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PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used. PolyVac's delivery systems are to be sterilized in one of the following cycles: Prevacuum Steam : 132°C - 4 minutes minimum; Gravity Steam: 132°C - 30 minutes minimum; Gravity Steam: 121°C - 55 minutes minimum

PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.

The PolyVac Surgical Instrument Delivery System is intended to protect medical device instrumentation and facilitate the sterilization process. The acceptance criteria and the study proving the device meets these criteria are detailed below. It's important to note that this document outlines safety and biocompatibility tests and sterilization efficacy, rather than performance in the sense of accuracy, sensitivity, or specificity, as seen in diagnostic AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Tests: The exact number of mice and rabbits used for the Acute Systemic Toxicity and Intracutaneous Toxicity tests, respectively, is not specified. For the Implantation Test, the number of implanted test articles is not specified. The provenance of the data is not explicitly stated (e.g., country of origin, specific lab), but these are standard USP (United States Pharmacopeia) tests, implying a controlled laboratory setting. The tests were likely conducted prospectively.

• Sterilization Qualification: The document refers to "test articles" that were inoculated with a biological indicator organism. The exact number of test articles (PolyVac Delivery Systems) used for each sterilization cycle is not specified. This testing would have been conducted prospectively in a controlled laboratory environment.

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

This type of device and testing does not typically involve "experts" in the sense of clinical specialists like radiologists establishing ground truth. The "ground truth" for these tests is based on objective, quantifiable biological and physical measurements:

• Biocompatibility: The assessment of systemic and tissue reactions, and macroscopic reactions, would be performed by trained laboratory personnel (e.g., toxicologists, histopathologists) following USP protocols. The document does not specify the number or qualifications of these individuals but implies adherence to established scientific standards.

• Sterilization Qualification: The "ground truth" for sterilization efficacy is the demonstrable six-log reduction of biological indicator spores and successful steam penetration, as measured by thermocouples. This is determined empirically by laboratory technicians following validated sterilization protocols. The "experts" in this context are those who design, execute, and interpret the microbiology and engineering aspects of sterilization studies, whose qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessments by multiple human readers (e.g., in medical image analysis). For the objective tests described here:

• Biocompatibility: The results (e.g., presence/absence of significant reaction) are based on direct observation and measurement by trained laboratory personnel, often against a control. Any ambiguous findings would typically be resolved by internal laboratory procedures or re-testing, rather than an "adjudication" process in the diagnostic sense.

• Sterilization Qualification: The outcomes (six-log reduction, steam penetration) are determined by quantitative laboratory methods. The results are binary (pass/fail) based on predefined criteria. No expert adjudication method is relevant here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to compare the performance of different diagnostic methods or to assess the impact of AI assistance on human reader performance. The PolyVac Surgical Instrument Delivery System is a medical device for sterilization and protection of instruments, not a diagnostic tool or AI system that involves human interpretation. Therefore, this type of study is not applicable.

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

No, this question is not applicable. The PolyVac Delivery System is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

The ground truth used for these studies is empirical and objective:

• Biocompatibility: The ground truth is based on biological response (e.g., observed systemic reactions in mice, tissue reactions in rabbits, macroscopic reactions in implant sites) against established USP standards and control samples.

• Sterilization Qualification: The ground truth is based on microbiological sterility (demonstrated by a six-log reduction of biological indicator spores) and physical parameters (successful steam penetration confirmed by thermocouple data) according to validated sterilization cycle parameters.

8. The Sample Size for the Training Set

No training set is applicable. This device is not an AI algorithm or a diagnostic model that requires a training set. The tests conducted are empirical performance validations of a physical product.

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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