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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 are intended for transport of non-sterile loads.

The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials which meet national or international specifications and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. 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 document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Medtronic Transportation/Sterilization Cassettes (K190840).

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

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of typical AI/ML medical devices (e.g., patient data). The testing performed seems to be for the physical characteristics and sterilization efficacy of the medical device (cassettes).

• Distribution Simulation Validation: The sample size for outer cases and inner trays is not explicitly mentioned, but the test involves subjecting these items to distribution cycles.
• Biocompatibility Testing: Not applicable to the cassettes themselves, but to the medical devices used in conjunction with them. No sample size for devices or data provenance (e.g., country of origin, retrospective/prospective) is provided for this aspect.
• ANSI/AMMI ISO 17665-1 (Sterilization Validation): The sample size refers to the "worst case" Medtronic Transportation/Sterilization Cassettes (22.75 x 11.26 x 5.5 inches), loaded with implants and common surgical instruments (total weight 28.6 lbs), including worst-case lumen dimensions. The number of cassettes or specific instruments tested is not quantified as a sample size.

Given the nature of the device (sterilization cassettes) and the tests conducted, the data provenance is likely from laboratory testing and engineering evaluations rather than clinical patient data. The document does not specify countries of origin or whether the data is retrospective or prospective, as these are not relevant to device performance for this type of product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for the performance testing is based on established industry standards (ASTM D4169-14, ISO 10993, ANSI/AAMI ISO 17665-1) and objective measurements.

4. Adjudication method for the test set

Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results. The "ground truth" is defined by the objective pass/fail criteria of the specified engineering and sterilization standards.

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. The device is a physical sterilization cassette, not an AI/ML diagnostic tool that assists human readers.

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

Not applicable. The device is a physical sterilization cassette, not an algorithm.

7. The type of ground truth used

The ground truth for the performance testing is based on:

• Objective Visual Inspection: For distribution simulation, assessing obvious damages.
• Compliance with Standards: For biocompatibility (ISO 10993) and sterilization efficacy (ANSI/AAMI ISO 17665-1), meeting defined performance metrics like an SAL of 10^-6. These are scientific and engineering benchmarks rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device, and therefore, does not have 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.

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The Medtronic Transportation Cassettes are intended for use in healthcare facilities to organize, enclose, sterlize, transport, and store medical devices and other instrumentation between surgical uses. The Medtronic Transportation/Sterilization Cassettes are not intent own to maintain sterility; they are 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 standards. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; they are 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 if 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 steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA-cleared wrap must be used for sterilization 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. As such, the Medtronic Transportation/Sterilization Cassettes are effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is a 510(k) summary for a medical device (Medtronic Transportation/Sterilization Cassettes) that states no changes were made to the device itself, only to the labeling to add manual cleaning instructions.

Therefore, the document explicitly states that the original biocompatibility and verification/validation data still applies, and it does not provide new, detailed acceptance criteria and performance data for the device's primary function of sterilization and transport. It mentions a cleaning validation study was performed for the new manual cleaning instructions, but provides no details on its methodology, sample size, or specific acceptance criteria and results beyond stating it was "effective."

Without specific acceptance criteria and reported device performance (e.g., sterilization efficacy rates, barrier properties, mechanical durability under specific tests), and details on the study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, etc.), I cannot fulfill your request.

Ask a specific question about this device

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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