(15 days)
The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The 0170 Intuition is not intended for mammography.
The 0170 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and a wall stand that has a floor mounted column with a detector holder. The ceiling stand and the table has automatic movements for up and downs, other movements are manual. The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance.
This document is a 510(k) summary for the Arcoma Intuition Model 0170, a stationary x-ray system. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Identification and Classification: Trade name, classification, review panel, product code, regulation number, and device classification.
- Predicate Devices: A list of previously cleared devices to which the Intuition Model 0170 is substantially equivalent.
- Device Description: A brief overview of the physical components and functionalities of the x-ray system.
- Intended Use: The specified clinical application (radiographic imaging of various portions of the human body, excluding mammography).
- FDA Clearance: The letter from the FDA confirming the substantial equivalence determination and allowing the device to be marketed.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance results
- Type of ground truth used (for test set)
- Sample size for the training set
- How ground truth for the training set was established
This type of detailed performance testing and clinical study information is typically found in accompanying technical documentation or clinical study reports, which are not part of this 510(k) summary. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which often relies on technical comparisons and non-clinical bench testing, rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics like sensitivity and specificity.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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 radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray 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.