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510(k) Data Aggregation
(72 days)
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 15 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 document is a 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 15 ultrasonic imaging system. It primarily details the device's substantial equivalence to a predicate device and its compliance with safety and performance standards.
Based on the provided information, here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity) for the E-CUBE 15's imaging performance. Instead, the "Summary of Non-Clinical Tests" and "Summary of Clinical Tests" sections indicate the following as the basis for device performance and safety:
| Acceptance Criterion Type | Details Provided in Document |
|---|---|
| Safety and Performance Standards Conformance | The device has been evaluated for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety. It conforms to applicable medical device safety standards and voluntary standards (NEMA UD2, UD3, AIUM Medical Ultrasound Safety, IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-37, ISO 10993-1). Transducer materials and other patient contact materials are biocompatible. |
| Substantial Equivalence to Predicate Device | The E-CUBE 15 employs the "same fundamental scientific technology" as its predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System). The conclusion explicitly states it is "as safe, as effective, and performance is substantially equivalent to the predicate device." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."
Therefore, there is:
- No test set sample size reported as no clinical studies were performed.
- No data provenance (country of origin, retrospective/prospective) because no clinical data was collected for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical studies were conducted for the E-CUBE 15 to establish performance against a test set, there is no information provided regarding:
- The number of experts.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
As no clinical studies were conducted involving expert interpretation of a test set, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
The document states that "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence." Therefore, no MRMC comparative effectiveness study was done, and thus no effect size of human readers improving with AI vs. without AI assistance is reported. (Note: AI is not explicitly mentioned as a component of this device, which is an ultrasonic imaging system.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is an ultrasonic imaging system. The submission focuses on its hardware and software for image acquisition and display, and its equivalence to a predicate device. It is not an AI/algorithm-only device, so a standalone algorithm performance study is not applicable and not reported. The "performance" assessment is based on compliance with safety standards and fundamental scientific equivalence to the predicate device.
7. The Type of Ground Truth Used
Given that no clinical studies were performed to evaluate the diagnostic performance of the device itself (only to affirm substantial equivalence to a predicate), no specific ground truth (expert consensus, pathology, outcomes data, etc.) was used for this submission's approval. The "truth" for this submission is based on the predicate device's established performance and the E-CUBE 15's compliance with engineering and safety standards.
8. The Sample Size for the Training Set
The document does not describe any machine learning or AI components that would require a "training set." Therefore, no sample size for a training set is reported.
9. How the Ground Truth for the Training Set was Established
Since there is no mention of a training set, no information is provided on how its ground truth would have been established.
Summary of Device Approval Approach:
The approval for the E-CUBE 15 appears to be based on the substantial equivalence pathway. This means the manufacturer demonstrated that the E-CUBE 15 is as safe and effective as a legally marketed predicate device (E-CUBE 9, K120060) and complies with relevant performance and safety standards. For this type of submission (ultrasound imaging system, not a novel diagnostic algorithm), extensive new clinical performance data or studies directly comparing its diagnostic accuracy to ground truth are often not required if substantial equivalence can be demonstrated through technical and non-clinical testing, and comparison with a predicate.
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