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The Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles:

Pre-vacuum Steam
Enclosure: Rigid Container1
Temperature: 132°C (270°F), 135°C (275°F)
Sterilization Time: 4 minutes, 3 minutes
Minimum Dry Time: 30 minutes, 30 minutes
Maximum Weight: 25 lbs / 11.36 kg, 25 lbs / 11.36 kg

1 Tray System has been validated in the following Aesculap SterilContainer cleared for pre-vacuum steam sterilization under K792558: Full DIN JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid).

The maximum validated product loads for the trays in containers are as follows:
Configuration: 3-Level Rack - Qty. 2 (29-13910) in a Full DIN Rigid Sterilization Container3
Maximum Validated Load Set Contents: 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941), 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941), 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941), 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941), 29-17903 1.7 Orthognathic Plates Inlay, 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941), 29-23905 2.0/2.3 Mini Plates Inlay, Large, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921)

Configuration: 3-Level Rack – Qty. 1 (29-13910) in a ½ DIN Rigid Sterilization Container4
Maximum Validated Load Set Contents: 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941), 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921), 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921)

1 Model numbers shown in table are Stryker® model numbers
2 Contents in the validated Tray System inplants (plates, meshes, bone screws, etc.), single-use instruments (drills), and revable surgical instruments (benders, forceps, handles, depth gauges, trocars, etc.)
3 Tray system components part of the worst-case configuration Container validation in an Aesculap SterilContainer Base (K446) and Lid (JK489) cleared under K792558
4 Tray system components part of the worst-case configuration in a 1/2 DN Rigid Sterilization in an Aesculap SteriliContainer Base (K346) and Lid (JK389) cleared under K792558
5 No lumened devices were validated within the tray system as part of the Stryker Universal Select Sterilization Tray System does not have any lumen claims.

The Stryker Universal Select Sterilization Tray System consists of anodized aluminum implant modules and inlays to store single-use titanium implants and stainless steel instrument and accessory trays for surgical instrumentation. The implant modules and trays have stainless steel lids which have a slide latch feature. Instrument trays are specific to a set configuration and have stainless steel and silicone brackets, removable screw caddy (for the 90° screwdriver instrument tray), and silkscreened artwork to assist the end user in correct placement of the instruments. Accessory trays are not specific to a set configuration, and have an open area designed for placement of commonly used instruments such as cutters, benders and forceps. The individual components of the system can be organized and stored in a 2-level or a 3-level stainless steel rack. The rack is designed to fit in an Aesculap rigid sterilization container (K792558). The tray system is reusable and provided in a non-sterile condition.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a numerical sample size for the test set in terms of individual devices or sterilization cycles. Instead, it refers to "worst case configured tray system" and "Both full size and ½ size rigid sterilization containers." This implies a representative selection of configurations rather than a large statistical sample.

The data provenance is from non-clinical performance testing conducted by Paragon Medical (the manufacturer) in the United States, as indicated by the company information and the FDA submission. This would be considered prospective for the device's validation.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation for sterilization, cleaning, and design verification appears to be based on adherence to established standards and scientific testing protocols (e.g., ANSI/AAMI/ISO 17665-1:2006, AAMI TIR 30:2011, ISO 10993-5, AAMI ST77:2013, EN 868-8:2009) rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, laboratory-based evaluations against predetermined criteria and standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the testing for a medical device (sterilization tray system), not an AI algorithm for diagnostic imaging. Therefore, MRMC studies are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests is derived from:

• Microbiological standards: For sterilization effectiveness, the ground truth is the complete inactivation of a specified challenge organism (Geobacillus stearothermophilus spores) as defined by biological indicator testing (ANSI/AAMI/ISO 17665-1:2006).
• Chemical/Physical standards: For cleaning validation, the ground truth involves objective measurements of soil removal based on AAMI TIR 30:2011.
• Engineering and material standards: For design verification (handle strength, stacking, edge sharpness, maximum weight) and material compatibility/biocompatibility, the ground truth is adherence to established industry standards and test methods (e.g., AAMI ST77:2013, EN 868-8:2009, ISO 10993-5).
• Functional performance: For life cycle testing, the ground truth is the continued functional operation and integrity of the device after simulated use and repeated processing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a training set. The device is a physical product, and its performance is validated through non-clinical laboratory testing.

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

Not applicable, as there is no training set for this type of medical device validation.

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