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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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Models SP-HF-2.8 and SP-HF-4.0 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.

Models SP-HF-2.8 and SP-HF-4.0 are a portable units which operate from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be either mounted to a tripod or support arm or can be hand held.

The provided document describes the safety and effectiveness summary for two portable X-ray units, Models SP-HF-2.8 and SP-HF-4.0. The study's acceptance criteria are implicitly defined by demonstrating substantial equivalence to a predicate device, the MinXray HF100H.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood to be that the new devices (Models SP-HF-2.8 and SP-HF-4.0) perform as safely and effectively as the predicate device (MinXray HF100H) and present no new indications for use or significant technological differences that would raise new questions of safety or effectiveness. The document achieves this by comparing technical specifications and intended use.

Note: For the physical and operational characteristics (Size, Weight, Energy Source, User Interface, Exposure times, Ma., KvP), the acceptance criteria are not explicitly stated as strict numerical equivalence. Instead, "substantial equivalence" is being claimed, meaning the differences are not considered to raise new questions of safety or effectiveness. The new devices often show improvements (e.g., wider range of mAs/kVp, lower weight) or minor variations that are deemed acceptable and within the scope of the predicate device's intended use.

2. Sample size used for the test set and the data provenance

The document states that "bench and user testing" was performed. However, there is no specific sample size provided for the test set. The data provenance (country of origin, retrospective/prospective) is also not specified.

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

The document mentions "user testing" but does not specify the number or qualifications of experts used to establish ground truth. Given the nature of the device (portable X-ray unit) and the era of the submission, "user testing" likely refers to evaluations by technicians or qualified medical personnel regarding the device's operational aspects and image acquisition capabilities rather than diagnostic interpretation.

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

The document does not describe any adjudication method for establishing ground truth from the "user testing."

5. 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 MRMC comparative effectiveness study was done or reported. This device is a portable X-ray unit, not an AI-powered diagnostic tool. The comparison is between the new X-ray unit and a predicate X-ray unit, focusing on technical specifications and overall safety/effectiveness in producing images, not on human reader performance or AI assistance.

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

No standalone algorithm performance study was done or reported. This is a hardware device for image acquisition, not a software algorithm.

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

The concept of a "ground truth" as typically applied to diagnostic performance studies (e.g., pathology, expert consensus on disease presence) is not applicable or described in this 510(k) summary. The "ground truth" for this submission revolves around the technical performance metrics of the X-ray unit (e.g., kVp, mA, exposure times, safety standards) and whether it can produce diagnostic-quality images, implicitly judged during "user testing." The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device based on its technical specifications and intended use.

8. The sample size for the training set

Not applicable. This submission is for a medical device (X-ray unit) that does not involve machine learning or AI algorithms requiring a training set in the typical sense.

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

Not applicable. As stated above, this device does not utilize a training set.

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