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PolyVac's delivery systems consist of perforated trays with llds, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used In conjunction with an approved sterilization wrap.

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 or Ethylene Oxide sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.

Here's an analysis of the provided text regarding the PolyVac Surgical Instrument Delivery System's acceptance criteria and the supporting study:

The provided text describes a 510(k) premarket notification for the "PolyVac Surgical Instrument Delivery System" seeking to add Ethylene Oxide (EO) sterilization as an approved method.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes a performance study aimed at demonstrating equivalence and efficacy for the new sterilization method. The implicit acceptance criterion is that the device successfully achieves sterilization in the specified Ethylene Oxide process.

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

• Sample Size for Test Set: The document does not explicitly state the number of PolyVac Delivery Systems (or individual materials/components) used for the Ethylene Oxide Qualification and Residual Evaluation tests. It refers to "test articles" and "Radel-R materials."
• Data Provenance: The data is likely prospective, generated specifically for this 510(k) submission to demonstrate the new sterilization method. The country of origin of the data is not specified, but given the company's location (Warsaw, Indiana) and submission to the FDA, it's presumed to be from the USA or a recognized testing facility.

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

This type of study does not involve experts establishing ground truth in the way a diagnostic AI study would (e.g., radiologists reviewing images). Instead, the "ground truth" is established by validated biological and chemical indicators.

• Ethylene Oxide Qualification: The "ground truth" for sterilization efficacy is the sterility of the devices, determined by the absence of growth from spore strips and biological indicator organisms after processing. This is an objective, laboratory-based assessment, not reliant on expert review.
• Ethylene Oxide Residual Evaluation: The "ground truth" for chemical residuals is determined by analytical chemistry techniques, measured against predefined acceptable limits.

Therefore, the concept of "number of experts" and "qualifications of those experts" for ground truth establishment does not apply in this context.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are relevant for studies where multiple human readers interpret data, and discrepancies need to be resolved for ground truth. This is not applicable here as the "ground truth" is determined by objective laboratory assays (biological indicator tests, chemical analyses).

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

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic devices involving human interpretation (e.g., comparing human performance with and without AI assistance). The PolyVac system is a surgical instrument delivery system, and its performance is evaluated through material compatibility and sterilization efficacy, not diagnostic interpretation.

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

No, a standalone (algorithm only) performance study was not done. The PolyVac system is a physical medical device, not a software algorithm. Its performance is inherent in its physical and material properties and its interaction with the sterilization process, not through an algorithm.

7. The Type of Ground Truth Used

• Ethylene Oxide Qualification: The ground truth is biological indicator sterility (absence of microbial growth) corroborated by chemical indicators. This is an objective, laboratory-based measurement of sterilization efficacy.
• Ethylene Oxide Residual Evaluation: The ground truth is objective chemical concentration measurements (EO, ECH, EGly) compared against predefined safety limits.

8. The Sample Size for the Training Set

The concept of a "training set" is applicable to machine learning algorithms. The PolyVac system is a physical device, not an AI, so there is no training set. Its performance relies on its physical design and materials, which are validated through specific testing.

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

As there is no training set for this physical device, this question is not applicable.

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