(137 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); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate).
And, in the imaging modes of 2D(B) mode; Harnonic 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 document is an FDA 510(k) premarket notification for the Alpinion Medical Systems Co., Ltd. X-CUBE 90 ultrasound system. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies for novel devices.
Therefore, the acceptance criteria and study detailed here are focused on demonstrating that the new device (X-CUBE 90) performs equivalently to previously cleared predicate devices and complies with relevant safety and performance standards. It does not involve a traditional clinical study with patient data in the sense of an Artificial Intelligence (AI) device seeking de novo authorization or PMA.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" related to specific performance metrics for the ultrasound imaging capabilities beyond what is implied by the comparison to predicate devices and adherence to standards. Instead, substantial equivalence is demonstrated by a comparison of features, technical specifications, and compliance with recognized safety standards. The "performance" is implicitly deemed equivalent if these factors are comparable to or better than the predicate devices.
Here's a breakdown of the comparison presented in the "Determination of Substantial Equivalence: Comparison table with Predicate devices" on page 25:
| Feature | Proposed X-CUBE 90 Performance | Predicate E-CUBE 12 (K181277) Performance (and other Reference Devices) |
|---|---|---|
| Indications for Use | 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), Urology (including prostate). | All listed indications are present ("√") for the predicate E-CUBE 12, suggesting that the X-CUBE 90 offers the same range of clinical applications. |
| Dimensions & Weight | Weight: 90kg, Height: 1325/1560 mm, Width: 554 mm, Depth: 815 mm | Weight: 94 kg, Height: 1,420/1,520 mm, Width: 590 mm, Depth: 895 mm (Comparable physical characteristics to predicate devices). |
| Electrical Power | Voltage: 100-120V~, 200-240V~, Frequency: 50-60 Hz, Power: Max. 700VA | Voltage: 100-120V~, 200-240V~, Frequency: 50/60 Hz, Power: Max. 600VA (The X-CUBE 90 has slightly higher max power, but this would be evaluated against safety standards). |
| Imaging Modes | 2D(B) mode, Harmonic mode (HAR), M mode, Color 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. | All listed imaging modes are present ("√") for the predicate E-CUBE 12, indicating functionally equivalent imaging capabilities. |
| Imaging Functions | Xpeed™, Full SRI™, Spatial Compounding Image (SCI), Frequency Compounding image (FCI), Panoramic, Stress Echo, Cube Strain™, Live HQ ™, Needle Vision™ / Needle Vision™ Plus, Elastography, Cube view™, Contrast Enhanced Ultrasound (CEUS), Cube Note, B-STIC, Point Shear Wave Elastography (PSWE), Microvascular Imaging (MVI), Volume Advance™ (Free Angle MSV, AnySlice™, Volume Analysis). | Many of these advanced imaging functions (Xpeed, Full SRI, SCI, FCI, Panic, Stress Echo, Cube Strain, Live HQ, Needle Vision, Elastography, Cube view, CEUS, Cube Note, B-STIC, Volume Advance) are also present in the predicate devices, though some (like PSWE, MVI) are new to this device and would be evaluated for safety and effectiveness on their own, or by comparison to similar functions. |
| Safety Standards | IEC60601-1, IEC60601-1-2, IEC60601-2-37, AAMI/ANSI/ISO10993-1, AAMI/ANSI/ISO14971, AIUM MUS, NEMA UD 2-2004(R2009), NEMA UD 3-2004(R2009). | The document states the X-CUBE 90 "has been found to conform to applicable medical device safety standards" and "comply with voluntary standards as detailed in this premarket submission." The predicate device also conforms to these same standards, indicating equivalent safety profiles. |
Acceptance Criteria (Implicit from Substantial Equivalence):
The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating that the X-CUBE 90 is "substantially equivalent" to legally marketed predicate devices (primarily K181277 E-CUBE 12). This means:
- Same intended use: The X-CUBE 90 has the same indications for use as the predicate device.
- Same technological characteristics: The device uses the same fundamental technology (ultrasound, various imaging modes and functions).
- No new questions of safety or effectiveness: Any differences in technological characteristics do not raise new questions of safety or effectiveness. This is primarily addressed through compliance with established safety and performance standards.
2. Sample size used for the test set and the data provenance
The document explicitly states: "The subject of this premarket submission, X-CUBE 90, did not require clinical studies to support substantial equivalence."
This means there was no dedicated clinical test set of patient data in the typical sense for demonstrating diagnostic accuracy or efficacy. The "study" for this submission primarily consists of non-clinical performance testing, compliance with international safety and performance standards, and comparisons of technical specifications and features to predicate devices.
Therefore, there is no sample size for an an imaging test set, and no data provenance relevant to patient-derived images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there was no clinical study involving a test set of patient data to establish ground truth diagnoses, this information is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical test set for which ground truth adjudication was required.
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
No MRMC study was conducted. This device is an ultrasound system, not an AI-assisted diagnostic tool that would typically be evaluated for reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical ground truth was established for a test set. The "ground truth" for this type of submission is adherence to recognized performance standards and demonstrated technological equivalence to already cleared devices.
8. The sample size for the training set
Not applicable. This device is an ultrasound imaging system, not an AI/machine learning model whose performance is enhanced through training on a dataset.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/machine learning model.
In summary, this 510(k) submission for the X-CUBE 90 ultrasound system primarily relies on non-clinical testing and comparison to predicate devices, rather than clinical studies with patient data and ground truth establishment, to demonstrate substantial equivalence. The "acceptance criteria" are met by demonstrating that the device's technical specifications, imaging modes, and overall performance fall within the established safety and effectiveness profile of already cleared ultrasound systems, and by proving compliance with relevant international and national medical device standards.
§ 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.