(41 days)
The Diaqnostic 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 diaqnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophaqeal, musculo-skeletal (both conventional and superficial) and laparoscopic.
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.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for the performance of the device's specific features. Instead, it describes performance testing conducted to demonstrate that the new and improved features performed as intended or equivalently to manual methods. The acceptance is based on demonstrating the functionality and clinical validity of the features.
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Shear Wave Measurement (Elasticity Phantom) | Accurate measurement of shear wave speed and elasticity of known targets within an elasticity phantom. | "The subject device accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom." (Page 47) |
| Smart 3D Feature | Successful display of 3D images using existing 2D transducers. | "The Smart 3D feature successfully displayed 3D images using existing 2D transducers." (Page 47) |
| Clinical Evaluation (Shear Wave) | Acceptable images and numerical Shear wave results in vivo in volunteers. | "Representative clinical images of volunteers were obtained to confirm that the system provides acceptable images and numerical Shear wave results in vivo." (Pages 47-48) |
| Auto-NT Feature | Equivalent measurement of Nuchal Translucency thickness when compared to manual measurement. | "The tool is able to equivalently measure Nuchal Translucency thickness when compared to manual measurement." (Page 48) |
| General System Performance | Device performs as expected; is safe and effective for its intended use. | "Based upon bench testing, clinical evaluations, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use." (Page 48) |
2. Sample Size Used for the Test Set and Data Provenance
The document provides very limited detail on sample sizes and data provenance:
- Shear Wave Measurement (Elasticity Phantom): Test set size is not specified, only "known targets within an elasticity phantom." Data provenance is not specified beyond "bench testing."
- Smart 3D Feature: Test set size is not specified, performed using "existing 2D transducers." Data provenance is not specified.
- Clinical Evaluation (Shear Wave): "Representative clinical images of volunteers" were used. The number of volunteers is not specified. Data provenance (e.g., country of origin, retrospective or prospective) is not specified.
- Auto-NT Feature: The study "validated the performance of the Auto NT feature by demonstrating that the tool is able to equivalently measure Nuchal Translucency thickness when compared to manual measurement." The sample size for this study (number of cases or measurements) is not specified. Data provenance (e.g., retrospective or prospective) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical evaluations (e.g., for the Auto-NT feature or clinical Shear Wave results).
- For the Shear Wave Measurement (Elasticity Phantom), the ground truth was "known targets within an elasticity phantom," implying a controlled, manufactured standard rather than expert interpretation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication methods (e.g., 2+1, 3+1, none) for any of the performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The clinical evaluation for Auto-NT compares the tool's measurement to manual measurement, but it's not structured as an MRMC study to show reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document implies standalone performance testing for some features:
- Shear Wave Measurement (Elasticity Phantom): This appears to be a standalone test of the algorithm's measurement accuracy against a known physical standard.
- Smart 3D Feature: The testing confirmed the feature "successfully displayed 3D images using existing 2D transducers," suggesting standalone functional validation.
- Auto-NT Feature: The validation compares the tool's measurement to manual measurement, which hints at standalone algorithm performance assessment.
The document does not explicitly use the term "standalone performance" but the descriptions of these tests align with the concept.
7. The Type of Ground Truth Used
- Shear Wave Measurement (Elasticity Phantom): "known targets within an elasticity phantom" (physical phantoms with measurable properties).
- Smart 3D Feature: Implicitly, the ground truth is the expected correct 3D image reconstruction from 2D data, likely evaluated visually for correct render and correspondence.
- Clinical Evaluation (Shear Wave): For "numerical Shear wave results in vivo," the ground truth is clinical acceptability, presumably against a clinician's expectation or established medical practice, though not explicitly defined (e.g., pathology, outcomes, expert consensus).
- Auto-NT Feature: "manual measurement" as the comparator for equivalence.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. Given that this is a 510(k) submission for an ultrasound system with updated features (rather than a de novo AI/ML medical device submission), details about training data for specific "tools" or "features" are not typically as extensively detailed unless they represent a novel AI component requiring such validation. The features mentioned, while advanced (e.g., Auto-NT, Smart 3D), might rely on established signal processing or image reconstruction algorithms rather than deep learning models requiring extensive training data.
9. How the Ground Truth for the Training Set Was Established
Since no information about a training set is provided, there is also no information on how ground truth for any potential training set was established.
§ 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.