(16 days)
The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.
The ABUS system, with automated ultrasound im-aging of the breast, gives the radiologist a cost effective solution for reviewing the ultrasound images with the corresponding mammogram. The FFBU Diagnostic Ultrasound System modification represents limited hardware and software changes to the Sponsor's predicate device.
The provided document is a 510(k) summary for the U-Systems ABUS Diagnostic Ultrasound System, dated September 14, 2005. This submission focuses on modifications to an already cleared predicate device (FFBU Diagnostic Ultrasound System, K032640), as well as comparing it to other legally marketed devices.
Crucially, this document only describes the device and its intended use, and affirms that its performance has been verified according to the U-Systems' Design Control process (compliant with 21 CFR Part 820.30). It does not contain specific acceptance criteria, performance data, or details of a clinical study proving the device meets acceptance criteria.
The sections on "Performance Data" ([0], E) and "Indications for Use" ([5], [6], [7], [8], [9]) indicate that the device's technical performance and clinical applications are deemed substantially equivalent or consistent with existing cleared devices for certain modes (e.g., B-mode, Harmonic Imaging, Spatial Compounding) and for specific transducers (L9-5XW, L10-5XW, L12-6XW). The "Notes" on the Indications for Use forms also point to new capabilities (Harmonic Imaging, Spatial Compounding) being added for the small organ (breast, thyroid, testes) application.
Therefore, I cannot provide the requested table or detailed study information because the provided text does not contain this information. The submission aims to demonstrate substantial equivalence based on technical specifications and intended use consistent with predicate devices, rather than a new standalone clinical efficacy study with specific acceptance criteria and performance metrics.
In summary, the provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details of a study with ground truth establishment.
- Information on the number of experts or their qualifications for ground truth.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Results of a standalone performance study.
- Details on the type of ground truth used for performance evaluation.
- Sample size for the training set or how ground truth was established for it.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.