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The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee devices between surgical uses. The EZ-TRAX™ Persona Knee 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 EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Persona Knee Devices between surgical uses.

The EZ-TRAX™ Persona Knee 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 svstem.

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

The EZ-TRAX™ Persona Knee 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.

The EZ-TRAX™ Persona Knee Containment Device underwent a series of non-clinical tests to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

| Test Methodology | Purpose | Acceptance Criteria | Results |
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| 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 132°C 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. | 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 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. | 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 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 µg/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/(R)2014 and concluded that test articles met the requirements of the test 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 132°C for 4 minutes. | The sterilization validation of the EZ-TRAX™ containment system included pre-vacuum steam 132°C 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 132°C for 4 minutes. | 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 132°C for 4 minutes. | The thermal profile study of the EZ-TRAX™ Containment Device included pre-vacuum steam 132°C 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 132°C for 4 minutes. | 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 132°C for 4 minutes and dry time of 10 minutes. | 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 / 270°F, Exposure Time 4.0 minutes, and Dry Time 10.0 minimum. | Passed |
| Handle 100 lbs force test
AAMI ST77:2013 | To verify that tray handles did not break or showed 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. | Passed |
| Sterilization Validation of the Zimmer Persona Total Knee Set with EZ-TRAX™ Cassette (unorganized).
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 sterilization cycle of 132°C for 4 minutes while containing the Zimmer Persona Total Knee Set. | The testing verified that a Sterility Assurance Level of 10⁻⁶ can be achieved after processing EZ-TRAX™ Persona Knee Containment Device in a steam pre-vacuum cycle at 132°C (270°F) and 4.0 minutes. | Passed |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the specific number of units or samples used for each test. However, the tests are described as non-clinical and they are conducted according to general standards (AAMI, ISO, ASTM). This implies that the tests were likely conducted on specific test articles (i.e., multiple instances of the device or relevant components) in a laboratory setting, rather than on patient data. No information about data provenance (country of origin, retrospective/prospective) is provided, as it is not applicable for this type of non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided nor applicable. The tests performed are laboratory-based compliance tests against established physical and microbiological standards, not diagnostic or interpretive tasks requiring human expert ground truth.

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

Not applicable. The tests are based on objective measurements against predefined criteria and standards, not on subjective assessments requiring adjudication.

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. This device is a sterilization containment device, not a diagnostic tool utilizing AI. Therefore, an MRMC study with human readers and AI assistance is irrelevant.

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

Not applicable. This device is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for these non-clinical tests is based on established scientific and engineering standards and methodologies (e.g., AAMI, ISO, ASTM). For example:

• Material Compatibility: Physical observation of degradation or loss of functionality after stress cycles.
• Mechanical Cleaning Validation (Hemoglobin/Protein): Quantitative measurement of residual hemoglobin/protein levels below specified thresholds (e.g.,

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