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The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam: 4 minutes at 134 ℃; 10 minute dry time.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.

The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.

The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.

The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.

There are 2 models of the Sterilization Pouches in this application with different physical specification. The Disposable Medical Device Seff-seal Sterilization Pouch is made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

The Disposable Medical Device Sterilization Reel Pouch are made from a medical grade paper and plastic (PP/PET) film that are heat sealed on opposite two sides. It will be cut to suitable length and the opened sides will be heat-sealed. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

The provided document is a 510(k) Summary for a medical device, which is an application to demonstrate substantial equivalence to an existing legally marketed device. It describes the device, its intended use, and the non-clinical tests conducted. However, it does not detail specific acceptance criteria for a study in the way one might expect for a clinical trial or a performance study with numerical thresholds.

Instead, the document primarily focuses on verifying that the proposed device (Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch) meets design specifications and complies with recognized standards and validation tests. The "acceptance criteria" can be inferred from the successful completion of these tests as per the relevant standards.

Here's an attempt to extract the requested information, acknowledging that the document doesn't explicitly present acceptance criteria and reported performance in a table format for a single study, but rather refers to various validation methods.

Acceptance Criteria and Device Performance for Disposable Medical Device Self-seal Sterilization Pouch and Disposable Medical Device Sterilization Reel Pouch

The device's performance is demonstrated through non-clinical testing against various international and ASTM standards. The acceptance criteria are implicit in the successful fulfillment of these standards and validation tests.

1. Table of Acceptance Criteria and Reported Device Performance

• Half cycle overkill: No microbiological growth after half-cycle sterilization.
• Dry time validation: Samples free of visible moisture with no significant weight gain after full cycle sterilization and specified dry time. | "Half cycle overkill validation of the claimed steam sterilization cycle: Challenge loads consisted of scalers, hemostatic forceps and tooth probes. No cavities or complex devices. All loads showed no growth at 1/2 cycle."
  "Dry time validation: Full cycle sterilization testing showed samples to be free of visible moisture with no signification weight gain following sterilization and stated dry time." (Both criteria were met). |
  | Material Compatibility: Materials must not degrade after sterilization. | "After sterilization, the materials were not degraded." (Reported as met for the proposed device, predicate, and reference devices). |

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

The document does not explicitly state the sample sizes for each non-clinical test. It lists the standards and types of validation performed. The data provenance is not specified beyond the tests being conducted for submission to the U.S. FDA, likely implying internal company testing or testing by certified labs for the manufacturer (Weihai Xingtai Packaging Products Co., Ltd. from China). The tests are retrospective in the sense that they were performed on manufactured devices to demonstrate compliance.

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

Not applicable. This device is a sterilization packaging material, and its performance is evaluated against engineering, material, microbiological, and chemical standards, not by human interpretation of medical images or diagnoses. Ground truth is established by the specified test methods and criteria within the aforementioned standards.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical testing. The outcomes of the tests are objective measurements and observations (e.g., color change, absence of microbial growth, resistance to pressure, absence of leaks, material integrity).

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

No. This is a Class II medical device (sterilization wrap) and the validation is based on non-clinical performance standards. MRMC studies are typically for diagnostic imaging devices where human reader performance is a key metric.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This concept is not directly applicable. The device itself is not an algorithm. Its performance is inherent in its physical and chemical properties when subjected to sterilization processes. The "standalone" performance here refers to the device's ability to meet its functional requirements (e.g., maintain sterility, indicate sterilization) independent of human variability in the use of the device, assuming proper handling and sterilization procedures are followed. The non-clinical tests validate these inherent properties.

7. Type of Ground Truth Used

The ground truth used for evaluating this device's performance is based on established scientific and engineering standards and validation protocols. This includes:

• Physical measurements (e.g., pressure resistance, seal integrity).
• Microbiological challenge testing (e.g., absence of growth).
• Chemical reactions (e.g., specific color change of indicators).
• Biocompatibility assessments (e.g., cytotoxicity, irritation).
• Material science evaluations (e.g., material degradation, aging).

8. Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set. The "training" for this device comes from its design and manufacturing process, optimized to meet the performance standards.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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