(85 days)
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 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, intra-operative (abdominal), pediatric, small organs(thyroid, breast and testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatic), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.
The Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-Al800, and Aplio i700 Model TUS-Al700, V5.1 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. 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 30 MHz.
The provided text does not contain specific acceptance criteria or details of a study explicitly proving the device meets acceptance criteria in the format typically expected for AI/ML device evaluations (e.g., sensitivity, specificity, AUC thresholds). Instead, it describes a substantial equivalence submission for an ultrasound system, focusing on comparing its features and performance with predicate devices.
However, based on the information provided, I can infer the "acceptance criteria" and the "study" in a broader sense of device performance validation, particularly regarding changes and new features.
Here's an interpretation based on the provided text:
Acceptance Criteria and Device Performance for Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
The submission focuses on establishing substantial equivalence for an updated ultrasound system (Software V5.1). The "acceptance criteria" can be broadly interpreted as ensuring that the new and improved features perform as intended and/or are substantially equivalent to existing features or predicate devices, without introducing new safety or effectiveness concerns.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Implied) | Reported Device Performance (Summary from text) |
|---|---|---|
| General Functionality & Performance | Device functions as intended for diagnostic ultrasound in specified clinical applications. | "Results of all these studies demonstrated that the improvements met specifications are performed as intended." |
| New Features: | ||
| Smart Fetal Heart | Improves existing manual workflow for fetal heart views. | Improved existing manual workflow for fetal heart views. |
| LI-RADS Checklist | Supports standardization of liver characterization based on ACR guidelines. | Supports standardization of liver characterization based on ACR guidelines. |
| Fluctuational imaging | Displays degree of fluctuation in tissue, similar to Attenuation Imaging. | Displays the degree of fluctuation in tissue, similar to Attenuation Imaging functionality. |
| Workflow Navigator | Provides workflow and reporting support based on ASE guidelines. | Provides workflow and reporting support based on ASE guidelines. |
| Smart Optimization | Improves image quality targeting the abdominal region, similar to "Whizz" on GE Healthcare Versana Premier. | Intended to improve image quality targeting the abdominal region. |
| Prostate Biopsy Report | Adds functionality for biopsy procedures and 3D modeling. | Adds functionality for biopsy procedures and 3D modeling. |
| Improved Existing Features: | ||
| Smart Body Mark | Improved manual breast scan workflow. | Improved manual breast scan workflow by incorporation of previously cleared functionality. |
| MSK Protocol movie | Supports display of MSK instructional movies. | Supports the display of musculo-skeletal (MSK) instructional movies. |
| Wide View support | Expansion of scan range with convex transducers. | Expansion of the scan range available with convex transducers. |
| iBeam+ | Increased processing speed over conventional iBeam. | Increased processing speed. |
| SMI G4 | Enhanced clutter suppression and higher detection range. | Enhanced clutter suppression, supported by higher detection range. |
| Sensor 3D | Improved resolution. | Improved resolution. |
| Obstetric Image quality | Improved visualization. | Improved visualization. |
| Cardiac 4D Luminance | Migration of previously cleared feature, an improvement to conventional Luminance. | Improvement to conventional Luminance by migration of a previously cleared feature. |
| Safety and Standards Compliance | Conformance to relevant medical device and electrical safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62359, ISO 10993-1). | "This device is in conformance with the applicable parts of the AAMI/ANSI ES60601-1:2012, IEC 60601-1-2 (2014), IEC 60601-2-37 (2015), IEC 62304 (2015), IEC 62359 (2017) and ISO 10993-1(2009) standards." |
| Cybersecurity | Documentation per FDA cybersecurity guidance. | "Cybersecurity documentation... was also referenced for this submission." |
| Software Validation | Software functions as intended, validation successfully completed. | "Successful completion of software validation." |
| Risk Management | Risks identified and mitigated. | "Application of risk management and design controls." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "bench testing and clinical evaluation" and "additional performance testing, using test data and volunteer studies." However, it does not provide specific sample sizes for these test sets, nor does it specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. The "LI-RADS Checklist" and "Workflow Navigator" features reference ACR and ASE guidelines, implying expert consensus underlies these guidelines, but not directly for validating the device's implementation.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating device performance in a multi-expert setting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not report a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance, nor does it provide any effect size for such a comparison. The device is a diagnostic ultrasound system, and while it has "smart" features, it's not presented as an AI-assisted diagnostic tool that directly impacts human reader interpretation in a comparative effectiveness study as typically found for CADe/CADx devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
The document does not provide specific standalone performance metrics (e.g., sensitivity, specificity, AUC) for any of its "smart" or improved features. The description focuses on functionality, workflow improvement, and image quality enhancements within the context of a diagnostic ultrasound system used by a clinician.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for evaluating the device's performance. The nature of an ultrasound system update suggests that ground truth would likely be established through:
- Clinical observation/expert assessment: For image quality, workflow efficiency, and visualization improvements.
- Conformance to guidelines: For features like the LI-RADS Checklist (ACR guidelines) and Workflow Navigator (ASE guidelines).
- Technical specifications/measurements: For aspects like processing speed (iBeam+), resolution (Sensor 3D), and detection range (SMI G4).
8. Sample Size for the Training Set:
This information is not provided in the document. As this is an ultrasound system submission focusing on feature updates and substantial equivalence, the concept of a "training set" in the context of machine learning for novel AI algorithms is not explicitly addressed in the provided summary. While "Smart Fetal Heart," "Smart Optimization," and "SMI G4" might incorporate machine learning components, no details on their training are given.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document, as no details about a "training set" or its ground truth establishment are mentioned.
§ 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.