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Indications for Use: Sedecal Portable X-Ray Units with Detector are 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.

SPS-HF-4.0-D Portable X-ray Unit with Detector is a portable unit which operate from 120 V 50-60~ AC. The unit utilizes a high frequency inverter mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G.

The provided text describes a 510(k) summary for the SEDECAL SPS-HF-4.0-D Portable X-ray Units with Detector. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria are not directly applicable or explicitly detailed in the provided document, as the submission relies on the established safety and effectiveness of the predicate devices.

However, I can extract the relevant information where available and note when the information is not present or not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices in terms of intended use, safety, and effectiveness.

The "reported device performance" is a comparison of characteristics to the predicate devices.

Note: The term "SAME" in the table for "reported device performance" refers to being the same as or comparable to the predicate devices, which is the basis for substantial equivalence. The specific resolution is from the Canon CXDI-50G predicate, which the combined device utilizes.

Study Details (Based on the provided document)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench, user, and standards testing data, it is the conclusion of Sedecal that the Sedecal Portable X-ray Units with Detector are as safe and effective as the predicate devices..."
   • No specific sample size for a "test set" from a clinical performance study is mentioned. The "tests" refer to bench testing, user testing (which might involve testing the combined user interface and functionality), and compliance with standards.
   • Data provenance is not specified. These are likely internal company tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not specified. This document is not a clinical study report that establishes ground truth for a test set based on expert review. It's a 510(k) summary focused on substantial equivalence.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable / Not specified. As no clinical "test set" requiring ground truth establishment or adjudication is described, this information is not present.

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 not an AI-assisted device, and no MRMC study is mentioned. This is a submission for a combined X-ray unit (hardware and controlling software).

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

   • No. This is a hardware device with associated control software, not an algorithm being tested in a standalone capacity. Its performance is intrinsically linked to its intended use by a human operator.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not applicable / Not specified. The validation focuses on comparison of technical specifications and compliance with safety standards rather than diagnostic ground truth in a clinical performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

7. The sample size for the training set

   • Not applicable. This submission describes a medical device (X-ray unit), not a machine learning algorithm that requires a "training set."

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

   • Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

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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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The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF) 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 "Easy Moving"M" Mobile X-ray Unit (Model SM-HF)" is a mobile unit which operates from 120 V 50-60~ AC or batteries. 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 base unit housing the high voltage generator and controls and a turnable arm with rotatable tube head. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design "Easy Moving™™ Mobile X-ray Unit is a low-cost radiography system which takes up little space and is quick to set up and operate.

The provided text describes a 510(k) premarket notification for a mobile X-ray unit. Rather than detailing acceptance criteria and a study proving the device meets them in the traditional sense of a clinical trial with performance metrics, this submission is focused on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission doesn't present a table of acceptance criteria in terms of specific performance thresholds for diagnostic accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly defined by the characteristics and performance of the predicate device, the IROM IMAGING, INC MXR-2000 MOBILE X-RAY UNIT (K010304). The "performance" of the new device is its similarity to the predicate.

The core acceptance criterion is that the new device is "as safe and effective" and "substantially equivalent" to the predicate device. The performance is reported as meeting or exceeding these equivalency standards for the specified characteristics.

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

The document mentions "bench and user testing" but does not specify a sample size for either. There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. Given the nature of a substantial equivalence claim for an X-ray unit, the "ground truth" for comparative effectiveness would likely involve expert evaluation of image quality or overall clinical utility, but no details are given.

4. Adjudication Method for the Test Set

The adjudication method is not specified.

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

There is no mention of an MRMC comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. This submission pertains to an X-ray hardware device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable/not provided. The device is an X-ray unit, not an algorithm. Therefore, a standalone algorithm performance study was not conducted or reported.

7. Type of Ground Truth Used

The type of "ground truth" used for evaluation is not explicitly stated. However, considering "bench and user testing" was performed, the ground truth would likely be based on:

• Technical specifications conformance: Ensuring the device meets relevant electrical and radiation safety standards (e.g., 21 CFR 1020.30, UL standards, IEC standards).
• Qualitative assessment of image quality: During "user testing," qualified personnel (doctors or technicians) would evaluate the diagnostic quality of images produced by the new device in comparison to images from the predicate device. This would implicitly form the "ground truth" for functionality and diagnostic utility.

8. Sample Size for the Training Set

This information is not applicable/not provided. The submission is for a medical device (X-ray unit), not a machine learning algorithm that requires a training set.

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

This information is not applicable/not provided as there is no training set for an algorithm.

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