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The Galaxy Plus Digital Radiography System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

The digital diagnostic x-ray system consists of a generator, a tube, an x-ray console, a beam limiting device, an image receptor, a u-arm stand and software. The digital panels supplied are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. Product features: This system is designed to maintain the alignment between a tube and the image receptor, regardless of the angle on the image receptor or image tilt positions. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on patients. Its flexibility makes the system ideal for all patient examinations including the standing, sitting and lying patient positions.

The provided 510(k) summary for K132921 describes the Galaxy Plus Digital Radiography System.

Here's an analysis based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, resolution targets) for the device. Instead, the primary acceptance criterion appears to be demonstrated substantial equivalence to the predicate device (DRGEM Corporation's DIAMOND-5A, 6A, 8A, K102408) through non-clinical and clinical testing, and the ability to produce images of "good diagnostic quality."

Given this, the table would look like this:

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

• Sample Size: The document does not specify a numerical sample size for the clinical test set (i.e., the number of patients or images). It vaguely states "Clinical images for all four panels were obtained."
• Data Provenance: Not explicitly stated (e.g., country of origin). It states the images were obtained "in accordance with the FDA Guidance Document on Solid State Imaging Devices," implying they met U.S. regulatory standards for data collection, but no further details on location or retrospective/prospective nature are provided. It is likely retrospective or a limited prospective case series given the summary nature.

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

• Number of Experts: Not specified. The document states "They were evaluated by board certified radiologist." This could imply one or more radiologists.
• Qualifications: "board certified radiologist." The experience level in years is not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1, none). It simply states the images "were evaluated by board certified radiologist." This suggests either independent evaluations or a consensus approach, but the specific process is not detailed.

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

No. The document does not mention an MRMC study. The comparison is primarily against the predicate device's technological characteristics and the general standard of "good diagnostic quality" for radiographic images, rather than a comparative effectiveness study with human readers.

6. Standalone Performance

Yes, a standalone evaluation was performed. The clinical images generated by the algorithm/system only (i.e., the Galaxy Plus Digital Radiography System itself) were evaluated by radiologists for their diagnostic quality. This evaluation was independent of human interpretation improvements; it assessed the quality of the raw output from the device.

7. Type of Ground Truth Used

The ground truth used for the clinical evaluation was expert consensus/evaluation by "board certified radiologist[s]" who determined the images were of "good diagnostic quality." There is no mention of pathology, outcomes data, or other objective measures of truth. For a diagnostic imaging device like an X-ray system, "good diagnostic quality" determined by an expert is a common form of ground truth for substantial equivalence.

8. Sample Size for the Training Set

The document does not mention a "training set" or provide any sample size for training. This device is a digital radiography system, not an AI/ML algorithm that typically requires a large training set in the way a diagnostic AI would. The software components are an update of previously cleared software (K093816), implying its core functionality was already established. The emphasis is on the image acquisition hardware and its ability to produce images.

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

As no training set is mentioned in the context of this 510(k) summary (because it's not a de novo AI/ML solution), the method for establishing ground truth for a non-existent training set is not applicable here. The software is an update of a previously cleared version, suggesting its underlying principles and performance were evaluated during its initial clearance (K093816).

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