(15 days)
The DIGITAL RADIOGRAPHY CXDI-55C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-55C is a solid state x-ray imager which has 35 x 43 cm imaging area. The DIGITAL RADIOGRAPHY CXDI-55C intercepts x-ray photons and the scintillator of the CXDI-55C emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the images are converted to digital and displayed on a monitor.
The provided text is related to a 510(k) submission for a digital radiography device (CXDI-55C). However, it focuses on demonstrating substantial equivalence to a predicate device (CXDI-50C) rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria with specific performance metrics.
Here's a breakdown of what can be extracted and what is NOT available based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided text. The document states "The Performance Data demonstrates that CXDI-55C is safe and effective just as the CXDI-50C," but it does not provide specific performance metrics or acceptance criteria in a table format.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided text. The document refers to "Performance Data" and "non-clinical testing" but does not detail the nature of these tests, the sample sizes used, or the data provenance.
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):
This information is not present in the provided text. There is no mention of expert involvement in establishing ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided text.
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:
This information is not present in the provided text. The device described is a digital X-ray imager, not an AI-assisted diagnostic tool. Its comparison is to a previous model of a similar imager, not to human readers with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided text. The device is a hardware component for capturing X-ray images, not an algorithm that performs a diagnostic task independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present in the provided text.
8. The sample size for the training set:
This information is not present in the provided text. The device is a digital radiography imager, not an AI model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
This information is not present in the provided text.
Summary of available information related to acceptance criteria and study:
The provided document is a 510(k) summary for the Canon CXDI-55C, a solid-state x-ray imager. The primary method for gaining market clearance through this submission is demonstrating substantial equivalence to a predicate device, the Canon CXDI-50C.
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Acceptance Criteria & Reported Performance:
- Acceptance Criteria (Implied): Substantial equivalence to the predicate device, CXDI-50C, in terms of safety and effectiveness. This implies meeting similar performance standards to the predicate device.
- Reported Device Performance: "The Performance Data demonstrates that CXDI-55C is safe and effective just as the CXDI-50C." However, no specific quantitative metrics (e.g., DQE, MTF, SNR) are provided to exemplify this safety and effectiveness.
- Basis for Equivalence: The primary differences highlighted are physical characteristics:
- External Dimensions: CXDI-55C changed from 491 x 477 x 23 mm (CXDI-50C) to 480 x 481 x 15 mm.
- Weight: CXDI-55C changed from 4.8kg (CXDI-50C) to 3.4kg.
- Intended Use: Identical to the predicate device: "digital image capture for conventional film/screen radiographic examinations... to replace radiographic film/screen systems in all general purpose diagnostic procedures." (Not for mammography).
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Study Details (Limited):
- The document refers to "design control activities and non-clinical testing" that led to the conclusion of substantial equivalence. However, no specific details about these tests are provided, such as sample sizes, methodologies, or outcomes in measurable terms.
- There is no evidence of studies involving human readers, AI assistance, expert review for ground truth, or adjudication methods for diagnostic performance in this document. The focus is on the equivalence of the hardware's imaging capabilities.
In conclusion, this document demonstrates substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study for the device's diagnostic performance. The "performance data" mentioned is not quantified or elaborated upon in this summary.
§ 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.