(189 days)
The Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
The Aplio 500/400/300 system is a mobile ultrasound system. It 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. The Aplio 500/400/300 is designed to support a wide rauge of applications depending on which software is installed. The system can be a dedicated system or a eneral purpose system.
The provided document is a 510(k) Premarket Notification for the Toshiba Aplio™ TUS-A300/400/500 (v2.0) Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than on detailed performance criteria from a clinical study for a specific disease or condition. Therefore, directly addressing some of your questions, particularly those related to clinical performance metrics and ground truth establishment in a study for AI device detection, is not possible with this type of document because it describes a general-purpose diagnostic ultrasound system, not an AI-powered detection/diagnosis device.
However, I can extract information relevant to the device's functional performance and general safety/effectiveness criteria as described in this 510(k) submission:
The Aplio™ TUS-A300/400/500 (v2.0) is a diagnostic ultrasound system. Its acceptance criteria and proof of meeting these criteria are established through adherence to recognized medical device standards and demonstrating substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit acceptance criteria with numerical performance targets (e.g., sensitivity, specificity for a particular disease) in the way one might expect for an AI-based detection device. Instead, the "acceptance criteria" for a diagnostic ultrasound system in a 510(k) context are primarily related to:
- Compliance with recognized standards: Ensuring the device meets international and national standards for safety and performance.
- Substantial equivalence: Demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.
- Intended Use: The device performs its intended functions for specified clinical applications.
The 'reported device performance' is implicitly the successful demonstration of compliance with these standards and equivalence in the 510(k) submission.
| Acceptance Criterion Type | Specific Criteria Described in Document | Reported Device Performance |
|---|---|---|
| Safety & Essential Performance Standards | - IEC 60601-1 (medical electrical equipment general requirements) |
- IEC 60601-1-1 (safety requirements medical electrical systems)
- IEC 60601-1-2 (electromagnetic compatibility)
- IEC 60601-1-4 (programmable electrical medical systems)
- IEC 60601-2-37 (specific requirements for ultrasonic medical diagnostic and monitoring equipment)
- IEC 62304 (medical device software life cycle processes)
- AIUM-NEMA UD2 Output Measurement Standard (for Track 3 Ultrasound systems)
- AIUM-NEMA UD3 Output Display Standard (for Track 3 Ultrasound systems)
- Quality System Regulation (QSR) | Device is designed and manufactured in conjunction with these standards. Testing has been conducted as per these standards. (Implicitly, compliance is achieved for clearance). |
| Intended Use Equivalence | Performance for specified clinical applications (fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal) across various transducers and operating modes (B, M, PWD, CWD, Color Doppler, Combined, THI, Dynamic Flow, Power, CHI 2D, 4D, etc.). | Determined "substantially equivalent" to predicate devices for the stated indications for use and associated transducers. (K103645, K090158, K092271) |
| Predicate Device Comparison | Substantial equivalence to: - K103645 Toshiba Diagnostic System Aplio XG SSA-790A v5.2
- K090158 Toshiba Diagnostic Ultrasound system Aplio Artida SSH-880A v2.0
- K092271 General Electric LOGIC E.9 Ultrasound System | FDA has determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific "test set" sample sizes in terms of patient data or images for a comparative clinical performance study comparing the new device's diagnostic accuracy to a gold standard. For general-purpose ultrasound systems submitted under 510(k), real-world clinical performance data in terms of diagnostic accuracy (like sensitivity/specificity) is often not required if technical and safety specifications are met and substantial equivalence to existing devices can be proven. The "testing" mentioned refers to engineering and bench testing to demonstrate compliance with standards and a safety profile similar to predicate devices.
Therefore, this document does not provide information on:
- Sample size used for a test set (in terms of patient data/images).
- Data provenance (country of origin, retrospective/prospective).
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)
This information is not applicable and not provided in this 510(k) summary. Since it's a general diagnostic ultrasound system and not an AI-powered analysis tool, there would not be a "ground truth" to establish for its diagnostic output in the way an AI diagnostic device needs. Its output is raw image data and measurements which are then interpreted by a human expert.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided for the same reasons as in point 3.
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 not an AI-assisted device; it is a diagnostic ultrasound system that produces images and measurements. Therefore, no MRMC study comparing human readers with and without AI assistance would have been performed or reported in this type of 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm for standalone performance; it is a medical imaging hardware system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As explained above, for a general-purpose ultrasound system, the "ground truth" concept for diagnostic accuracy is not typically applied to the device itself but rather to the interpretation of its images by a clinician.
8. The sample size for the training set
Not applicable. This device is a traditional diagnostic ultrasound system, not an AI/machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable for the same reasons as in point 8.
§ 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.