(85 days)
The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are intended for use by a qualified/ trained doctor or technician on both adult and pediatic subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
This device represents a new combination of already cleared solid state digital x-ray acquisition panels and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:
- Toshiba wireless flat panel detector (FDX-3543RP, FDX-3543RPW, 14 in. x 17 in.) or Toshiba wired flat panel detector (FDX-4343R, 17 in x 17in). (K130883)
- Vieworks all series: (FXRD-1717SA/SB, or FXRD-1417SA/SB or FXRD-1417WA/WB. (K130337, Medicatech "New Series.")
- PerkinElmer XRpad™ 4336 MED, (K140551).
The purchaser can select either a "C" arm configuration (KrystalRad 1100) or an overhead tube crane configuration (KrystalRad 3000). The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. An IBA kerma meter model 120-131 is supplied.
The provided text describes the KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems. However, it does not contain detailed information regarding the acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in a clinical study report for AI-powered devices.
This document is a 510(k) premarket notification for a traditional medical device (an X-ray system), not an AI/ML-powered device that requires extensive clinical performance evaluation against specific acceptance criteria. The approval is based on substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and that its components have been previously cleared.
Here's a breakdown of the available information based on your request, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical acceptance criteria for a clinical study. The document focuses on demonstrating substantial equivalence to a predicate device. | "The images were found to be of excellent diagnostic quality." (Based on radiologist review) |
Missing: Specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) or defined acceptance thresholds for diagnostic accuracy that would be typical for an AI device.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document states "Clinical images were acquired from each panel".
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One
- Qualifications of Experts: "a board certified radiologist."
4. Adjudication Method for the Test Set
- Adjudication Method: Implicitly "none," as only one radiologist reviewed the images. There was no consensus or arbitration process mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is more common for assessing the impact of AI on human reader performance.
- Effect size of improvement with AI vs. without AI: Not applicable, as this is not an AI-powered device.
6. Standalone Performance Study (Algorithm Only)
- Was a standalone study done? No. This device is a radiographic system, and its performance is evaluated as an integrated system producing images for human interpretation.
7. Type of Ground Truth Used
- Ground Truth Type: Expert opinion/review ("clinical images... reviewed by a board certified radiologist").
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a traditional X-ray system, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for an AI/ML model.
Summary of Device and Study Context:
The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are conventional X-ray machines. Their FDA clearance (K143257) is based on demonstrating substantial equivalence to an existing legally marketed device (Sedecal Nova FA DR System, K133782). The "study" described is a non-clinical bench testing and review of clinical images to ensure the system functions correctly and produces diagnostically acceptable images. It is not a clinical trial designed to establish specific performance metrics against a medical condition, nor does it involve an AI algorithm with training and test sets. The focus is on the safety and effectiveness of the hardware and integrated software for image acquisition, primarily through demonstrating that its components (cleared digital panels, generator, collimator) work together to produce images of "excellent diagnostic quality" as judged by a single radiologist.
§ 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.