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The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors.

The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors.

The PSD consists of several small (1-4) sensors on cables connected to a display unit. The sensors can be placed anywhere on the body and will leave a minimal footprint on the X-Ray image.

The 1-4 sensors can independently measure dose. The PSD has two keys, ON/OFF and SELECT. The SELECT key is used to step through measured values and to enter software menus. An audio-visual 4 level warning system indicates to the user when specific dose levels are reached.

The PSD is provided non-sterile and is not programmable. Thus, there is no software to be concerned with.

Accessories that can/may accompany the PSD are an aluminum holder to hold the PSD to a patient side rail and a hard case to protect the PSD during shipping and storage. These are the only two accessories.

The provided text is a 510(k) summary for the Unfors Patient Skin Dosimeter (PSD). It describes the device, its intended use, and compares it to a legally marketed predicate device (Skin Dose Monitor, SDM). However, the document does not contain information about acceptance criteria, detailed study design, or performance metrics that would typically be found in a study demonstrating the device meets specific acceptance criteria. This summary is primarily focused on establishing substantial equivalence to a predicate device for regulatory clearance.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy, precision, error margins) or report specific performance values from a study against such criteria. The submission is a 510(k) summary, which generally focuses on substantial equivalence rather than detailed performance study results.

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

• Cannot be provided. The document does not describe any specific test set, its sample size, or data provenance. It mentions "The PSD is provided non-sterile and is not programmable. Thus, there is no software to be concerned with," and focuses on comparison to a predicate device. There is no performance study described.

3. 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)

• Cannot be provided. No ground truth establishment is described as there is no performance study detailed in this summary.

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

• Cannot be provided. No adjudication method is described as there is no performance study detailed.

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

• Cannot be provided. This device is a passive dosimeter, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

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

• Cannot be provided. This device is a hardware dosimeter, not an algorithm, so a standalone algorithm performance study is not applicable.

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

• Cannot be provided. No ground truth is described. Performance for dosimeters is typically evaluated against calibrated radiation sources or reference dosimetry standards, rather than expert consensus, pathology, or outcomes data. However, the details of such testing are not in this summary.

8. The sample size for the training set

• Cannot be provided. This device is a hardware dosimeter developed by Unfors Instruments, Inc., not an AI algorithm requiring a training set.

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

• Cannot be provided. Not applicable, as detailed above.

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