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The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremties and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system. The system has been designed for indoor usage. It is intended for qualified medical persomel or operators who have been trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography.

SKANRAD 400 is a high frequency radiography system with 32kW generator X-Ray power. It can be used with table (recumbent position) as well as chest stand (standing position) for general radiography purpose. Electronic circuits incorporated for control, user interface, feedback circuits to ensure accuracy & reproducibility of X-Ray output. lt consists of:

1. Tube head and collimator assembly
2. Floating table assembly
3. Chest stand assembly
4. HV generator assembly
   SKANRAD 400 can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software.

The provided FDA 510(k) summary for the SKANRAD 400 describes performance testing for substantial equivalence to a predicate device, rather than explicit acceptance criteria for a new clinical indication or capability. The document focuses on demonstrating that the SKANRAD 400 X-ray system is as safe and effective as the predicate device (RADspeed Fit K173517) through non-clinical performance data and compliance with relevant standards.

Therefore, the response will interpret "acceptance criteria" as the performance aspects and standards the device must meet to demonstrate substantial equivalence, as indicated in the provided text.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for an X-ray system demonstrating substantial equivalence, the "acceptance criteria" are implied by the comparison to the predicate device and adherence to industry standards, rather than specific performance metrics for a novel clinical function. The reported device performance is primarily a statement of compliance with these standards and the successful validation of its components.

• IEC 60601-1 Ed. 3.1 (2012)+EN 60601-1:2006+A1:2013+A12:2014 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (EMC)
• IEC 60601-1-3:2008 + A1:2013 (Radiation protection)
• IEC 60601-2-54 Ed. 1.2 2018-06 (X-ray equipment for radiography and radioscopy)
• IEC 60601-2-28:2017 (X-Ray tube assemblies)
• IEC 60601-1-6:2010/AMD1:2013 (Usability)
• IEC 62304:2006+A1:2015 (Software Life-Cycle processes)
• ISO 10993-1:2018 (Biological evaluation of medical devices)
• ISO 14971:2007 (Application of risk management)
  "The risks identified during risk analysis were reduced by applying suitable risk control measures and it was noted that there were no unacceptable risks after risk control measures."
  "Design verification, design validation and performance testing activities have been documented and indicate that the subject device is as safe and effective as the predicate device." |
  | Compatibility with Image Receptors | The device was tested and verified with Varex PaxScan 4336W v4 (K161459) and Varex PaxScan 4343RC (K172951) flat panel detectors and DROC image acquisition software (K130883) to meet required performance. The validation activity for the detector and software with SKANRAD 400 has been performed and documented. |
  | Biocompatibility | Materials of both floor table and chest stand are evaluated for biocompatibility. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set or data provenance in the context of a clinical performance study using patient data. The "tests" mentioned are primarily engineering verification and validation activities against standards and functional comparisons with the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As noted above, there was no clinical test set requiring expert ground truth establishment for a diagnostic output. The study focused on engineering performance and substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document states: "As per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices document, subject device does not have major difference when compared to the predicate device. Considering this, non-clinical data is sufficient to support the safety and performance of SKANRAD 400. Hence clinical studies are not required."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. The SKANRAD 400 is an X-ray generation system, not an AI algorithm for diagnostic interpretation. Its performance is related to generating X-rays and imaging capabilities, not standalone algorithmic interpretation.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic performance (e.g., pathology, outcomes data). The "ground truth" implicitly used in this 510(k) submission relates to established engineering standards for X-ray devices and the performance characteristics of the legally marketed predicate device (K173517). The performance tests would verify that the device meets its design specifications and standard requirements.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device requiring a training set.

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