(103 days)
The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
The Head Fixation Arc and Table Base is designed to immobilize the patients head during the surqical procedure. It has secondary design intent to provide mounting method for the headcoil and optional camera system. The patient's head is positioned inside the headcoil and attached rigidly to the Head Fixation Arc. The patients head never touches the head coil.
This is a 510(k) submission for a physical medical device, not an AI/ML powered device. As such, many of the requested categories (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.
Here's the available information presented according to your request:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions as intended to clamp and hold the patient's head in a particular position for procedures requiring MRI of the brain structure and targets. | The device passed performance testing (bench testing) with positive outcomes. It is stated to have the "same method of construction and use as the predicates," implying equivalent performance in head fixation and MRI compatibility. |
| Compliance with applicable standards. | Testing to applicable Standards has been completed with positive outcomes. |
| Equivalent in scope of practical application to predicate devices. | The Head Fixation Arc and Table Base is equivalent to the predicate devices in the scope of practical application. |
| Equivalent in effectiveness at this application to predicate devices. | The Head Fixation Arc and Table Base is equivalent to the predicate devices in effectiveness at this application. |
| Ensuring the safety of its subject. | The Head Fixation Arc and Table Base is equivalent to the predicate devices in ensuring the safety of its subject. |
| No new safety or effectiveness issues. | The Head Fixation Arc and Table Base do not raise any new safety or effectiveness issues. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. This device is a physical head fixation system, not an AI/ML device that processes data. Testing was likely bench-top performance testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance is not relevant here. Device performance was likely assessed against engineering specifications and industry standards during bench testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The nature of the testing described (bench testing for a physical device) does not typically involve human adjudication in the way AI/ML studies do.
- 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: Not applicable. This is a physical device, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, "ground truth" would likely refer to objective engineering measurements and the ability to maintain specified physical parameters (e.g., stability, secure fixation, MRI compatibility) under controlled conditions, as determined by bench testing against established performance standards. The submission implies compliance with these standards and equivalence to predicate devices.
- The sample size for the training set: Not applicable. This is a physical device, not an AI/ML powered device, so there is no training set in the AI/ML sense.
- How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.
§ 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).