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The "Optima URS" Universal Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The "Optima URS" is a stationary unit which operates from 120 V 50-60~ AC. Optima URS is a universal swivel arm X-ray system. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a floor-to wall column and a turnable arm with variable high center. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design Optima URS is a low-cost radiography system which takes up little space and is quick to install.

The provided text describes a 510(k) premarket notification for the "Optima URS" Universal Radiographic System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a detailed study on diagnostic accuracy or clinical outcomes.

The "study" that proves the device meets its "acceptance criteria" here is the bench and user testing conducted to show substantial equivalence to the predicate device, the Siemens Multix Stationary X-Ray System (K001201). The acceptance criteria are primarily related to safety, operational performance, and intended use as compared to this predicate.

Here's an analysis based on the information provided:

Description of Acceptance Criteria and Device Performance

The acceptance criteria for the "Optima URS" Universal Radiographic System are defined by its substantial equivalence to the Siemens Multix Stationary X-Ray System (K001201). The key deemed "acceptance criteria" and the device's reported performance are summarized below:

Table of Acceptance Criteria and Reported Device Performance

Conclusion from the Submission: "After analyzing both bench and user testing data, it is the conclusion of Sedecal USA that the 'Optima URS' Universal Radiographic System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

Study Details to Prove Acceptance

The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence. The "study" referenced in the document is "bench and user testing."

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify a numerical sample size for either the "bench" or "user testing." This type of submission typically involves engineering evaluations and potentially limited clinical feedback rather than large-scale clinical trials with specific patient sample sizes.
   • Data Provenance: Not explicitly stated, but the manufacturer is SEDECAL SA (Spain) with an initial importer in the USA. The "bench testing" likely occurred at the manufacturer's facility. "User testing" could imply testing by qualified personnel in a simulated or real clinical environment, but details are not provided. The data is retrospective in the sense that it supports a premarket notification for an existing design.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention a ground truth established by experts for a test set in the context of diagnostic accuracy. The "user testing" likely evaluated system usability, functionality, and image quality from a technical perspective, not diagnostic performance tied to a "ground truth" of disease presence/absence.

3. Adjudication method for the test set:

   • Not applicable as there is no mention of a diagnostic accuracy test set requiring adjudication of findings.

4. 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 an X-ray system, not an AI-powered diagnostic tool. MRMC studies or AI assistance effect sizes are not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is an X-ray system, not an algorithm. Standalone algorithm performance is not applicable.

6. The type of ground truth used:

   • Not applicable for diagnostic accuracy. The "ground truth" in this context relates to meeting engineering specifications, safety standards, and functional equivalence to the predicate device.

7. The sample size for the training set:

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

8. How the ground truth for the training set was established:

   • Not applicable.

Summary of the "Study" and its limitations for diagnostic claims:

The "study" consists of "bench and user testing." This testing was sufficient to conclude that the "Optima URS" is "as safe and effective as the predicate device" in terms of its mechanical, electrical, and radiation generation aspects. The acceptance criteria here are functional and safety equivalency to a legally marketed device, not specific quantitative diagnostic performance metrics like sensitivity, specificity, or AUC against a clinical "ground truth." The 510(k) pathway specifically seeks to avoid the need for extensive clinical trials when substantial equivalence can be demonstrated.

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