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The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks.
The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated or non-perforated bottoms. All models are intended to be used with single use paper filter.
The container is a reusable device designed to be used with the following sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle:
4 minutes
132°C (270 °F)
Drying Time Minimum: 30 minutes

The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. They consist of various sizes of bottoms and lids that provide an effective packaging method for sterilization, storage and transportation of surgical instruments by healthcare providers. These containers are suitable for use in pre-vacuum Steam Sterilizers with a tray or basket accessory. Metal (Stainless Steel) surgical instruments like forceps, scissors, clamps, etc. including lumened/cannulated instruments are placed in the trays or baskets for sterilization.
Note: The maximum number of Lumens/Lumen Configuration is as follow:
2 lumens with ≥ 1mm I.D. x ≤ 200mm and a second lumen ≥ 5mm I.D. x ≤ 400mm
The containers are available in different models such as full size (1/1), three-quarter size (3/4), half size (1/2) and XL.
InstruSafe® Sterilization Container is manufactured using aluminum alloy, stainless steel, silicone and the surfaces are protected by a layer of anodized aluminum oxide to prevent corrosion.
The containers must only be used with single use paper filters.

This document describes the regulatory submission for the InstruSafe® Sterilization Container (K180528) and demonstrates its substantial equivalence to predicate devices. The information provided heavily relies on non-clinical performance data rather than a study with human readers or AI algorithms. As such, many of the requested data points related to MRMC studies, training sets, and expert consensus for ground truth are not applicable to this type of device and submission.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through various non-clinical performance tests, ensuring its ability to sterilize enclosed medical devices and maintain sterility.

Study Proving Device Meets Acceptance Criteria

The studies detailed for the InstruSafe® Sterilization Container are non-clinical, bench-validation studies, rather than clinical trials or AI performance evaluations.

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

   • The document does not specify numerical sample sizes for the non-clinical tests (e.g., number of containers tested, number of sterilization cycles performed, or number of microbial challenges). It states "The sterilization containers were tested..." which implies a sufficient number for validation, but no precise count is given.
   • Data Provenance: The studies were non-clinical bench testing. The country of origin for the data is not explicitly stated but can be inferred to be in the USA, given the FDA submission. The studies were designed to be prospective validation tests according to established medical device testing standards.

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

   • This is not applicable as the studies are non-clinical, bench-level performance validations for a sterilization container. Ground truth is established by objective measurements against predefined industry standards (e.g., AAMI, ISO) rather than subjective expert interpretation of medical images or data.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human readers and subjective assessments (e.g., radiology reads). For non-clinical, objective performance testing, results are determined by adherence to pre-defined scientific and engineering standards and pass/fail criteria.

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 device is a reusable sterilization container and does not involve AI or human "readers" in the context of medical image interpretation or diagnosis. Therefore, an MRMC comparative effectiveness study was not performed.

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

   • Not applicable. This device is a physical medical device (sterilization container), not an AI algorithm.

6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device is based on objective, verifiable measurements against established medical device sterilization, biocompatibility, and mechanical performance standards, such as those published by AAMI (Association for the Advancement of Medical Instrumentation) and ISO (International Organization for Standardization). For example:
     • Sterilization Efficacy: Measured by indicator organisms (bioburden reduction) after a sterilization cycle.
     • Dry Time: Measured objectively following a sterilization cycle.
     • Sterility Maintenance/Microbial Aerosol Challenge: Measured by preventing microbial ingress over time.
     • Biocompatibility: In vitro and in vivo tests against ISO 10993 standards.
     • Mechanical Integrity: Measured by stress tests, weight limits, and functional checks.

7. The Sample Size for the Training Set:

   • Not applicable. This device is hardware, not a machine learning model, so there is no "training set."

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As there is no training set for a machine learning model, this question is irrelevant to the described device.

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