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The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.

The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices which meet national or international specifications. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation/Sterilization Cassettes design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components of the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for sterilization via steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Thus allowing the Medtronic Transportation/Sterilization Cassettes to be effective for sterilization and are designed such that they withstand the environment of repeated steam sterilization cycles.

The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation. They are not intended to maintain sterility on their own but are to be used with an FDA-cleared sterilization wrap. The device was evaluated for its ability to withstand the distribution environment, achieve sterility, and for biocompatibility.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Gravity Displacement:

• 250°F (121°C) for 30 minutes, 30 minutes dry time
• 270°F (132°C) for 15 minutes, 30 minutes dry time
• 275°F (135°C) for 10 minutes, 30 minutes dry time

Dynamic-Air-Removal (4 Pre-conditioning pulses):

• 270°F (132°C) for 4 minutes, 30 minutes dry time
• 275°F (135°C) for 3 minutes, 30 minutes dry time |
  | Durability (Distribution Environment) | The Medtronic Transportation/Sterilization Cassettes were able to withstand the distribution environment. Testing was conducted in accordance with ASTM D4169: 2009 – "Standard Practice for Performance Testing of Shipping Containers and Systems". |
  | Biocompatibility | Materials used in the Medtronic Transportation/Sterilization Cassettes are biocompatible, including thermoplastic polymers, aluminum, and stainless steel. An assessment based on ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" concluded that if substances were to transfer, they would not present a chemical hazard. The device does not have direct patient contact. |

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 specify a distinct "test set" sample size for the performance validation in the way a clinical trial would. Instead, the validation involved a "worst case" Medtronic Transportation/Sterilization Cassette configuration. This configuration was described as:

• Dimensions: 22.75 x 11.26 x 5.5 inches
• Total Weight: 28.4 lbs (including implants and common surgical instruments)
• Lumen Dimensions (worst case): 363 x 1.575mm and 247.5 x 4.1mm

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, the testing was prospective and conducted by the manufacturer, Medtronic Sofamor Danek, likely in the USA where the company is located.

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 information is not applicable. The ground truth for sterilization validation is established through recognized and standardized microbiological and physical testing methods (e.g., biological indicators, chemical indicators, physical monitoring) designed to demonstrate a specific Sterility Assurance Level (SAL). It does not involve human expert consensus in the same way a diagnostic imaging study would.

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

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. The performance testing for this device (sterilization validation, durability, biocompatibility) relies on objective, standardized laboratory measurements and methodologies.

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:

No. A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic AI devices where human readers interpret medical images or data. The Medtronic Transportation/Sterilization Cassettes are physical medical device accessories for sterilization and transportation, not an AI-powered diagnostic tool.

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

Yes, the performance testing was effectively "standalone" in that the device's ability to maintain sterility, withstand distribution, and its biocompatibility were evaluated directly through standardized physical and microbiological tests. There is no "algorithm" or "human-in-the-loop" component to the function of this medical device. The validation confirmed the device's inherent design capabilities.

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

The ground truth used for the performance evaluation was established through adherence to recognized industry standards and scientific principles for sterilization, durability, and biocompatibility.

• For Sterilization: The ground truth for sterility was defined by achieving a Sterility Assurance Level (SAL) of $10^{-6}$, which is a universally accepted standard for terminally sterilized medical devices. This is demonstrated through biological indicator (BI) and physical parameter monitoring as per AAMI and ISO standards.
• For Durability: The ground truth for durability was the successful completion of distribution testing as per ASTM D4169: 2009, indicating the device's ability to withstand simulated shipping environments without damage affecting its function.
• For Biocompatibility: The ground truth for biocompatibility was compliance with ISO 10993-1:2009, demonstrating that the materials are suitable for their intended use and do not pose a chemical hazard.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical device accessory, not a machine learning model. Therefore, there is no "training set" in the context of AI or 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 device.

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