(30 days)
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
The provided text describes Analogic Corporation's AN5150 and AN7150 Digital Radiology Systems and their 510(k) submission (K033345). However, this submission does not include a clinical study with acceptance criteria, reported device performance, or details about ground truth, expert adjudication, or reader studies.
The document focuses on demonstrating substantial equivalence to predicate devices (Analogic DR 5000, DR 9000, and Sterling Diagnostic DirectRay Operator Console) through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from non-clinical tests) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Safety of medical electrical equipment) | Passed |
| EN 55011, Group 1, Class B emissions limits (Electromagnetic Emissions) | Compliant |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Passed |
| Line Dropout and Variation Susceptibility (per FDA Reviewer Guidance, Nov 1993) | Tested, Passed |
| Mechanical Shock and Vibration Tests | Passed |
| Shipping Container Transportation Test | Passed |
2. Sample size used for the test set and the data provenance
- Not applicable. No clinical test set or data provenance from a clinical study is described. The validation was based on unit and system-level non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth established by experts for a test set is described.
4. Adjudication method for the test set
- Not applicable. No adjudication method for a test set 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
- No. An MRMC comparative effectiveness study was not done. The device is a digital radiology system, not an AI-powered diagnostic tool as described in this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. No standalone algorithm performance study was done as the device is a digital radiology system, not an algorithm being evaluated in isolation.
7. The type of ground truth used
- Not applicable. For the non-clinical tests, the "ground truth" was compliance with established engineering and safety standards and specifications, rather than clinical ground truth (e.g., pathology, expert consensus).
8. The sample size for the training set
- Not applicable. The device is a digital radiology system, not an AI-based system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set ground truth was established for this device.
§ 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.