(73 days)
CRystalView is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
The Alara CRystalView™ is a Desktop Computed Radiography (CR) System designed to generate digital x-ray images by scanning photo-stimulable storage phosphor imaging plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC workstation with software, cassettes, and imaging plates. Image data is sent via a dedicated connection from the Reader to the CRystalView QC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView System includes acquisition console software and post-processing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state quantitative acceptance criteria in a table format. However, it implicitly defines the acceptance criteria as demonstrating substantial equivalence to predicate devices. The performance is reported in terms of comparability.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Equivalence | "demonstrate that CRystalView is substantially equivalent to the predicate devices." |
| Image Quality | "Clinically, no statistically significant difference was found in image quality ratings of CRystalView and the Agfa ADC Compact when images were judged by a radiologist." |
| Functional Characteristics | "CRystalView performance characteristics are comparable with those of the predicate devices." |
| Indications for Use | "CRystalView has the same or similar indications for use as the predicate devices." |
| Technological Characteristics | "CRystalView shares the same technological characteristics as the predicate devices." |
| Safety and Standards | "CRystalView complies with applicable FDA and international standards pertaining to electrical, mechanical. EMC, and laser safety of medical and/or laser devices." (This is a design requirement, but also implies performance in meeting safety standards) |
Notes on Acceptance Criteria:
- The primary acceptance criterion is substantial equivalence to the predicate devices (PhorMax Eagle Scanner (K001499) and Agfa ADC Compact (K974597)).
- For clinical performance, the key metric for image quality was "no statistically significant difference" compared to a predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact number of images or cases used in the clinical concurrence study. It only states that "a clinical concurrence study" was carried out, where "images were judged by a radiologist."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a radiologist" (singular, implying one radiologist).
- Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty) of the radiologist are not provided.
4. Adjudication method for the test set
- Adjudication Method: Not explicitly stated. Given that only "a radiologist" was mentioned, it suggests a single-reader assessment rather than a multi-reader adjudication method (like 2+1, 3+1).
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 Conducted: No, an MRMC study was not conducted. The study described is a "clinical concurrence study" where images from the CRystalView and a predicate device (Agfa ADC Compact) were judged by a single radiologist for image quality.
- Effect Size: Not applicable, as this was not an MRMC study nor an AI-assisted study. The device itself (CRystalView) is a Computed Radiography (CR) system, not an AI-based diagnostic tool for assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The performance of the CRystalView system itself (the algorithm and hardware) was evaluated through laboratory and clinical studies. The "image quality ratings" of the CRystalView were compared to those of the predicate. This is a standalone evaluation of the device's output quality.
7. The type of ground truth used
- Type of Ground Truth: "Image quality ratings... judged by a radiologist." This implies expert consensus (or in this case, expert judgment by a single radiologist) was used to establish the "ground truth" for image quality comparison. It's not pathology or outcomes data.
8. The sample size for the training set
- Sample Size for Training Set: Not mentioned or applicable. This documentation focuses on the validation of the device and does not describe the development or training of any machine learning component. The CRystalView system described here is a Computed Radiography system for image generation, not an AI diagnostic algorithm that requires a "training set" in the conventional machine learning sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as this device does not describe an AI/ML algorithm requiring a training set with established ground truth.
§ 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.