(42 days)
The Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 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 followinq clinical applications: fetal, abdominal, intraoperative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
The provided text is a 510(k) summary for a Diagnostic Ultrasound System (Aplio 500, 400, 300 V3.0). It primarily details the device description, intended uses, and safety standards it complies with. However, it does not include information about specific acceptance criteria related to a study proving the device meets performance metrics, nor does it describe such a study. The "Testing" section mentions "Verification/Validation testing conducted through bench testing," but provides no details on the methodology, sample sizes, or results of these tests, particularly concerning clinical performance or AI integration.
Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and a study to prove device performance because the provided document does not contain that level of detail. It is a regulatory submission focused on substantial equivalence to a predicate device and compliance with general safety and performance standards rather than a performance study report.
Here's what can be extracted based on the provided text, and where information is missing:
Acceptance Criteria and Study for Device Performance (Based on available information and typical assumptions for such submissions):
The document details compliance with various standards and states that "Verification/Validation testing conducted through bench testing...demonstrates that the requirements for the improved/added features have been met." However, specific numerical or qualitative acceptance criteria for these tests or the detailed performance metrics are not provided in this summary.
Given that this is a 510(k) for a modification of an existing diagnostic ultrasound system, the acceptance criteria would typically revolve around demonstrating that the modified device performs equivalently to the predicate device and continues to meet established safety and effectiveness standards for diagnostic ultrasound imaging. These standards are general for an ultrasound system and are linked to the capabilities of the various transducers across different clinical applications (e.g., Fetal, Abdominal, Cardiac, Musculo-skeletal).
For example, implicit acceptance would involve:
- Image Quality: Resolution, contrast, penetration, and artifact levels being equivalent to or better than the predicate device.
- Doppler Accuracy: Accurate measurement of blood flow velocities.
- Safety: Compliance with acoustic output limits and electrical safety standards.
- Functionality: All advertised imaging modes (B-mode, M-mode, PWD, CWD, Color Doppler, THI, Dynamic Flow, Power, CHI 2D, 4D, etc.) function as intended.
Study Proving Device Meets Acceptance Criteria:
The document mentions "Verification/Validation testing conducted through bench testing." This refers to internal company testing to ensure the device performs as designed and meets regulatory requirements. It is not a clinical study designed to statistically prove the device's diagnostic performance against a ground truth in real patient scenarios.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied/General) | Reported Device Performance (Summary Statement) |
|---|---|
| Compliance with general safety and performance standards (e.g., IEC) | "This device is in conformance with the applicable parts of the IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, NEMA UD3 Output Display and ISO 10993-1 standards." (Section 14) |
| Device functions as intended and improves existing features | "Verification/Validation testing conducted through bench testing...demonstrates that the requirements for the improved/added features have been met." (Section 15) |
| Image quality and functionality equivalent to predicate device | "The Aplio 500 Model TUS-A500 Version 3.0, Aplio 400 Model TUS-A400 Version 3.0 and Aplio 300 Model TUS-A300 Version 3.0, functions in a manner similar to and is intended for the same use as the predicate device." (Section 13) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. "Bench testing" generally implies testing on phantoms, cadavers, or simulated environments, rather than a specific sample size of human subjects for clinical performance evaluation as would be seen in an AI/software study.
- Data Provenance: Not specified. Given it's "bench testing," it would be internally generated data, likely from controlled laboratory environments. No indication of country of origin, or retrospective/prospective acquisition.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For "bench testing" of an ultrasound system, "ground truth" would be established through physical measurements, known properties of test objects (phantoms), and engineering specifications rather than expert human interpretation of images for diagnostic accuracy.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication is typically for human interpretations or highly subjective measurements, not standard engineering bench tests of a diagnostic imaging system's technical performance.
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:
- No. This submission predates widespread AI-assisted diagnostic ultrasound systems (2013) and is for a general diagnostic ultrasound system, not an AI-specific device or feature. Therefore, no MRMC study or AI assistance effect size 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, which inherently requires human operation and interpretation. There is no "algorithm only" performance reported in this context.
7. The type of ground truth used:
- For "bench testing," the ground truth would typically be:
- Engineering Specifications: Measured values compared against design specifications.
- Physical Phantoms: Known properties (e.g., size, density, flow rate) of objects within a phantom.
- Reference Devices: Comparison against calibrated reference measurement equipment.
8. The sample size for the training set:
- Not applicable/Not specified. This document describes a diagnostic ultrasound hardware and software system, not an AI/machine learning algorithm that requires a "training set" in the context of deep learning models.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a "training set" in the AI/machine learning sense.
§ 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.