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510(k) Data Aggregation
(103 days)
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)
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 < 6.4 µg/cm² and hemoglobin < 2.2 µg/cm². | Pass – The skull clamp demonstrated a protein level < 6.4 µg/cm² and hemoglobin < 2.2 µg/cm² following the manual cleaning process. |
| Low Level Disinfection Validation (Effectiveness of Low-Level Disinfection) | 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa. | Pass – The skull clamp demonstrated a 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa following the low level disinfection process. |
| Thermal Disinfection Validation (Effectiveness of Thermal Disinfection) | 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa. | Pass – The skull clamp demonstrated a 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa following the thermal disinfection process. |
| WHO Performance Test (Withstand Repeated Decontamination Cycles) | Withstand 15 cycles of WHO decontamination process without mechanical failure. | Pass – The skull clamp was capable of withstanding 15 cycles of the WHO decontamination process without mechanical failure. |
| Autoclave Preconditioning Test (Withstand Repeated Autoclave Cycles) | Withstand 15 autoclave cycles of 134°C for 60 minutes and pass all mechanical testing afterward. | Pass – The skull clamp was capable of withstanding 15 autoclave cycles of 134°C for 60 minutes, and passed all mechanical testing following autoclave preconditioning. |
| Shipping Verification Test (Packaging Protection during Transit) | Packaging not breached, device undamaged, and passes all function checks during inspection to ISTA Procedure 2A standards. | Pass – The packaging for the skull clamp was not breached during the ship test. The skull clamp remained undamaged and passed all function checks during inspection. |
| Biocompatibility (Patient Contact) | N/A (no patient contact by the device itself) | No component contacts the patient; therefore, no biocompatibility studies are required. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of units or samples) used for each specific test. However, the tests are primarily engineering and laboratory-based performance tests on the device itself (e.g., strength, load-bearing, cleaning efficacy).
The data provenance is retrospective, as the tests were conducted prior to the 510(k) submission to demonstrate the device's performance against predefined specifications. The country of origin of the data is implicitly the USA, given the submitting company's address and the FDA submission context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of device (a mechanical skull clamp) does not involve subjective interpretation or a "ground truth" derived from expert consensus in the way medical imaging AI devices do. The "ground truth" for the performance tests listed (e.g., ability to sustain a load, accuracy of a force gauge, effectiveness of cleaning) is based on objective, measurable engineering specifications and standardized testing protocols (e.g., WHO guidelines, ISTA standards). Therefore:
- Number of experts: Not applicable in the context of expert medical review. The "experts" involved would be the engineers, technicians, and potentially microbiologists designing and conducting the tests, and interpreting the results against the predetermined specifications.
- Qualifications of those experts: Not specified in the document, but they would be professionals skilled in mechanical engineering, materials science, microbiology, and quality assurance relevant to medical device testing.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used in studies where there is subjective interpretation (e.g., reading medical images) and a need to reach consensus among experts. For the objective, laboratory-based performance tests conducted for the MAYFIELD Skull Clamp, no such adjudication method was used or needed. The results were directly measured against predefined numerical or qualitative criteria (e.g., "Pass" if within ± 4 lb limit, "Pass" if ≥ 6 log10 reduction).
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. This type of study is relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without AI assistance to measure the AI's impact on diagnostic performance. The MAYFIELD Skull Clamp is a mechanical surgical instrument, not an interpretive device, so an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This concept is also specific to AI/software algorithms. The performance of the skull clamp is its inherent mechanical and functional characteristics, not an algorithm's output. The performance tests evaluate the device itself, not an algorithm running independently.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on objective, measurable physical and chemical properties, and adherence to defined standards or specifications. This includes:
- Engineering specifications: For force, range, load bearing, torque resistance.
- Microbiological standards: For cleaning and disinfection efficacy (e.g., 6 log10 reduction of specific bacteria).
- Mechanical integrity standards: For resistance to repeated cycles (WHO performance, autoclave preconditioning).
- Industry packaging standards: For shipping verification (ISTA Procedure 2A).
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of these specific tests.
8. The Sample Size for the Training Set
Not applicable. The MAYFIELD Skull Clamp is a mechanical device, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this type of device.
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