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The X-CUBE 50, X-CUBE 60 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-rectal; 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(Pulse Repetition Frequency) Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.

The X-CUBE 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.

The X-CUBE 50 and X-CUBE 60 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 50 and X-CUBE 60 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 document is a 510(k) Summary for the X-CUBE 50 and X-CUBE 60 diagnostic ultrasound systems. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for device performance. Instead, it states that the devices have been evaluated for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The performance is implicitly assessed against these standards and against the characteristics of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: “The subject of this premarket submission, X-CUBE 50 and X-CUBE 60, did not require clinical studies to support substantial equivalence.” Therefore, there is no specific test set or data provenance related to a clinical study. The evaluation appears to be based on adherence to standards and comparison of technical specifications with predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical studies with a specific test set requiring expert-established ground truth were performed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies with a test set requiring adjudication were performed.

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 50 and X-CUBE 60 are diagnostic ultrasound systems, not AI-powered interpretation software meant to assist human readers. The document does not describe any AI component or human reader effectiveness studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable, as the device is a diagnostic ultrasound system and not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies with a specific test set were performed to assess diagnostic accuracy against a ground truth.

8. The Sample Size for the Training Set

Not applicable, as the device is a diagnostic ultrasound system and not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as the device is a diagnostic ultrasound system and not an AI algorithm requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is not a traditional clinical trial or performance study against specific diagnostic metrics. Instead, it is an engineering and regulatory compliance assessment designed to demonstrate "substantial equivalence" to legally marketed predicate devices.

The proof that the device meets its implicit acceptance criteria (that it is as safe and effective as the predicate) is based on:

• Non-Clinical Tests: Evaluation for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, confirming adherence to various international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AAMI/ANSI/ISO 10993-1, AAMI/ANSI/ISO 14971, AIUM MUS, NEMA UD 2, NEMA UD 3).
• Quality Management System Measures: Adherence to 21 CFR 820 and ISO 13485, including medical device risk management, requirements reviews, design reviews, component verification, integration review, performance testing, safety testing, and design validation.
• Comparison to Predicate Devices: A detailed comparison (table provided in the 510(k) summary) of the proposed devices (X-CUBE 50, X-CUBE 60) with predicate devices (K220857 X-CUBE 50, X-CUBE 60, and K221093 X-CUBE 70, X-CUBE 90). This comparison covers indications for use, physical dimensions, electrical power, imaging modes, imaging features, accessories, and compliance to safety standards. The document highlights that the new devices have minor changes (e.g., model name changes, addition of some transducers) and maintain the same operating principles, intended use, risk grade, and design/manufacturing characteristics as the predicate devices.
• Conclusion of Substantial Equivalence: The manufacturer concluded that the differences between the proposed and predicate devices would not affect safety, effectiveness, and essential performance, thus arguing for substantial equivalence.

In essence, the proof relies on a comprehensive engineering and regulatory checklist showing that the new devices meet established safety standards and are technically similar to previously cleared devices for their intended use. No new clinical performance data was deemed necessary by the FDA for this 510(k) clearance process.

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