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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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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.

Ask a specific question about this device

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 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.

This document is a 510(k) premarket notification for general purpose ultrasonic imaging systems (X-CUBE 50 and X-CUBE 60). It does not involve an AI-powered device, but rather a traditional medical imaging device. Therefore, the information requested regarding acceptance criteria and study for AI performance is not applicable.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices by comparing their intended use, imaging modes, physical specifications, and compliance with various safety and performance standards. It explicitly states: "The subject of this premarket submission, X-CUBE 50 and X-CUBE 60, did not require clinical studies to support substantial equivalence." This indicates that no new clinical performance data (which would include data for AI performance if it were an AI device) was generated or submitted for this clearance.

Therefore, I cannot provide the requested information as it pertains to a study proving an AI device meets acceptance criteria.

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The X-CUBE i8, X-CUBE i9 diagnostic ultrasound systems are intended for use by, or by the order 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, 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.

The X-CUBE i8. X-CUBE i9 are intended to be used in a hospital or medical clinic.

X-CUBE i8 and X-CUBE i9 products are an ultrasound imaging system for medical diagnosis. This system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

Signal Mode:
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

Combination Mode:
B/Color Doppler, B/PWD, B/Color Doppler/PWD

Acoustic output track: Track 3

This document is a 510(k) premarket notification for an ultrasound imaging system. It demonstrates substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific performance acceptance criteria for an AI/ML-driven medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details for an AI/ML system.

The "Summary of Non-Clinical Tests" and "Summary of Clinical Tests" sections explicitly state:

• Non-Clinical: "X-CUBE i8 and X-CUBE i9 have been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards." This refers to general device safety and performance based on standards like IEC 60601-1, NEMA UD 2, etc., not AI/ML performance.
• Clinical: "The subject of this premarket submission, X-CUBE i8 and X-CUBE i9, did not require clinical studies to support substantial equivalence." This means no human-in-the-loop or standalone clinical AI/ML performance studies were conducted or presented for this submission.

Therefore, I cannot fulfill your request to extract the specific information about acceptance criteria and a study proving AI/ML device performance from the provided document, as the document does not contain this type of information.

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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 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.

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.

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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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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:

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.

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The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable(only body) and mobile(with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode, 3D, 4D

B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

The provided text describes a 510(k) premarket notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE i7 ultrasound system. This submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a novel device with specific acceptance criteria that require proof through a new study.

Therefore, there is no specific study mentioned in this document that proves the device meets particular acceptance criteria in the format requested. The document asserts substantial equivalence based on comparisons to predicate devices and adherence to established safety and performance standards.

Here's an attempt to structure the information based on your request, highlighting what is (and isn't) present in the provided text:

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly defined by the safety and performance characteristics of the predicate devices and relevant industry standards. The "reported device performance" is essentially the statement that the E-CUBE i7 is equivalent in performance to these predicates.

The document states, "Therefore, the differences between E-CUBE i7 and the predicate devices would not affect the safety, effectiveness and essential performance." This is the core "proof" in a 510(k) context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The subject of this premarket submission, E-CUBE i7, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set, sample size, or data provenance information of this nature provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies with test sets were conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies with test sets were conducted.

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 E-CUBE i7 is an ultrasound imaging system, and the submission does not mention any AI assistance features or MRMC 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 algorithm-only device. Performance assessment is based on demonstrating equivalence to predicate ultrasound systems through engineering and performance testing against standards, not through standalone algorithm performance studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that no clinical studies were performed, there's no clinical "ground truth" established in this submission. The "ground truth" for demonstrating substantial equivalence relies on:

• Engineering principles and design specifications.
• Performance testing against recognized standards (e.g., NEMA UD2, AIUM Medical Ultrasound Safety, IEC 60601 series).
• Comparison of features and specifications to legally marketed predicate devices.

8. The sample size for the training set

Not applicable, as no machine learning/AI models are discussed that would require a training set in the context of this submission. The device is an ultrasound imaging system.

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

Not applicable.

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The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).

minisono product is an ultrasound imaging system for medical diagnosis. This device is available for portable and tablet PC (Microsoft corp., Surface pro). Also, this innovative system platform provides optimal patient diagnosis workflow with the tablet PC, optimal image quality.

1. Signal Mode: B(2D) mode, M mode, Pulsed Wave Doppler(PWD) mode, Color Doppler, Power Doppler, Tissue Harmonic Imaging
2. Combination Mode: B/Color Doppler, B/PWD, B/Color Doppler/PWD

The Alpinion Medical Systems Co., Ltd. minisono is an ultrasound imaging system for medical diagnosis. It is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in various clinical applications including Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Musculo-skeletal (Conventional and Superficial), Peripheral Vascular (PV), and Urology (including prostate).

This document does not contain details of a study with acceptance criteria and reported device performance in the format of a table, efficacy data, or diagnostic performance metrics typically associated with AI/ML devices. Instead, it is a 510(k) premarket notification for a medical device that argues for substantial equivalence to a predicate device, the E-CUBE i7 Diagnostic Ultrasound System (K153444).

Therefore, specific information regarding the acceptance criteria and study proving the device meets them, as requested in the prompt, cannot be fully extracted in the requested format for a diagnostic AI/ML device. However, based on the provided text, here is a summary of the information related to the device's validation and comparison to a predicate:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria and reported device performance in the context of diagnostic accuracy or clinical efficacy for an AI/ML component. The submission focuses on substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and compliance with safety standards.

The acceptance criteria for this submission appear to be demonstrating that the minisono system possesses the same fundamental scientific technology, intended use, and similar technological characteristics as the predicate device (E-CUBE i7), and that any differences do not raise new questions of safety or effectiveness.

The document lists the following as "reported device performance" indirectly by comparing features to the predicate:

The "acceptance criteria" here is primarily the demonstration of substantial equivalence to the predicate device in terms of intended use, technology, and compliance with safety standards, rather than a specific performance metric like sensitivity or specificity for a diagnostic algorithm.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, minisono, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set, sample size, or data provenance related to clinical performance or diagnostic accuracy provided. The evaluation was based on non-clinical tests demonstrating biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety according to applicable medical device safety standards.

3. Number of Experts and Qualifications for Ground Truth

Since no clinical studies were conducted to support substantial equivalence, there were no experts used to establish ground truth for a test set in the context of diagnostic performance. The evaluation was based on engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for diagnostic performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The document states that clinical studies were not required, and there is no mention of an MRMC study or evaluation of human reader improvement with AI assistance. The device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an ultrasound imaging system, not an algorithm being deployed in a standalone capacity for diagnostic interpretation. Its "software" features are related to image processing and user interface, not automated diagnostic algorithms.

7. Type of Ground Truth Used

Not applicable for diagnostic performance. For safety and functional aspects, the "ground truth" would be established by validated test methods and compliance with recognized standards (e.g., IEC, ISO, AIUM/NEMA).

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML-driven diagnostic device that would require a "training set" in the conventional sense. The device's "software" features are implemented based on established imaging principles and signal processing, not statistical learning from a dataset.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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