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The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time).

When used in conjunction with an FDA cleared sterility of the enclosed medical device is maintained until used.

The system has been validated with devices with working channels >= 0.2mm and a maximum length of 240mm.

Device Description

The KARL STORZ-ENDOSCOPE Metal Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization. the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray.

The tray configurations are all baskets, available in various sizes, which are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a stainless steel metal mesh base and lid. Lids are attached to the trays with assembled hardware.

The sterilization trays are constructed from mesh material to allow for permeation of sterilant during sterilization. The mesh basket design has a higher percentage of open cells than metal mesh allowing for complete permeation. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and provide protection of the medical devices in the sterilization tray.

AI/ML Overview

The document describes the acceptance criteria and the results of non-clinical testing for the KARL STORZ Metal Sterilization Trays. It does not describe a study involving a medical device that uses artificial intelligence or machine learning. Therefore, many of the requested elements of the response (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for the training set) are not applicable or cannot be extracted from the provided text.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-Clinical Testing" table.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance

Type of Testing	Purpose	Acceptance Criteria	Reported Device Performance/Result
Pre-vacuum sterilization efficacy AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products Moist Heat Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices	Demonstrate sterilization capabilities.	10-6 SAL (Sterility Assurance Level)	PASSED
Pre-vacuum dry time AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products Moist Heat Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices	To establish minimum dry time.	Pre and Post Sterilization weight difference <3% after drying	PASSED (20 minutes dry time)
Manual Cleaning - Protein, Hemoglobin AAMI TIR 30 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices	To demonstrate manual cleaning.	< 6.4 $\mu g/cm^2$ protein and < 2.2 $\mu g/cm^2$ hemoglobin on device after cleaning	PASS
Mechanical Cleaning - Protein, Hemoglobin AAMI TIR 30 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices	To demonstrate mechanical cleaning.	< 6.4 $\mu g/cm^2$ protein and < 2.2 $\mu g/cm^2$ hemoglobin on device after cleaning	PASS
Material biocompatibility ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity	To demonstrate no Cytotoxic properties.	Cytotoxicity: No evidence of lysis	PASS

2. Sample sized 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 refers to non-clinical testing performed with the subject device and standards used, but details on sample sizes for specific tests or data provenance are absent.

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 applicable as the document describes non-clinical performance and safety testing of a physical medical device (sterilization trays), not an AI/ML diagnostic or prognostic device that would require expert-established ground truths.

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

This information is not applicable for the same reasons as 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

An MRMC comparative effectiveness study is not applicable as the device is a sterilization tray, not an AI-assisted diagnostic tool.

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

Standalone performance refers to AI algorithm performance. This is not applicable to the KARL STORZ Metal Sterilization Trays.

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

For the non-clinical tests described, the "ground truth" is established by the specified standards and test methods (e.g., AAMI ST77, ISO 17665-1, AAMI TIR 30, ISO 10993-5) which define what constitutes a "passed" result based on quantifiable metrics (e.g., 10-6 SAL, weight difference <3%, specific protein/hemoglobin concentrations, no evidence of lysis). These are objective measurements rather than expert consensus on a clinical diagnosis.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML product that would require a training set.

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

This information is not applicable for the same reasons as point 8.

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