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FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).

FlashPak® Model/Maximum Instrument Load Weight Recommendation:

9020 w/ 9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg)

9030 w/ 9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55 Kg)

9040 w/ 9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg)

9050 w/ 9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg)

The FlashPak Container System consists of a Radel® lid and base that together fully enclose a removable metal wire basket that holds items to be sterilized. A silicone gasket creates an air tight seal between the lid and base by means of metal latches. Two pressure actuated valves; one in the center of the lid and one in the center of the base, allow ingress and egress of steam sterilant into the container during the sterilization cycle and when closed form an airtight enclosure against separate silicone seals. The container comes in four sizes and is indicated for use with gravity-displacement and dynamic-air-removal sterilization modes recommended in ANSI/AAMI ST79 for immediate use steam sterilization (IUSS). Approved chemical indicators are recommended for use during each sterilization cycle.

Here's a breakdown of the acceptance criteria and study information for the FlashPak® Sterilization Container System, based on the provided document:

This document is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "study" described is a validation of additional sterilization parameters rather than a comparative effectiveness study in the typical sense of AI/human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this submission are based on the successful demonstration of sterilization efficacy for the newly added sterilization cycles. The existing acceptance criteria for the device's physical and chemical properties, material compatibility, and microbial barrier properties are implicitly met because the device itself is physically identical to the previously cleared predicate.

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

• Test Set: Biological indicators (BIs) with Geobacillus Stearothermophilus were used for efficacy testing. The document states "Half cycles were run three times for each sterilization mode, gravity displacement and dynamic-air removal." This means a total of 6 half-cycle runs were performed (3 for gravity-displacement, 3 for dynamic-air-removal). The number of BIs per run is not explicitly stated, but they were placed "throughout the container among the devices and four devices were directly inoculated."
• Data Provenance: The study was conducted by Symmetry Surgical, Inc. (the manufacturer) for their device. The provenance is internal, prospective testing conducted to validate the new sterilization parameters. No country of origin is specified for the data itself, but the company is located in Antioch, TN, USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable in the context of this device and study. The "ground truth" for sterilization efficacy is the sterility assurance level (SAL) achieved, which is a microbiological outcome determined through standardized laboratory testing, not expert consensus.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Sterilization efficacy is an objective outcome based on microbial growth, not a subjective interpretation requiring adjudication. Positive and negative controls were concurrently processed and passed, indicating proper test execution.

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:

• MRMC Study: No. This device is a sterilization container, not a diagnostic imaging device or an AI-powered tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Study: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Ground Truth: Microbiological outcome data, specifically the absence of microbial growth on biological indicators after sterilization and incubation, demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶. Thermal mapping data provided evidence of sterilant penetration.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is a physical device; there is no "training set" in the context of machine learning. The device was developed and validated through engineering design, material science, and microbiological testing, not machine learning.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no training set, there is no corresponding ground truth to establish in that context.

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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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