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The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Utra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra Sterilization Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:

Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes

Vacuum Dry: 20 minutes

The iDrive™ Ultra sterilization tray is an optional, over-the counter, accessory to aid in storage and sterilization of the iDrive™ Ultra powered handle, Endo GIA™ adapter, iDrive™ battery insertion guide and iDrive™ Ultra manual adapter tool. It can simultaneously accommodate the following components:

One (1) iDrive™ Ultra powered handle

Two (2) Endo GIA™ adapters

Two (2) iDrive™ battery insertion guides

One (1) iDrive™ Ultra manual adapter tool

The iDrive™ Ultra sterilization tray is an aluminum tray which is perforated to allow penetration of steam during steam sterilization. The tray can be processed through a minimum autoclave cycle of either 134°C for 3 minutes or 132°C for 4 minutes while being wrapped with a CSR wrap or within a sterilization container system.

Here's an analysis of the provided text regarding the iDrive™ Ultra sterilization tray, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a new clinical study. As such, information regarding AI performance metrics (like sensitivity, specificity, F1 score), sample sizes for AI training/testing, expert qualifications, and MRMC studies will not be present as this device is a physical sterilization tray, not an AI diagnostic or assistive tool.

1. Table of Acceptance Criteria and Reported Device Performance

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

Due to the nature of the device (a physical sterilization tray) and the document (510(k) Summary), this information is not applicable in the context of an AI/algorithm test set. The "test set" here refers to the actual physical trays and associated sterilization equipment used for physical, performance-based testing.

• Sample Size: Not explicitly stated as a number of "samples" in the way an AI study would define it. The testing involved multiple sterilization cycles and evaluations on the physical device. Typically, for such devices, a statistically significant number of cycles or tests are performed (e.g., n=3 for replicates, or stress testing until failure for durability), but the exact numbers are not detailed in this summary.
• Data Provenance: Not explicitly stated. The testing would have been conducted by Covidien, LLC, likely in their own laboratories or through contract labs. It's prospective testing for the purpose of this submission.
• Country of Origin: Not specified for the testing itself, but the submitter is Covidien LLC from North Haven, CT, USA.

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

This is not applicable as the device is a physical sterilization tray, not an AI system requiring expert-derived ground truth. The "ground truth" for sterilization effectiveness would be determined by objective measures (e.g., biological indicators, chemical integrators, sterility assays, temperature/pressure monitoring) according to validated protocols, not expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

Not applicable for a physical device. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert ratings are resolved for diagnostic classifications, which is irrelevant for a sterilization tray.

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 a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of a sterilization tray involves objective, verifiable outcomes related to sterilization efficacy and device integrity:

• Sterilization Efficacy: Achieved by passing established sterilization cycle parameters (temperature, pressure, time, vacuum dry time) and demonstrated sterility through biological indicators (killing of spore-forming bacteria), chemical indicators (color change), and physical monitoring of the autoclave cycle.
• Material Compatibility: Demonstrated by conformity to ISO 10993-1.
• Durability/Reusability: Demonstrated by the tray's physical integrity and functional performance after repeated sterilization cycles.
• Containment/Organization: Demonstrated by the physical fit of the specified components within the tray.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

Summary of the Study Proving Device Meets Acceptance Criteria (from the 510(k) Summary):

The document states: "PERFORMANCE DATA: Testing has been performed and includes testing to the following standards: - ANSI/AAMI ST77:2006 - AAMI TIR30:2003 ."

These standards are critical for sterilization practices and medical device material compatibility, respectively:

• ANSI/AAMI ST77:2006 (or its current version): This standard typically covers "Containment devices for reusable medical device sterilization." It would detail requirements and test methods for instrument trays, wrappers, and containers regarding their ability to facilitate sterilization, prevent recontamination, and withstand reprocessing.
• AAMI TIR30:2003 (or its current version): This Technical Information Report (TIR) from AAMI focuses on "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices." While the tray itself isn't a "reusable medical device" in the same sense as an instrument, this TIR often provides guidance on material compatibility and resistance to reprocessing methods, including sterilization.

Implicit Study Design:

The "study" would involve:

1. Preparation: Loading the iDrive™ Ultra sterilization tray with the specified maximum configuration of instruments/components.
2. Sterilization Cycles: Running the loaded tray through the specified prevacuum steam cycles (132°C for 4 minutes and 134°C for 3 minutes, both with a 20-minute vacuum dry time) in a validated autoclave, likely using an FDA-cleared sterilization wrap.
3. Sterility Assurance: Monitoring the sterilization cycle parameters, and using biological and chemical indicators to confirm that sterility was achieved within the tray.
4. Material Compatibility/Integrity: Visual and functional inspection of the tray and its components after multiple sterilization cycles to ensure no degradation, melting, warping, or other adverse effects that would compromise its function or the sterility of the contents.
5. Biocompatibility: Evidence of compliance with ISO 10993-1, likely through material certificates and prior evaluations of the silicone and aluminum materials.
6. Load Capacity Testing: Demonstrating that the tray can safely support 15 pounds without structural failure.

The "acceptance criteria" are implied by the successful completion of these tests in accordance with the cited standards and the stated operational parameters for the device. The conclusion of the 510(k) is that, based on this testing and comparison to predicate devices, the iDrive™ Ultra sterilization tray is substantially equivalent and safe and effective for its intended use.

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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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