(11 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intracperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Siemens Acuson X300 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a FPD(Flat Panel Display) display.
This Siemens Acuson X300 Diagnostic Ultrasound System 510(k) submission does not contain information about acceptance criteria or a study proving the device meets said criteria. This document is a summary of safety and effectiveness, focused on establishing substantial equivalence to predicate devices and detailing the intended uses for various transducers. It does not include specific performance metrics, clinical study design, or results that would typically be found in a study demonstrating adherence to acceptance criteria.
The provided text lists the product safety standards the device has been designed to meet:
- UL 60601-1, Safety Requirements for Medical Equipment
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment (EN 60601-1, EN 60601-1-1, EN 60601-1-2)
- IEC 61157 Declaration of Acoustic Power
- ISO 10993 Biocompatibility
However, it does not provide any acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) or reported device performance against such criteria. The document states that the device has been designed to meet these standards, but it does not present data from a study demonstrating active compliance or performance metrics.
Therefore, I cannot populate the requested table or answer most of the other questions, as the information is not present within this 510(k) summary. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria for performance. For clinical effectiveness data, one would typically look for a full clinical study report, which is not part of this summary document.
Here's a breakdown of why each specific point cannot be addressed:
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A table of acceptance criteria and the reported device performance
- Reason Not Found: The document lists general safety and acoustic output standards but does not define specific performance acceptance criteria (e.g., image quality metrics, diagnostic accuracy thresholds) nor does it report any device performance against such metrics. It mentions that "analysis packages... provide information that is used for clinical diagnosis purposes" but provides no performance data for these.
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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)
- Reason Not Found: There is no mention of a test set, clinical data, or studies that would involve a sample size. The submission focuses on device design and comparison to predicate devices, not clinical performance evaluation with a test set.
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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)
- Reason Not Found: As no test set data is provided, there is no mention of experts or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Reason Not Found: No test set or related adjudication method 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
- Reason Not Found: This document is about a diagnostic ultrasound system (hardware and general software capabilities), not an AI-assisted diagnostic tool. There is no mention of an MRMC study or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Reason Not Found: This is not an algorithm-only device; it's a general-purpose ultrasound system. No standalone algorithm performance is discussed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Reason Not Found: No ground truth information is provided, as clinical performance data is absent.
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The sample size for the training set
- Reason Not Found: No training set or data used for training (e.g., for an AI algorithm) is mentioned in this submission.
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How the ground truth for the training set was established
- Reason Not Found: As no training set is indicated, there's no information on how its ground truth would have been established.
In summary, this 510(k) submission establishes the substantial equivalence of the Siemens Acuson X300 Diagnostic Ultrasound System to existing predicate devices based on technological characteristics and intended uses. It does not provide the kind of detailed performance study data, acceptance criteria, or clinical validation results that would address the specific questions posed.
§ 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.