(58 days)
The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode.
Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.
The device under review is a family of Anchor Bolts. Anchor Bolts are optional accessories to Depth Electrodes. These Anchor Bolts provide an optional access point through the skull and stabilization support for Depth Electrodes.
The provided text describes the 510(k) premarket notification for "Anchor Bolts as Accessories to Depth Electrodes." This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not describe a software-as-a-medical-device (SaMD) or AI/ML-based device that would require the kind of complex clinical study with human readers and ground truth adjudication methods typically seen for such applications.
Therefore, many of the requested criteria, such as expert opinions, MRMC studies, standalone algorithm performance, and training set information, are not applicable or mentioned in this type of submission. The information provided is for a physical medical device.
However, I can extract the relevant "acceptance criteria" (performance requirements for the device) and the "study" (non-clinical performance tests) that prove the device meets these criteria.
Device Name: Anchor Bolts as Accessories to Depth Electrodes
Device Type: Physical Medical Device (Accessory to Depth Electrodes)
Study Focus: Non-clinical performance tests to demonstrate substantial equivalence to a predicate device.
Here's the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|
| Torque required to insert to pre-drilled skull hole: | Pass: All results ≤ 1 in-lbs. (Acceptance Criteria: ≤ 8 in-lbs.) |
| Axial tension to pull Anchor Bolt out of pre-drilled skull hole: | Pass: All results > 48 lbf. (Acceptance Criteria: ≥ 40 lbf.) |
| Axial tension to pull Depth Electrode from the Anchor Bolt: | Pass: All results > 140 grams. (Acceptance Criteria: ≥ 100 grams.) |
| Anchor Bolt gasket resist CSF leakage: | Pass: No leaks observed after 24 hours. (Acceptance Criteria: No leakage at the Depth Electrode, Anchor Bolt after 24 hours, under 15 mmHg hydrostatic pressure.) |
| Sterility: | Pass: Terminally ethylene oxide sterilized devices by a validated EtO sterilization cycle, per ANSI/AAMI/ISO 11135-1:2007 half-cycle method. The sterility assurance level (SAL) is ≤ SAL of 10-6. |
| Sterile barrier integrity: | Pass: Evaluated by simulated distribution, seal peel, and bubble emission testing for the double Tyvek pouch after terminal sterilization. |
| Anchor Bolt silicone gasket shelf life: | Pass: The same acceptance criteria were met. (Ability of real-time aged Anchor Bolts with Silicone Gaskets to meet Depth Electrode retention requirements and minimize cerebrospinal fluid (CSF) leakage were evaluated to the methods used for Axial tension to pull Depth Electrode from the Anchor Bolt and Anchor Bolt gasket resist CSF leakage.) |
| Biocompatibility: | Pass: Following test methods applied to final finished form Anchor Bolts (patient contacting materials), with passing results: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Genotoxicity (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, Mouse Lymphoma Mutagenesis Assay), Hemocompatibility, Neurotoxicity, Subacute/Subchronic Toxicity, Implantation (Neurological (Brain) Implantation Test). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For the mechanical performance tests (Torque, Axial tension, CSF leakage), a sample size of N=10 was generally used. For the CSF leakage test, N=22 samples were used. Other tests like sterility, sterile barrier integrity, shelf life, and biocompatibility applied broader methods/principles to the devices.
- Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, Ad-Tech Medical Instrument Corporation. The document does not specify the country of origin for the data beyond the company's address in Oak Creek, WI, USA. This is retrospective data from device testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This submission is for a physical medical device and relies on engineering and material science testing methods (e.g., tensile testers, torque wrenches, established biocompatibility protocols) rather than human expert interpretation of medical images or clinical outcomes. Therefore, no "medical experts" in the sense of radiologists or similar were used to establish ground truth for these non-clinical performance tests.
4. Adjudication Method for the Test Set:
- None. As the tests are non-clinical, objective measurements, there is no human interpretation or "adjudication" required in the way it would be for a diagnostic AI. The results are quantitative and pass/fail based on pre-defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not a diagnostic imaging device or an AI/ML-based device. Thus, MRMC studies are not relevant to demonstrating the safety and effectiveness of an anchor bolt for depth electrodes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance tests is based on objective, quantitative measurements against defined engineering specifications and industry standards for mechanical performance, sterility, and biocompatibility. For instance, the "ground truth" for axial tension is the measured force in lbf, compared to a ≥ 40 lbf requirement. The "skull bone" simulation was polyurethane foam (40 pcf).
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. There is no "training set."
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).