(103 days)
The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate).
And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 70 is intended to be used in a hospital or medical clinic.
X-CUBE 70 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
The information provided about the X-CUBE 70 ultrasound system primarily pertains to its technical specifications and regulatory compliance for medical device safety standards, rather than performance against specific clinical acceptance criteria or a study with clinical endpoints.
The document states: "The subject of this premarket submission, X-CUBE 70, did not require clinical studies to support substantial equivalence." This means that the device was deemed substantially equivalent to a predicate device (X-CUBE 70, K200450) based on non-clinical tests rather than clinical performance trials demonstrating specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria derived from a clinical study, sample size, expert ground truth, and comparative effectiveness studies are not available in the provided text.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the X-CUBE 70 as being in conformance with various safety and performance standards for ultrasound equipment. The "acceptance criteria" here relate to meeting these standards for safety and technical specifications, as opposed to clinical performance benchmarks.
| Acceptance Criteria (General Categories based on Non-Clinical Tests) | Reported Device Performance |
|---|---|
| Biocompatibility | Confirmed |
| Acoustic Output | Conforms to NEMA UD2, UD3 and AIUM Medical Ultrasound Safety |
| Thermal Safety | Conforms to IEC 60601-1 and IEC 60601-2-37 |
| Electrical Safety | Conforms to IEC 60601-1 and IEC 60601-2-37 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 |
| Mechanical Safety | Confirmed |
| Quality Management System (QMS) adherence | Conforms to 21 CFR 820 and ISO 13485 |
| Imaging Modes and Clinical Applications | Supports listed modes (2D(B), Harmonic, M, Color M, Anatomical M, Color Flow Doppler, Power Doppler, Directional PD, Pulsed Wave Doppler, Continuous Wave Doppler, High PRF Doppler, Tissue Doppler Imaging, 3D/4D) and clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel, Urology) across various transducers. |
| Dimensions and Weight | (See detailed table, e.g., Weight: 90kg, Height: 1325/1560 mm, Width: 554 mm, Depth: 815 mm) |
| Electrical Power | (See detailed table, e.g., Voltage: 100-120V~, 200-240V~; Frequency: 50-60 Hz; Power: Max. 700VA) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable as no clinical study with a "test set" of patient data was conducted or referenced for performance evaluation in this submission. The evaluation was based on non-clinical testing against industry standards.
- Data Provenance: Not applicable for a clinical test set. The data provenance for the non-clinical tests would be from laboratory testing according to the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical ground truth assessment by experts was explicitly mentioned in the context of performance testing for this submission. The compliance was assessed against safety and performance standards by the manufacturer and reviewed by the FDA.
4. Adjudication method for the test set:
- Not applicable due to the absence of a clinical test set requiring expert 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. The X-CUBE 70 is a diagnostic ultrasound system and the submission does not describe any AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as the device is an ultrasound system, not a standalone algorithm.
7. The type of ground truth used:
- The "ground truth" for the device's acceptable performance was established through adherence to recognized medical device safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AAMI/ANSI/ISO10993-1, AIUM MUS, NEMA UD 2, NEMA UD 3) and comparison to predicates for substantial equivalence. There is no mention of clinical ground truth (e.g., pathology, outcomes data).
8. The sample size for the training set:
- Not applicable. The document does not describe any machine learning or AI component requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned in this submission.
§ 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.