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The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:

• Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty Cycles of the V-PRO Low Temperature Sterilization Systems
• Default Cycle of the STERRAD®* 100S Sterilizer
• Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
• . Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX and 100 NX with ALLClear Technology Sterilizers

*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

Prior to placing in the Sterilizer, the trays must either be:

• wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above. or
• . placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.

The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems and the following STERRAD Sterilizers and cycles. The trays are available in various sizes to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K222440) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. Optional instrument organizers and sterilization mats are also described as accessories.

The provided text describes the PRO-LITE Sterilization Tray, which is a device used to contain medical instruments for sterilization. The submission aims to add or expand claims for the use of these tray models specifically in the V-PRO maX 2 Specialty Cycle.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the test set (number of trays or instruments tested).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given this is an FDA 510(k) submission, it's customary for such performance data to be collected specifically for the submission, implying a prospective study conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA).

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

The document does not mention the use of experts or their qualifications for establishing ground truth for the test set. For sterilization validation, the ground truth is typically established through direct microbial inactivation (sterilization) testing using biological indicators or test articles inoculated with specific microorganisms, rather than expert consensus on images or observations.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set. This is consistent with the nature of sterilization efficacy testing, which relies on objective measurements of microbial kill.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or similar AI applications where human interpretation is involved. For a sterilization tray, the primary performance is objective sterilant penetration and microbial inactivation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable to the device described. The device is a physical sterilization tray, not an algorithm. The "performance" being evaluated is the ability of the tray to facilitate sterilization in specific cycles, which is a standalone performance of the device in conjunction with a sterilizer, without any human-in-the-loop "algorithm" performance.

7. Type of Ground Truth Used

The ground truth used for this type of sterilization study is typically:

• Microbial Inactivation/Sterility: This is established by demonstrating a specific sterility assurance level (SAL), often through the successful inactivation of highly resistant biological indicators (e.g., Geobacillus stearothermophilus spores) placed within the test articles. The "½ cycle conditions" mentioned indicate a stringent test designed to challenge the sterilization process.

8. Sample Size for the Training Set

The document does not describe a "training set" as this term primarily applies to the development of AI/ML algorithms. This device is a physical product, not an AI model.

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

This question is not applicable as there is no "training set" for a physical sterilization tray.

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The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:

• Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems
• Default Cycle of the STERRAD®* 100S Sterilizer
• Standard and Advanced Cycles of the STERRAD NX and NX with . ALLClear Technology Sterilizers
• Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX . and 100 NX with ALLClear Technology Sterilizers

*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

Prior to placing in the Sterilizer, the trays must either be:

• wrapped with a legally marketed sterilization wrap for use in the V-PRO ● or STERRAD Sterilization Systems. or
• . placed inside a legally marketed pouch for enclosing trays in the V-PRO or STERRAD Sterilization Systems.

The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated. FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems and the following STERRAD Sterilizers and cycles. The trays are available in various sizes to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K172755) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. Optional instrument organizers and sterilization mats are also described as accessories.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PRO-LITE Sterilization Tray:

The document (K183402) is not a multi-reader multi-case comparative effectiveness study nor does it describe a standalone algorithm performance study. It's a 510(k) premarket notification for a medical device (sterilization tray) aiming to demonstrate substantial equivalence to a predicate device. Therefore, questions related to AI-specific metrics, expert ground truth adjudication methods, and training set information are not applicable to this type of submission.

The study focuses on the physical and functional performance of the sterilization tray itself when used with specific sterilization systems.

Acceptance Criteria and Reported Device Performance

Additional Information Not Applicable to This Document:

2. Sample sizes used for the test set and the data provenance: This information is not provided in a way that relates to an "AI test set." The study involves physical testing of devices with sterilization cycles. The number of sterilization cycles and units tested for each criterion would be part of detailed test protocols, not typically summarized in this FDA 510(k) summary. Data provenance is not specified beyond being "non-clinical tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device is established through scientific and engineering tests (e.g., microbial log reduction for sterility, chemical analysis for residuals, functional testing for material compatibility).
4. Adjudication method for the test set: Not applicable. Decisions are based on objective measurement against defined criteria, not expert adjudication of subjective assessments.
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 is not an AI device or an imaging device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: For "Demonstration of Effective Sterilant Penetration," the ground truth would be based on validated biological indicator (BI) testing (e.g., showing a 10^-6 or greater sterility assurance level, typically through half-cycle challenges). For "Drying and Aeration" it's chemical analysis (residual H2O2). For "Material Compatibility" it's functional assessment and integrity checks. For "Biocompatibility" it's laboratory assays (e.g., cytotoxicity tests). For "Cleaning," it's visual inspection and potentially tests for residual soil/protein.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the following cycles: Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems

Prior to placing in the Sterilizer, the trays must either be:

• · wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above or
• · placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above

The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2, V-PRO 60 and V-PRO s2 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Trav (K172755) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material.

Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 5-3 to fit the nine PRO-LITE Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.

The provided text describes the PRO-LITE Sterilization Tray and its performance in various sterilization cycles. There is no information about an AI/ML device in the document. Therefore, I cannot provide details on sample size for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies, as these are not relevant to the described device.

However, I can provide the acceptance criteria and reported device performance based on the provided "Summary of Non-clinical Tests" table.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes the performance testing for a sterilization tray, which does not typically involve test sets, data provenance, or data types like those associated with AI/ML or clinical studies.

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 in the document and is not relevant to the type of device described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document and is not relevant to the type of device described.

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 information is not provided in the document and is not relevant to the type of device described, which is a sterilization tray, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document and is not relevant as it is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Demonstration of Effective Sterilant Penetration" tests, the ground truth is implicitly defined by the ability to achieve "reproducible sterilization" of test articles/spaces under specified worst-case conditions. This is a direct measurement of sterility, likely using biological indicators or similar validated methods, rather than expert consensus or pathology in a clinical sense. For other tests like drying, material compatibility, biocompatibility, and cleaning, the ground truth involves objective measurements against established engineering and regulatory standards (e.g., residual hydrogen peroxide levels below acceptable levels, retention of functionality, non-cytotoxicity, visual cleanliness, etc.).

8. The sample size for the training set
This information is not provided in the document and is not relevant as it is not an AI/ML device.

9. How the ground truth for the training set was established
This information is not provided in the document and is not relevant as it is not an AI/ML device.

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The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen, Flexible, and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be:

• wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization . Systems or
• placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems

The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60 and V-PRO maX 2 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate Sterilization Trav (K160912) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. Optional instrument organizers and sterilization mats are also described as accessories.

The provided text is a 510(k) Premarket Notification for a medical device (PRO-LITE™ Sterilization Trays). It describes the device's intended use, its technical characteristics, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states "PASS" for the performance. It does not provide specific quantitative results (e.g., actual residual hydrogen peroxide levels or specific functionality test results after cycles).

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

The document does not explicitly state the sample size used for the test set. It mentions "worst case test article" and "multiple worst case sterilization cycles" but not the number of units or cycles.

The data provenance is not specified in terms of country of origin. The studies appear to be pre-market, non-clinical tests conducted by the manufacturer, STERIS Corporation, for regulatory submission to the FDA. The tests are designed to demonstrate the device's performance under simulated "worst-case" conditions for sterilization. It's not a retrospective or prospective study on patient data, but rather a laboratory-based performance validation.

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

This information is not provided in the document. The tests described are non-clinical, performance-based, not involving interpretation by human experts. The "ground truth" for these tests relates to defined sterilization efficacy (e.g., absence of viable microorganisms after sterilization) and material integrity standards.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication processes like those in clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images and their performance with and without AI assistance is evaluated. The PRO-LITE™ Sterilization Trays are a medical device accessory for sterilization, not a diagnostic or AI-powered device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not performed in the context of an algorithm. This device is not an algorithm or AI. The performance tests conducted are standalone in the sense that they evaluate the device's physical and functional properties without human intervention during the sterilization process itself.

7. Type of Ground Truth Used

The ground truth for these tests is based on defined standards for sterilization efficacy and material properties.

• For sterilant penetration, the ground truth is the complete and reproducible sterilization of test articles, likely verified through biological indicators or other validated methods to confirm the absence of viable microorganisms.
• For drying/aeration, the ground truth is the acceptable level of residual hydrogen peroxide, measured against predefined safety limits.
• For material compatibility, the ground truth is the retention of functionality and structural integrity after multiple sterilization cycles, and for biocompatibility, it's the demonstration of non-cytotoxicity according to established standards.
• For cleaning, the ground truth is the device being clean per established protocols.

8. Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI/ML model that requires training data.

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

This is not applicable as there is no training set for this type of device.

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