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The X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems are 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-raginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph(Cardiac), Peripheral Vessel(PV); and Urology(including prostate).

And, the imaging modes are 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 and X-CUBE 90 are intended to be used in a hospital or medical clinic.

The X-CUBE 70 and X-CUBE 90 products are general purpose ultrasound imaging system for medical diagnosis assistance.

These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device.

Also X-CUBE 70 and X-CUBE 90 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices.

This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.

The provided text describes the regulatory clearance of the ALPINION Medical Systems X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems. It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-driven medical device, as the device itself is a diagnostic ultrasound system and not an AI/ML product.

However, the document lists several standards and regulations that the device conforms to to establish its safety and effectiveness relative to predicate devices. These can be interpreted as the high-level criteria for substantial equivalence.

Here's a breakdown of the information that is available, reframed to address your request where possible, and noting where information is explicitly not present for an AI/ML context:

1. A table of acceptance criteria and the reported device performance:

The document does not specify performance acceptance criteria in terms of metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML device study. Instead, it states the device's conformance to various safety and performance standards. The "New Technologies" are features of the ultrasound system itself, not standalone AI algorithms with performance metrics.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. The document states: "The subject of this premarket submission, X-CUBE 70 and X-CUBE 90, did not require clinical studies to support substantial equivalence." This means there was no specific clinical test set used to evaluate performance in the way an AI/ML device would be tested. The evaluation was based on conformance to engineering and safety standards and comparison to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. As no clinical study or test set for an AI/ML algorithm was conducted, there was no need for experts to establish ground truth in this context.

4. Adjudication method for the test set:

• Not applicable / Not provided. No clinical test set.

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 / Not provided. This is not an AI-assisted device, so no such study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable / Not provided. This is an ultrasound imaging system, not a standalone AI algorithm.

7. The type of ground truth used:

• Not applicable / Not provided. As no clinical evaluation study requiring ground truth was performed, this information is not available. The "ground truth" for this submission was based on the technical specifications and validated performance against established standards for ultrasound devices, as well as comparison to predicate devices.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable / Not provided. This is not an AI/ML device.

In summary, the provided document is a 510(k) clearance letter for a diagnostic ultrasound system. It outlines the regulatory process for demonstrating "substantial equivalence" to existing devices, primarily through adherence to safety and performance standards and a comparison of technological characteristics. It is not a submission for an AI/ML product and therefore does not contain the specific types of acceptance criteria and study details you would expect for such a device.

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