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Sterile Radiolucent Skull Pins are designed for the fixation of a compatible head-holder unit to the patient's skull. This allows the fixation of the head and neck during craniotomy and subsequent neurosurgical procedures. These pins reduce the incidence of artifacts in images acquired intra- operatively using CT, MR (Conditional) or fluoroscopy

The Sterile Radiolucent Skull Pins are part of a fixation system which provides rigid immobilization of the patient's skull during surgery. The Pins are the components which get in direct contact with the patient and are made of Carbon-Fiber Reinforced PEEK. The Pins are designed to penetrate the skull tabula externa to provide rigid fixation to compatible head-holder units while significantly reducing imaging artifacts.
The Sterile Radiolucent Skull Pins are intended for use by physicians or their assistants in a hospital environment only. The product may not be used repeatedly and is a single-use device accordingly. A compatible head- holder unit is required for the safe and effective use of the device.
The use scenario is primarily rigid fixation of the patient's skull during surgery e.g. percutaneous craniotomy. The device requires the same user actions as the listed predicate device, namely insertion and removal from the head-holder unit. A valid fixation setup with a compatible head- holder unit consists of exactly three sterile pins.

Here's a breakdown of the acceptance criteria and the study information for the Sterile Radiolucent Skull Pins, based on the provided text:

Acceptance Criteria and Device Performance

Important Note: The document explicitly states, "All tests were passed according to the predetermined acceptance criteria stemming from the intended use." While some criteria are quantitatively defined (e.g., specific artifact measurements, temperature rise), others are more qualitative (e.g., "required performance," "safe and effective").

Study Details

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

   • Clinical Study (Patients): 11 patients (male and female, aged over 5 years old). The document does not specify the country of origin but mentions Brainlab is a German manufacturer. It is described as a "clinical study," which implies prospective data collection, though it also refers to it as a "Post-Market Clinical Study" in non-US markets, suggesting a retrospective collection of real-world use for feedback.
   • Clinical Study (Cadavers): Not explicitly stated, but "a series of mechanical tests on human cadavers" implies a test set of cadavers.
   • Non-Clinical Data: Not explicitly specified (e.g., number of pins or test repetitions for mechanical, imaging, and MR compatibility 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)

   • Clinical Study (Patients): "Users" (physicians or their assistants in a hospital environment) provided feedback on safety and effectiveness. Their specific number or qualifications are not provided beyond being medical professionals.
   • Other tests: Ground truth for mechanical, imaging, and MR compatibility tests was based on standardized protocols (ASTM) and internal comparative analysis, rather than expert consensus on individual "cases" in the traditional sense of diagnostic imaging.

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

   • Not applicable in the context described. The clinical study involved user feedback, not an adjudication of diagnostic labels. Mechanical and imaging tests rely on measurements against standards/benchmarks.

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 MRMC study was performed or described. This device is a physical medical device (skull pins) and not an AI/software device intended to assist human readers in image interpretation.

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

   • Not applicable, as this is a physical medical device, not an algorithm.

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

   • Clinical Study (Patients): User feedback on "safe and effective to use for rigid head fixation" serves as the ground truth. This is a form of performance outcome/user experience data.
   • Cadaver Study: The ground truth was based on the "required performance and properties to meet the intended use" as determined by mechanical tests. This is engineering/performance specification truth.
   • Non-Clinical Data (Mechanical, Imaging, MR): Ground truth was established by adherence to recognized industry standards (ASTM) and comparative testing against a predicate device and other commercially available devices to demonstrate improvement in artifact performance.

7. The sample size for the training set

   • Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a "training set." The design and development of the device would have involved internal testing and iterations, but not in the sense of a machine learning training set.

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

   • Not applicable, as there is no training set in the context of this device.

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