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The Target Positioner (TaPo) is used to position the patient for the stereotactic radiotherapy/radiosurgery.

The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.

The Target Positioner is a non-invasive mechanical device that consists of an aluminum frame and four Target Positioner Carrier Plates made of transparent plastics.

In order to ensure a rigid fixation to different types of Headring respectively to the BrainLAB Mask System, various Target Positioners with adapted interface specifications are provided. The Target Positioner enables alignment of the planned patient's treatment isocenter with the LINAC Isocenter.

Prior to the treatment the Target Positioner has to be removed.

The usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.

The provided documentation is a 510(k) summary for the BrainLAB Target Positioner. It describes the device, its intended use, and states that its safety and effectiveness have been "verified and validated according to BrainLAB's procedures for product design and development." It concludes that the device is "substantially equivalent" to a predicate device.

However, the document does not include specific acceptance criteria, detailed study results, or the other specific pieces of information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, details of standalone or MRMC studies, training set information, or ground truth establishment). Instead, it makes a general statement about validation and substantial equivalence.

Therefore, I cannot extract the specific information you requested from the provided text.

Based on the information provided, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: The document generally states, "The validation proves the safety and effectiveness of the system." No specific performance metrics (e.g., accuracy, precision) or numerical results are provided.

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

• Not specified. The document only mentions "validation" without detailing the study methodology or the data used.

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

• Not applicable/Not specified. The document does not describe the use of experts for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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:

• Not applicable. This device is a mechanical positioning device, not an AI-assisted diagnostic or interpretation tool. The concept of "human readers improving with AI" does not apply here.

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

• Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used:

• Not specified. The document only refers to "validation" in general terms.

8. The sample size for the training set:

• Not applicable/Not specified. (This would typically apply to machine learning algorithms, which this device is not).

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

• Not applicable/Not specified.

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