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The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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

Validations included the worst case load configurations of the EZ- TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Devices.

. Contents in the validated configuration include reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc)
No lumened devices were validated within the tray system as part of the product load. The EZ-. TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims.
Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + Sterile Barrier . System + Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices).

Device Description

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store G7 Acetabular System / Taperloc Complete Hip System Devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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.

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

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 travs are fully perforated with an evenly distributed hole pattern. The sides of the travs are partially perforated. The travs 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

This document describes the safety and performance of the EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device, a sterilization cassette. The information provided relates to non-clinical testing for mechanical, thermal, and biological compatibility, not a study involving human subjects or AI-assisted diagnosis.

Therefore, many of the requested categories, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and effect size of human reader improvement with AI assistance, are not applicable to this type of device and study.

Here's the information that can be extracted and a clear indication of why other information is not present:

Acceptance Criteria and Reported Device Performance

The device passed all non-clinical performance tests.

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Results)
Material Compatibility (AAMI TIR12:2010, AAMI ST81:2004/R2016, ISO 17665-1:2006/R2013)	To verify the device did not degrade or lose functionality after 25 reprocessing cycles at worst case conditions.	Material compatibility pre-vacuum 132C for 4 minutes. Mechanical Washing and Steam Sterilization. The testing subjected the device to repetitive cleaning and sterilization processing cycles at parameters that represented worst case conditions. Chemical indicators were utilized to demonstrate steam penetration.	No degradation or lack of functionality after 25 cycles. (Passed)
Mechanical Cleaning Validation - Hemoglobin (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18)	To verify the manufacturer's cleaning instructions are effective for removing gross amounts of soil to a hemoglobin level less than 2.2 ug/cm2 per device.	The mechanical cleaning validation concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a hemoglobin level less than 2.2 ug/cm2 per device.	Manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a hemoglobin level less than 2.2 ug/cm2 per device. (Passed)
Mechanical Cleaning Validation - Protein Analysis (AAMI TIR30:2011, ASTM F32018-18, ASTM F3293-18)	To verify the manufacturer's cleaning instructions are effective for removing gross amounts of soil to a protein level of less than 6.4 ug/cm2 per device.	The mechanical cleaning validation concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a protein level less than 6.4 ug/cm2 per device.	Manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a protein level less than 6.4 ug/cm2 per device. (Passed)
MEM Elution Cytotoxicity (ISO 10993-5:2009 / R2014)	To verify that the device meets requirements of ISO 10993-5 and is not considered cytotoxic.	The cytotoxicity testing was conducted per ISO 10993-5:2009 /R2014 and concluded that test articles met the requirements of the test and are NOT considered to have a cytotoxic potential.	Test articles met the requirements and are NOT considered to have a cytotoxic potential. (Passed)
Sterilization Validation (AAMI ST77:2013, ISO 14937:2009, AAMI ST8:2013)	To verify that the device could achieve a sterility assurance level of 10-6 after processing in pre-vacuum steam sterilization cycle of 132C (270F) for 4 minutes.	The sterilization validation concluded the device could achieve a Sterility Assurance Level (SAL) of 10-6 after processing in the specified pre-vacuum steam sterilization cycle.	Sterility Assurance Level (SAL) of 10-6 achieved. (Passed)
Thermal Profile Study (AAMI ST77:2013)	To verify that adequate sterilant penetration can be achieved when processed in pre-vacuum steam sterilization cycle of 132C (270F) for 4 minutes.	The thermal profile study demonstrated that adequate sterilant penetration can be achieved. The device can reach and maintain steady-state thermal conditions throughout the exposure phase.	Adequate sterilant penetration achieved; device maintained steady-state thermal conditions. (Passed)
Drying Time Test (AAMI ST77:2013, ISO 17665-1:2006/R2013)	To verify that the device is properly dried following processing in pre-vacuum steam sterilization cycle of 132C for 4.0 minutes and dry time of 10 minutes.	The results demonstrate the device meets or exceeds the minimum acceptance criteria for dry time. The device is considered properly dried.	Device meets/exceeds minimum acceptance criteria for dry time; considered properly dried. (Passed)
Handle 100 lbs force test (AAMI ST77:2013)	To verify that tray handles did not break or show evidence of distortion, cracking or other failure following testing with 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.	No breakage, distortion, cracking, or failure. (Passed)
Sterilization Validation of the EZ-TRAX™ Zimmer G7 Acetabular & Taperloc Containment Device (unorganized) steam pre-vacuum 132C (270F) for 4 minutes (AAMI ST8:2013, TIR12:2010, ST77:2013/R2018, ST79:2017, ISO 14937:2009/R2013, ISO 17665-1:2006/R2013)	To verify that a Sterility Assurance Level of 10-6 can be achieved after processing in pre-vacuum steam.	The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing in a steam pre-vacuum cycle at 132C (270F) and 4.0 minutes.	Sterility Assurance Level of 10-6 achieved. (Passed)

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

This document describes non-clinical laboratory testing of a medical device (sterilization cassette), not a study involving patient data. Therefore, concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they relate to clinical or AI diagnostic studies are not applicable. The sample size for each specific test (e.g., number of units tested for mechanical cleaning, number of cycles for material compatibility) is not explicitly detailed in this summary document beyond "repetitive cleaning and sterilization processing cycles" or testing a specific number of cycles (e.g., 25 cycles for material compatibility). The data provenance is from laboratory testing performed according to recognized standards (e.g., AAMI, ISO, ASTM).

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

This is not applicable. Ground truth, in this context, refers to scientific and engineering standards for evaluating physical and biological performance (e.g., sterility, cleanliness levels, material degradation). These are established through validated test methods and instrumentation, not through expert human interpretation of medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as it pertains to human interpretation/diagnosis, not physical device performance testing.

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

This is not applicable. This device is a sterilization cassette, not an AI-powered diagnostic tool.

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

This is not applicable. This device does not involve an algorithm.

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

The "ground truth" for this device's performance is based on established engineering and microbiological standards and measurable parameters (e.g., sterility assurance level (SAL) of 10-6, specific levels of residual hemoglobin and protein, material integrity after defined cycles, maintenance of temperature profiles). This is determined by validated laboratory test methods, not clinical expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm that requires a training set.

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

This is not applicable.

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