(102 days)
The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.
The IMRIS Head Fixation Device System (HFD100) is an MR compatible mechanical support system intended to be used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.
The HFD100 and its accessories are designed to immobilize the head during surgical procedures and support the patient in the prone, supine or lateral positions. The HFD100 system can be use with either the operating room table or the angiography room table. The IMRIS HFD100 consists of the Table Adapter, Linkage System. Skull Clamp and Skull Pins. The linkage system is used to mount the Skull Clamp (including 3 skull pins) to the table Adaptor is used to mount HFD100 on the table. The 3-point rigid cranial fixation device, skull clamp, provides multifunctional options for cranial stabilization and provides maximum immobilization of the patient's skull during the procedure. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope during intraoperative procedure with minimal artifacts in the acquired images.
The provided document is a 510(k) summary for the IMRIS Head Fixation Device (HFD100). This type of submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not provide information about clinical studies or acceptance criteria typical for AI/ML devices, such as performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, expert consensus for ground truth, or MRMC studies.
Therefore, many of the requested elements for describing acceptance criteria and study details cannot be extracted from this document, as they are not relevant to a 510(k) for a mechanical support system.
However, I can extract the information related to the device's functional and safety performance as demonstrated through non-clinical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests passed by the HFD100 system, indicating that it meets product specifications. While specific numerical acceptance criteria (e.g., minimum load in Newtons) are not detailed in the summary, the fact that the tests were "passed" implies that the device met pre-defined criteria for each test.
| Acceptance Criteria (Implied by Passed Test) | Reported Device Performance |
|---|---|
| Biocompatibility: Meets ISO 10993-1:2003 and relevant series standards for invasive skull pins. | Pins verified for biocompatibility by Integra LifeSciences Corporation (K072208). IMRIS uses the same pins without modification. |
| Mechanical Loading: Withstand specified loads. | "Passed the Loading test." Supported load: 20kg (same as MAYFIELD® skull clamp). Pin force: 80lb (same as predicates). |
| MR Image Artifacts: Minimal artifacts in acquired images. | "Passed the MR image artifacts test." Provides rigid skeletal fixation within the optimal imaging envelope during intraoperative procedure with minimal artifacts. |
| MR Heating: No significant heating during MR. | "Passed the MR heating test." |
| Cleaning, Marking, & Labeling: Compliance with requirements. | "Passed the Cleaning, marking and labeling requirements." |
| Marking Durability: Markings remain legible. | "Passed Marking durability." |
| Flammability: Meets flammability requirements. | "Passed Flammability requirement." |
| Usability & Workflow: Meets usability metrics. | "Passed Usability requirements and workflow." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable to this 510(k) summary. The testing described is non-clinical bench testing of a mechanical device, not clinical performance evaluation using patient data. Therefore, there's no "test set" in the context of clinical data, no data provenance (country of origin), and no retrospective or prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Ground truth, in the context of expert consensus, is typically for evaluating diagnostic or predictive algorithms, not for mechanical device performance in non-clinical bench tests.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert assessments, which is not relevant for bench testing of a mechanical device.
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
This information is not applicable. The device is a mechanical head fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human reader performance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a mechanical head fixation system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on engineering specifications, safety standards, and validated testing protocols (e.g., ISO standards for biocompatibility, specified load limits for mechanical strength, established methods for MR compatibility testing). For example, the biocompatibility "ground truth" relies on adherence to ISO 10993 standards and prior verification by the predicate device manufacturer.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set.
§ 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).