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Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum's position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

The Radlink® GPS Pro Imaging is an image processing software designed to assist orthopedic surgeons in positioning hip, knee, and trauma components. The software leverages advanced geographic measurement and stitching technologies, which have been previously FDA cleared, ensuring precise and reliable image handling. These foundational technologies continue to be the primary features of software. Additionally, Radlink GPS Pro Imaging software supports complete image acquisition and DICOM transmission capabilities, facilitating seamless integration with existing hospital systems. It is compatible with Windows operating system, and requires minimal hardware specifications, making it a versatile solution for different clinical setups.

The provided text describes the Radlink GPS Pro Imaging device and its substantial equivalence to predicate devices, but it does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria with statistical significance.

The "Performance Data" section ([6]) states: "Comprehensive cybersecurity testing and software verification activities were conducted in accordance with applicable FDA guidance and recognized standards. These assessments confirm that the device's software meets the required performance, safety, and security criteria." However, it does not specify what those "required performance... criteria" are in quantifiable terms, nor does it provide a study with specific results.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be gathered and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document vaguely states "required performance... criteria" but does not define them or report specific device performance metrics against these criteria.

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

Not available in the provided document. No information is given regarding the sample size of any test set or the provenance of the data (e.g., country of origin, retrospective/prospective).

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

Not available in the provided document. There is no mention of experts or how ground truth might have been established for a test set.

4. Adjudication Method for the Test Set

Not available in the provided document. The document does not describe any adjudication methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not available in the provided document. The document does not mention an MRMC study or any effect size for human reader improvement with AI assistance. The "Indications for Use" section ([3]) explicitly states, "Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation." and "The software is not for use on mobile phones.", which suggests it is an assistive tool, but no comparative study is detailed.

6. Standalone Performance Study

Not available in the provided document. While "software performance, segmentation accuracy" are mentioned as being tested ([6]), no specific standalone performance study results, metrics, or methods are provided. The statement that "Clinical judgment and experience are required to properly use the software" ([3]) reinforces that it's not intended for standalone interpretation.

7. Type of Ground Truth Used

Not available in the provided document. The document broadly states "segmentation accuracy" was part of testing ([6]), implying some form of ground truth for segmentation, but the specific type (e.g., expert consensus, pathology, outcome data) is not detailed.

8. Sample Size for the Training Set

Not available in the provided document. The document does not provide any information about a training set or its size.

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

Not available in the provided document. As there is no information about a training set, the method for establishing its ground truth is also not provided.

In summary, the provided FDA 510(k) clearance letter and summary discuss the device's function, intended use, and its substantial equivalence to predicate devices, but they do not disclose the detailed technical performance data, acceptance criteria, or study methodologies that would typically be found in a full submission or scientific publication. The document focuses on regulatory compliance and the claim of substantial equivalence rather than explicit performance metrics and supporting study details.

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Radlink GPS is intended for digital image capture use in general radiographic examinations, whenever conventional screen-film systems may be used. Radlink GPS allows imaging of the pelvis, knee, skull, chest, shoulder, spine, abdomen and extremities. The digital images are transmitted from the panel or from a connection to PACS via computer networks or from a video input port to a personal computer (PC) where they may be displayed, processed, altered, overlaid with templates, compressed for archiving or transmission via computer networks to other medical facility sites. Not for mammography.

The Radlink GPS system represents the straightforward integration of digital x-ray receptor panels with their own FDA 510(k) clearance and our acquisition software that has been previously cleared by the FDA for use with our Radlink CR-Pro Solid State X-ray Imager (K052938) and Radlink LaserPro-16 (K020243). The Radlink GPS is compatible with the following digital x-ray receptor panels:

• . Vieworks VIVIX-S (K120020) and VIVIX-S Wireless (K122865)
• . Trixell Artpix Mobile EZ2GO with portable PIXIUM 3543EZ (K110849)
• -Perkin Elmer XRpad 4336 MED (K140551)
  Radlink GPS is a Digital Radiography (DR) system, featuring an integrated flat panel digital detector (FPD). Radlink GPS is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operations of the Radlink CR Pro acquisition software and PACS were not changed. The digital copies are transmitted to an internal personal computer (PC) where they may be displayed, processed for archiving or transmission via computer networks to other medical facility sites. Images can be rotated, flipped, coomed, window level, overlaid and annotated (markers, text, freestyle, line distance measurements, angles). Digital images may be received via the flat panel digital detector (FPD), from a connection to PACS via computer networks or from a video input port.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Radlink GPS device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets for performance metrics (e.g., sensitivity, specificity, image quality scores). Instead, the "acceptance criteria" appear to be implicit in demonstrating that the device is "as safe and effective as products currently legally for sale in the USA" and "substantially equivalent to predicate devices."

The reported device performance primarily focuses on functionality, safety, and diagnostic quality rather than specific quantitative performance metrics.

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

• Test Set Sample Size: The document states that "Human images were obtained from each of the panels." It does not specify the exact number of human images or cases used for this review.
• Data Provenance: Not explicitly stated. Given the context of seeking FDA clearance in the USA, it's likely the images were acquired in a medical setting, possibly in the USA, but no specific country or retrospective/prospective nature is mentioned.

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

• Number of Experts: "a Board Certified Radiologist." (Singular)
• Qualifications of Experts: "Board Certified Radiologist." No specific number of years of experience is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "reviewed by a Board Certified Radiologist." There is no mention of multiple readers or an adjudication process (e.g., 2+1, 3+1). The assessment appears to be a single-reader evaluation.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence primarily through functional comparison, technical performance verification, and a limited clinical review by a single radiologist. There is no mention of comparing human readers with and without AI assistance. The device itself is an image acquisition and processing system, not an AI diagnostic aid.

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

• Standalone Performance: The Radlink GPS is a digital radiography system, not an AI algorithm in the context typically discussed for standalone performance (e.g., detecting disease). Its "performance" is inherently linked to image acquisition and display. The "algorithm" here refers to the acquisition and processing software, and its standalone performance is tested through aspects like "conformance to its defined specifications" using phantoms, software validation, and DICOM compatibility. While not referred to as "standalone AI performance," the non-clinical testing and software validation serve a similar function for the core components of the system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the diagnostic quality assessment was based on expert consensus (from a single Board Certified Radiologist) who evaluated the human images and found them to be of "good diagnostic quality." For other aspects like image acquisition and technical specifications, the ground truth was based on physical measurements (e.g., gray-scale wedge, line resolution phantom) against predefined technical standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable in the context of this submission. The Radlink GPS is described as an integration of existing cleared components (digital panels and acquisition software that was previously cleared). It is not an AI/machine learning model that undergoes a distinct "training phase" on a dataset in the way a diagnostic algorithm would. The software was previously cleared (K052938, K020243), implying its development and validation occurred prior to this submission.

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

• Ground Truth for Training Set: Not applicable. As mentioned above, this is an integration of pre-cleared components, not a new AI algorithm requiring a dedicated training set and associated ground truth establishment for that training. The development and validation of the constituent software and hardware components would have involved their own respective "ground truths" at the time of their original clearance.

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