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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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FlashPak® is a reusable rigid container system to be used during flash sterilization by hospitals and healthcare facilities. It is intended to enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravitydisplacement flash sterilization using a 10 minute cycle at 132° C and with pre-vacuum flash sterilization using a 4 minute cycle at 132° C. FlashPak is recommended for surface sterilization of stainless steel instruments and for 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).

The FlashPak Container System consists of a family of rigid reusable containers that provide an effective sterilization packaging method for surgical instruments requiring flash steam sterilization. Each FlashPak system is comprised of an upper lid that seals by means of a silicone gasket and latches to a lower base creating a totally enclosed environment. A stainless steel wire basket is utilized inside the container to facilitate handling of sterilized items. The lid and base incorporate pressure actuated valves that open to allow sterilant to enter the container during the pressurization portion of the sterilization cycle and then close to seal the container once the cycle is over so the container and its contents can be removed from the sterilizer and immediately transported to the point of use without the risk of recontamination.

This is not an AI-enabled device. This is a medical device, specifically a sterilization container system, for which the submitted information confirms its substantial equivalence to a predicate device.

Therefore, questions regarding AI-specific elements such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established are not applicable.

Here's the relevant information based on the provided text for the FlashPak® Sterilization Container System:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are established by demonstrating that it functions as intended and is substantially equivalent to a legally marketed predicate device (K871202) by meeting applicable standards, specifically ANSI/AAMI ST77:2006 "Containment Devices for Reusable Medical Device Sterilization".

The "performance" section of the 510(k) summary (page 2) outlines the key performance aspects that were evaluated.

Study Information

The study demonstrating the device meets the acceptance criteria is a series of performance tests and validations adhering to the ANSI/AAMI ST77:2006 standard.

1. Sample size used for the test set and the data provenance:

   • The document does not specify exact sample sizes for each test (e.g., number of containers tested, number of sterilization cycles). It states that "Testing to applicable standard, ANSVAAMI ST77:2006... has been completed with acceptable outcomes."
   • Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing conducted by Symmetry Medical Inc. (the device manufacturer). This would typically be prospective testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device is defined by passing specific physical, chemical, and biological performance tests according to established standards. This is not a diagnostic device requiring expert interpretation of results.

3. Adjudication method for the test set: Not applicable. Test results are objectively measured against predefined criteria in the standard.

4. 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: Not applicable. This is not an AI-enabled device and does not involve human readers interpreting data.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used:

   • Performance against established standards: The ground truth is determined by objective measurements and biological indicators (e.g., sterility assurance level for sterilization validation, absence of cytotoxicity/irritation for biocompatibility, physical integrity for handle strength/valve life) as defined in ANSI/AAMI ST77:2006 and ISO 10993 standards.

7. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning device. The design and manufacturing process for the physical device are based on engineering principles and material science.

8. How the ground truth for the training set was established: Not applicable. No training set is used for a physical medical device like this.

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