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510(k) Data Aggregation
(15 days)
The Power Vision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz.
The provided document is a 510(k) Summary for the Toshiba SSA-390A/PowerVision 8000 Ultrasound Imaging System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily by comparing intended use, technological characteristics, and safety considerations. It does not contain information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a test set with ground truth established by experts.
The core of this submission is to confirm that the new device does not raise new questions of safety or effectiveness compared to previously cleared devices. It relies on the predicate devices' prior approvals and compliance with general safety standards.
Therefore, many of the requested details about acceptance criteria and a performance study demonstrating those criteria cannot be extracted from this document, as such a study is not presented.
Here's a breakdown of what can be inferred or directly stated from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This table cannot be fully completed from the provided document as specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, or accuracy thresholds) and corresponding reported performance are not included. The "acceptance criteria" here relate to demonstrating substantial equivalence based on technical specifications and indications of use, rather than a clinical performance study.
| Acceptance Criterion Type | Acceptance Criterion (Threshold) | Reported Device Performance |
|---|---|---|
| Safety Compliance | Compliance with Quality System Regulation, IEC 60601 (applicable portions), AIUM-NEMA UD2, AIUM-NEMA UD3 | Device is designed and manufactured in conjunction with these standards. Engineering assessments identify no new issues of risk or safety compared to the predicate device. |
| Substantial Equivalence | Device is substantially equivalent to a legally marketed predicate device (SSA-380A/PowerVision 7000 and associated transducers). | FDA determined the device is substantially equivalent to the predicate devices for the stated indications for use. |
| Intended Use | Intended uses are consistent with predicate devices and accepted clinical applications for diagnostic ultrasound. | The device is intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transesophageal, Peripheral Vascular, and Musculo-skeletal (conventional and superficial) studies. No new indications for in vitro fertilization or percutaneous umbilical blood sampling are permitted. |
| Technological Characteristics | Wide array of probes: flat linear, convex linear, sector array; Frequency range: 2 MHz to 10 MHz. | Device employs a wide array of probes including flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz. |
| Post-Clearance Acoustic Output | Submit a post-clearance special report with complete information, including acoustic output measurement based on production line devices, requested in Appendix G of "Information for Manufacturer's Seeking Marketing Clearance of Diagnostic Ultrasound System and Transducers." | A condition of clearance is to submit this report. No performance data is reported here, only the requirement. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No diagnostic performance study with a test set is described. The submission relies on establishing substantial equivalence to a predicate device, which usually involves demonstrating similar technical specifications and safety profiles rather than a clinical study comparing diagnostic outputs.
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. No diagnostic performance study with a test set and ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic performance study with a test set is described.
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 a 1999 submission for a diagnostic ultrasound system, not an AI-assisted device. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No diagnostic performance study with ground truth is described. The "ground truth" in this context is the FDA's existing clearance for the predicate device and its established safety and effectiveness.
8. The sample size for the training set
Not applicable. This is a diagnostic ultrasound system, not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This is a diagnostic ultrasound system, not an AI/ML device that undergoes training.
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(15 days)
The Power Vision 6000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The PowerVision 6000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz.
The provided document is a 510(k) Summary for the Toshiba SSA-370A/PowerVision 6000 Ultrasound Imaging System. It outlines the device description, intended use, and substantial equivalence to predicate devices, but does not contain any information regarding acceptance criteria or specific studies proving the device meets acceptance criteria.
The tables within the document (pages 3-20) are "Diagnostic Ultrasound Indications For Use Form" for various transducers. These tables indicate whether certain clinical applications (e.g., Fetal, Abdominal, Cardiac) and modes of operation (e.g., B, M, PWD, Color Doppler) are "New indication (N)", "Previously Cleared by FDA (P)", or "Added under Appendix E (LTF)". This information describes the intended uses of the device and its transducers based on prior clearances or new submissions, but does not present performance data or acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory classification and claiming substantial equivalence to predicate devices rather than providing performance study details.
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(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.
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