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The Dinkler Surgical Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

The Dinkler Surgical Skull Clamp is a device used for rigid fixation of the skull. The design of the Skull Clamp allows the surgeon more freedom in positioning the skull pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arc which rotates 360°. The main body of the clamp is made from aluminum. The rocker arc assembly, which houses an additional skull pin, is made from stainless steel. A torque screw device on the main body of the clamp is used to apply load to the skull mainly for support and an additional torque screw, on the arc, provides load to resist head rotation. To accommodate the different sizes of patient heads, the skull clamp can be slid opened or closed and then locked.

The Dinkler Surgical Skull Clamp is a device used for rigid fixation of the skull during surgical procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state a numerical sample size for the "test set" in terms of number of devices or number of test replicates. It refers to "mechanical testing of the clamp."
• Data Provenance: The tests were conducted as "Non-Clinical Tests" by the manufacturer, Dinkler Surgical Devices, Inc. This indicates internal testing. The country of origin for the data is not explicitly stated but is implied to be within the US, where the company is located. The study is prospective in the sense that the tests were designed and conducted to evaluate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This information is not applicable to this type of device and study. The "ground truth" for a mechanical device like a skull clamp is established through engineering principles, load specifications, and physical testing, not by expert interpretation of data like in image analysis or diagnostic studies. The "results" of the tests (i.e., whether the clamp performed adequately under load) are objective measurements.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic studies. For mechanical testing, the failure or success of the device under specific loads is a measurable outcome, not subject to subjective adjudication.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human readers interpret medical cases. The Dinkler Surgical Skull Clamp is a mechanical surgical device.

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

• This information is not applicable. A "standalone" performance evaluation typically refers to the performance of an algorithm without human intervention, which is relevant for AI or automated diagnostic tools. The Dinkler Surgical Skull Clamp is a mechanical device requiring human operation during surgery.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is based on pre-defined engineering specifications and mechanical load limits derived from simulating surgical conditions.
  • Vertical Loading: The device's ability to "fixate a test block 'head'" under simulated patient weight and external surgical loads.
  • Maximum Horizontal Loading: The device's ability to resist forces attempting to spread its "C" arms (ensuring stability).
• The "adequacy" and "acceptability" of the performance are determined against these mechanical requirements, rather than clinical outcomes or diagnostic interpretations.

8. The Sample Size for the Training Set

• This information is not applicable. The Dinkler Surgical Skull Clamp is a mechanical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the reasons stated in point 8.

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The Limited Artifact Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is required and during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.

The Limited Artifact Skull Pins are used in open and percutaneous craniotomies such as biopsies, thalamotomies and electrode implants; and in spinal surgeries when rigid skeletal fixation is necessary. The pins are also indicated for use during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.

The Limited Artifact Skull Pins consists of an injection molded PEEK polymer base, a machined titanium pin tip, and an O-ring. These components are assembled to each other to represent the finished skull pin. The pins are packaged three (3) pins per pouch, twelve (12) pouches per carton and radiation sterilized.

The provided text describes the Dinkler Surgical Devices, Inc. Limited Artifact Skull Pin and its performance in comparison to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical "sample size" for the mechanical and MRI tests in terms of number of pins or test replicates. It only mentions "Pins" were placed or tested.

• Data Provenance: The studies were non-clinical (bench testing) performed by Dinkler Surgical Devices, Inc. The location of the testing is not specified, but the company is based in Dayton, Ohio, USA. The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies described are non-clinical (mechanical and MRI bench testing), not clinical studies involving human patients or expert interpretation of diagnostic images. Therefore, clinical ground truth established by experts is not relevant to these specific tests.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are mechanical and MRI bench tests, not clinical studies requiring expert adjudication of outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a physical surgical pin, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by direct measurement of physical properties and observable outcomes.

• Mechanical Tests: The ground truth was the physical response of the pins and skull clamp system under controlled loads (e.g., "no failures," "pin failure," "pin slip") measured by testing equipment.
• MRI Testing: The ground truth was the degree of artifact produced, which would be objectively measured/observed in the MR images.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical medical device.

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