(14 days)
The JustVision is intended to be used for the following type of studies; fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The JustVision Ultrasound System is available as a compact portable system or can be configured as a mobile system with a 12 inch monitor. This system is a Track 1 device that employs a wide array of probes that include flat linear array and convex linear array, with a frequency range of approximately 2 MHz to 10 MHz.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Toshiba JustVision Ultrasound System:
Summary of Device and Evidence:
The Toshiba JustVision 200 and JustVision 400 are Ultrasound Imaging Systems. The application focuses on demonstrating substantial equivalence to a predicate device (SSA-220A Capasee, K933747) and expanding the indications for use for various transducers. The "study" here is primarily a substantial equivalence comparison and declaration of compliance with relevant standards, rather than a clinical trial in the traditional sense for a new diagnostic accuracy claim.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional quantitative acceptance criteria (e.g., sensitivity, specificity), the approval documentation for the Toshiba JustVision Ultrasound System and its transducers relies on substantial equivalence to a predicate device and adherence to recognized safety standards. The "performance" is implicitly deemed equivalent if these conditions are met.
| Acceptance Criterion (Implicit) | Reported Device Performance/Evidence |
|---|---|
| Substantial Equivalence to Predicate Device | The device (JustVision 200/400) is "substantially equivalent to the SSA-220A Capasee, 510(k) control number K933747." |
| Safety and Effectiveness Assessment (via Standards Compliance) | "This device is designed and manufactured in conjunction with the Quality System Regulation, ISO-60601 (applicable portions) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 1 Ultrasound systems. This unit is similar to that of the Toshiba SSA-220A Capasee and engineering assessments identify no new issues of risk or safety." |
The FDA grants clearance "on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G... "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply..." |
| Equivalent Intended Use/Clinical Indications | The document extensively lists various clinical applications for the system and each transducer. For many transducers, indications are marked "P" (Previously Cleared by FDA) indicating they match the predicate device's cleared indications. For some indications, they are marked "N" (New Indication), suggesting these were assessed as equivalent despite being new to that specific transducer. |
2. Sample Size for the Test Set and Data Provenance
The provided text does not describe a specific clinical test set with patient data or a sample size in the context of diagnostic accuracy for this 510(k) submission. The "study" is primarily an engineering and regulatory assessment comparing the new device to a predicate. The compliance is based on:
- Engineering assessments (comparison of design, specifications, and safety features to the predicate).
- Adherence to recognized industry standards (ISO-60601, AIUM-NEMA UD2 for acoustic output).
- A post-clearance report requiring acoustic output measurements from production units.
Therefore, there is no "test set" in the traditional sense of a patient cohort, nor is there information about data provenance (country of origin, retrospective/prospective).
3. Number of Experts and Qualifications for Ground Truth
No experts were used to establish ground truth for a diagnostic performance test set, as no such test set is described or required for this type of substantial equivalence submission. The "ground truth" here is compliance with safety standards and functional equivalence to the predicate device, which is assessed through engineering analysis and regulatory review.
4. Adjudication Method for the Test Set
Not applicable as there is no diagnostic test set requiring human expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or is mentioned. The submission is not for an AI-assisted device in the context of improving human reader performance. It's for an ultrasound imaging system.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is an ultrasound imaging system, not an algorithm, and the submission is not focused on an AI algorithm's standalone performance.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Predicate Device Equivalence: The gold standard is the legally marketed predicate device (SSA-220A Capasee, K933747) and its established safety and effectiveness.
- Engineering Standards Compliance: Adherence to recognized national and international safety and performance standards for ultrasound devices (Quality System Regulation, ISO-60601, AIUM-NEMA UD2).
- Acoustic Output Measurements: Post-clearance measurements of acoustic output from production line devices to ensure they fall within approved levels.
8. Sample Size for the Training Set
Not applicable. This is not a submission for a machine learning or AI-driven device that requires a training set. The device is a traditional ultrasound imaging system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.