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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).

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.

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.

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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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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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"

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, 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.

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

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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The EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ 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-TRAXTM Containment Device includes bases with dividers, lids, and brackets fabricated from a variety of materials commonly used to enclose, protect, and organize non-sterile medical devices. The subject device is not intended to maintain sterility, but it is intended to be used in conjunction with a legally marketed, validated, FDA cleared sterilization wrap. The subject device protects the interior components during transportation, and storage. The EZ-TRAX TM 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 bases are fully perforated with an evenly distributed hole pattern. The sides of the bases are partially perforated. The trays are used with locking lids. The bases / lid assembly was 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 provided text is a 510(k) summary for the EZ-TRAX™ Containment Device, which is a sterilization cassette. This document describes non-clinical performance data to demonstrate substantial equivalence to a predicate device, rather than a study involving human-in-the-loop performance or expert interpretation of AI output.

Therefore, many of the requested elements related to AI/human reader studies, expert ground truth establishment, adjudication methods, and training/test set sample sizes (as they pertain to AI model development) are not applicable to this submission.

However, I can extract information related to the acceptance criteria and the studies that prove the device meets these criteria in the context of device performance, specifically its ability to be cleaned, sterilized, and withstand repeated use.

Here's a breakdown of the applicable information:

Acceptance Criteria and Device Performance (Non-Clinical Study)

The EZ-TRAX™ Containment Device is a medical device accessory used for organization, reprocessing, transport, and storage of medical devices, specifically designed to withstand steam sterilization cycles. The performance studies detailed are validation tests to ensure the device itself can be effectively cleaned, sterilized, and remains functional over time.

1. Table of Acceptance Criteria & Reported Device Performance:

Reported Device Performance: All tests listed above were reported as "Passed".

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

• Sample Size: The document does not specify a numerical sample size for the devices tested in these non-clinical performance studies (e.g., number of EZ-TRAX™ units). However, for material compatibility, it states "repetitive cleaning and sterilization processing for 25 reprocessing cycles." This implies each test subject underwent 25 cycles.
• Data Provenance: The studies are non-clinical, conducted as part of the device's development and regulatory submission. The document inherently suggests these were prospective, controlled laboratory studies. No country of origin for the data is explicitly mentioned, but it's part of a U.S. FDA submission (K1 Medical LLC, based in Woodbridge, CT).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This document describes non-clinical performance testing of a physical device. Ground truth, in this context, refers to measured physical and biological parameters (e.g., residual protein levels, sterility assurance levels, material integrity), established by standardized laboratory procedures and scientific instruments, not expert interpretation or consensus.

4. Adjudication Method for the Test Set:

• Not Applicable. This is a non-clinical performance study. Adjudication methods like 2+1 or 3+1 refer to human expert consensus for interpreting data, typically in diagnostic studies. Here, the "ground truth" is determined by objective measurements meeting predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No. This is a non-clinical evaluation of a physical medical device (sterilization cassette), not an AI system that requires human reader interaction.

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

• Not Applicable. This is a physical device, not an algorithm. The "standalone" performance here refers to the device's inherent ability to undergo cleaning and sterilization processes and maintain its integrity.

7. The type of ground truth used:

• Objective Measurement Data and Compliance with Standards. The ground truth for these tests was established through:
  • Direct Analytical Measurements: For cleaning validation (hemoglobin, protein levels) and biocompatibility (cytotoxicity).
  • Performance Metrics: For sterilization validation (achieving SAL 10⁻⁶), thermal profile (adequate sterilant penetration, steady-state thermal conditions), drying time (meeting minimum dry time), and mechanical strength (no deformation/failure under specified force).
  • Adherence to Recognized Standards: Each test referenced relevant ISO, AAMI, and ASTM standards (e.g., ISO 10993-5, AAMI ST77, AAMI ST79, AAMI TIR30, ASTM F32018-18, ASTM F3293-18).

8. The sample size for the training set:

• Not Applicable. This refers to empirical testing of a physical device, not the training of an AI model.

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

• Not Applicable. See point 8.

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