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The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

Cycle: Dynamic Air Removal
Temperature: 270 F/132 C
Exposure Time: 4 minutes
Drying Time: 10 minutes

Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.

. Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws, arrays, etc.)
. No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims
Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon Containment devices).

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes:

Brand Name: EZ-TRAX™ Model: BASE.ASSY.AL.24.12.2.4 Dimensions: L) 22.97" (W) 11.18" (H) 2.44"
Brand Name: EZ-TRAX™ Model: BASE.ASSY.AL.21.12.4 Dimensions: (L) 19.97" (W) 11.18" (H) 4.187"

Device Description

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier system.

The subject device protects the interior components during transportation, and storage.

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.

The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids.

The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.

AI/ML Overview

The provided text contains details about the regulatory approval (510(k) clearance) of a medical device, the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device. It outlines testing performed to demonstrate the device's safety and effectiveness, specifically for sterilization and material compatibility.

However, the request asks for information typically associated with the development and validation of an AI/machine learning-based medical device where "acceptance criteria" and "study that proves the device meets the acceptance criteria" would refer to performance metrics like sensitivity, specificity, AUC, or reader studies. The provided document concerns a physical medical device (a sterilization containment system), not an AI or software device. Therefore, many of the requested items, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "training set," and "type of ground truth (pathology, outcomes data)," are not applicable to this type of device and are not present in the document.

The "acceptance criteria" in this context refer to engineering and functional performance thresholds for sterilization, cleaning, and material integrity, as outlined in the "Summary of Nonclinical Testing" section.

Below is an attempt to answer the questions based on the provided document, where applicable. For questions that are not relevant to this type of medical device (physical containment system) or not explicitly stated in the document, it will be noted as "Not Applicable (N/A)" or "Not specified."

Acceptance Criteria and Study for EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device

This device is a sterilization containment system. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to physical, chemical, and microbiological performance standards for sterilization, cleaning, and material compatibility, not AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Test / Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Material Compatibility (AAMI TIR12:2010, AAMI ST81:2004/R2016, ISO 17665-1:2006/R2013)	Verify no degradation or lack of functionality after repetitive cleaning and sterilization processing for 25 cycles.	Verify no degradation or lack of functionality after repetitive cleaning and sterilization processing for 25 cycles.	Material compatibility pre-vacuum 132C for 4 minutes - Mechanical Washing and Steam Sterilization. The testing subjected the device to repetitive cleaning and sterilization processing for 25 reprocessing cycles at parameters that represented the worst-case conditions. Chemical indicators were utilized to demonstrate steam penetration. The study found no degradation or lack of functionality after 25 cycles.
Mechanical Cleaning Validation - Hemoglobin (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18)	Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a hemoglobin level less than 2.2 µg/cm2 per device.	Hemoglobin level less than 2.2 µg/cm2 per device.	The mechanical cleaning validation of the EZ-TRAX™ containment system concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a hemoglobin level less than 2.2 µg/cm2 per device.
Mechanical Cleaning Validation - Protein Analysis (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18)	Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a protein level less than 6.4 µg/cm2 per device.	Protein level less than 6.4 µg/cm2 per device.	The mechanical cleaning validation of the EZ-TRAX™ containment system protein concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a protein level less than 6.4 ug/cm2 per device.
MEM Elution Cytotoxicity (ISO 10993-5:2009 / R2014)	Verify the device does not have a cytotoxic potential.	No cytotoxic potential.	The cytotoxicity testing was conducted per ISO 10993-5:2009/(R)2014 and concluded that test articles met the requirements of the test and are NOT considered to have a cytotoxic potential.
Sterilization Validation (AAMI ST77:2013, ISO 14937:2009, AAMI ST8:2013)	Verify the device and cycle parameters achieve a Sterility Assurance Level (SAL) of 10-6.	Sterility Assurance Level (SAL) of 10-6.	The sterilization validation of the EZ-TRAX™ containment system included pre-vacuum steam 132C for 4 minutes. The conclusion could achieve a Sterility Assurance Level (SAL) of 10-6 after processing in the following pre-vacuum steam sterilization cycle 132C for 4 minutes.
Thermal Profile Study (AAMI ST77:2013)	Verify the device and cycle parameters demonstrate that adequate sterilant penetration is achieved.	Adequate sterilant penetration is achieved.	The thermal profile study of the EZ-TRAX™ Containment Device included pre-vacuum steam 132C for 4 minutes. The study demonstrated that adequate sterilant penetration can be achieved. The EZ-TRAX™ Containment Device can reach and maintain a steady-state thermal conditions throughout the exposure phase when processed in the following pre-vacuum steam sterilization cycle 132C for 4 minutes.
Drying Time Test (AAMI ST77:2013, ISO 17665-1:2006/R 2013)	Verify the device is properly dried using the specified cycle parameters.	Device is properly dried.	The results demonstrate EZ-TRAX™ meets or exceeds the minimum acceptance criteria for dry time. The EZ-TRAX™ is considered properly dried following processing in the steam pre-vacuum sterilization cycle of 132 C / 270F, Exposure Time 4.0 minutes, and Dry Time 10.0 minimum.
Handle 100 lbs force test (AAMI ST77:2013)	Verify the handles do not show evidence of permanent distortion, cracking, or other evidence of failure when tested with a force of 50 lbs.	No permanent distortion, cracking, or other evidence of failure when tested with a force of 50 lbs.	None of the tray handles broke loose, showed evidence of permanent distortion, cracking, or other evidence of failure when tested with force of 50 lbs.
Sterilization Validation of Stryker Mako Triathlon Instrument Set #1 with MICS with EZ-TRAX™ (AAMI ST8:2013, TIR12:2010, ST77:2013/R2018, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013)	Verify that the device with instrument set specific to device and specified cycle parameters achieve a Sterility Assurance Level of 10-6.	Sterility Assurance Level (SAL) of 10-6.	The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing Stryker Mako Triathlon Instrument Set #1 with MICS in a steam pre-vacuum cycle at 132C and 4 minutes.
Sterilization validation of Stryker Mako Triathlon Universal TKA with EZ-TRAX™ (AAMI ST77:2013, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013)	Verify that the device with implants specific to device and specified cycle parameters achieve a Sterility Assurance Level of 10-6.	Sterility Assurance Level (SAL) of 10-6.	The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing Stryker Mako Triathlon Universal TKA01 and TKA03 in a steam pre-vacuum cycle at 132C and 4 minutes.

2. Sample size used for the test set and the data provenance

The document describes non-clinical laboratory testing (e.g., repeating sterilization cycles, cleaning efficacy tests). It does not explicitly state the "sample size" in terms of number of patient cases or specific devices tested for each test, beyond mentioning "25 cycles" for material compatibility. The nature of these tests is typically to test a representative number of devices or components to demonstrate compliance with standards.

Sample Size for Test Set:
- Material compatibility, cleaning, sterilization validation, thermal profile, and drying time tests were performed for "25 cycles" (for material compatibility) or against specific instrument load configurations. The exact number of containment devices subjected to each specific test (e.g., how many trays were cytotoxic tested) is not specified beyond "test articles."
Data Provenance: Not specified, but standard safety/performance testing for FDA clearance is typically conducted in a controlled laboratory environment conforming to relevant ISO/AAMI standards. It is not patient or country-specific data in the way an AI/ML study would be. This is pre-clinical/non-clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A). This is a physical device, not an AI/ML device that requires human expert review to establish "ground truth" for diagnostic or predictive performance. The "ground truth" for these tests comes from established international and national standards (e.g., AAMI, ISO, ASTM) and laboratory testing protocols (e.g., sterilization validation using biological indicators to confirm SAL, chemical assays for cleaning efficacy).

4. Adjudication method for the test set

Not Applicable (N/A). (See point 3).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable (N/A). This type of study is relevant for AI-assisted diagnostic devices, not for a physical sterilization containment system.

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

Not Applicable (N/A). This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this physical device, the "ground truth" is based on:
- Validated microbiological endpoints: e.g., achieving a Sterility Assurance Level (SAL) of 10^-6, which is confirmed using biological indicators.
- Chemical and Physical Measurements: e.g., quantifiable levels of residual protein/hemoglobin after cleaning, stable material properties after repeated cycles, achievement and maintenance of specified temperatures during sterilization.
- Industry Standards: Compliance with recognized international and national standards (AAMI, ISO, ASTM) for sterilization, cleaning, and biocompatibility.

8. The sample size for the training set

Not Applicable (N/A). This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable (N/A). (See point 8).

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