(30 days)
The A35 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The A35 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The A35 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The A35 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text describes the SAMSUNG MEDISON A35 Diagnostic Ultrasound System and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study that proves the device meets specific performance acceptance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria for a novel algorithm or AI.
Therefore, for your requested information, I can only provide the following based on the available text:
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A table of acceptance criteria and the reported device performance: This information is not explicitly stated in the document. The document lists the intended uses, modes of operation, and features of the A35 and its transducers, and states that these are "consistent with traditional clinical practices and FDA guidelines" and that the device is considered "as safe, as effective, and performance is substantially equivalent to the predicate devices." No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are reported for an AI/algorithm.
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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): Not applicable, as no clinical performance study for an AI/algorithm is described.
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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): Not applicable, as no clinical performance study for an AI/algorithm is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical performance study for an AI/algorithm is described.
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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: Not applicable. The document states "Summary of Clinical Tests: Not applicable. The subject of this submission. A35, did not require clinical studies to support substantial equivalence." This indicates no MRMC or other clinical study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The document does not describe any standalone algorithm performance testing. The mentioned "SW Features" (Volume IT, FVR, Stereo cine (5D Cine), Stress Echo, Strain) are integral functionalities of the ultrasound system, not standalone AI algorithms with independent performance metrics usually associated with diagnostic AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study for an AI/algorithm is described.
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The sample size for the training set: Not applicable, as the document does not describe the development or training of an AI/algorithm.
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How the ground truth for the training set was established: Not applicable, as the document does not describe the development or training of an AI/algorithm.
In summary, this 510(k) pertains to a diagnostic ultrasound system (A35) and its transducers. The review focuses on demonstrating its safety and effectiveness through substantial equivalence to existing, legally marketed predicate devices, rather than on the performance of a novel AI or algorithm against specific acceptance criteria in a clinical study. The "SW Features" mentioned are functionalities of the ultrasound system itself, not separate AI tools requiring independent validation studies with specific performance metrics.
§ 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.