(52 days)
The Aplio XG is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
The Aplio XG 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 12 MHz.
This is a 510(k) premarket notification for the Toshiba Aplio XG SSA-790A (v2.2) Diagnostic Ultrasound System and its associated transducers. The document primarily focuses on demonstrating substantial equivalence to predicate devices and lists the intended uses and safety considerations. It does not contain information typically found in acceptance criteria or a study proving that the device meets specific performance metrics in the way an AI/ML device submission would.
Therefore, I cannot extract acceptance criteria and a study that proves the device meets those criteria from the provided text in the manner requested for AI/ML performance.
Here's why and what information can be provided:
- Device Type: This is a diagnostic ultrasound system, not an AI/ML device. For such medical imaging systems, FDA clearance typically relies on demonstrating safety and effectiveness based on established performance standards (e.g., electrical safety, acoustic output, image quality, and clinical functionality) rather than a statistically robust clinical performance study with specific acceptance criteria like accuracy, sensitivity, or specificity.
- "Acceptance Criteria" in this context refers to regulatory compliance and equivalence, not clinical performance metrics for a specific algorithm. The "acceptance criteria" here are met by demonstrating that the device conforms to relevant industry standards and is substantially equivalent to a legally marketed predicate device.
- "Study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission process itself. The process of compiling and submitting the necessary documentation (including comparisons to predicate devices, engineering tests, and adherence to safety standards) is the "study" that proves regulatory acceptance.
Based on the provided text, here's what can be extracted, framed within the context of a traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance (Regulatory Equivalence / Compliance)
| Acceptance Criterion (Implicit) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Substantial Equivalence to Predicate Devices | The device is believed to be substantially equivalent to: |
- Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound (K072000)
- General Electric Co. VOLUSON E8 Ultrasound System (K061682) |
| Compliance with Regulatory Class II Requirements | Classified as II, Review Category: Tier II. Product Codes: 90-IYN, 90-IYO, 90-ITX. |
| Adherence to Safety Standards (General Controls) | Designed and manufactured in conjunction with Quality System Regulation, IEC 60601-1, IEC 60601-1-2, IEC60601-2-37, AIUM-NEMA UD2, and AIUM-NEMA UD3. |
| Intended Use Statement Consistency | Intended for fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, and musculo-skeletal studies. This aligns with predicate devices (K072000) for all listed applications and transducer modes (as indicated by 'P' in the detailed tables). |
| Acoustic Output within Approved Levels (Post-Clearance) | A post-clearance special report is required containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G. (This is a condition for clearance, implying that meeting these levels is an acceptance criterion). |
Note: Specific quantitative performance metrics (e.g., image resolution, penetration depth, frame rates) are typically part of internal design specifications and testing for traditional ultrasound devices but are not explicitly detailed as "acceptance criteria" in this FDA summary document, which focuses on regulatory clearance. The "performance" here is primarily about functional equivalence and safety.
Regarding the other requested information (which is more relevant for AI/ML studies):
- 2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of images for algorithm performance evaluation. It's a regulatory submission for a hardware/software system.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the same reason as above.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a traditional device clearance, not an AI/ML effectiveness study.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound system that is operated by a human.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML evaluation. For an ultrasound system, "ground truth" would relate to the physical accuracy of its measurements and image rendering against known standards, and its safety.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.