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The CODMAN Sterilization Container System is indicated for use by hospitals and by health care facilities to:

• organize and protect stainless steel, aluminum, and titanium general surgical instruments that will be sterilized
• allow sterilization of the contained instruments by prevacuum steam sterilization (validated parameters shown in Table 1)
• maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised
  The system has not been tested for maintenance of sterility after transportation outside the health care facility.
  The system is intended for use with stainless steel, aluminum, and titanium general surgical instruments.
  The system is intended for use with lumen instruments as follows:
  Lumen inner diameter: 3 mm or larger
  Lumen length: 400 mm or less (medium and large size containers), 250 mm or less (small size containers)
  Quantity: Up to 4 lumen instruments per container
  The system is not intended for the sterilization of endoscopes.
  For effective sterilization and drying of any size CODMAN Sterilization Container, the recommended maximum combined weight of the single container, lid, basket and basket contents is 25 lb. (11.3 kg).

The Codman Sterile Container System is designed and manufactured on the basis of use to hospitals and operating rooms, where hygienic and sterile conditions are fully provided.

The provided document describes the Codman® Sterilization Containers and details its intended use and sterilization parameters, but it does not contain a study that proves the device meets specific acceptance criteria in the manner of an AI/software medical device.

This document is a 510(k) Summary for a Class II medical device (rigid sterilization container), which is a physical product, not a software or AI-driven diagnostic/therapeutic tool. The "Performance Data" section merely states: "Testing has been completed and supports the safety and effectiveness of the proposed device for its intended use." It does not provide the details of specific acceptance criteria, experimental designs, sample sizes, or results of a study as would be required for a digital health product.

Therefore, I cannot fulfill the request to provide the requested information for acceptance criteria and a study proving device performance, as the nature of the device (physical sterilization container) and the type of regulatory submission (510(k) summary for a physical device) does not typically include the detailed statistical performance metrics you've asked for that are common in AI/software medical device evaluations.

To explain why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This document lists sterilization parameters (temperature, exposure time, dry time) and limitations (lumen length, quantity, weight), but these are operating instructions and validated limits, not statistical performance metrics against predefined acceptance criteria for a diagnostic/therapeutic AI.
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to "testing" performed, likely involving microbiology (e.g., sterilization of biological indicators) and physical integrity tests for the container, but specific sample sizes for such tests are not provided nor is data provenance in the context of clinical data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be related to sterility or mechanical integrity, established through laboratory methods, not expert consensus on medical images or patient data.
4. Adjudication method: Not applicable for a physical device.
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, as this is not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI or software device.
7. The type of ground truth used: For a sterilization container, ground truth would relate to the sterility of contents after the sterilization cycle (e.g., negative growth in biological indicators) and the structural integrity of the container over the stated shelf-life. This is not explicitly detailed in the summary.
8. The sample size for the training set: Not applicable, as there is no AI algorithm to train.
9. How the ground truth for the training set was established: Not applicable, as there is no AI algorithm to train.

In summary, the provided text concerns the regulatory approval of a physical medical device. The framework of acceptance criteria and study design requested is tailored for AI/software medical devices, which is not what this document describes.

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