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The ERMIS Sterilization Container System is intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, ¾ Size, ½ size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters.

The containers are reusable devices designed to be used with the following sterilization cycle parameters:

Pre Vacuum cycle: 4 minutes 132°C (270°F) Drying Time minimum 20 minutes

3 minutes 135°C (273°F) Drying Time minimum 16 minutes

Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles

Ermis Medizintechnik Sterilization Container Systems are reusable devices intended to allow sterilization of enclosed medical devices and to maintain sterility of the enclosed devices until used.

• Interchangeable components within the different sizes (Full size, ¼ size, ½ size, Wide Body, Den-. tal, Mini, Flat).
• Containers are available with perforated and non-perforated bottom and perforated lids. .
• Safety lids are available for 1/1 size, 3/4 size and 1/2 size. Safety lids protect filters during storage . and/or transportation. The Lids are not intended to be used during sterilization.
• The lids are equipped with a silicone based gasket. .
• All containers incorporate a filter system to be used with Ermis disposable paper filters without . chemical indicator.
• To ensure effective sterilization and organization of sterilized goods, wire and screen baskets are . available.

The provided text describes the acceptance criteria and study proving the device meets those criteria. The device in question is the "Ermis Medizintechnik Sterilization Container System."

Here's the information extracted from the text, formatted according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The performance of the subject container was validated for sterilant penetration/efficacy, maintenance of sterility, microbial barrier properties and use life. The container met acceptance criteria for all claimed tests."

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "performance testing has been conducted."

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

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

No MRMC comparative effectiveness study is mentioned, as the device is a sterilization container and not an AI or imaging diagnostic tool that would typically involve human readers.

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

This question is not applicable. The device is a physical sterilization container, not an algorithm or AI system. The "performance" refers to the physical container's ability to be sterilized, maintain sterility, and resist microbial penetration.

7. The Type of Ground Truth Used

The ground truth implicitly used for the testing of the sterilization container system is based on established scientific and regulatory standards for sterilization and sterility maintenance. The tests conducted (sterilant penetration/efficacy, maintenance of sterility, microbial barrier properties, use life) would have involved objective measurements against predefined thresholds, rather than expert consensus (as in image interpretation) or pathology/outcomes data (as in disease diagnosis). The document mentions testing was performed "according to the requirements set out in ISO 10993-1," which implies adherence to recognized standards for evaluating medical device performance.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical sterilization container, not a machine learning model, so there is no "training set."

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

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

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