(181 days)
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, 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 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, Power 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, V6.5 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 30 MHz.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Canon Medical Systems Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5.
Based on the provided FDA 510(k) summary, this submission is for a modification of an existing device (Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1). The primary goal of the submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish de novo safety and efficacy with novel acceptance criteria and extensive clinical studies.
Therefore, the information regarding specific acceptance criteria and detailed clinical study results (like sample size for test sets, ground truth establishment for test sets, MRMC studies, standalone performance, etc.) is largely absent from this particular document, as it focuses on demonstrating equivalence through verification and validation activities rather than extensive comparative clinical trials.
The document implicitly states that the acceptance criteria for the modifications were met through internal testing and verification, aligning with established specifications and relevant standards.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format requested. Instead, it broadly states that:
- "Risk Analysis and verification and validation activities demonstrate that the established specifications for these devices have been met."
- "Additional performance testing, using phantoms, test data, and volunteer data, were conducted in order to demonstrate that the requirements for the new and improved features were met."
- "The results of all of these studies demonstrate that the new and improved features meet established specifications and perform as intended."
This suggests that the acceptance criteria are tied to the "established specifications" and "requirements" of the new and improved features, and the "reported device performance" is that these criteria were "met." However, no quantifiable performance metrics against specific acceptance thresholds are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "performance testing, using phantoms, test data, and volunteer data," but does not specify the sample size for any of these. It also does not detail the data provenance (e.g., country of origin, retrospective or prospective).
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)
The document does not specify the number or qualifications of experts used to establish ground truth because it wasn't a clinical study designed with external expert adjudication for a test set. The validation relies on internal testing against established specifications. The reference to "volunteer data" might imply some form of clinical input, but details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given the lack of a detailed clinical test set and expert review, no specific adjudication method is described. The assessment seems to be based on internal verification against engineering and design specifications.
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
The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Aplio i900/i800/i700, V6.5 systems."
Therefore, no MRMC comparative effectiveness study was performed as part of this submission for the clinical improvements of human readers with AI assistance. The mention of AI/ML support for "2D Wall Motion Tracking for left ventricle (2D WMT) and Auto Ejection Fraction for left ventricle (Auto EF)" is an expansion of marketing language for previously cleared features, not a new AI feature requiring a new clinical efficacy study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While the AI/ML features (2D WMT with Full-assist and Auto EF with Full-assist) are mentioned, the document does not provide details on standalone algorithm performance studies. The focus of this 510(k) is on the substantial equivalence of the modified device, not the de novo validation of new AI algorithms. The existing AI features are likely part of the overall system and their performance would have been assessed in prior clearances for predicate devices/software versions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the internal testing which demonstrated that "requirements for the new and improved features were met," the "ground truth" would likely have been established through phantom measurements and reference values for simulated data, along with objective assessments of the volunteer data for functionality. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this particular submission.
8. The sample size for the training set
The document does not provide any information regarding the sample size for a training set. This is consistent with the nature of the submission being a modification to an existing device, where the AI/ML features mentioned are described as expansions of marketing language for previously cleared functionalities, not new, de novo AI developments requiring new training data disclosures.
9. How the ground truth for the training set was established
Since no training set details are provided, how its ground truth was established is not discussed in this document.
In summary, this FDA 510(k) summary focuses on demonstrating substantial equivalence of a software update (V6.5) to a predicate device (V5.1). It highlights that internal verification and validation activities were conducted to ensure the new and improved features meet established specifications. However, it explicitly states that no clinical studies were required for this submission, and therefore, detailed information on clinical acceptance criteria, sample sizes, expert ground truth establishment, or clinical performance of specific AI features (as would be expected for a de novo clearance or a significant new AI feature) is not present in this document.
§ 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.