(79 days)
This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand (fixed detector only) or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest; abdomen, spine, neck and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices. Excluded indications include mammography, fluoroscopy and angiography studies.
The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based device that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an optional auto stitching function.
The provided document K083503 is a 510(k) Pre-market Notification for the Toshiba DRAD-3000E, RADREX-I, a general-purpose x-ray system. The document does not contain information about a study that establishes performance against specific acceptance criteria for a new or modified feature that would typically require such a study (e.g., AI performance, new diagnostic capability). Instead, it primarily focuses on demonstrating substantial equivalence to predicate devices, which implies that its performance is implicitly acceptable because it is similar to already approved devices.
Therefore, many of the requested sections regarding acceptance criteria and performance studies are not explicitly stated or applicable in this 510(k) submission, as it is largely a declaration of substantial equivalence for a direct conversion flat panel detector.
Here's a breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
The document describes the device as being "of comparable type and substantially equivalent" to its predicate devices. This means that the acceptance criteria are implicitly that the device performs at least as well as or similarly to the predicate devices. Specific quantitative acceptance criteria or objective performance results in a table are not provided because the submission mechanism is substantial equivalence, not a de novo pathway requiring novel performance benchmarks.
The "reported device performance" in this context refers to its operational characteristics and conformity to general standards, rather than specific diagnostic accuracy metrics.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Submission) |
|---|---|---|
| Intended Use | Must match or be very similar to the predicate device, for radiography of head, chest, abdomen, spine, neck, and limbs; image acquisition, display, transmission/output. Excludes mammography, fluoroscopy, angiography. | The device's stated Intended Use is for radiography of the head, chest, abdomen, spine, neck and limbs, image acquisition, image display and transmission/output or images to external devices. Excluded indications include mammography, fluoroscopy and angiography studies. This matches the predicate devices. |
| Technological Characteristics | Must employ similar materials and processes (e.g., solid-state imager for direct conversion of x-rays) as predicate devices. | The device employs similar materials and processes as found in the predicate devices, specifically utilizing Solid State Imagers (SSXI) to convert x-rays directly into electrical signals. |
| Safety and Effectiveness | Must conform to all applicable Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020), and relevant Medical Device Safety standards (e.g., IEC 60601 series). | The device is designed and manufactured under the Quality System Regulations (21 CFR § 820). All requirements of the Federal Diagnostic Equipment Standard (21 CFR § 1020) and applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28 are met. |
| Predicate Device Similarity | Substantially equivalent to listed predicate devices (Toshiba DRAD-3000E, RADREX-i [K082494] and Philips Medical Systems Bucky Vision (Digital Diagnost) [K982795]). | The RADREX-I is stated to be substantially equivalent to Toshiba DRAD-3000E, RADREX-i [K082494] and Philips Digital Diagnost; [K982795]. |
Study Details (Not applicable for this type of submission)
Since this 510(k) submission primarily establishes substantial equivalence based on technological characteristics and intended use similar to existing devices, it does not describe a performance study as would be required for a novel device or AI component that needs to demonstrate specific diagnostic accuracy or efficacy. Therefore, details regarding test sets, experts, ground truth, and effectiveness studies are not provided in this document.
- Sample size used for the test set and the data provenance: Not mentioned, as no specific performance study is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. This system is a general x-ray imaging system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This device is an imaging system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not applicable, as this is a hardware device submission, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
§ 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.