(16 days)
The AN6250 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 AN6250 Digital Radiology System 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 AN6250 is a Stationary, General Radiology X-ray System.
Here's an analysis of the provided text regarding the Analogic AN6250 Digital Radiology System, focusing on acceptance criteria and study information:
Based on the provided 510(k) summary for the Analogic AN6250 Digital Radiology System, there is no detailed information provided regarding specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.
The summary focuses on demonstrating substantial equivalence to a predicate device (Analogic AN6150 Digital Radiology System) based on similar design and technological principles. The "tests" mentioned are primarily non-clinical, related to safety, electromagnetic compatibility, mechanical integrity, and compliance with voluntary standards for medical electrical equipment.
Therefore, many of the requested details about a clinical performance study using a test set, ground truth, experts, etc., are not present in this document.
Here's a breakdown of what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical Performance: No specific clinical performance criteria (e.g., sensitivity, specificity, image quality metrics relevant to diagnostic accuracy) are stated. | Not applicable - no clinical performance study results are reported for the AN6250 in this document. |
| Safety: Compliance with IEC 60601-1 and related collateral standards for medical electrical equipment. | "The AN6250 Digital Radiology System will be thoroughly validated at the unit and system level to meets all elements of its Requirements Specification. This includes the following non-clinical tests: IEC 60601-1:1988, +A1:1991, +A2:1995, IEC 60601-1-1, IEC 60601-1-3:1994, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32." (Implies compliance, but no specific performance metrics are given). |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | "IEC 60601-1-2:2001, an FDA recognized consensus standard for electromagnetic compatibility." (Implies compliance, but no specific performance metrics are given). |
| Environmental/Mechanical Robustness: Withstand line dropout, voltage variations, mechanical shock, vibration, and transportation. | "Line Dropout and Variation Susceptibility were tested according to the FDA Reviewer Guidance for premarket Notification Submissions, November 1993." "Mechanical Shock and Vibration Tests." "Shipping Container Transportation Test." (Implies successful completion, but no specific performance metrics are given). |
| Image Availability: Images available for preview within seconds. | "Images from the AN6250 Digital Radiology System are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure." (This is a functional requirement, not a performance metric like diagnostic accuracy). |
Regarding a "study that proves the device meets the acceptance criteria":
The document refers to "thorough validation at the unit and system level to meets all elements of its Requirements Specification" which includes the listed non-clinical tests. This implies a series of engineering and quality assurance tests rather than a clinical study evaluating diagnostic performance. The primary "proof" sought by the 510(k) pathway is substantial equivalence to a predicate device, not necessarily a de novo clinical efficacy study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a clinical test set or data for evaluating diagnostic performance. The "tests" mentioned are non-clinical hardware/software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No clinical ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set adjudication 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. This is not an AI-assisted device. It's a digital radiology system (hardware and associated software for image acquisition and display). Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / No. The device is a complete X-ray system, not a standalone algorithm. Its performance is tied to the entire system (image acquisition, processing, display).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided for clinical performance. For the non-clinical tests, the "ground truth" would be established engineering specifications and industry standards (e.g., a device must operate within specified voltage ranges, or external radiation leakage must be below a certain limit as defined by IEC standards).
8. The sample size for the training set
- Not applicable / Not provided. This is not a machine learning/AI device that undergoes "training."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set for an AI/ML algorithm is mentioned.
Summary:
The provided 510(k) summary for the Analogic AN6250 Digital Radiology System is focused on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with non-clinical safety and performance standards. It does not contain information about clinical performance studies, diagnostic accuracy metrics, or the use of AI/ML algorithms. The "acceptance criteria" are predominantly related to engineering specifications and regulatory compliance for medical devices, rather than clinical efficacy.
§ 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.