(31 days)
The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
SiteLink™ Image Manager is a software accessory for SonoSite Maxx Series medical diagnostic ultrasound systems. SiteLink enables image download, in full resolution .bmp format or compressed .jpg format, from SonoSite systems to a Windows-based PC.
The SonoSite® DICOM/Clips Bundle is a software option available on SonoSite Maxx Series™ medical diagnostic uitrasound systems. It is intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, 2D Chroma, THI, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler, Anatomical M-Mode, Color M-Mode, Pulsed Wave Tissue Doppler Imaging (PW-TDI), Color Tissue Doppler Imaging (Color-TDI), Elastography (Strain), Strain Rate Imaging, tissue 4D and flow 3D imaging or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.
The provided document is a 510(k) Summary of Safety and Effectiveness for the SonoSite Maxx™ Series Ultrasound System and its associated transducers. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance metrics against acceptance criteria in the way a clinical study report would for a new feature or algorithm.
Therefore, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of accuracy, sensitivity, or other quantitative performance measures for an AI/algorithm.
Instead, the document focuses on demonstrating substantial equivalence by stating that the device is compliant with existing standards and has comparable technological characteristics, safety, and effectiveness to its predicate devices.
Here's a breakdown of why the requested information is absent:
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A table of acceptance criteria and the reported device performance: This is not present in the document. The tables (4.3-1 through 4.3-34) list "Indications for Use" for the main system and various transducers, detailing the clinical applications and available modes of operation (B-mode, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Doppler, and combined modes). They indicate whether these indications were "previously cleared by FDA" (P) or are "new indications" (N). This is a statement of intended use and cleared functionalities, not a performance report against acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not describe any specific test set or data used to evaluate the performance of a new algorithm or feature. It mentions "The device is verified and validated according to the company's design control process," but details of such testing (including sample size or data provenance) are not provided in this summary.
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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): Since no specific performance study against a test set is described, there is no mention of experts or their qualifications for establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: As no test set performance is detailed, there is no information on an adjudication method.
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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: This document predates widespread AI integration in medical devices. There is no mention of AI, human readers, or MRMC studies. The device is a diagnostic ultrasound system, and the clearance is for its functionalities as an imaging system and associated accessories (SiteLink Image Manager, DICOM/Clips Bundle).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed, as the device is an ultrasound system with various imaging modes, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed performance validation against an established ground truth is not provided in this summary.
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The sample size for the training set: Not applicable, as there is no indication of an AI/machine learning algorithm that would require a training set.
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How the ground truth for the training set was established: Not applicable, for the same reason as point 8.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a diagnostic ultrasound system and its transducers to existing predicate devices. It confirms compliance with design control processes and safety standards but does not include specific performance data or studies that would typically be required to prove an AI/algorithm meets detailed acceptance criteria.
§ 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.