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510(k) Data Aggregation
(119 days)
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging system intended for use by sufficiently trained healthcare professionals for ultrasound imaging, measurement, and analysis of the human body, which is intended to be used in a hospital or medical clinic.
The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Contrast imaging and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.
This X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/SU11C CU Digital Color Doppler Ultrasound System (hereafter as "X11 Exp Series Digital Color Doppler Ultrasound System") is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array phased array and etc.
This system consists of a console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, contrast, 3D/4D.
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(57 days)
The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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, intraoperative (abdominal), pediatric, small organs (including thyroid, breast, 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 of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, CWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision Imaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. 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 a550 Model CUS-AA550, Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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 20 MHz.
The provided document describes the Canon Medical Systems Corporation's Aplio a550, Aplio a450, and Aplio a Diagnostic Ultrasound System, Software V5.1. While it outlines many aspects of the device and its substantial equivalence to predicate devices, it does not contain information regarding a specific clinical study with acceptance criteria and reported device performance in the format requested.
The document states: "Risk Analysis and Verification/Validation testing conducted through the bench testing which is included in this submission demonstrate that the requirements for the new and improved features have been met. Additional performance testing, using test data and volunteer studies, were conducted to assess improvements to existing features. Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended."
This statement indicates that testing was performed, but it lacks the specific details required to populate the requested table and answer questions about sample size, ground truth, expert qualifications, adjudication, or MRMC studies.
Therefore, I cannot fulfill all parts of your request with the provided input. However, I can infer some general information about the device and the nature of the testing mentioned:
Since this is a 510(k) submission for a diagnostic ultrasound system, the acceptance criteria would typically revolve around demonstrating substantial equivalence to a predicate device. This usually involves showing that the new device has the same intended use, fundamental technological characteristics, and performs as safely and effectively as the predicate device(s).
The "performance testing, using test data and volunteer studies" likely focused on proving the functionality of new and improved features, and that any modifications did not negatively impact existing functionalities.
Here's what can be inferred and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from general statement) |
|---|---|
| Maintain existing image quality and diagnostic capability for all cleared modes and applications. | "Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended." |
| Demonstrate functionality and safety of new features (e.g., LI-RADS Checklist, Workflow Navigator, Smart Optimization, Prostate Biopsy Report). | "The requirements for the new and improved features have been met." |
| Ensure improved functionality for modified features (e.g., Smart Body Mark, MSK Protocol movie, Wide View support, Sensor 3D, Obstetric Image quality). | "Additional performance testing... were conducted to assess improvements to existing features. Results... demonstrate that the features included in this submission meet specifications and perform as intended." |
| Compatibility and performance of new transducer PST-65BT. | (No specific performance reported, just that it was previously cleared and shares fundamental characteristics.) |
| Adherence to relevant safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC series, ISO 10993-1). | "The device is designed and manufactured under the Quality System Regulations... 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." |
Missing Information for specific studies:
2. Sample size used for the test set and the data provenance: Not specified. The document mentions "test data and volunteer studies" but gives no numbers or details on provenance (e.g., 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: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not specified. The document does not mention any comparative effectiveness study with human readers with and without AI assistance. The features described (like LI-RADS Checklist, Workflow Navigator, Smart Optimization) are assistive tools, but a formal MRMC study demonstrating an "effect size" (improvement in human performance) is not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The new features like LI-RADS Checklist and Smart Optimization imply algorithmic components, and their "requirements" were met, but specific standalone performance metrics are not provided. Given the nature of a diagnostic ultrasound system (where the human user is always in the loop), a purely standalone algorithm evaluation might not be the primary focus for the entire system at this clearance level.
7. The type of ground truth used: Not specified. For an ultrasound system, ground truth could be a combination of expert consensus readings, follow-up imaging, biopsy results (especially for features like LI-RADS or BI-RADS), or surgical findings, but these are not explicitly mentioned for the reported studies.
8. The sample size for the training set: Not applicable and not specified. This document describes a medical device, specifically an ultrasound system with software enhancements, not an AI/ML model that typically undergoes specific "training" on a dataset in the conventional sense. The "test data" mentioned refers to verification and validation data.
9. How the ground truth for the training set was established: Not applicable and not specified, as this isn't a traditional AI/ML training context.
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