(58 days)
The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. The Digital X-ray Radiography System is designed to perform rudiographic X-ray cvario 1. consists of a control cabinet, a high voltage (HV) generator, an X-ray source assembly including an X-ray tube and an collimator, an Overhead Tube Suspension, a amorphous silicon (a-Si) detector, an elevating radiographic Table, a radiographic wall stand unit and a workstation.
The provided text describes a 510(k) submission for a Digital X-ray Radiography System (model Eagle-DR2000A). The submission aims to demonstrate substantial equivalence to a predicate device, the Revolution XR/d Digital Radiographic Imaging System (K012389).
However, the provided document does not contain any information about the acceptance criteria or the study that proves the device meets those criteria, specifically concerning device performance in terms of image quality metrics, clinical outcomes, or comparative effectiveness studies (e.g., MRMC studies).
The document primarily focuses on:
- General device identification and classification.
- Intended use statement.
- Comparison to a predicate device.
- A high-level description of the device components.
- Non-clinical bench tests conducted to verify compliance with various safety and performance standards (e.g., IEC standards for electrical safety, radiation protection, and biological evaluation).
- The FDA's letter of clearance, stating substantial equivalence.
Therefore, I cannot populate the requested table and study information based on the provided text. The document states that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards." This indicates that the acceptance criteria for this 510(k) submission were primarily related to compliance with established safety and performance standards for X-ray equipment and demonstrating equivalence to a legally marketed predicate device, rather than detailed clinical performance metrics in a human study.
Based on the provided text, I can only provide the following, with many fields explicitly stated as "Not mentioned in the provided text":
Analysis of Acceptance Criteria and Study to Prove Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through compliance with recognized standards and general safety/performance. It does not detail specific performance criteria related to diagnostic accuracy, image quality metrics, or human reader performance, nor does it describe any associated clinical studies or reader studies. The "Non-Clinical Test Conclusion" section primarily lists compliance with various IEC and CFR standards related to electrical safety, radiation protection, and biological compatibility.
Given the nature of a 510(k) for a general radiography system as a replacement for film/screen systems, the primary "acceptance criteria" appear to be robust engineering and safety compliance, and equivalence to a predicate device, rather than a specific clinical performance threshold beyond what the predicate already demonstrated.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Substantial Equivalence | Device is Substantially Equivalent (SE) to predicate (Revolution XR/d Digital Radiographic X-ray System, K012389) in respect of safety and effectiveness. | "The proposed device... is determined to be Substantially Equivalent (SE) to the predicate device..." |
| Electrical Safety | Compliance with IEC60601-1+A1+A2 | "The test results demonstrated that the proposed device complies with the following standards: IEC60601-1+A1+A2..." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "The test results demonstrated that the proposed device complies with... IEC 60601-1-2..." |
| Radiation Performance Standards | Compliance with CFR 1020.30, CFR 1020.31, IEC 60601-2-7, IEC 60601-1-3, IEC 60601-2-28, IEC60601-2-32 | "The test results demonstrated that the proposed device complies with... CFR 1020.30, CFR 1020.31, IEC 60601-2-7, IEC 60601-1-3, IEC 60601-2-28, IEC60601-2-32." |
| Biocompatibility | Compliance with ISO 10993-5 (In Vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization) | "The test results demonstrated that the proposed device complies with... ISO 10993-5, ISO 10993-10." |
| Image Quality / Clinical Performance | Not mentioned in the provided text. | Not mentioned in the provided text (beyond general statement of SE). There is no mention of specific image quality metrics (e.g., DQE, MTF, SNR) or clinical performance studies (e.g., diagnostic accuracy, sensitivity, specificity). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not mentioned in the provided text. The document refers to "bench tests" for compliance with standards, not a test set of patient data.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not mentioned in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: Not mentioned in the provided text.
- Qualifications: Not mentioned in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned in the provided text. This type of method would typically be used in reader studies or clinical trials, which are not 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
- MRMC Study: Not mentioned in the provided text. The device is a digital X-ray radiography system, not specifically an AI-based diagnostic tool for assisting human readers. Its primary purpose, as stated, is to "replace radiographic film/screen systems," implying a direct imaging modality replacement.
- Effect Size of Improvement: Not applicable/not mentioned, as no such study is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable/not mentioned. This device is an imaging system, not an algorithm being evaluated for standalone diagnostic performance. Its primary function is to generate images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not mentioned in the provided text. This information would be relevant if clinical performance or diagnostic accuracy studies were conducted, which are not detailed here. The "ground truth" for this 510(k) appears to be compliance with engineering and safety standards, as well as functional equivalence to a predicate device.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable/not mentioned. The provided document does not describe any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable/not mentioned, as no training set is described.
§ 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.