control | Step, play backward, play continuously (Same as predicates) |
| Freeze Control | Toggling freeze key (Same as predicates) |
| Safety Compliance | ANSI/AAMI ES60601-1, IEC60601-1, IEC60601-2-37, IEC60601-1-2, ISO 10993-1 (Same as predicates) |
| Operation Modes | B mode, PW mode, B/M mode, CFM mode, FHI (Same as predicates, FHI corresponds to predicate's IQ) |
| Image Controls | Gain, Depth, STC, Compound, Frequency Scaling, Freeze/Unfreeze, Zoom (Same as predicates) |
| Measurements (2D mode) | Depth, Distance, Area, Volume (Same as predicates, volume mentioned which some predicates have) |
| Measurements (Doppler mode) | Velocity, Time, B/M mode: Distance, Time, HR (Same as predicates) |
| Specialized Measurement Packages | Vessel measure package, Small Organ measure package (Same as predicates) |
| Reporting | General report, Vessel report, Small Organ report (Same as predicates) |
| User Interface Features | Multi-language Interface, Clipboard (Thumbnail), Instant AIO (iTouch), Biopsy Guide, SonoRemote (Reacts Session Views), SonoNeedle (iNeedle), SuperNeedle (NeedleEnhance), Save Cine, Save Image, Cine Loop, Annotation, Bodymark, Arrow Mark, Patient management, Voice/Angle/Baseline on PW, Physical key, Setting, Archives (Patient database), Tutorials, Easyview (Review), Demo, About, Sample Gate adjustments (Same as predicates, with some naming differences) |
| Display Annotations | Logo; Hospital Name; Exam date; Exam time; Mechanical index; Thermal index; Probe model; STC; Focus position; Imaging parameters; System status; Gray/Color bar (Same as predicates, STC vs TGC) |
| Transducer Types & Connectors | Linear Array, USB interface (Subset of predicate types) |
| Users / Sites | Hospitals, clinics usage (Same as predicates) |
| Acoustic Output | Track 3, Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0 (Same as predicates) |
| Power Requirements | DC 5V, Operating temperature: 10-38°C, Relative humidity: 30-75%, Barometric pressure: 700 to 1060 hPa (Different from predicate, but verified compliant with standards) |
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 explicitly states: "No clinical testing was required." This indicates that there was no test set involving human subjects or clinical data for performance evaluation in the usual sense of a clinical study. The evaluation focused on non-clinical tests and comparisons to predicate devices. Therefore, information on sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable.
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)
Since no clinical testing was performed, there was no "test set" in the context of clinical images requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing and no clinical test set were used.
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. The device is a "Digital Color Doppler Palm Ultrasound System," which is a diagnostic imaging system, not an AI-assisted diagnostic tool for interpretation. The document does not mention any AI capabilities or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an ultrasound system with human-in-the-loop operation for image acquisition and interpretation. There's no "algorithm only" performance reported in the context of a diagnostic interpretation task. The non-clinical tests indicate standalone performance of the device in terms of safety and technical specifications, but not diagnostic accuracy of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing was performed for diagnostic accuracy. The ground truth for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601-1, ISO 10993-1) against which the device's technical performance was measured.
8. The sample size for the training set
Not applicable. The document does not indicate the use of machine learning or AI models requiring a training set for diagnostic purposes. The software mentioned is a "CHISON Ultrasound software" running as an Android app, which enables the device's functionalities, not a learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set for AI/ML was mentioned or implied.
§ 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.