Search Results

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.

Ask a specific question about this device

ONE TRAY® Sealed Sterilization Containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments or an instruments or an instrument set for immediate use following flash sterilization. This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm.

After sterilization, ONE TRAY provides for the safe transport and assured delivery for immediate use of the enclosed devices in a sealed container with tamper evident security and load record documentation according to AAMI and AORN guidelines.

ONE TRAY® is a sealed rigid container with a rectangular patterned group of perforations forming vented areas in the lid and base. Dispossable hydrophobic SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filters cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.

The provided 510(k) summary for the "ONE TRAY® Sealed Sterilization Container" (K052567) details its intended use and performance testing relative to predicate devices. However, it does not contain specific numerical acceptance criteria or a detailed study report that would typically include the requested information for AI/ML device evaluations.

This submission is for a physical medical device (a sterilization container), not an AI/ML diagnostic or predictive device. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set sample size," or "expert qualifications for ground truth," are not applicable.

The performance testing described is focused on the functional equivalence of the sterilization container to predicate devices, assessing its ability to achieve sterilization and maintain sterility.

Here's a breakdown of the information available based on your request, with a clear indication of what is not present due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "laboratory tests" but does not detail the number of containers tested, cycles performed, or specific test articles used.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been conducted by the manufacturer, Sterile Containment Technology, LLC, likely in a controlled laboratory environment. It is a prospective evaluation as the device was being developed and tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. This information is not relevant for a physical sterilization container. "Ground truth" in this context would refer to objective measurements of sterility, steam penetration, integrity, etc., performed in a laboratory, not subjective interpretations by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, typically in diagnostic imaging or clinical trials involving human readers. This is not applicable to performance testing of a physical sterilization container.

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

• N/A. This device is not an AI-assisted diagnostic tool, so an MRMC study and
  measurement of human reader improvement with AI assistance are irrelevant.

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

• N/A. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device would be established through objective laboratory measurements based on recognized standards for sterilization (e.g., AAMI, AORN guidelines mentioned) and device performance (e.g., sterility indicators, microbial challenge tests, physical integrity assessments). It would not be expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic tools.

8. The sample size for the training set

• N/A. This device does not involve a training set as it's not an AI/ML algorithm.

9. How the ground truth for the training set was established

• N/A. Not applicable, as there is no training set for this physical device.

Ask a specific question about this device