(94 days)
The SonoScape S30 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.
The SonoScape S30 Digital Color Doppler 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. 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, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes. 3D/4D.
This 510(k) submission (K132527 for the SonoScape S30 Digital Color Doppler Ultrasound System) does not contain a study comparing the device's performance to specific acceptance criteria. Instead, it relies on a substantial equivalence (SE) comparison to a legally marketed predicate device (SonoScape SSI-8000, K102642).
The document explicitly states: "No clinical testing was required" (Section 8, page 2). This indicates that a study demonstrating the device meets quantified acceptance criteria through clinical performance was not performed for this submission.
The acceptance criteria are implicitly defined by the parameters and performance of the predicate device, with the claim that the proposed device either matches or is "better" in certain aspects without raising new safety or effectiveness concerns.
Here's the breakdown of the requested information based on the provided text, while acknowledging the lack of a traditional performance study:
1. Table of Acceptance Criteria and Reported Device Performance
Since there isn't a direct "acceptance criteria" table with specific thresholds, the comparison table from the 510(k) summary (Table 4: Specifications Comparison, page 7-8) serves as the de facto acceptance target, with the predicate device's performance being the benchmark. "Acceptance" here means demonstrating equivalence or superiority without introducing new risks.
| ID | Comparison Items | Acceptance Criteria (Predicate Device SSI-8000) | Reported Device Performance (Proposed Device S30) | Evaluation (Remark from document) |
|---|---|---|---|---|
| 15 | Power Supply (Voltage) | 100/220VAC | 110-127/220-240 VAC | SE Analysis 4 |
| 15 | Power Supply (Power Cons.) | 330 VA | 450VA | SE Analysis 4 |
| 16 | Operating Condition (Temp) | 10~40°C | 10~40°C | Same |
| 16 | Operating Condition (Humid.) | 30~75% | 30~75% | Same |
| 16 | Operating Condition (Pressure) | 700hPa ~1060hPa | 700hPa ~1060hPa | Same |
| 17 | Storage Condition (Temp) | -20~55°C | -20~55°C | Same |
| 17 | Storage Condition (Humid.) | 20~90% | 20~90% | Same |
| 17 | Storage Condition (Pressure) | 700hPa ~1060hPa | 700hPa ~1060hPa | Same |
| 18 | Screen Size | 17 inch LCD color monitor | 19 inch Widescreen LCD monitor | SE Analysis 5 |
| 19 | Measurement Accuracy (Display Depth) | Max 32.9cm; (Probe depend), ±3% | Max 32.9cm; (Probe depend), ±3% | Same |
| 19 | Measurement Accuracy (Distance) | 0~31.0cm, ±3% | 0~31.0cm, ±3% | Same |
| 19 | Measurement Accuracy (Area) | Max. ≥855cm², ±7% | Max. ≥855cm², ±7% | Same |
| 19 | Measurement Accuracy (Angle) | 10~193° (Probe depend), ±3% | 10~193°, ±3% | Same |
| 19 | Measurement Accuracy (Circumference) | 200 cm, ±3% | 200 cm, ±3% | Same |
| 19 | Measurement Accuracy (Volume) | Max. 25000 cm³, ±10% | Max. 25000 cm³, ±10% | Same |
| 19 | Measurement Accuracy (M-Mode time) | 2,4,6,8S, ±1% | 2,4,6,8S, ±1% | Same |
| 19 | Measurement Accuracy (Heart Rate) | 8-1000 beats/sec, ±3% | 8-1000 beats/sec, ±3% | Same |
| 19 | Measurement Accuracy (Slope) | 1300 cm/s, ±3% | 1300 cm/s, ±3% | Same |
| 19 | Measurement Accuracy (Velocity(PW)) | 0.04-2940 cm/s, Angle ≤60°, ≤5% | 0.04-2940 cm/s, Angle ≤60°, ≤5% | Same |
| 19 | Measurement Accuracy (Velocity(CW)) | 0.13-3529 cm/s, Angles 60°, ≤5% | 0.12-3795 cm/s, Angle ≤60°, ≤5% | SE Analysis 6 (Proposed better) |
| 19 | Measurement Accuracy (Velocity(Color)) | 2-226cm/s, Angles 60°, ≤5% | 1-298 cm/s, Angle ≤60°, ≤5% | SE Analysis 6 (Proposed better) |
| 20 | Acoustic Output | Track 3:MI,TIS,TIC,TIB; Derated ispta: 720Mw/cm² max; TIS/TIB/TIC: 6.0 Max; MI: 1.9 Max; Derated Isppa: 190W/cm² max | Track 3:MI,TIS,TIC,TIB; Derated ispta: 720Mw/cm² max; TIS/TIB/TIC: 6.0 Max; MI: 1.9 Max; Derated Isppa: 190W/cm² max | Same |
Other differences noted in the "General Comparison" and "Functions Comparison" tables (pages 3-6) include:
- Probe Type & Connectors (ID 7): The proposed device has different or additional probe types/frequencies. SE Analysis 1 states these comply with IEC 60601-2-37 and raise no new risks.
- Design (ID 9):
- User Interface: Proposed device has a touch panel, predicate has a full keyboard. SE Analysis 2 deems this equivalent based on compliance with IEC 60601-1 and IEC 60601-1-2.
- Image Sector Size: Proposed device: 32 lines to full B (512 lines); Predicate: 32 lines to full B (256 lines). SE Analysis 3 states the proposed device is "better."
- Focal Number: Proposed device: 12 focal zone setting; Predicate: 9 focal zone setting. SE Analysis 3 states the proposed device is "better."
- Controls (ID 10):
- PW angle correction: Proposed device: 0 to 80 degree user control; Predicate: 0 to 72 degree user control. SE Analysis 3 states the proposed device is "better."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The submission explicitly states, "No clinical testing was required" (Section 8, page 2). The device's performance was evaluated through laboratory testing and comparison to an existing predicate device's specifications.
- Data Provenance: Not applicable, as no clinical test data was generated for this submission. The comparison relies on the verified specifications of the predicate device (SonoScape SSI-8000, K102642) and the proposed device's compliance with general safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical test set that required ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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 submission is for a general-purpose ultrasound system, not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm for standalone performance evaluation. Its performance is evaluated as an integrated hardware and software ultrasound system under the guidance of a qualified physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established as no clinical testing was required. The "truth" for this submission are the established safety and performance specifications and standards for diagnostic ultrasound systems, to which both the proposed and predicate devices are demonstrated to conform.
8. The sample size for the training set
- Not applicable. This device is a preprogrammed ultrasound system, not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/machine learning model.
§ 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.