(141 days)
The iBur hubs and cutting accessories are intended to be used with the Stryker Core Consolidated Operating Room (CORE) Console and electric and pneumatic motors. When used with these motors, the iBur hubs and cutting accessories are intended to cut bone in the following manner; drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.
Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transsphenoidal, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
iBur™ Hubs and Cutting Accessories are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Endoscopic.
The Stryker iBur™ Hubs are available in straight and angled styles and in one length – 12.5cm.
Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.
Here's a breakdown of the acceptance criteria and the study information for the Stryker iBur™ hubs and cutting accessories, based on the provided document:
This document does not include specific quantitative acceptance criteria or detailed study results for performance metrics like accuracy, sensitivity, or specificity. Instead, it describes a non-clinical performance study designed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific numerical acceptance criteria or performance metrics for the device. The reported performance is a qualitative statement of efficacy in comparison to the predicate device.
| Category | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Functional / Performance | Device must perform its intended function (cutting bone) comparable to predicate. | "The results of the performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the iBur™ Hubs and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence to the predicate device." |
"Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use and support a determination of substantial equivalence." |
| Biocompatibility | Device materials must be biocompatible. | Confirmed "Biocompatibility testing" was conducted, and results supported substantial equivalence. No details on specific criteria or results are provided. |
| Sterilization & Packaging | Device must be sterilizable and maintain sterility. | Confirmed "Sterilization and packaging testing" was conducted, and results supported substantial equivalence. No details on specific criteria or results are provided. |
| Shelf Life | Shelf life must be adequate. | Reported shelf lives: Diamond Cutting Accessories = 1 year, Fluted Cutting Accessories Tool Steel = 1 year. (Predicate had 5 years and 3 years respectively, but deemed "Similar"). Hubs are reusable, so not applicable. Deemed "Similar" to predicate. |
| Cleaning Methods | Cleaning methods must be effective. | Reported as "Manual and mechanical (automated)" for both proposed and predicate devices. Deemed "Same". |
| Sterility Assurance Level | Maintain a specified sterility assurance level. | Reported as 10^-6 for both attachments (hubs) and cutting accessories for both proposed and predicate devices. Deemed "Same". |
| Energy Source | Must operate within specified parameters (RPM, pressure). | Reported as 5000-75000 rpm and 120 psi pneumatic pressure for both proposed and predicate devices. Deemed "Same". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "performance testing" that was conducted. It generally refers to "the proposed devices" and "the products."
- Data Provenance: The document does not provide information about the country of origin of the data or whether the study was retrospective or prospective. Given it is a non-clinical performance test for a medical device, the data provenance likely refers to in-house laboratory testing at Stryker.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This was a non-clinical performance test of a surgical tool, not a diagnostic device requiring expert interpretation of results to establish ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This was a non-clinical performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)."
- Effect Size: Not applicable.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone (algorithm only without human-in-the-loop performance) non-clinical performance study was done for the device itself, separate from human interaction. This is described as "Functional / Performance Testing, Biocompatibility testing, Sterilization and packaging testing." This type of testing aims to confirm the physical and mechanical properties and safety aspects of the device in isolation, or with simulated use, rather than involving human operators for performance evaluation.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "Performance Data (Non-Clinical Tests)," the ground truth would be based on engineering specifications, material science standards, and established test methodologies to assess functionality, integrity, biocompatibility, and sterilization effectiveness. It's not based on expert consensus, pathology, or outcomes data in the traditional sense, as it's a hardware device rather than a diagnostic or interpretive tool.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a mechanical/surgical device, not an AI/Machine Learning algorithm that requires a "training set." The development process for such a device would involve design, prototyping, and iterative testing, not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this type of device.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).