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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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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.

The provided 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 7 Ultrasonic Pulsed Doppler Imaging System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or standalone testing.

Instead, the submission leverages substantial equivalence to a predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System). This means the manufacturer is asserting that the E-CUBE 7 is as safe and effective as the already-marketed predicate device, and therefore does not require new clinical studies to demonstrate performance.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided for the E-CUBE 7 beyond conforming to general safety standards. The document states:

"E-CUBE 7 has 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. E-CUBE 7 and its application comply with voluntary standards as detailed in this premarket submission."

The submission focuses on comparing the E-CUBE 7's technology to its predicate device, stating:

"E-CUBE 7 employs the same fundamental scientific technology as its predicate device."
"Some image parameters are added for operational convenience which means these parameters do not affect to the measurement accuracy. So there is no significant difference in essential performance, safety and effectiveness with the predicate device and the image parameter functions do not change the intended use."

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

No test set sample size, data provenance, or details about patient data (e.g., country of origin, retrospective/prospective) are mentioned. The application explicitly states that clinical studies were not required.

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 or test sets with ground truth established by experts were conducted or reported in this 510(k) summary.

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

Not applicable, as no clinical studies or test sets requiring adjudication were conducted or reported.

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 imaging system, not an AI-assisted diagnostic tool, and no MRMC study was performed or reported.

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

Not applicable. This is a standalone ultrasound imaging system, not an algorithm, and its performance is considered substantially equivalent to a predicate device without the need for independent standalone performance studies in this submission.

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

Not applicable, as no clinical studies requiring ground truth establishment were conducted or reported.

8. The sample size for the training set

Not applicable, as this is a medical imaging device for which "training sets" in the context of machine learning are not mentioned or relevant to the substantial equivalence argument presented.

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

Not applicable, for the same reasons as point 8.

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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); 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.

The provided 510(k) summary for the E-CUBE 7 Ultrasonic Pulsed Doppler Imaging System states that clinical studies were not required to support substantial equivalence to its predicate device, the E-CUBE 9 Diagnostic Ultrasound System (K120060).

Therefore, the following information regarding acceptance criteria and performance study details cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts involved in establishing ground truth for a clinical test.
4. Adjudication method for the test set: No adjudication method specified as there was 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: No MRMC study was conducted. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool for reading improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance was assessed for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No clinical ground truth was established for a performance study.
8. The sample size for the training set: No training set was used for an AI/machine learning model.
9. How the ground truth for the training set was established: No ground truth for a training set was established.

Summary based on the provided document:

The E-CUBE 7 was deemed substantially equivalent to its predicate device, E-CUBE 9, based on non-clinical tests and the same fundamental scientific technology.

Non-clinical tests performed include:

• Biocompatibility
• Acoustic output
• Thermal safety
• Electrical safety
• Electromagnetic safety
• Mechanical safety

The device was found to conform to applicable medical device safety standards and complies with voluntary standards. Quality management system measures applied to its development include: Medical Device Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), and Design Validation. Transducer materials and other patient contact materials are also stated to be biocompatible.

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