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These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic ratiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the pationi sitting, standing, or lying in the prone or supine position.

This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a U-Arm suspension along with a generator, generator control, and a mobile patient table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. 64 kw is the standard size. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10s. The system is provided with a digital imaging detector, either the QXR16 or the QXR9 CCD Image Detector and Acquisition Workstation. This device represents the interconnection of two already cleared devices: The X-ray system and the digital detector system.

The provided text describes a 510(k) submission (K082261) for the DX800 & DX808 Digital Diagnostic Radiographic Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with strict acceptance criteria.

Therefore, the submission does not contain the detailed clinical study information typically associated with establishing specific performance criteria and device performance as might be seen for novel devices. Instead, it relies on demonstrating that the new device is as safe and effective as existing predicate devices.

Here's a breakdown of the information given in the document, formatted to address your request as much as possible, along with explanations for missing sections where the document does not provide the requested detail:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating substantial equivalence to existing predicate devices based on technical specifications and safety standards, rather than clinical performance metrics (like sensitivity, specificity, or reader agreement).

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is the 510(k) submission itself and the associated testing summarized within it. The document states: "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of dxRAD that the DX800 & DX808 Digital Diagnostic Radiographic Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

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

• Sample Size for Test Set: Not applicable or not specified in this type of submission. This 510(k) is based on technical comparisons and bench/laboratory testing, not a clinical study with a "test set" of patient data in the typical sense for evaluating diagnostic accuracy.
• Data Provenance: Not applicable or not specified. This document does not refer to clinical patient data from a specific country or whether it was retrospective/prospective. The testing mentioned is "bench and test laboratory" and "external laboratory testing."

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

• Number of Experts: Not applicable. As this relies on technical equivalence, there is no mention of human experts establishing ground truth for a clinical test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this submission.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in this submission. This 510(k) does not present evidence from such a clinical study.
• Effect Size: Not applicable.

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

• Standalone Performance: Not explicitly detailed in the context of an "algorithm only" performance. The device is a complete X-ray system. The performance is assessed against standards and predicate devices for the system's output and safety, not a standalone algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" used is primarily compliance with established performance standards (e.g., 21 CFR 1020.30, IEC-60601), technical specifications of predicate devices, and bench/laboratory test results demonstrating that the device functions as intended and is comparable to its predicates in terms of safety and effectiveness. There is no mention of clinical ground truth like pathology or outcomes data in this document.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document does not describe the development or training of an AI algorithm or model. The device is a hardware system.

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

• Ground Truth for Training Set: Not applicable. As no AI algorithm training is described, there's no mention of a training set or its ground truth establishment.

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