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The VersiTomic™ ACL Flexible Reamer System Sterilization Trav is indicated to enclose the VersiTomic ACL Flexible Reamer System instruments that are to be sterilized by a health care provider.

The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside.

The VersiTomic™ ACL Flexible Reamer System Sterilization tray has been validated with a load that consists of various metallic instruments and implants up to a length of 340 mm and minimum internal diameter of 1.4 mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally within the tray.

The VersiTomic™ ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters:

Gravity-Displacement Steam Sterilization

• Sterilizer Type: Gravity .
• Minimum Temperature: 132°C (270°F) .
• Minimum Exposure Time: 10 minutes .
• Minimum Dry Time: 40 minutes .

Pre-Vacuum Steam Sterilization

• Sterilizer Type: Pre-Vacuum .
• Minimum Temperature: 132°C (270°F) ●
• Minimum Exposure Time: 4 minutes .
• Minimum Dry Time: 15 minutes .

The VersiTomic ™ACL Flexible Reamer System Sterilization Tray is a reusable sterilization container system intended to be used to enclose other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and also (when properly wrapped) maintain their sterility device until used. This device is made of durable materials and designed with perforations or slots to allow for steam penetration. It is constructed of machined and formed metal.

The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside.

The device in question is the "VersiTomic™ ACL Flexible Reamer System Sterilization Tray," a reusable sterilization container system.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states the device "has been validated with a load that consists of various metallic instruments and implants." It describes the characteristics of this load (length, minimum internal diameter, and maximum weight). However, the exact sample size (number of sterilization cycles, number of trays tested, number of instruments per tray) is not explicitly provided.

The data provenance is from T.A.G. Medical Products Corporation, Ltd. in Israel, submitted to the FDA by MedicSense, USA. This appears to be prospective testing conducted specifically for the purpose of validating the sterilization tray's performance.

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

This information is not provided in the document. For a sterilization container, the "ground truth" would typically involve microbiological culture tests (e.g., spore-bearing coupons) to confirm sterility after the sterilization cycle. Such tests are usually performed by trained laboratory personnel or microbiologists, but the specific number or qualifications are not mentioned.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of medical images or data where there might be inter-reader variability. For a device validation study like this, the results of physical and microbiological tests are objective measures that do not require expert adjudication in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The VersiTomic™ ACL Flexible Reamer System Sterilization Tray is a passive medical device for sterilization, not an AI or diagnostic imaging tool.

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

Yes, the study was effectively a standalone performance test of the device. While there's no "algorithm" in the conventional AI sense, the validation tests demonstrate the performance of the sterilization tray itself, under specified sterilization parameters, without human intervention in the sterilization process needing to compensate for device shortcomings. The goal was to show the device's inherent capability to facilitate sterilization.

7. The Type of Ground Truth Used:

The ground truth used for this type of validation typically involves:

• Physical and chemical indicators: To confirm that the specified sterilization parameters (temperature, exposure time, steam penetration) were met inside the tray.
• Biological indicators: Contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that are placed within the tray. Their absence of growth after the sterilization cycle confirms that a sufficient sterilizing agent has reached them, thus establishing a high level of sterility assurance (sterility ground truth).
• Functionality testing: To ensure the instruments remain contained and undamaged, and that the tray itself withstands the sterilization process without degradation.

While the document summarizes the validated parameters, it does not explicitly detail the specific ground truth methodologies (e.g., which biological indicators were used, specific culture results). However, "validated for steam sterilization" implies these standard methods were employed.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. A "training set" refers to data used to train a machine learning algorithm. The VersiTomic™ ACL Flexible Reamer System Sterilization Tray is a physical medical device, not an AI system. Its performance is evaluated through validation testing, not by training algorithms.

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

This information is not applicable as there is no training set for this type of medical device.

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