Search Results

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.

Ask a specific question about this device

The Gyrus ACMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACMI telescopes during Steam Sterilization using the following parameters:

STEAM Sterilization Parameters:

The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI telescopes. Telescopes without lumens up to 31 cm in length may be sterilized in the tray with a diameter between 2.7mm to 4mm. Two telescopes can be sterilized at one time.

Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the approved sterilization wrap and follow recommended storage conditions and timeframes for shelf life of the sterilization wrap.

The Gyrus ACMI Telescope Storage-Sterilization Trav is a two-piece container made of a plastic lid containing 14 holes, and a plastic trav containing 18 holes that permit ready ingress of Steam. The tray provides protection to the telescopes during sterilization and storage.

The provided document, K120474, describes the Gyrus ACMI Telescope Storage-Sterilization Tray. This is a medical device, and the information presented is for a 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report with performance metrics in the way one would for a diagnostic or AI-driven decision support system.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of device submission. The "study" described is a validation of the sterilization process through parameters, not a clinical performance study.

Here's an attempt to populate the table and answer the questions based on the available information:

Acceptance Criteria and Device Performance for Gyrus ACMI Telescope Storage-Sterilization Tray (K120474)

The Gyrus ACMI Telescope Storage-Sterilization Tray is intended for use in steam sterilization. The "acceptance criteria" for this device are fundamentally linked to its ability to facilitate effective steam sterilization and protect the enclosed telescopes. The "performance" is demonstrated by its compatibility with specific sterilization parameters and its design features that allow for proper steam ingress.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of statistical analysis of a diagnostic or AI device. The validation described is for the sterilization process parameters using the tray. While specific numbers of sterilization cycles or tests are implied by "validation," the sample size and data provenance (country of origin, retrospective/prospective) are not detailed in this 510(k) summary. This is typical for a device like a sterilization tray where the focus is on process validation rather than clinical outcome studies.

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

Not applicable. There is no mention of experts establishing a "ground truth" for a test set in the context of this device. The "ground truth" for sterilization effectiveness would be defined by standard microbiological testing and physical indicators during the validation process, which is established by established protocols and regulatory standards, not expert consensus on individual cases.

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

Not applicable. There is no test set requiring expert adjudication for this type of device.

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 not a diagnostic device or an AI-assisted device.

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

Not applicable. This is not an algorithmic device.

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

For the sterilization effectiveness, the "ground truth" is established by adherence to validated sterilization parameters, successful inactivation of biological indicators if used, and sterility assurance levels as defined by relevant standards (e.g., AAMI/ANSI ST77, ST79). For biocompatibility, the ground truth is established by material testing against ISO10993-1. These are physical/microbiological truths, not expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device requiring a training set.

Ask a specific question about this device