(103 days)
The X-CUBE 90 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); Cardiatric); 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 90 is intended to be used in a hospital or medical clinic.
X-CUBE 90 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 provided text describes the Alpinion Medical Systems Co., Ltd. X-CUBE 90 ultrasound system and its equivalence to predicate devices, but it does not include information about acceptance criteria or a study proving device performance in the context of AI/ML.
The document is a 510(k) summary for a traditional medical device (ultrasound system), not an AI/ML-powered device. Therefore, it focuses on demonstrating substantial equivalence to previously cleared ultrasound systems based on technical characteristics, indications for use, and compliance with general medical device safety standards.
Here's what can be extracted from the document, with the understanding that the request for AI/ML-specific details cannot be fully met from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative clinical performance acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices. Instead, it demonstrates performance by comparing its features and characteristics to legally marketed predicate devices, asserting that it is as safe and effective.
The acceptance criteria are implicitly based on compliance with recognized medical device standards and having equivalent specifications and functionalities to the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Compliance with IEC 60601-1 (General Safety) | X-CUBE 90 conforms to IEC60601-1:2005(Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012 |
| Compliance with IEC 60601-1-2 (EMC) | X-CUBE 90 conforms to IEC60601-1-2:2014 |
| Compliance with IEC 60601-2-37 (Ultrasonic Specific Safety) | X-CUBE 90 conforms to IEC60601-2-37:2007/AMD1:2015 |
| Biocompatibility of patient contact materials | Transducer materials and other patient contact materials are biocompatible (conforming to AAMI/ANSI/ISO10993-1:2009(R)2013) |
| Compliance with risk management standards | Conforms to AAMI/ANSI/ISO14971:2007/(R)2010 |
| Compliance with Acoustic Output Measurement Standard | Conforms to NEMA UD 2-2004(R2009) |
| Compliance with Real Time Display of Thermal and Mechanical AI | Conforms to NEMA UD 3-2004(R2009) |
| Indications for Use (equivalent to predicate) | The X-CUBE 90 has the same clinical applications and imaging modes as its primary predicate (K200449 X-CUBE 90). |
| Technical Specifications (dimensions, electrical power, etc.) | Specifications are comparable or slightly improved to predicate devices, not affecting safety or effectiveness. |
Regarding the sections specific to AI/ML devices (points 2-9 in your request), the provided text does not contain this information as it describes a conventional ultrasound system, not an AI/ML powered one.
Therefore, the following cannot be answered from the provided document:
- 2. Sample size used for the test set and the data provenance: Not applicable, as no AI/ML test set is mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable, as no AI/ML training set is mentioned.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of Non-Clinical and Clinical Tests (from the document):
- Summary of Non-Clinical Tests: The X-CUBE 90 was evaluated for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety. It was found to conform to various medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AAMI/ANSI/ISO10993-1, AAMI/ANSI/ISO14971, AIUM MUS, NEMA UD 2, NEMA UD 3). Quality management system measures were also applied, including risk management, requirements reviews, design reviews, component verification, integration review, performance testing, safety testing, and design validation.
- Summary of Clinical Tests: The submission explicitly states: "The subject of this premarket submission, X-CUBE 90, did not require clinical studies to support substantial equivalence." This is typical for 510(k) submissions of conventional devices demonstrating equivalence to existing ones.
§ 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.