(39 days)
The AN6150 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 AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the 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 AN6150 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 AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
This 510(k) summary for the Analogic Corporation AN6150 Digital Radiology System primarily focuses on its substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about clinical performance studies, reader studies, or detailed acceptance criteria related to diagnostic accuracy or reader improvement with AI assistance.
Therefore, many of the requested sections about clinical performance, training sets, and ground truth cannot be filled from the provided text.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with recognized safety standards: |
- IEC 60601-1:1988, +A1:1991, +A2:1995 (safety of medical electrical equipment)
- IEC 60601-1-1
- IEC 60601-1-3:1994 (radiation protection)
- IEC 60601-2-7
- IEC 60601-2-28
- IEC 60601-2-32
- IEC 60601-1-2:2001 (electromagnetic compatibility)
- FDA Reviewer Guidance (Nov 1993) for Line Dropout and Variation Susceptibility
- Mechanical Shock and Vibration Tests
- Shipping Container Transportation Test | "All tests passed the stated criteria."
"The testing of the AN6150 Digital Radiology System demonstrates that the performance is substantially equivalent to the predicate devices cited above." |
| Functional Performance (implicitly expected for digital radiography system comparable to predicate) | Images available for preview on operator's workstation within seconds of x-ray exposure. Digital (DICOM) images can be stored, exported to DICOM/PACS network, clinical review station, or film printer. |
2. Sample size used for the test set and the data provenance:
- Not provided. The document refers to "nonclinical testing" and validation "at the unit and system level," which implies hardware and software engineering tests rather than clinical image evaluations. There is no mention of a "test set" in the context of diagnostic performance or clinical image data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth establishment by experts is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set is mentioned.
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. The AN6150 Digital Radiology System is described as a general digital X-ray system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related performance metrics are relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware and software system for acquiring and processing X-ray images, not an AI algorithm. Standalone algorithm performance is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth is mentioned. The "ground truth" for the non-clinical tests would be the specifications and requirements of the standards themselves (e.g., passing specific voltage tolerances, radiation leakage limits, or electromagnetic compatibility thresholds).
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI/machine learning model or training set, this question is not relevant.
Summary of what the document does provide:
The document describes the AN6150 Digital Radiology System and its substantial equivalence to predicate devices (Analogic AN5150 and AN7150). The proof of meeting acceptance criteria primarily comes from non-clinical testing against a series of recognized international and FDA-specific standards for safety, radiation protection, and electromagnetic compatibility. The conclusion drawn is that the device "passed the stated criteria" for these engineering and safety tests, demonstrating its performance is "substantially equivalent" to its predecessors. This type of submission focuses on regulatory compliance for a new version of an established technology rather than demonstrating new clinical diagnostic capabilities or AI performance.
§ 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.