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The Olympus MAJ-172 Instrument Tray for LTF Videoscope is intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in medical facilities to accommodate an endoscope from the Olympus LTF range of videoscopes, plus certain identified accessories, for reprocessing by autoclaving (steam) or ETO sterilization (depending on the model). LTF Type 160 and VH videoscopes are compatible with Steam and ETO sterilization cycles. LTF Type V3 and VP are compatible only with ETO sterilization cycles.

The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and its accessories for sterilization at a healthcare facility. Refer to the instrument tray instructions for use for the proper orientation of the videoscope and accessories within the instrument tray. The recommended sterilization cycles for the LTF videoscopes are as follows:

ETO Sterilization .. . .. 100% ETO concentration: 735 mg/L Temp: 57 °C -------------Relative Humidity: 70% Processing (Hold) Time: 1 hour Aeration Time: 12 hours

Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temp: 135 °C Exposure Time: 3 minutes Drving Time: 20 minutes

The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a polymer tray with a perforated lid intended to secure an endoscope and accessories during exposure to gaseous sterilization methods.

The provided document, K122818, is a 510(k) summary for the Olympus MAJ-172 Instrument Tray for LTF Videoscope. This document details the device's substantial equivalence to predicate devices based on non-clinical performance testing. It is important to note that this document is for a medical device tray used for sterilization, not an AI/ML-driven diagnostic or prognostic device, therefore many of the requested criteria regarding AI model evaluation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.

Here's an analysis based on the available information:

1. Acceptance Criteria and Reported Device Performance

The device is a non-measuring, non-analytical, and non-AI product. Its "performance" is determined by its ability to safely contain and allow sterilization of specific medical instruments without degradation or compromise. The acceptance criteria are implicitly derived from the design specifications and the tests conducted.

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

This is not applicable as the device is a physical instrument tray, not an AI model that processes data. The "test set" would refer to the physical units of the instrument tray used in the non-clinical studies. The document does not specify the exact number of trays tested.

• Data Provenance: The (non-clinical) studies were conducted by KeyMed (Medical & Industrial) Ltd. in the United Kingdom, as indicated by the submitter's address. The studies are by nature prospective with respect to the testing of the specific MAJ-172 trays.

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

This is not applicable for a physical device like a sterilization tray. "Ground truth" in this context would be established by validated engineering and microbiological testing methods, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. The performance was assessed through established laboratory and engineering testing protocols, not through expert adjudication of ambiguous cases.

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

No, an MRMC study was not done as this is a physical medical device, not a diagnostic or prognostic AI/ML system.

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

Yes, in a sense, the performance described is "standalone" in that it refers to the intrinsic capabilities of the physical device to withstand various sterilization processes and functional demands. There is no "algorithm" or "human-in-the-loop" concept applicable here. The device's performance was evaluated independently.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the sterilization tray was established through:

• Engineering and Physical Testing: Such as simulated use tests, drop testing, and resistance to chemical agents, which evaluate the physical integrity and durability of the tray.
• Sterilization Efficacy Studies: These studies confirm that the tray allows effective sterilization of its contents without impeding the sterilant's penetration or compromising the sterility maintenance, as validated by microbiological assays in accordance with relevant standards. These would involve monitoring parameters like temperature, pressure, exposure time, and potentially biological indicators to confirm sterilization.

8. The Sample Size for the Training Set

This is not applicable. As a physical device, there is no "training set" in the context of machine learning. The design and manufacturing process would involve engineering specifications and quality control, not AI model training.

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

This is not applicable for the reasons stated above. The "ground truth" for product development would be established through engineering design principles, material science, and regulatory standards for medical device manufacturing.

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The Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray.

The trays are indicated for ETO sterilization of only of the following :

Gyrus ACMI Flexible Endoscopes ICN-0564, ICN-0565 ICN DUR-D DUR-D, DUR-DBA
ACN ACN-2T, ACN-2TBA DUR-8 DUR-8, DUR-8-BA, DUR-8E, DUR-8E-BA,DUR-8 Ultra AUR AUR AUR-7. AUR-735

EtO Sterilization parameters:

EtO Sterilize using 100% ethylene oxide

Temp: 55°C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 725-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃

The Gyrus ACMI® Flexible Endoscope Storage-Sterilization trays are comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage. The trays are constructed of biocompatible RADEL-R. The trays do not contact the patient. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with EtO sterilization.

The Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays are designed to protect Gyrus ACMI flexible endoscopes during Ethylene Oxide (EtO) sterilization, using an FDA-cleared sterilization wrap. The key acceptance criterion is to ensure that the trays allow for effective EtO sterilization and maintain sterility through the wrap.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Sample Size for Test Set: The document mentions "PCDs (process challenge devices) were placed in the trays" and "Test systems were exposed to 60 minute full cycles". This implies multiple trays with PCDs were tested. However, a specific numerical sample size (e.g., number of trays, number of cycles per tray) for the sterilization effectiveness and residual testing is not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission to the U.S. FDA for regulatory clearance. The study appears to be prospective in nature, as new testing was conducted specifically for this device (e.g., "The PCDs...were placed in the trays and inoculated...").

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• This study is a physical and chemical performance test rather than a diagnostic device that requires expert interpretation of results for ground truth.
• The "ground truth" for sterilization effectiveness (6 log reduction) is established by industrial standards and scientific principles related to biological indicators (e.g., spore-forming bacteria) and their inactivation kinetics. This does not involve human experts establishing a "ground truth" in the same way as, for example, radiologists interpreting images.
• For EtO residual testing, the "ground truth" is adherence to established chemical safety standards like ISO 10993-7, which are objective measurements.

4. Adjudication Method for the Test Set:

• No adjudication method (e.g., 2+1, 3+1) is applicable or mentioned, as this is not a study involving human interpretation or subjective assessment of results. The results are based on objective, quantifiable measurements of biological indicator inactivation and chemical residue levels.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays are a medical device accessory for sterilization, not a diagnostic tool, and their performance is evaluated through physical and chemical testing.

6. Standalone Performance:

• A standalone performance study was done. The described testing, where PCDs and chemical indicators were placed in the trays and processed through sterilization cycles, is a direct assessment of the device's ability to facilitate effective sterilization without human intervention in the sterilization process itself (beyond loading and operating the sterilizer).

7. Type of Ground Truth Used:

• The ground truth for sterilization effectiveness was based on the inactivation of biological indicator organisms (demonstrating a 6 log reduction, or a sterility assurance level of $10^{-6}$), which is an objective, scientifically established method for validating sterilization processes.
• The ground truth for Ethylene Oxide residuals was based on compliance with ISO 10993-7, a recognized international standard for the biological evaluation of medical devices, specifically regarding acceptable limits for EtO residuals.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical accessory evaluated through performance testing, not an algorithm or AI system that requires a training set of data.

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

• Not applicable, as there is no training set for this type of device.

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