(29 days)
The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the OREX Computed Radiography Ltd. "Point of care including LLI" device:
The provided 510(k) summary (K073670) is very high-level and does not contain the detailed information required to fully answer all aspects of your request. Specifically, it lacks quantitative acceptance criteria and detailed study parameters.
However, I can extract and infer some information based on typical 510(k) submissions:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Bench and clinical data demonstrate that the device meets the required specifications." However, it does not explicitly list quantitative acceptance criteria (e.g., specific imaging parameters like DQE, spatial resolution, contrast-to-noise ratio, or specific clinical performance metrics). Therefore, a table with specific numbers cannot be generated from this text.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench and clinical data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information about the number of experts, their qualifications, or how ground truth was established for any clinical evaluations.
4. Adjudication Method
The document does not specify any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (Algorithm Only) Performance Study
The device is a Computer Radiography (CR) acquisition scanner. The "LLI" component is a CR cassette for Long Length Imaging. This is a hardware and software system for image acquisition, not an AI algorithm for image interpretation. Therefore, a "standalone algorithm only" performance study in the context of AI without human-in-the-loop is not applicable to this type of device as described. Its performance would be evaluated on image quality metrics and clinical utility for capturing long-length images.
7. Type of Ground Truth Used
The document mentions "clinical data" but does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). For an image acquisition system, the ground truth would typically relate to the accuracy and quality of the acquired image compared to a reference standard, and the ability of the acquired image to allow for accurate diagnosis by radiologists.
8. Sample Size for the Training Set
The document does not provide any information about a training set size. As this is a CR acquisition scanner and cassette, not an AI diagnostic algorithm, the concept of a "training set" in the machine learning sense is unlikely to apply in the same way.
9. How Ground Truth for the Training Set Was Established
The document does not provide any information about how ground truth for a training set was established, as it does not mention a training set.
Summary of what can be extracted/inferred:
- Acceptance Criteria: Stated as "required specifications" and met by "Bench and clinical data," but no quantitative details are provided.
- Study Type: Bench and clinical data were collected.
- Device Type: CR acquisition scanner with a long-length imaging cassette. Its evaluation would focus on image quality, safety, and functionality, rather than diagnostic accuracy of an AI algorithm.
- Regulatory Pathway: Special 510(k), indicating modifications to an existing predicate device (Orex K003256 and Kodak K021829). This often implies that the modifications are minor and do not significantly alter the fundamental scientific technology or risks, and therefore, extensive new clinical studies with detailed acceptance criteria might not be required if performance is shown to be equivalent to the predicate.
In conclusion, the provided 510(k) summary is insufficient to answer many of your specific questions, particularly those related to quantitative acceptance criteria, clinical study parameters, and AI-specific evaluation metrics. This is common for 510(k) summaries, which aim to provide a high-level overview rather than the full detailed submission. The full 510(k) submission would contain this information, but it is not publicly available in this snippet.
§ 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.