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The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses.

The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization.

The validated sterilization cycles are provided in Table II.

The cycles were validated using Kimguard (Kimberly Clark).

The sterilization exposure times are extended. Please refer to Table 2 for cycle tines. Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays.

The sterilized contents are for immediate use and should not be stored for any duration.

The trays are intended for sterilization of non-porous loads, e.g. hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.

The ConMed Linvatec sterilization trays consist of base trays, lids and internal individualized insert travs. Each trav is composed of multiple pieces and is designed to be integrated into a single unit, which will contain and protect the interior components during sterilization. The interior structures of the tray have the ability to separately hold each individual piece during the entire duration they are in contact with the tray.

The rigid, multi piece tray holds medical device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain products, which is held to the base by latches designed to fasten the lid to the base not allowing the two to separate. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in a normal operating room.

The tray is designed to allow repeated sterilization cycles. Though these travs are reusable they will not be serviced or repaired. Like the outer containing trays, the interior trays with individual containment custom brackets have been developed to withstand repeated use and will not be serviced or repaired. These custom brackets are made of materials that do not contaminate the tray or any of the parts or pieces contained within the tray.

The lid, base and insert for the proposed trays are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC. This material is identical to the Radel used in the predicate device cleared under K993535. Attachment I includes the material composition for the Radel R-5000.

The latches, which secure the lid to the base, are constructed of 300 Series Stainless Steel, identical to the stainless steel in the predicate devices cleared under K993535 and K944025.

The instruments to be sterilized in the proposed trays are all non-porous devices and including instruments such as suture snares, various hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obturators, etc.

Each tray includes brackets and containment mats which are made of a biomedical grade silicone. These are used to secure the instruments during transport, sterilization and storage. The drawings in Attachment III include the brackets and mats.

Additional device characteristics can be found in the chart included as Attachment A of this 510(k) Summary.

The brackets and containment mats are both constructed from biomedical grade silicone which has been manufactured to meet FDA CFR 177.2600. This material is identical to the predicate devices cleared under K993535 and K944025.

The provided text is a 510(k) Summary of Safety and Effectiveness for an "Instrument Sterilization Tray" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, ground truth type) are not applicable or cannot be extracted from this document, as it is not a study report for a novel AI/medical device with such performance claims.

The document states that "The ConMed Linvatec Instrument Sterilization Tray has the same intended use, technological characteristics and performance characteristics as the predicate devices." and that "The sterilization validation of all trays has met the requirements of the same performance standard, AAMI TIR No.12-1994." This indicates that the device's performance is demonstrated by adhering to an established standard, rather than through a comparative effectiveness study with specific acceptance criteria as you might find for an AI-powered diagnostic device.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "validated sterilization cycles" as a key performance characteristic and references a standard. The acceptance criteria are implicitly meeting the requirements of AAMI TIR No.12-1994 and successful completion of the specified sterilization cycles.

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

• Sample Size: Not explicitly stated as a "test set" in the context of a dataset for evaluation. The "sample" here refers to the actual trays tested during the sterilization validation. The document lists three specific tray models (9895, 8217, C6355) that were included in the submission and for which characteristics are provided. It's not clear if all trays were tested or representatives, but the total number of distinct tray models is 3.
• Data Provenance: Not applicable in the sense of country of origin for retrospective/prospective data. The "study" here is physical testing/validation of material properties and sterilization efficacy conducted by the manufacturer, ConMed Linvatec.

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

• Not Applicable. This is a physical device subject to performance standards and material compatibility tests, not an AI/diagnostic device where expert interpretation is used to establish ground truth for a test set.

4. Adjudication method for the test set

• Not Applicable. 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

• No. This is a physical instrument sterilization tray, not an AI-assisted diagnostic tool.

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

• Not Applicable. See point 5.

7. The type of ground truth used

• For material composition: Chemical analysis and material specifications (e.g., Radel R-5000 properties, 300 Series Stainless Steel, biomedical grade silicone meeting FDA CFR 177.2600).
• For sterilization efficacy: Adherence to a recognized industry standard (AAMI TIR No.12-1994) and successful completion of defined steam sterilization cycles (temperature, exposure time, dry time). The "ground truth" is established by the standard itself and physical measurement/bioburden reduction studies performed during validation.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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