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The Vis-U-All Low Temperature Tyvek Sterilization Pouches are sterilization containment pouches for use by the health care providers to enclose medical devices to be sterilized in the Amsco V-PRO 1 Low Temperature Sterilization System. The pouches maintain the sterility of the enclosed device during normal handling and storage until the pouch is opened and the medical device is removed for use.

The proposed Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in the Amsco V-PRO 1 Low Temperature Sterilization System. The proposed pouch is available as either a self seal pouch, a heat seal pouch, or heat seal tubing.

The provided text describes a medical device submission (510(k)) for a sterilization pouch and focuses on its substantial equivalence to predicate devices, rather than an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and studies (like sample size for test sets, expert qualifications, and MRMC studies) for an AI device are not applicable here.

However, I can extract the relevant information from the document related to the device's performance and the study performed, framed as closely as possible to your request.

Here's an interpretation based on the provided text:

Acceptance Criteria and Study for Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System

Since this is a sterilization pouch and not an AI device, the "acceptance criteria" revolve around its ability to perform its function (maintaining sterility, allowing sterilization) and demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (for the "Study" as described)

• Test Set Description: The document refers to "Testing" but does not specify a separate "test set" in the context of a dataset for an algorithm. Rather, it refers to testing of the physical device.
• Sample Size: Not explicitly stated as a number of Pouches/Tubing tested. The document says "Testing of the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System demonstrated...".
• Data Provenance: Not applicable in the context of country of origin for a data set. The testing would have been conducted by STERIS Corporation, likely at their facilities in the USA.
• Retrospective/Prospective: Not applicable. This refers to physical product testing.

3. Number of Experts and Qualifications (for establishing "ground truth")

• Ground Truth Establishment: The "ground truth" here pertains to the physical performance of the sterilization pouch. The document does not specify a number of experts or their qualifications for establishing this "ground truth" in terms of clinical interpretation. The "ground truth" is based on established engineering and sterilization efficacy standards that STERIS would have followed during their testing.

4. Adjudication Method

• Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert opinions on data, which isn't the type of "study" described for this physical device.

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

• MRMC Study: No, an MRMC study was not done. This type of study is for evaluating the performance of diagnostic devices (often AI-assisted) with human readers, which is not relevant for a sterilization pouch.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No, this is not an AI algorithm. Therefore, a standalone performance study in that context is not applicable. The closest equivalent would be the performance testing of the device itself (the pouch) to ensure it meets specifications.

7. Type of Ground Truth Used

• Ground Truth Type: Not explicitly stated, but for this type of device, the "ground truth" would be established through:
  • Engineering specifications and standards: Relating to material properties, seal integrity, and permeability for sterilization agents.
  • Sterilization efficacy testing: Demonstrating that the pouch allows the sterilization process to occur effectively and maintains sterility afterwards. This would likely involve microbiological challenge tests.
  • Comparison to predicate devices: Verifying that the new device performs identically or equivalently to legally marketed predicate devices.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI model, so there is no "training set."

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

• Training Set Ground Truth: Not applicable, as there is no training set for an AI model.

In summary, the provided document describes a 510(k) submission for a physical medical device (a sterilization pouch), not an AI-powered diagnostic tool. Therefore, many of the questions regarding AI-specific study methodologies are not applicable. The "study" here refers to the testing conducted by the manufacturer to demonstrate the device's safety, effectiveness, and substantial equivalence to predicate devices for its intended use, particularly for "double-pouching."

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