(79 days)
DIGITAL RADIOGRAPHY CXDI-501G and CXDI-501C provide digital image capture for conventional film/screen radiographic examinations.
These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
These devices are not intended for mammography applications.
The Digital Radiography CXDI-501G and CXDL-501C are solid state x-ray imagers which have 35.0 x 42.6 cm imaging area. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated it is converted to digital value. and the images will be displayed on monitors.
The CXDI-501G uses GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-501C uses Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. Both models employ housing for easy installation in stand and table unit.
The provided text, K111682, does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt's request. This document is a 510(k) summary for a medical device (Digital Radiography CXDI-501G and CXDI-501C) and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through a detailed clinical or standalone performance study.
Here's an analysis of the provided information based on your requested points:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics like sensitivity, specificity, accuracy, or AUC. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness | "demonstrated that these devices are safe and effective" |
| Equivalence to Predicate Devices | "are equivalent to the predicate devices" |
| "are as safe and effective as the predicate devices" | |
| "are substantially equivalent to the predicate devices" | |
| Compliance with Electrical Safety and EMC | "The Electrical safety, Electromagnetic compatibility and other performance testings were performed" |
The primary "acceptance criterion" in this 510(k) submission is substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as those existing devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a test set or data from human subjects. The performance testing mentioned refers to electrical safety, electromagnetic compatibility, and "other performance testings" which are typically non-clinical, bench-top tests, and do not involve patient data.
3. 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)
Not applicable. No test set involving human data or expert review for ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
5. 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 applicable. The document describes a digital radiography system, not an AI-assisted diagnostic tool. No MRMC study involving human readers or AI is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a digital radiography device, not a standalone algorithm. The "performance testing" mentioned refers to the physical device's characteristics (electrical safety, EMC) rather than a diagnostic algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no mention of a diagnostic performance study that would require establishing a "ground truth" for medical conditions. The "performance testing" relates to the device's operational characteristics.
8. The sample size for the training set
Not applicable. This document describes a hardware device (digital X-ray imager), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an algorithm requiring a training set.
Summary of Document Focus:
The K111682 document is a Pre-Market Notification (510(k)) that focuses on demonstrating "substantial equivalence" of the new Digital Radiography CXDI-501G and CXDI-501C devices to previously cleared predicate devices. The arguments are based on:
- Same intended use: Digital image capture for general purpose diagnostic procedures, replacing film/screen systems.
- Similar imaging principle: Solid state X-ray imagers using scintillator materials (GOS or CsI) to convert X-rays to visible light, then to electrical signals, and finally to digital images.
- Performance testing: This testing primarily refers to non-clinical evaluations such as electrical safety, electromagnetic compatibility (EMC), and other technical parameters to ensure the device is safe and performs comparably to the predicate devices on a technical level. It does not involve clinical performance metrics (e.g., diagnostic accuracy in detecting diseases) derived from human patient data.
Therefore, this document does not contain the type of detailed study data regarding acceptance criteria for diagnostic performance that your prompt is seeking.
§ 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.