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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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The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) 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 of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks.

The SterilContainer with PrimeLine Pro Lid is used in conjunction with Aesculap's Sterilcontainer Systems (K792558/K944864/K053389/K112671). The SterilContainer with PrimeLine Pro Lid is designed to be compatible for use with pre-vacuum steam and IUSS sterilization. The lid is manufactured from anodized aluminum and utilizes a reusable polytetrafluoroethylene (PTFE) filter. The SterilContainer with PrimeLine Pro Lid is offered in a various colors and range of sizes as the predicates including full, ¾, and half sizes lids.

The Aesculap SterilContainer with PrimeLine Pro Lid is a reusable sterilization container system designed to sterilize and maintain the sterility of medical devices. The device was found to be substantially equivalent to its predicate devices based on non-clinical performance testing.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each test. It mentions that "Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size." The data provenance is not specified, but the testing was conducted by a "qualified testing laboratory" in accordance with FDA guidance and AAMI standards. This indicates a prospective and controlled experimental design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is not an AI/imaging device requiring expert interpretation for ground truth. The performance testing involves objective measures of sterilization efficacy, microbial challenge, sterility maintenance, and cleaning effectiveness, which do not typically rely on expert consensus for ground truth establishment in the same way an AI diagnostic tool would.

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

Not applicable. As noted above, this device does not involve human interpretation or subjective assessment that would require an adjudication method.

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

Not applicable. This is not an AI device, so MRMC studies and the concept of human readers improving with AI assistance are not relevant.

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

Not applicable. This is not an algorithm-based device. The testing focuses on the physical and functional performance of the sterilization container system.

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

The ground truth for the performance testing is based on established scientific and regulatory standards for sterilization, microbial challenge, sterility maintenance, and cleaning efficacy.

• Sterilization Efficacy: Ground truth is a 6 log reduction and SAL of $10^{-6}$ as per biological indicator results and half-cycle validations.
• Microbial Aerosol Challenge: Ground truth is the absence of microbial growth in the contents after exposure to a defined amount of aerosol microorganisms.
• Event Related Sterility Maintenance: Ground truth is the absence of microbial growth in the contents after storage periods, indicating sterility was maintained.
• Cleaning Effectiveness: Ground truth is a protein level of less than $6.4 \mu g/cm^2$ and a hemoglobin level of less than $2.2 \mu g/cm^2$ per device, as determined by laboratory analysis.

These are objective, measurable outcomes based on established scientific principles and regulatory benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set for this device, a method for establishing its ground truth is not relevant.

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