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The Surface Applicator Set is intended for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR Brachytherapy.

The Surface Applicator Set is an applicator for Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The provided text describes a 510(k) premarket notification for a medical device called the "Surface Applicator Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or superiority through extensive clinical trials. As such, the information you've requested regarding detailed acceptance criteria, study methodologies, expert qualifications, and specific performance metrics often associated with AI/ML device evaluations or new clinical indications is not explicitly available in this document.

Here's an analysis based on the provided text, addressing your points where possible, and noting when information is absent:

1. A table of acceptance criteria and the reported device performance

The document states: "Bench testing was performed to evaluate the suitability of the applicator sets repeated use for up to 500 times and 100 cleaning cycles. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating that the device performs as intended."

This indicates that acceptance criteria were pre-defined, but the actual numerical values or specific performance metrics are not provided in the summary. For example, it might have involved acceptable levels of wear, deformation, or structural integrity after repeated use/cleaning, but these details are not disclosed.

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

The document mentions "Bench testing." For bench testing of physical devices, the "sample size" typically refers to the number of units tested. This specific number is not provided. The data provenance would be a laboratory setting, not patient data, so "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical data.

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)

This information is not applicable and therefore not provided. Since this is a physical medical device (applicator) for brachytherapy and the testing was "bench testing" focusing on mechanical and material integrity (repeated use, cleaning cycles), there is no "ground truth" established by medical experts in the way it would be for an AI diagnostic device. The acceptance criteria would likely be engineering specifications.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation of medical images or patient outcomes, which is not what was performed here.

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

This information is not applicable and therefore not provided. The device is a physical applicator, not an AI or imaging device that involves human readers or AI assistance. No MRMC study was conducted.

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

This information is not applicable and therefore not provided. This device is a physical applicator, not an algorithm.

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

As explained in point 3, the concept of "ground truth" as typically discussed for diagnostic or AI devices is not applicable to the bench testing of this physical applicator. The "ground truth" here would be the engineering specifications and performance requirements derived from the device's intended use and design, verified through controlled laboratory testing.

8. The sample size for the training set

This is not applicable and therefore not provided. The device is a physical product, not a software algorithm that requires a training set.

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

This is not applicable and therefore not provided. As above, there is no training set for this physical device.

In summary: The provided document is for a 510(k) premarket notification for a physical medical device (a brachytherapy applicator). The regulatory pathway focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing. Consequently, the detailed clinical study information, expert ground truth establishment, and AI-related metrics you've inquired about are generally not part of such submissions and are therefore not present in this document. The "performance data" section explicitly states "No clinical tests have been included in this pre-market submission."

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The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy.

The Surface Applicator Set with Leipzig-style Cone is a Brachytherapy applicator set. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumour to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.

The provided text describes a 510(k) submission for a medical device, the "Surface Applicator Set with Leipzig-style Cone," used for brachytherapy. The submission focuses on demonstrating substantial equivalence to a predicate device and includes details about non-clinical testing.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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

The text mentions "Non Clinical Tests Bericht Testing has been performed" which refers to bench testing. There is no information provided about a "test set" in the context of patient data, clinical studies, or country of origin. The testing described is entirely physical and functional testing of the device itself.

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)

Not applicable. This device is not an AI/diagnostic device that requires expert opinion to establish ground truth for a test set. The acceptance criteria relate to engineering and functional performance, verified through bench testing.

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

Not applicable. As noted above, this device did not involve patient data or readings that would require an adjudication method.

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. This device is an applicator set for brachytherapy, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant and was not performed.

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

No. This device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not applicable.

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

For the non-clinical tests, the "ground truth" was established by engineering specifications, design requirements, and relevant international standards (e.g., IEC 62366:2007). For example, the "accuracy required" for source location would be defined by the design and safety specifications for brachytherapy devices.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. As above, this device does not involve AI or machine learning algorithms, so there is no training set and no ground truth for a training set.

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