(183 days)
The Diagnostic Ultrasound System Aplio i900 Model TUS-A1900. Aplio i800 Model TUS-A1800 and Aplio i700 Model TUS-AI700 are 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 pediatric), 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-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V7.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33 MHz.
This FDA 510(k) summary describes a modification to an existing diagnostic ultrasound system, the Aplio i900/i800/i700 Diagnostic Ultrasound System, moving from Software V6.5 (predicate device K212333) to Software V7.0 (subject device K223017).
The documentation does not provide detailed acceptance criteria or a specific study proving the device meets those criteria in the way one might expect for a new AI/CADx device that targets a specific clinical outcome with clear metrics like sensitivity, specificity, or AUC. Instead, it focuses on demonstrating substantial equivalence to the predicate device by showing that the V7.0 software has the same intended use, fundamental scientific technology, and similar function, with improvements to existing features and functionality.
Therefore, the "acceptance criteria" here are primarily about meeting specified performance targets for the improved features and demonstrating that the overall system remains safe and effective for its indicated uses, similar to the predicate device. The "study" mentioned refers to the verification and validation activities and performance testing of these improved features.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for new clinical outcomes. The "acceptance criteria" are implied by the comprehensive testing and verification that the improved features function as intended and meet established specifications.
| Feature Improvement/Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| New Transducer (PSI-28VX) | Technological and biocompatibility equivalence to existing transducers; does not introduce new indications for use. | Met; shares technological and biocompatibility characteristics with predicate transducers and does not introduce new indications. |
| ApliCam kit | Ability to display and store images from a supported USB camera on the ultrasound system. | Functions as intended; supports display and storage of images. |
| Contrast Enhance kit (Clarity) | Improves cardiac image quality. | Improvements in cardiac image quality demonstrated. |
| 2D Wall Motion Tracking | Improved to support the new clinical target (left atrium). | Functions as intended with support for the left atrium. |
| Enhanced contrast with Quick Scan | New setting provides enhanced contrast. | New setting enhances contrast. |
| Expanded Full Focus | Availability for select non-iBeam+ transducers. | Expanded availability for select non-iBeam+ transducers. |
| Attenuation Imaging (ATI) | Addition of filter to exclude abdominal wall multiplex; support of trend graph for existing calculations; added "Mini-Worksheet." | Filter incorporated; trend graph supported; Mini-Worksheet added. |
| Ultrasound Scanning Condition Export Function kit | Enables export of images and info to Canon Angiography workstation. | Functionality confirmed; enables export to workstation. |
| Triplex improvement (OB) | New setting for existing modes for improved image quality. | New setting introduced for improved image quality. |
| OB 4D image quality | Improvements related to brightness and smoothness; improved Luminance and Flexible cutline functionality. | Improvements confirmed for brightness, smoothness, Luminance, and Flexible cutline. |
| TCD image quality | Better visibility of structures in B mode; better visibility and sensitivity in CDI mode. | Improvements confirmed for B mode structure visibility and CDI mode visibility/sensitivity. |
| Higher frequency (PLI-3003BX) | Support of higher frequency. | Higher frequency supported. |
| Workflow improvements | Functionality as described (e.g., enable/disable PRF, improved scale marker, thumbnail preview, Smart body mark, Smart Fusion, Prostate Biopsy, RAD features). | All specified workflow improvements implemented and functioning as intended. |
| Multi-Parametric Report (user customization) | Addition of formula derived from existing measurement values. | Formula added. |
| Expanded Smart3D (Laparoscopic) | Support for Laparoscopic transducer model PET-805LA. | Support expanded. |
| DICOM support | Support for additional data types (RG, RTSTRUCT). | Additional data types supported. |
| TCS font | Ability to change font and font size. | Functionality confirmed. |
| Patient ID only registration | Ability to support new registration method. | New registration method supported. |
| PVA Dur-A Dur(MV) format | Additional support for the format. | Additional support provided. |
| OB measurement capabilities | Added support for "%tile" display for Doppler measurements; ability to output heartrate from Uterine Artery. | Improvements confirmed. |
| Cardiac Doppler manual measurements | Support for additional measurements. | Additional measurements supported. |
| STIC feature | Ability to preset STIC state and Cine playback rate. | Presetting capability added. |
| Smart Fetal Heart feature | Addition of several buttons for workflow improvements. | Buttons added, improving workflow. |
| DICOM voxel export format | Improved resolution. | Resolution improved. |
| 2D/3D Wall Motion Tracking | Ability to preset auto trace mode; auto trace for inverted images (2D); SmartFetal2D ROI retention. | Improvements confirmed. |
| Overall Safety & Effectiveness | Meets established specifications; performs as intended; substantially equivalent to predicate. | Verified through risk analysis, V&V activities, performance testing, and adherence to standards. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in terms of patient data or image count. The testing conducted primarily involves verification and validation activities and performance testing of the improved features. This typically involves internal R&D testing environments, phantom studies, and potentially a limited number of clinical cases (likely internal and for feature validation rather than a large clinical study for a specific diagnostic accuracy claim).
- Sample Size: Not specified in terms of patient numbers or image volume.
- Data Provenance: Not specified. It's common for such V&V to occur internally, potentially using a mix of synthetic data, phantom data, and potentially a small set of retrospective clinical data for feature-specific validation.
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)
Not applicable. This submission focuses on software changes and feature improvements for an existing diagnostic ultrasound system. There is no mention of a clinical study that required expert-established ground truth for a test set to determine diagnostic accuracy. The "ground truth" for these types of V&V activities generally comes from engineering specifications, established physical principles, and clinical user feedback on the functionality of the improvements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No mention of a clinical test set requiring expert adjudication for ground truth.
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 submission is for a general diagnostic ultrasound system with feature improvements, not a specific AI/CADx device that provides diagnostic assistance to human readers in a comparative effectiveness study setting. The "AI" mentioned (e.g., Smart3D, SmartFetalHeart) refers to advanced processing and workflow-enhancing features of the ultrasound system, not typically external AI tools requiring MRMC studies for regulatory clearance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a diagnostic ultrasound system intended for use by trained physicians, with human-in-the-loop performance inherent to its design and indications for use. No standalone algorithm performance is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for a typical clinical ground truth definition in this submission. The ground truth for the verification and validation of the improved features would be based on:
- Engineering specifications and design requirements.
- Physical measurements and phantom studies (e.g., for image quality, frequency range).
- Clinical utility and user feedback for workflow improvements.
- Referencing the performance of the predicate device for features that are simply being improved rather than fundamentally changed.
8. The sample size for the training set
Not applicable. This document describes improvements to existing software functions of a diagnostic ultrasound system. There is no indication of a new machine learning model being trained that would require a "training set" in the context of deep learning or similar AI/ML development. The "learning" for any adaptive features would be built into the algorithms through design and established parameters, not via large-scale training data in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as no dedicated training set is described.
§ 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.