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The Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial; Dental; and Endoscopic applications.

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

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.

The Stryker Elite and HD 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 Elite and HD Attachments are offered for prescription use only. The Elite and HD 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 Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 17cm, and 20cm. The Stryker HD Attachments are offered in the following lengths: 9cm and 14cm. The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.

The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility.

The purpose of this submission is to gain clearance for colorant band modification 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".

The provided text is a 510(k) summary for the Stryker Elite and Heavy Duty (HD) Attachments, focusing on a colorant band modification. This document does not contain the detailed acceptance criteria or the study results for the original device's performance, but rather for the modification.

Therefore, I cannot populate all sections of your request comprehensively. However, I can provide information based on what is available regarding the modification to the device.

Here's a breakdown of the available information and what is missing:

Description of Acceptance Criteria and Study for Colorant Band Modification

The submission concerns a modification to the colorant band on the Stryker Elite and Heavy Duty (HD) Attachments. The primary purpose of this 510(k) is to gain clearance for this specific modification which "exceeds the threshold as per FDA Guidance, 'Deciding When to Submit a 510(k) for a Change to an Existing Device'". The underlying assumption is that the original device, without this specific color band modification, has already met its acceptance criteria through prior submissions (e.g., K143320).

The study performed here specifically addresses the safety and effectiveness of the new colorant band material and colorant.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for bench testing, colorfastness, or durability tests for the specific modification. Biocompatibility testing was "adopted from K143320," implying reliance on prior data. The context suggests that the testing was performed on representative samples of the modified attachments.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, it is a prospective laboratory-based study for the modification.

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

• Not Applicable. This submission focuses on engineering bench testing and biocompatibility for a material change, not on diagnostic performance where expert ground truth would typically be established.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is for engineering and material testing, not clinical diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not a diagnostic device or an AI-assisted device, so MRMC studies are not relevant. This is for a surgical instrument attachment.

6. Standalone Performance (Algorithm Only without Human-in-the-loop)

• Not Applicable. This device is a mechanical surgical attachment, not an algorithm.

7. Type of Ground Truth Used

• Bench Testing Results and Biocompatibility Standards. The "ground truth" for this modification's safety and effectiveness is established by meeting predefined engineering performance specifications and biological safety standards (ISO 10993-1, FDA Guidance) through laboratory testing.

8. Sample Size for the Training Set

• Not Applicable. This is not a machine learning device that requires a "training set."

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

• Not Applicable. As above, no training set is relevant here.

Summary of what the document confirms about the modification:

• The change is related to the color band material and colorant.
• The indications for use, intended use, operating principles, energy source, and functional outputs remain unchanged from the predicate device (K143320).
• Bench testing (colorfastness, durability) was performed and met acceptance criteria.
• Biocompatibility evaluation was performed, including chemical characterization (ICP-MS) and toxicological risk assessment, following established standards (ISO 10993-1, FDA Guidance). This biocompatibility testing was adopted from the predicate K143320, suggesting the new material passed similar or identical tests as the previous material.
• No animal or clinical testing was required for this specific modification.
• The conclusion is that the device, with the modification, is as safe and effective as the predicate device.

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