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The MIS 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 MIS 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)/ Otorhinolaryngology; and Endoscopic applications.

Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/ Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.

These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

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, dissecting, and shaping for the following medical applications: Neuro: Spine; Ear. Nose, and Throat (ENT) /Otology/Neurotology/ Otorhinolaryngology; Craniofacial and Maxillofacial; and Sternotomy.

Specific applications include Craniotomy, 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. It is also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

Device Description

The Stryker MIS and Footed Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker MIS and Footed Attachments are offered for prescription use only. The MIS and Footed Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:

Cutting bone, bone cement, and teeth;
Placing or cutting screws, metal, wires, pins, and other fixation devices; and
Providing a location for the user to hold and grip the device system.

The Stryker MIS Attachments are available in straight, curved and angled styles.

The Stryker Footed attachments are available as fixed footed, rotating footed, and nonfooted attachments

The MIS and Footed Attachments are made of stainless steel (SST). All MIS and Footed Attachments have a color band on the proximal end of the outer surface to aid the user in correct system assembly. The color band serves to enhance the distinction of attachment and cutting accessory compatibility.

The purpose of this submission is to gain clearance for the color band modifications for the Subject Device Attachments color band that exceeds the threshold as per FDA Guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device".

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Stryker MIS and Footed Attachments. This submission seeks clearance for a modification to an existing device, specifically a change in the color band of the attachments. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through clinical trials for novel devices.

Therefore, the type of "study" described here is primarily verification testing to ensure the modified device (the new color band) does not negatively impact the safety and effectiveness established for the original predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The Subject Device met all pre-defined acceptance criteria." However, the specific quantitative acceptance criteria are not detailed in the provided text. The performance data presented focuses on passing specific tests related to the modification.

Test Performed	Acceptance Criteria (Not explicitly stated, but implied "pass")	Reported Device Performance
Colorfastness and Durability test	Implied: No significant degradation or color transfer that would impact safety or function.	Passed
Colorfastness Test	Implied: No significant color transfer.	Passed
Biocompatibility Evaluation (Chemical Characterization: ICP-MS, Toxicological Risk Assessment)	Implied: No detectable release of harmful substances; acceptable biocompatibility profile.	Performed, adopted from predicate submissions, no new risks identified.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact number of devices or components tested for the Colorfastness and Durability tests or the Chemical Characterization. It generally refers to "the Subject Devices."
Data Provenance: Not explicitly stated as retrospective or prospective in the context of clinical data, as this was not a clinical study. The tests were performed on the modified devices. There is no information regarding the country of origin for the data generation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the clearance is for a modification to an accessory and relies on verification testing and comparison to predicates, not a diagnostic accuracy study requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation did not involve human interpretation or diagnostic assessment that would require adjudication. The testing was objective (e.g., colorfastness, chemical characterization).

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. This type of study is typically conducted for diagnostic imaging devices to assess the performance of humans with and without AI assistance. The Stryker MIS and Footed Attachments are surgical power tool accessories, not diagnostic devices.

6. If a Standalone Study (i.e. algorithm only without human-in-the loop performance) was done

Yes, in essence, standalone performance testing was done. The "Performance Data" section describes "Verification testing" performed on the Subject Devices in isolation from human operators, focusing on the material properties and safety of the color band modification. These tests (Colorfastness, Durability, Biocompatibility) evaluate the device's characteristics directly.

7. The Type of Ground Truth Used

For the verification testing related to the color band modification, the "ground truth" was based on pre-defined acceptance criteria for material performance and safety standards. For example, "Passed" for colorfastness implies meeting a predefined threshold for acceptable color transfer or degradation. For biocompatibility, the ground truth is adherence to ISO 10993-1 standards and FDA guidance.

8. The Sample Size for the Training Set

This section is not applicable. This submission is for a physical medical device (surgical tool attachment) and its modification, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as there was no training set for an algorithm.

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