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Skeletal Dynamics Sterilization Trays are intended to contain Skeletal Dynamics reusable medical devices for convenient organized storage, sterilization and transport between usages. The full Din and half DIN trays include as accessories an insert to hold instruments and a caddy to hold implants and smaller components. The Akro-Vu tray only contains brackets to hold the Akro-Vu System's reusable components.

The full DIN and half DIN trays are suitable for use in both pre-vacuum steam and high temperature gravity steam sterilization methods. The Akro-Vu tray is suitable for use in pre-vacuum steam sterilization method. The trays are not intended to maintain sterility; they are intended to be used with a validated sterilization wrap in order to maintain the sterility of the enclosed devices.

Skeletal Dynamics Sterilization Trays are designed to contain Skeletal Dynamics reusable medical devices during transport, sterilization and storage and to allow optimal exposure of the tray's contents to sterilization process. The trays are intended ONLY for use with Skeletal Dynamics medical devices. The trays must be used in conjunction with an FDA cleared sterilization wrap in order to maintain the sterility of the contents.

The trays are different sizes of the same basic configuration and consist of a rectangular base with a lid that fastens to the base with latches. The trays have perforations on the lid, base bottom and sides. Insert trays with custom made brackets can be used to organize instruments and hold caddies in which smaller components are stored. The insert trays and caddies facilitate organization, storage and transport. They also contain perforations to allow optimal exposure of the tray's contents to sterilant during the sterilization process.

The document describes the Skeletal Dynamics Sterilization Trays and their performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for these sterilization trays are their ability to effectively allow sterilization of the contained medical devices according to validated sterilization parameters.

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

The document states that "Performance testing was conducted which confirmed that sterilization was achieved to the validated sterilization parameters above indicated for all three device models..." This implies that the three distinct device models (TRAY-STT-CBF1, TRAY-STT-CBH1, AKR-CTR-CBC1) were part of the test set. The exact number of units of each model tested is not specified.

The data provenance is retrospective, as the testing was conducted to support a 510(k) submission for a device already developed. The country of origin of the data is not explicitly stated, but it is for a US FDA submission, suggesting the testing was likely conducted in the US or under US regulatory standards.

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

This information is not provided in the document. For sterilization efficacy testing, ground truth is typically established by laboratory methods (e.g., sterility testing of Biological Indicators or Process Challenge Devices) rather than expert consensus on images or observations.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in diagnostic imaging or clinical trials where expert opinions may differ. For objective performance testing of sterilization efficacy, such adjudication is not applicable. The assessment would involve direct measurement of sterility based on established laboratory protocols.

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 used to evaluate the impact of a new technology (like an AI algorithm) on human reader performance, often in diagnostic settings. The Skeletal Dynamics Sterilization Trays are physical medical devices for containing instruments during sterilization, not diagnostic tools.

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

No, a standalone algorithm-only performance study was not done. This concept is not applicable to the Skeletal Dynamics Sterilization Trays, as they are not software algorithms. The performance testing described is for the physical device's ability to facilitate sterilization.

7. The Type of Ground Truth Used:

The ground truth used for this type of performance testing is sterility, as determined by validated laboratory methods (e.g., inoculation of biological indicators and subsequent incubation to check for microbial growth, or other standard sterility assurance level testing). The document states that "sterilization was achieved," implying such objective methods were used to confirm efficacy.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The Skeletal Dynamics Sterilization Trays are physical medical devices, not an AI or machine learning model that requires a training set.

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

This information is not applicable. As these are physical medical devices and not an AI/ML model, there is no training set or associated ground truth establishment for a training set.

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