(161 days)
The Footed Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro: Spine: Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy.
Specific applications include Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
Footed Attachments 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 Footed Attachments are intended cut, drill, ream, dissect and shape bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Sternotomy and Orthopedics.
The Stryker Footed Attachments are available in footed and non-footed configurations. The primary difference is the addition of the foot feature at the end of the nose tube.
The footed attachment is offered in two configurations: Fixed Footed Attachments and Rotating Footed Attachments. The primary difference between the Fixed and the Rotating Footed Attachment is the ability to rotate the foot portion of the device independently from the motor.
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 cutting accessories when used with a high speed drill and Footed Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.
The document provided is a 510(k) Premarket Notification for Stryker Footed Attachments and Cutting Accessories. It outlines the device's indications for use, describes the device, and discusses performance and biocompatibility testing. However, it does not include an acceptance criteria table with reported device performance in the manner typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity, AUC).
Instead, the document details a comparative study against predicate and reference devices, focusing on demonstrating substantial equivalence for a medical device that cuts bone. The "acceptance criteria" here are met through various non-clinical performance tests and biocompatibility assessments, and by showing similarity to legally marketed devices.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method for ground truth, MRMC study, standalone performance, training set sample size and ground truth establishment) are not applicable in the context of this device and the type of information presented in a 510(k) for a surgical tool like this one. This document focuses on demonstrating physical, functional, and material equivalence rather than diagnostic performance metrics.
Here's an attempt to answer the questions based on the provided document, noting where information is not present or not applicable:
Acceptance Criteria and Device Performance Study
The acceptance criteria for the Stryker Footed Attachments and Cutting Accessories are demonstrated through a series of non-clinical performance tests and biocompatibility evaluations, aimed at showing that the device meets its performance requirements and is substantially equivalent to legally marketed predicate devices. The study detailed is primarily a bench-testing and comparative analysis rather than a clinical trial or diagnostic performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance / Conclusion |
|---|---|---|
| Performance Requirements | Life Testing - Fluted Bur cutting accessories | Meets performance requirements |
| Life Testing – Spiral Routers | Meets performance requirements | |
| Life Testing – Tapered and Straight cutting accessories | Meets performance requirements | |
| Life testing – Diamond bur cutting accessories | Meets performance requirements | |
| Temperature Testing – Bur Cutting Accessory | Meets performance requirements | |
| Temperature Testing - Router Cutting Accessory | Meets performance requirements | |
| Life, Functional and Graphics Testing of Footed Attachments | Sufficient for intended use | |
| Attachment Latch Test | Sufficient for intended use | |
| Biocompatibility | Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing | |
| Irritation | Negligible irritant | |
| Acute Systemic Toxicity | Non-toxic | |
| Material Mediated Pyrogenicity (Attachments) | Non-pyrogen | |
| Bacterial Endotoxin Testing (Cutting Accessories) | Requirement met | |
| Colorant Leachables | Pass | |
| Substantial Equivalence | Comparison to Predicate and Reference Devices (K112593, K113476, K081475) | Similar safety and effectiveness profile |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual non-clinical performance and biocompatibility tests. It indicates these were "verification tests" performed to demonstrate performance. The data provenance is internal to Stryker Instruments, as these are non-clinical bench tests. There is no mention of country of origin for data as it's not a clinical study involving patients. The tests are prospective in nature, as they are part of the device development and verification process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable (N/A). For this type of device (a surgical cutting tool), "ground truth" as it pertains to diagnostic accuracy (e.g., for an AI algorithm) is not relevant. The "ground truth" for performance is established by engineering specifications, safety standards, and functional requirements for cutting bone, which are verified through the described non-clinical tests.
4. Adjudication Method for the Test Set
Not Applicable (N/A). There is no "adjudication method" in the context of diagnostic agreement, as this is not a diagnostic device or a study involving subjective assessment of output by multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission for a surgical instrument.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable (N/A). This device is a mechanical surgical tool, not an algorithm or AI system. Therefore, a standalone performance study in that context is not relevant. The device implicitly performs "stand-alone" in its function as a tool, but its performance is measured against engineering and safety criteria, not AI metrics.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the engineering specifications, functional requirements, and safety standards for a device intended to cut bone. For biocompatibility, the ground truth is established by international standards (e.g., AAMI/ANSI/ISO 10993-1) for biological evaluation of medical devices. The assessment of "substantial equivalence" is based on comparing the subject device's features and performance to those of legally marketed predicate devices.
8. Sample Size for the Training Set
Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable (N/A). As there is no training set, this question is not applicable.
§ 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).