(38 days)
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
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Effectively hold a patient's head and neck securely in a particular position on the skull. | "Is placed on the patient's skull to hold their head and neck securely in a particular position." |
| Indications for Use | Suitable for use in open and percutaneous craniotomies, as well as spinal surgery requiring rigid fixation. | "Indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary." |
| Materials | Use of biocompatible and durable materials suitable for medical devices, similar to predicate devices. | "Aluminum and stainless steel." (Same as predicate devices) |
| Manufacturing | Components machined by conventional methods, ensuring quality and consistency. | "Components are machined by conventional methods using manual or CNC machinery." (Same as predicate devices) |
| Preparation for Surgery (Cleaning) | Ability to be thoroughly cleaned and disinfected according to hospital protocols. | "Thoroughly clean by scrubbing with a brush and neutral pH detergent." (Similar to predicate devices) |
| Method of Use | Functional and safe mechanism for installing skull pins, maneuvering, seating, and adjusting for proper fixation. | "Install (3) skull pins in clamp, maneuver into position, seat opposing skull pins to desired reading, adjust and seat rocker arc pin to desired reading, readjust opposing pin readings if necessary." (Slightly different from predicates, but functional) |
| Vertical Loading in a Skull Clamp | Ability to withstand loads simulating patient head weight and external pressure during surgery without failure. | "The results of the 2 tests show the Dinkler Surgical Skull Clamp performance to be more than adequate and very acceptable in fixating the skull." (Stated as successful) |
| Maximum Horizontal Loading in a Skull Clamp | Ability to resist forces attempting to spread the "C" arms apart, ensuring stable fixation. | "The results of the 2 tests show the Dinkler Surgical Skull Clamp performance to be more than adequate and very acceptable in fixating the skull." (Stated as successful) |
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.
§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).