(111 days)
The Limited Artifact Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is required and during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.
The Limited Artifact Skull Pins are used in open and percutaneous craniotomies such as biopsies, thalamotomies and electrode implants; and in spinal surgeries when rigid skeletal fixation is necessary. The pins are also indicated for use during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.
The Limited Artifact Skull Pins consists of an injection molded PEEK polymer base, a machined titanium pin tip, and an O-ring. These components are assembled to each other to represent the finished skull pin. The pins are packaged three (3) pins per pouch, twelve (12) pouches per carton and radiation sterilized.
The provided text describes the Dinkler Surgical Devices, Inc. Limited Artifact Skull Pin and its performance in comparison to a predicate device. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Limited Artifact Skull Pin) | Predicate Device Performance (Mayfield Disposable Skull Pin) |
|---|---|---|
| Combined Load Testing (simulating surgical loads) | No failures | No failures |
| Maximum Vertical Loading in a Skull Clamp (simulating patient head weight) | Pin failure (indicates a controlled failure point, likely designed for safety or to indicate mechanical limits) | Pin slip |
| MRI Compatibility (up to 1.5 Tesla magnetic field) | MR Conditional; revealed significantly less artifact than magnetic stainless steel pins. Superior to the predicate device in this regard. | None (not indicated for MRS environment, made of 17-4PH stainless steel which is magnetic) |
| Durability during penetration exercises of "head" fixture | Excelled no differently than predicate device; sufficient durability. | Excelled no differently than the Limited Artifact Skull Pin; sufficient durability. |
| Mechanical Testing Equivalence to Predicate Device | Substantially equivalent to the predicate device while subjected to loading similar to an operating room procedure. | - |
| Sterility Assurance Level (SAL) | 10⁻⁴ (validated radiation sterilization process, ANSI/AAMI/ISO 11137) | Similar (supplied sterile in a 3-pack pouch ready for use) |
| Packaging Suitability | Industry standard medical grade packaging (sealed TYVEK/flexible film pouches) suitable for sterile surgical devices; Box Carton suitable for product sterility, identification, and protection. | Industry standard medical grade packaging (sealed TYVEK/flexible film pouches) suitable for sterile surgical devices; Box Carton nearly identical or the same. |
| Cleaning for Manufacturing Residue | Cleaned using a process to remove manufacturing residue. | Similar (implied, as final product is sterile) |
| Assembly/Fabrication | Pin tips machined, plastic bases molded. Components assembled. | Pin point machined, pin base injection molded. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical "sample size" for the mechanical and MRI tests in terms of number of pins or test replicates. It only mentions "Pins" were placed or tested.
- Data Provenance: The studies were non-clinical (bench testing) performed by Dinkler Surgical Devices, Inc. The location of the testing is not specified, but the company is based in Dayton, Ohio, USA. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are non-clinical (mechanical and MRI bench testing), not clinical studies involving human patients or expert interpretation of diagnostic images. Therefore, clinical ground truth established by experts is not relevant to these specific tests.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are mechanical and MRI bench tests, not clinical studies requiring expert adjudication of outcomes.
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. The document describes non-clinical bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical surgical pin, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by direct measurement of physical properties and observable outcomes.
- Mechanical Tests: The ground truth was the physical response of the pins and skull clamp system under controlled loads (e.g., "no failures," "pin failure," "pin slip") measured by testing equipment.
- MRI Testing: The ground truth was the degree of artifact produced, which would be objectively measured/observed in the MR images.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical 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).