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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 (renal & GYN/pelvic), Pediatric, Small Organ (breast, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardia (adult& pediatric), Peripheral Vascular (PV), and Urology (including prostate).

E-CUBE 8 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 a 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 8 ultrasound system. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily addresses equivalence and adherence to standards for safety and performance, rather than specific acceptance criteria and study designs typically found for novel devices or AI/ML-driven diagnostics.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) or independent reported device performance metrics in the way one would for an AI/ML diagnostic or a more novel technology. Instead, it demonstrates performance by:

• Claiming Substantial Equivalence: The primary "performance" metric is that the E-CUBE 8 is "as safe, as effective" and its "Performance, technology and software are substantially equivalent" to several predicate ultrasound devices (e.g., K172732, K161439, K153424, K132687, K163691, K163120).
• Listing Supported Indications and Imaging Modes: The device supports a wide range of clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional & Superficial), Cardiac (Adult & Pediatric), Peripheral Vascular, Urology) and various imaging modes (2D(B), Harmonic, M, Color M, Anatomical M, Color Flow Doppler (CF), Power Doppler (PD), Directional PD, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), High PRF Doppler, Tissue Doppler Imaging (TDI), 3D/4D). The presence of these modes and applications, matching those of predicate devices, implicitly serves as a performance metric of functional equivalence.
• Compliance with Voluntary Standards: Adherence to standards like IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, AIUM Medical Ultrasound Safety, NEMA UD 2, and NEMA UD 3 indicates that the device meets established safety and basic performance criteria common to ultrasound systems.

Acceptance Criteria (Implicitly based on predicate device equivalence and standards compliance):

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

The document states: "The subject of this premarket submission, E-CUBE 8, did not require clinical studies to support substantial equivalence." This means there was no specific test set of patient data used in a clinical study to evaluate the device against acceptance criteria in the typical sense for a new diagnostic claim. Instead, the evaluation was primarily based on engineering tests, compliance with standards, and comparison of technical specifications to predicate devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not applicable here.

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

As no clinical studies were required, there was no "test set" in the context of diagnostic performance involving ground truth established by experts.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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 device is an ultrasound system, not an AI-driven image analysis tool intended to assist human readers for diagnostic interpretation in the manner described. The document does not mention any AI components in K181617.

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

Not applicable. The E-CUBE 8 is an ultrasound imaging system, an equipment device, not a standalone AI algorithm. The document makes no mention of AI/ML functionality.

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

Not applicable, as no clinical studies with "ground truth" for diagnostic performance were conducted. The "ground truth" in this context refers to the established safety and performance characteristics of legally marketed predicate ultrasound devices and the voluntary standards for ultrasound equipment.

8. The sample size for the training set

Not applicable. This device is an ultrasound system hardware/software combination, not an AI/ML product developed with a training dataset.

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

Not applicable, as no AI/ML training set was involved.

Ask a specific question about this device

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), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac (adult& pediatric), Peripheral Vascular (PV), and Urology (including prostate).

E-CUBE 12 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 acceptance criteria and study proving the device meets them are described in the Summary of Non-Clinical Tests.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
Not applicable. The document states, "The subject of this premarket submission, E-CUBE 12, did not require clinical studies to support substantial equivalence." The evaluation was based on non-clinical tests and conformance to established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical studies were conducted for this submission, and therefore no "experts" were used to establish ground truth in a clinical sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical studies were conducted for this submission.

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 device is an ultrasound imaging system, and the submission does not mention any AI capabilities or MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an ultrasound imaging system, and the submission does not mention any standalone algorithm performance studies. The evaluation focused on the physical device's adherence to safety and performance standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is adherence to established international and national voluntary standards for medical devices, specifically regarding safety (thermal, electrical, electromagnetic, mechanical), biocompatibility, and acoustic output. There is no biological or diagnostic ground truth established by experts or pathology for a clinical study in this document.

8. The sample size for the training set:
Not applicable. The document does not describe any machine learning or algorithm development that would involve a training set. The evaluation is based on engineering and safety standards compliance.

9. How the ground truth for the training set was established:
Not applicable. As there is no mention of a training set, the establishment of its ground truth is not relevant here.

Ask a specific question about this device

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); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 8 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.

Here's an analysis of the acceptance criteria and study information for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 8 ultrasound system, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification from the FDA for a medical ultrasound system. It primarily focuses on demonstrating "substantial equivalence" to existing predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study in the way an AI/ML device might. Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with ground truth, and training set details) are not applicable or not provided in this type of regulatory document for a general ultrasound system. The "studies" mentioned are largely non-clinical engineering and safety compliance tests.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the E-CUBE 8 are primarily related to its equivalency with predicate devices regarding Indications for Use, Imaging Modes, Imaging Functions, and adherence to established safety and performance standards. The reported device performance is that it meets these criteria by incorporating similar or improved features and by complying with relevant medical device standards.

Study Information

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

   • N/A. The document does not describe a "test set" in the context of a dataset used for performance evaluation (e.g., for an AI/ML algorithm). The "testing" involved non-clinical validation against engineering specifications and industry standards.
   • Data Provenance: Not applicable in the context of device performance testing. The provenance of regulatory compliance data is the manufacturing and testing environment of ALPINION Medical Systems Co., Ltd., based in the Republic of Korea.

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

   • N/A. This information is not relevant or provided for a general ultrasound system's 510(k) submission. "Ground truth" in this context would primarily relate to the accuracy of physical measurements and image quality, which are assessed through engineering tests rather than expert interpretation of a diagnostic dataset.

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

   • N/A. No adjudication method for a test set is mentioned, as there isn't a diagnostic performance study described that would require it.

4. 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. An MRMC comparative effectiveness study was not performed or referenced. This document is for a traditional ultrasound imaging system, not an AI-assisted diagnostic device.

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

   • No. This device is a diagnostic ultrasound system intended for use by a qualified physician. Its performance is inherent to the imaging capabilities and is not evaluated as a standalone algorithm without human intervention.

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

   • N/A. For this type of submission, "ground truth" refers to the established engineering specifications, physical laws, and recognized standards against which the device's technical performance (e.g., acoustic output, image resolution, measurement accuracy) is validated. It does not involve medical ground truth from patient data like pathology or outcomes.

7. The sample size for the training set:

   • N/A. This device does not use a "training set" in the context of machine learning. Its functionality is based on established ultrasound physics and engineering design.

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

   • N/A. Not applicable, as there is no training set for this device.

Ask a specific question about this device

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 (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 11 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. E-CUBE 11 ultrasound system, a Class II medical device, and its substantial equivalence to predicate devices, focusing on technical characteristics and safety standards rather than human performance studies or detailed acceptance criteria with reported device performance.

Therefore, the following information cannot be fully extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document states: "The subject of this premarket submission, E-CUBE 11, did not require clinical studies to support substantial equivalence." This indicates that no new clinical efficacy studies evaluating device performance against acceptance criteria were conducted or presented in this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices by comparing technical specifications, imaging modes, and adherence to safety standards.

However, I can provide the acceptance criteria in terms of the standards and features the device conforms to, as reported in the "Summary of Non-Clinical Tests" and "Determination of Substantial Equivalence" sections.

1. Table of Acceptance Criteria (as per conformance to standards and features) and the Reported Device Performance (as stated in the summary of non-clinical tests and comparison to predicates):

2. Sample sized 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 11, did not require clinical studies to support substantial equivalence." Therefore, no specific test set sample size or data provenance from clinical studies is provided. The evaluation was based on non-clinical tests ensuring safety and performance compliance with standards and comparison to predicate devices' technical specifications.

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 expert-established ground truth were conducted for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were conducted for this submission.

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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC studies were conducted.

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, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies with ground truth establishment were conducted for this submission.

8. The sample size for the training set
Not applicable, as the device is a diagnostic ultrasound system and no specific training set for an AI model is mentioned or relevant to this 510(k) submission.

9. How the ground truth for the training set was established
Not applicable, as no training set for an AI model is mentioned or relevant to this 510(k) submission.

Ask a specific question about this device

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 (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac 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
2. Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE i7 ultrasonic pulsed doppler imaging system (K153424):

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel device's primary clinical efficacy study. Therefore, the "acceptance criteria" discussed here are primarily related to safety, performance, and equivalence to existing devices, not necessarily a clinical effectiveness threshold. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted to confirm compliance with recognized medical device standards and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are predominantly compliance with recognized standards and equivalence in features and performance to predicate devices. The "reported device performance" is demonstrated by affirming compliance and similarity.

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

• Sample Size: The document explicitly states: "The subject of this premarket submission, E-CUBE i7, did not require clinical studies to support substantial equivalence." This means there was no clinical test set of patients or images used for efficacy comparison. The "test set" for this submission primarily consisted of the device itself and its components tested against engineering and safety standards.
• Data Provenance: Not applicable for a clinical test set in this context. The data provenance would be internal engineering tests and design documentation.

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

• Not applicable as there was no clinical study involving human reads or a ground truth established by experts for a test set. This submission is based on engineering verification and validation (V&V) against technical standards and comparison to predicate devices, which involves engineers, quality assurance personnel, and regulatory specialists.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical test set requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC study was done. This device is an ultrasonic imaging system, not an AI-assisted diagnostic tool. Its substantial equivalence is based on its core imaging capabilities and safety, not on improving human reader performance.

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

• No standalone algorithm performance study was done. The E-CUBE i7 is a diagnostic ultrasound system intended to be operated by a qualified physician, not an autonomous algorithmic device.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the adherence to established international and national medical device standards (e.g., IEC, NEMA, AIUM, ISO) for safety and performance, and the documented specifications and performance of legally marketed predicate devices. This is established through engineering testing and documented comparisons, rather than clinical outcomes, pathology, or expert consensus on patient data.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a hardware and software system, not a machine learning model that would require a "training set" of data.

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

• Not applicable. There was no training set for a machine learning model.

Ask a specific question about this device

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 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" (or 19.5") wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging (THI)
2. Combination Mode:
   B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
   Acoustic output track: Track 3

The provided text describes the "E-CUBE 15 Diagnostic Ultrasound System" and its various transducers but does not contain information about specific acceptance criteria, studies proving performance, sample sizes, data provenance, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to any AI components. The document is a 510(k) premarket notification to the FDA, focusing on establishing substantial equivalence to previously cleared predicate devices for various clinical applications and operating modes.

The document lists the intended uses and technical specifications of the E-CUBE 15 system and its transducers, comparing it to predicate devices (E-CUBE 9 and iU22). The "Summary of Non-Clinical Tests" mentions evaluation for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards. It also lists quality management system measures applied during development.

Crucially, the "Summary of Clinical Tests" section explicitly states:
"The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."

This means that for the purposes of this 510(k) submission, the device's substantial equivalence was established through non-clinical testing and comparison to predicate devices, rather than through clinical trials with defined acceptance criteria for AI performance, independent test sets, expert ground truth, or MRMC studies.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance for AI components cannot be extracted from this document, as it appears the submission did not rely on such data for device clearance. The document focuses on hardware aspects and basic functional modes, not advanced AI features requiring such rigorous evaluation.

Ask a specific question about this device

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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 5 product is an ultrasound imaging system for medical diagnosis. The 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.

Modes of operation:

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI)
2. Combination Mode:
   B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
   Acoustic output track: Track 3

The provided text describes the acceptance criteria and the study conducted for the ALPINION MEDICAL SYSTEMS Co., Ltd.'s E-CUBE 5 Diagnostic Ultrasound System.

Here's the breakdown of the information requested:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative way. Instead, it states that the E-CUBE 5's safety, effectiveness, and essential performance are considered substantially equivalent to the predicate device (E-CUBE 7) based on non-clinical testing and conformance to applicable medical device safety standards.

Acceptance Criteria (Implied from the document):

• Conformance to applicable medical device safety standards (e.g., NEMA UD2, UD3, AIUM Medical Ultrasound Safety, IEC60601-1, IEC60601-1-2, IEC60601-2-37).
• Biocompatibility of transducer materials and other patient contact materials.
• Evaluation of acoustic output.
• Evaluation of thermal, electrical, electromagnetic, and mechanical safety.
• Performance, technology, and software are substantially equivalent to the predicate device (E-CUBE 7).

Reported Device Performance (Implied from the document):

• The E-CUBE 5 was found to conform to the listed applicable medical device safety standards.
• Transducer materials and patient contact materials are biocompatible.
• Non-clinical testing verified design changes compared to the predicate device.
• The differences between E-CUBE 5 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 5.

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 5, did not require clinical studies to support substantial equivalence." This means no clinical test set was used to evaluate the device's performance in humans. The evaluation was based on non-clinical tests. Therefore, there is no information on sample size or data provenance for a clinical test set.

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)

Since no clinical studies were performed, there are no experts or ground truth established from human data as part of a clinical test set. The validation was based on non-clinical engineering and safety standards.

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

Not applicable, as no clinical test set was used.

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 not an AI/CAD device. The submission does not mention any MRMC study or AI assistance.

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

Not applicable, as this is a diagnostic ultrasound system, not an algorithm being evaluated in isolation. The evaluation was for the entire system and its transducers.

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

For the non-clinical tests, the "ground truth" would be established by reference to engineering specifications, national and international safety standards, and established metrics for acoustic output and electrical safety. For example, for biocompatibility, the ground truth would be established by laboratory tests conforming to ISO standards for material compatibility.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The evaluation is for a diagnostic ultrasound system based on its hardware and software design, and adherence to safety and performance standards.

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

Not applicable, as no training set was used.

Ask a specific question about this device

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; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 21.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

This document is a 510(k) Premarket Notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 12 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device, the E-CUBE 15 Diagnostic Ultrasound System (K123610), rather than outlining specific acceptance criteria and detailed study results for a new device's performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and the type of ground truth used as part of a comparative effectiveness study or standalone performance evaluation is not explicitly provided in the given text.

The document states: "The subject of this premarket submission, E-CUBE 12, did not require clinical studies to support substantial equivalence." This means that rigorous clinical performance studies with acceptance criteria and detailed statistical analysis, as typically expected for proving device performance, were not conducted or submitted for this specific 510(k) approval. Instead, the approval is based on comparing the new device to a legally marketed predicate.

However, I can extract and infer some information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence): The E-CUBE 12 must perform as safely and effectively as the predicate device (E-CUBE 15 K123610) for its intended uses. This is primarily demonstrated by showing conformity to applicable safety standards and similar technological characteristics.

Missing Information Details:

2. Sample sizes used for the test set and the data provenance: Not provided. The submission states no clinical studies were required for substantial equivalence, implying no dedicated "test set" in the context of clinical performance evaluation studies was used. The focus was on non-clinical testing to verify design changes.
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 studies with expert ground truth establishment for a test set were conducted.
4. Adjudication method for the test set: Not applicable, as no clinical studies with a test set requiring adjudication 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. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool for interpretation, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical imaging device, not an algorithm being evaluated in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance studies requiring ground truth were conducted. The "ground truth" here is conformity to safety standards and equivalence to an already approved device.
8. The sample size for the training set: Not applicable, as no machine learning algorithm development requiring a "training set" is described for this premarket notification.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary of the "Study" (Non-Clinical Evaluation):

The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence is a non-clinical evaluation rather than a traditional clinical trial.

• Non-Clinical Tests: ALPINION MEDICAL SYSTEMS Co., Ltd. conducted evaluations for:
  • Biocompatibility of transducer materials and patient contact materials.
  • Acoustic output.
  • Thermal, electrical, electromagnetic, and mechanical safety.
• Standards Conformance: The device was found to conform to applicable medical device safety standards, specifically:
  • NEMA UD2, UD3
  • AIUM Medical Ultrasound Safety
  • IEC60601-1
  • IEC60601-1-2
  • IEC60601-2-37
• Quality Management System Measures: The development process followed these measures:
  • Medical Device Risk Management
  • Requirements Reviews
  • Design Reviews
  • Component Verification
  • Integration Review (System Verification)
  • Performance Testing (System Verification)
  • Safety Testing (Compliance Test)
  • Design Validation
• Basis for Equivalence: The manufacturer concluded that the E-CUBE 12 is "as safe, as effective" as the predicate device (E-CUBE 15, K123610) because it employs the same fundamental scientific technology, and any differences in clinical applications or operating modes were verified through these non-clinical tests to not affect safety, effectiveness, and essential performance.

In essence, the "study" for this 510(k) was a comprehensive set of engineering and safety tests and a review of the design and manufacturing process, all aimed at demonstrating that the device is equivalent to a previously cleared device.

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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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 7 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ALPINION MEDICAL SYSTEMS E-CUBE 7:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System). This means the acceptance criteria are implicitly that the E-CUBE 7 perform comparably to the predicate device in aspects of safety and effectiveness for its intended uses.

The "reported device performance" is also not given in quantitative metrics. The document only asserts that "Performance, technology and software are substantially equivalent to the predicate device." and that "Some image parameters are added for operational convenience which means these parameters do not affect to the measurement accuracy."

Therefore, I cannot populate a table with numerical acceptance criteria and reported performance based on the provided text.

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

The document explicitly states: "The subject of this premarket submission, E-CUBE 7, did not require clinical studies to support substantial equivalence."

This indicates that there was no test set of clinical data used to evaluate the device's performance against specific metrics. The assessment relied on non-clinical tests and a comparison to the predicate device's existing clearance.

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

Since no clinical studies were performed, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was conducted. The E-CUBE 7 is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations to human readers. Therefore, the concept of readers improving with vs. without AI assistance is not applicable to this submission.

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

No standalone algorithm performance study was performed, as the device is an ultrasound imaging system operated by a physician, not a standalone AI algorithm.

7. The Type of Ground Truth Used

Given that no clinical studies were performed, there was no specific ground truth established for the E-CUBE 7's performance in a clinical context. The basis for clearance is substantial equivalence to the predicate device, K120060, which would have established its own safety and effectiveness through prior regulatory processes.

8. The Sample Size for the Training Set

Since no clinical studies involving machine learning or AI models were conducted, there was no training set batch of data mentioned or used.

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

As there was no training set, this question is not applicable.

Summary of Findings:

The 510(k) submission for the ALPINION MEDICAL SYSTEMS E-CUBE 7 (K132687) did not involve clinical studies or performance evaluations against specific acceptance criteria for a new clinical dataset. Instead, the clearance was based on:

• Substantial Equivalence: The device was determined to be substantially equivalent to a legally marketed predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System).
• Non-Clinical Tests: Evaluation of biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, confirming conformity to applicable medical device safety standards.
• Quality Management System: Adherence to established quality management system measures (Risk Management, Requirements Reviews, Design Reviews, Component Verification, System Verification, Performance Testing, Safety Testing, Design Validation).

The document explicitly states that "E-CUBE 7... did not require clinical studies to support substantial equivalence." Therefore, details regarding clinical acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or types of ground truth for new clinical data are not present in this submission.

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