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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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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.

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.

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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; 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 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.

This document is an FDA 510(k) Premarket Notification stating that the Alpinion Medical Systems X-CUBE 70 ultrasound system is substantially equivalent to legally marketed predicate devices. It specifically outlines the indications for use, comparison to predicate devices, and a summary of non-clinical tests.

This document focuses on the substantial equivalence of the new device (X-CUBE 70) to existing predicate devices, primarily based on technical characteristics and compliance with safety standards, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study.

Therefore, most of the requested information regarding acceptance criteria, study details, sample size, ground truth, and expert reconciliation cannot be extracted from this particular document, as it describes a regulatory submission for a medical imaging device, not a performance study of an AI/algorithm-driven device.

However, I can provide information based on what is available in the document:

Acceptance Criteria and Device Performance (Not directly addressing AI/algorithmic performance)

This section is interpreted in the context of the device's functional and safety characteristics, as the document details its equivalence to predicate ultrasound systems, not an AI component with specific performance metrics.

Since this document is a 510(k) submission for an ultrasound system, not an AI or algorithm-driven device that requires clinical performance studies to demonstrate accuracy in a diagnostic task, the following points are generally not applicable or stated as not required by the document:

2. Sample size used for the test set and the data provenance: Not mentioned as no specific performance test set (in the context of AI/algorithm accuracy) was required. The substantial equivalence relies on technical specifications and safety profile similarity to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy (e.g., presence/absence of disease based on expert consensus) is not part of this type of submission for an ultrasound machine.
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. This is an ultrasound imaging system, not an AI-assisted diagnostic tool being evaluated for reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (ultrasound system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the adherence to safety standards and performance characteristics comparable to predicate devices.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set for a diagnostic algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Tests (from document):
The device underwent non-clinical tests to assess biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety. It was found to conform to applicable medical device safety standards and voluntary standards (listed in the table above).

Summary of Clinical Tests (from document):
The document explicitly states: "The subject of this premarket submission, X-CUBE 70, did not require clinical studies to support substantial equivalence." This reinforces that the focus of this 510(k) submission is on technical and safety equivalence to predicate devices, not on a new clinical claim or an AI/algorithmic performance claim.

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