(8 days)
The Aplio v4.0R001 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
Elastography is indicated for determining the relative elasticity of a lesion.
The Aplio XG v4.0R001 is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz
The provided FDA 510(k) premarket notification for the Toshiba Aplio XG (v4.0R001) SSA-790A Ultrasound System (K092179) focuses on the substantial equivalence of the device to existing predicate devices and the safety considerations. It outlines the intended uses for various transducers and notes the addition of "Elastography (New)" as an intended use for several of them.
However, the document does not contain a detailed description of acceptance criteria for Elastography, nor does it present a specific study proving the device meets particular acceptance criteria with reported performance metrics. The submission is primarily about demonstrating substantial equivalence and safety, not about presenting the results of a performance study with quantitative acceptance criteria for a new feature like Elastography.
The document states: "Elastography is indicated for determining the relative elasticity of a lesion." This is an indication for use, not an acceptance criterion or a performance claim with specific metrics.
Therefore, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy, precision for elasticity measurements) or present a table of reported device performance against such criteria for the Elastography feature.
2. Sample size used for the test set and the data provenance:
- Not provided. The document does not describe any specific test set size for evaluating Elastography performance, nor does it mention the data provenance (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 provided. There is no mention of experts establishing ground truth for a test set related to Elastography in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. No adjudication method is described.
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 / Not provided. The document does not describe an MRMC comparative effectiveness study for Elastography, nor does it mention AI assistance. The device is an ultrasound system with a new imaging mode (Elastography), not an AI-powered diagnostic tool in the sense of comparing human reader performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. Elastography in this context is an ultrasound imaging mode, which inherently involves a human operator acquiring and interpreting the images. It's not a standalone algorithm without human involvement in its operation or interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. No type of ground truth is specified for evaluating the Elastography feature. For a substantial equivalence submission, the primary "ground truth" implicitly relies on established performance of the predicate devices and general safety standards for ultrasound.
8. The sample size for the training set:
- Not provided. As this is not a submission for an AI/CAD system in the modern sense, there is no concept of a "training set" described for the Elastography feature. The development of an imaging mode is typically based on physics and engineering principles, and clinical validation would follow.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. See point 8.
Summary based on the provided text:
The provided 510(k) summary focuses on establishing substantial equivalence for the Toshiba Aplio XG ultrasound system and its various transducers, especially regarding the addition of "Elastography (New)" as an indication for use. It outlines the safety considerations and references adherence to various IEC and AIUM standards. However, it does not contain the detailed performance data, acceptance criteria, or study methodologies that would typically be associated with proving a novel AI/CAD device meets specific performance claims. For a new imaging mode like Elastography, the FDA's process at that time (2009) would have primarily looked at the technical safety and performance of the imaging modality itself, and the clinical utility for diagnostic purposes would be demonstrated through subsequent clinical literature and use, rather than a single premarket comparison study with specific acceptance criteria detailed in the 510(k) summary itself.
§ 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.