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510(k) Data Aggregation
(53 days)
The SonoScape S40 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, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
The SonoScape S40 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 document describes the SonoScape S40 Digital Color Doppler Ultrasound System and its substantial equivalence to a predicate device (SonoScape S6). The information provided is primarily for regulatory submission and does not detail a clinical study with an acceptance criterion for device performance in the way a clinical trial for an AI algorithm would. Instead, it focuses on technical specifications and compliance with safety standards to demonstrate substantial equivalence.
Based on the provided text, a "study" in the sense of a clinical performance study with human readers or standalone algorithm performance, as typically found in AI/ML device submissions, was not conducted. The study supporting this device's acceptance is a bench testing and comparison study against a predicate device and relevant safety standards.
Here's a breakdown of the requested information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the performance characteristics of the predicate device (SonoScape S6) and compliance with international safety and performance standards. The "reported device performance" is the comparison of the SonoScape S40 against the S6.
| Feature / Parameter | Acceptance Criteria (Predicate Device S6 Performance) | Reported Device Performance (SonoScape S40) | Remark |
|---|---|---|---|
| Intended Use | General-purpose ultrasonic imaging for Fetal, Abdominal, Pediatric, Small Organ, Cephalic, Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal, Cardiac, OB/Gyn, Urology. | Same | Same (Substantially Equivalent) |
| Classification | Same as predicate: Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer; Class II; Product Code IYN, IYO, ITX. | Same | Same (Substantially Equivalent) |
| Supported Probes | Specific list of Linear, Curved, Micro-curved, and Phased Array probes. | Includes new L752, C353, C322, 5P2, 8P1 probes, and different configuration of Phased Array probes (2P2, 3P1). Handles from 2 to 15 MHz. | Differences noted, but all comply with IEC 60601-2-37. Considered Substantially Equivalent in safety and effectiveness; no new risk. New probes potentially offer improved image quality. |
| Channel Beam Former | 64 channel full digital beam former. | 128 channel full digital beam former. | S40 has better image quality due to 128 channels. Considered Substantially Equivalent in safety and effectiveness. |
| Image Sector Size | 32 lines to full B (256 lines). | 32 lines to full B (512 lines). | S40 has better image quality due to 512 lines. Considered Substantially Equivalent in safety and effectiveness. |
| Display Depth | Max 32.9 cm; (Probe depend); Error range: ±3%. | Same (Max 32.9 cm; (Probe depend); Error range: ±3%). | Same (Substantially Equivalent) |
| Distance Measurement | 0~31.0 cm; Error range: ±3%. | Same (0~31.0 cm; Error range: ±3%). | Same (Substantially Equivalent) |
| Area Measurement | Max. ≥855 cm²; Error range: ±7%. | Same (Max. ≥855 cm²; Error range: ±7%). | Same (Substantially Equivalent) |
| Angle Measurement | 10~193°; Error range: ±3%. | Same (10~193°; Error range: ±3%). | Same (Substantially Equivalent) |
| Circumference Measurement | 200 cm; Error range: ±3%. | Same (200 cm; Error range: ±3%). | Same (Substantially Equivalent) |
| Volume Measurement | Max. 25000 cm³; Error range: ±10%. | Same (Max. 25000 cm³; Error range: ±10%). | Same (Substantially Equivalent) |
| M-Mode Time | 2,4,6,8 S; Error range: ±1%. | Same (2,4,6,8 S; Error range: ±1%). | Same (Substantially Equivalent) |
| Heart Rate | 8 ~ 1000 beats/sec; Error range: ±3%. | Same (8 ~ 1000 beats/sec; Error range: ±3%). | Same (Substantially Equivalent) |
| Slope | 1300 cm/s; Error range: ±3%. | Same (1300 cm/s; Error range: ±3%). | Same (Substantially Equivalent) |
| Velocity (PW) | 0.04-2940 cm/s; Angle ≤60°, ≤5% error. | Same (0.04-2940 cm/s; Angle ≤60°, ≤5% error). | Same (Substantially Equivalent) |
| Velocity (CW) | 0.13-3529 cm/s; Angle ≤60°, ≤5% error. | 0.12-3795 cm/s; Angle ≤60°, ≤5% error. | S40 has better/wider velocity range. Considered Substantially Equivalent in safety and effectiveness. |
| Velocity (Color) | 2-226 cm/s; Angle ≤60°, ≤5% error. | 1-298 cm/s; Angle ≤60°, ≤5% error. | S40 has better/wider velocity range. Considered Substantially Equivalent in safety and effectiveness. |
| Acoustic Output | Track 3:MI, TIS, TIC, TIB (Derated Ispta: 720Mw/cm2 maximum, TIS/TIB/TIC: 6.0 Maximum, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190W/cm2 max). | Same (Track 3:MI, TIS, TIC, TIB Derated ispta: 720Mw/cm2 maximum, TIS/TIB/TIC: 6.0 Maximum, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190W/cm2 max). | Same (Substantially Equivalent) - Measured and calculated per NEMA UD 2: 2004. |
| Electrical Safety | Complies with IEC 60601-1. | Complies with IEC 60601-1. | Same (Substantially Equivalent) |
| EMC | Complies with IEC 60601-1-2. | Complies with IEC 60601-1-2. | Same (Substantially Equivalent) |
| Performance (Safety) | Complies with IEC 60601-2-37. | Complies with IEC 60601-2-37. | Same (Substantially Equivalent) |
| Biocompatibility | Complies with ISO 10993-5, ISO 10993-10. | Complies with ISO 10993-5, ISO 10993-10. | Same (Substantially Equivalent) |
| Level of Concern of Software | Moderate. | Moderate. | Same (Substantially Equivalent) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a clinical performance study on patients. The testing involved laboratory testing to verify design specifications and compliance with standards. It's implied that various transducers were tested for their acoustic output and safety characteristics.
- Data Provenance: The testing was conducted internally by SonoScape Company Limited ("Laboratory testing was conducted to verify that the S40 system with added transducer met all design specification..."). The country of origin for the data would be China, where SonoScape is based.
- Retrospective or Prospective: This was likely prospective bench testing and engineering validation against predefined specifications and standards, rather than retrospective or prospective clinical data collection from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of information is not provided in the 510(k) summary. The submission does not describe a clinical study requiring human expert ground truth for interpretation of images. The ground truth for the technical measurements and safety compliance would be established by validated test equipment and calibration standards, assessed by qualified engineers and technicians, not clinical experts for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. Given that no clinical test with human experts interpreting results was conducted, an adjudication method like 2+1 or 3+1 is not relevant to this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "No clinical testing was required." (Section 8). The comparison was primarily technical specifications against a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable / No. This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone diagnostic interpretation. Its performance is evaluated based on its ability to acquire and display ultrasound data accurately and safely, matching or improving upon the predicate device's technical specifications.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the acceptance of this device relies on:
- Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed SonoScape S6 ultrasound system.
- International Safety and Performance Standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD3, ISO 10993-5, and ISO 10993-10.
- Bench Test Results: Direct measurements of technical parameters (e.g., measurement accuracy for distance, area, velocity, acoustic output) using calibrated equipment.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware and software system, not an AI/ML algorithm that is "trained" on a specific dataset. Its development involves standard engineering design, testing, and validation processes.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the AI/ML sense, there is no ground truth established for one. The device's functionality is based on established ultrasound physics and engineering principles.
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