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Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field.

A disposable reflective marker sphere consists of two bonded half spheres and a screw part that is cut in the lower sphere. An adhesive combines the upper and lower half spheres. The raw sphere is covered with a defined retro-reflective foil.

The provided text describes a 510(k) summary for the "Disposable Reflective Marker Spheres" by BrainLAB AG. This document outlines the device's intended use, description, and states that it has been verified and validated. However, it does not detail specific acceptance criteria for performance, nor does it present the results of a study designed to prove the device meets such criteria with quantitative metrics.

The document focuses on substantial equivalence to a predicate device (Cranial Image Guided Surgery System K082060) rather than a direct performance study against a predefined set of acceptance criteria for the "Disposable Reflective Marker Spheres" themselves.

Here's an attempt to answer your questions based only on the provided text, highlighting what is not available:

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

• Crucial physical properties (e.g., Impact resistance, homogeneous retroreflectivity, shelf life)
• Sterile Packaging
• Sterilization
  The document states "Objective evidence specifications conform with user needs and intended use has Objective onload that acture research, comparison with previously marketed devices and the results of a clinical evaluation." However, no specific performance data or numerical results are provided. |

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

• Sample size: Not specified.
• Data provenance: Not specified. The document mentions "comparison with previously marketed devices and the results of a clinical evaluation," but no details about the methods, sample sizes, or nature (retrospective/prospective) of these evaluations are provided for the "Disposable Reflective Marker Spheres."

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/Not specified. The document focuses on physical properties and claims of substantial equivalence rather than a diagnostic performance study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 physical marker sphere, not an AI or diagnostic tool that would typically involve human readers.

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

• Not applicable. This device is a physical marker sphere.

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

• Not applicable. The "ground truth" for this device would likely be adherence to engineering specifications and performance in tracking systems, rather than a clinical ground truth. The document alludes to "specifications conform[ing] with user needs and intended use."

8. The sample size for the training set

• Not applicable. This device is a physical marker sphere, not a machine learning algorithm that requires a training set.

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

• Not applicable.

Summary of missing information:

The provided document is a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence to a predicate device. It primarily lists verification and validation activities at a high level. It does not provide detailed performance data, specific quantitative acceptance criteria, study methodologies (like sample sizes, expert involvement, or adjudication methods), or the results of comparative effectiveness studies that would be typically found for diagnostic AI devices. The verification activities mentioned ("Impact resistance, homogenous retroreflectivity, shelf life," "Sterile Packaging," "Sterilization") imply that internal testing was conducted against company specifications, but these specifications and their results are not detailed in this summary.

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