The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-rectal, Obstetrics/ Gynecology and Urology applications.
The SIUI Apogee 5500/ Apogee 5300 /Apogee 5800 is a Digital Ultrasound Imaging System capable of the following operating modes: B-Mode(B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined(B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), and other(3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG).The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
This document describes the premarket notification for the SIUI Apogee 5500, Apogee 5300, and Apogee 5800 Digital Color Doppler Ultrasound Imaging Systems. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and performance data for a novel AI device or software. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods is not directly available in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly those required to demonstrate substantial equivalence to previously cleared predicate devices, as per FDA's 510(k) pathway. The reported performance is primarily functional similarity and adherence to safety standards, rather than specific quantitative metrics.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective for Intended Use | The device demonstrates substantial equivalence in intended use, technological characteristics, imaging modes, measurement functions, and safety standards to predicate devices. Testing was performed per FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 2008). The device conforms to applicable medical device safety standards, such as IEC 60601-1, ISO10993-5, and ISO 10993-10. Acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. |
| Similar Intended Use | Subject Device IFU: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-vaginal, Trans-rectal, Obstetrics/Gynecology and Urology applications. |
| Predicate Apogee 3800 IFU (K110841): Abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes. | |
| Predicate Acuson X700 IFU (K141846): Cardiac (Adult, Pediatric), Trans-esophageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The subject device's applications are covered by the Acuson X700. | |
| Similar Technological Characteristics (Imaging Modes & Functions) | Subject Device Modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), and other (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG). |
| Predicate Apogee 3800 (K110841): Same basic operating modes (B, M, PWD, Color Doppler, 3D imaging modes) as the subject device, with the subject device adding new modes like XBeam, Panoscope, 4D, Trapezoidal / Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, and ECG. These new modes were tested and proved no impact on device safety and effectiveness. | |
| Predicate Acuson X700 (K141846): The new imaging modes and applications in the subject device are similar to those in the Acuson X700. | |
| Similar Transducers and Applications Connected | Subject Device Transducers: Linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. Specifically mentioned additional transducers: V6LC, ECBP, L10LC, C6LC, U5LC. |
| Predicate Apogee 3800 (K110841): The subject device adds V6LC, ECBP, L10LC, C6LC, U5LC transducers, which are identical to those available on the Acuson X700 (K141846). | |
| Predicate Acuson X700 (K141846): The transducers of the subject device and Acuson X700 have similar technical parameters and hardware implementation principle. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of an AI/algorithm performance study. The evaluation appears to be based on engineering validation and verification testing of the ultrasound system's performance characteristics (e.g., acoustic output, image quality checks) and comparison to predicate devices, rather than a clinical study with a defined patient test set for an algorithm.
- Sample Size: Not specified for any performance testing beyond general system validation.
- Data Provenance: Not applicable from the provided text, as it doesn't describe a study with patient data for algorithm evaluation. The company (SIUI) is based in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided because the submission is for an ultrasound imaging system, not an AI algorithm that would typically require expert-established ground truth on a test set of medical images. The "ground truth" for an ultrasound system typically relates to its physical performance characteristics, image quality, and diagnostic accuracy as determined by established medical principles and comparison to predicate devices.
4. Adjudication Method
Not applicable, as there is no mention of a study involving human reader interpretation or ground truth establishment that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study would be relevant for evaluating the impact of AI assistance on human reader performance, which is not the subject of this 510(k) submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This submission is for a full ultrasound imaging system, not a standalone AI algorithm. While the system incorporates "new imaging modes" such as XBeam, Panoscope, 3D, 4D, Elastography, etc., these are features of the imaging system itself, not separate AI algorithms. The document states these new modes "were tested and proved no impact on device safety and effectiveness," which implies technical validation rather than a standalone clinical performance study typically associated with AI.
7. Type of Ground Truth Used
The ground truth for the device's performance is implicitly based on:
- Engineering specifications and measurements: Adherence to established standards for acoustic output (NEMA UD 2), electrical safety (IEC 60601-1), and biocompatibility (ISO 10993-5, ISO 10993-10).
- Comparison to predicate devices: The "ground truth" for substantial equivalence is the validated performance and safety profile of the legally marketed predicate devices (SIUI Apogee 3800 and SIEMENS Acuson X700).
- Qualitative assessment: Clinical utility and image quality are likely assessed by medical professionals during internal validation, but no specific study details are provided.
8. Sample Size for the Training Set
Not applicable. This is not a submission for an AI algorithm that involves a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 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.