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510(k) Data Aggregation
(103 days)
MAYFIELD Skull Clamp
The MAYFIELD 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 MAYFIELD Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. The MAYFIELD Skull Clamp supports a 2-pin rocker arm, which allows for 360° rotation under full impingement force. The device has the means for skull pin force
The provided text describes the MAYFIELD Skull Clamp, its indications for use, and nonclinical tests conducted to demonstrate its performance. However, it does not contain information about an AI-powered device, acceptance criteria or a study proving its performance for such a tool.
Therefore, the following information cannot be extracted from the given text:
- A table of acceptance criteria and the reported device performance (for an AI device).
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document is a 510(k) summary for a medical device that is a neurosurgical head holder (skull clamp), not an AI diagnostic or treatment device. The tests discussed are physical performance tests for a mechanical device.
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(84 days)
MAYFIELD SKULL CLAMP
The Mayfield® 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 skull fixation is necessary.
The MAYFIELD Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. The MAYFIELD Skull Clamp supports a 2-pin rocker arm, which allows for 360° rotation under full impingement force. The device has the means for skull pin force determination via an integral force gauge in the torque screw opposite the rocker arm. The device is equipped with an adjustable ratchet arm to allow the surgeon to adjust the clamp for various head sizes. The ratchet arm is released by side-acting pawls, which facilitate the removal of the clamp from the patient. The MAYFIELD Skull Clamp is available in three configurations, including the base configuration, A-3059. The A-3059 C clamp is equipped with a child rocker assembly, and is suitable for patients with smaller head sizes. The A-3059 S clamp is equipped with an adjustment knob at the base of the clamp, which allows the user to limit free play between the clamp base and ratchet extension. The MAYFIELD Skull Clamp does not directly contact the patient. The MAYFIELD Skull Pins used with the skull clamp are the components which contact the patient. The skull pins are supplied separately and are not the subject of this 510(k). The MAYFIELD Skull Clamp is intended to be used non-sterile. It can be autoclaved and cleaned using detergents ranging from a pH of 3 to a pH of 11 as part of the cleaning and decontamination process.
The Mayfield Skull Clamp (K120633) is a cranial stabilization device.
Here's an analysis of its acceptance criteria and the study proving it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Skull Clamp Gauge Characteristics (Force Gauge Accuracy) | Indicate impingement force in 20lb increments up to 80lbs, accurate within ± 4lbs. | Pass – The skull clamp was capable of indicating impingement force in increments of 20 lbs up to 80 lbs, and was accurate to within the ± 4 lb limit at each force graduation. |
| Skull Clamp Range (Physical Adjustment Limits) | Provide a range of positions from 4 inches through 9 inches. | Pass – The clamp provided a range of positions from 4 inches through 9 inches. |
| Skull Clamp Static Load (Ability to Sustain Load) | Support 160 lbs (2x factor of safety for 80lb load) for ≥ 24 hours without mechanical failure. | Pass – The clamp supported 160 lb for no less than 24 hours without mechanical failure. |
| Skull Clamp Load Loss (Maintain User-Defined Load) | Maintain an 80lb static clamping force for 24 hours with ≤ 5% loss of loading. | Pass – The clamp provided a static clamping force of 80 lbs for 24 hours without a loss of loading greater than 5%. |
| Skull Clamp Transient Torque (Resist Dynamic Torque) | Withstand a dynamic torque of 20 lb/ft for 30 seconds without mechanical failure. | Pass – The swivel locking mechanism was capable of withstanding a dynamic torque of 20 lb/ft for 30 seconds without mechanical failure. |
| Skull Clamp Static Torque (Resist Applied Torque) | Withstand a static torque of 10 lb/ft for 24 hours without slippage or mechanical failure. | Pass – The swivel locking mechanism was capable of withstanding a static torque of 10 lb/ft for 24 hours without slippage or mechanical failure. |
| Skull Clamp Vertical Shear (Support Vertical Load) | Withstand a vertical shear loading of at least 100 lbs at 80 lbs pin loading. | Pass – The loading mechanism was capable of withstanding a vertical shear loading of at least 100 lbs at 80 lbs pin loading. |
| Skull Pin Compatibility (Compatibility with MAYFIELD Pins and Base Units) | Compatible with MAYFIELD Skull Pins and A3100 series MAYFIELD Base Units. | Pass – The skull clamp demonstrated compatibility with MAYFIELD Skull Pins and the A3100 series of MAYFIELD Base Units. |
| Manual Cleaning Validation (Effectiveness of Manual Cleaning) | Protein level |
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