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Avinent Sterilization Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes.

Device Description

The Avinent Sterilization Cassettes are a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components – a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The trays in this submission are Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows them to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K191566. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

AI/ML Overview

The provided text is related to the FDA 510(k) premarket notification for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The document details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical testing.

However, the questions you've asked are typically relevant to studies evaluating the performance of AI/ML-driven medical devices (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details).

Since the Avinent Sterilization Cassettes are a physical medical device (sterilization trays), and not an AI/ML software or diagnostic tool, many of the requested data points (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, ground truth types related to expert consensus or pathology, etc.) do not apply to this type of submission.

The "studies" described are validation tests for the physical properties and functionality of the sterilization cassettes themselves (e.g., cleaning validation, steam sterilization validation, cycle life, cytotoxicity).

Let's adapt the answer based on the information available and the nature of the device:

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

Name of Testing	Purpose of Testing	Acceptance Criteria	Reported Device Performance / Results
Cleaning Validation	Validate the cleaning cycle in the instructions for use	No visible soil. Hemoglobin less than $2.2µg/cm²$. Protein level $≤6.4 µg/cm²$. MEM reactivity grade of 2 or less.	No visible soil. All acceptance criteria met ($<6.4 µg/cm² protein and $< 2.2 µg/cm²$ hemoglobin). PASS
Steam Sterilization Validation	Validate the half-cycle of the cycle in the instructions for use	No growth on half cycles. No moisture on full drying cycle. Pass on Chemical Indicators half and full cycle.	$10^{-6}$ SAL (Sterility Assurance Level). Pass on chemical indicators half and full cycle. No moisture on full drying cycle. No growth on half cycle.
100 cycles sterilization	Show the tray will last at least 100 sterilization cycles	Pass visual inspection and test of functionality.	At all cycle counts, passed visual inspection and test of functionality.
Cytotoxicity	Demonstrate no residuals on sterilized instruments change their biocompatibility	Pass is a score of no greater than 2 (indicating non-cytotoxicity).	Pass with score of 0. No evidence of lysis - Non-Cytotoxic.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cleaning Validation: "Four articles were used." (These are physical test articles, not data samples in the context of AI/ML).
Steam Sterilization Validation: "Each test article was evaluated..." The number of test articles isn't explicitly stated beyond "each," but it would typically involve multiple units for validation.
100 cycles sterilization: "No changes were noted in the test articles after 100 cycles." The number of test articles is not specified.
Cytotoxicity: "instruments placed in the tray for sterilization was done after a sterilization cycle". It refers to the instruments exposed to the tray, not the tray itself being "tested" for cytotoxicity.
Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests. These are typically laboratory-based validation studies rather than data collected from human subjects. They are prospective in the sense that the tests are designed and executed to validate the device.

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 question is not applicable. "Ground truth" in the context of expert consensus is specific to diagnostic AI/ML models. For a physical sterilization device, the "truth" is established by defined physical, chemical, and biological endpoints (e.g., quantitative residual levels, sterility assurance level, visual inspection).

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

This question is not applicable for a physical device validation. Adjudication methods are typically used to resolve conflicts in human expert interpretations, which is not relevant here.

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

This question is not applicable. An MRMC study evaluates human performance with and without AI assistance for diagnostic tasks. This device is a sterilization cassette, not a diagnostic tool or AI software.

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

This question is not applicable. The device is a physical product, not an algorithm. The "standalone" performance refers to the device's ability to sterilize instruments, which is what the Steam Sterilization Validation and Cleaning Validation tests assess.

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

For the tests performed:
- Cleaning Validation: Quantifiable chemical residues (Hemoglobin, Protein, MEM reactivity) and visual inspection.
- Steam Sterilization Validation: Biological indicators (to determine Sterility Assurance Level, SAL) and chemical indicators, along with moisture checks.
- 100 cycles sterilization: Visual inspection and functional testing (physical integrity and operation).
- Cytotoxicity: Cell culture assays (scores quantify cellular response to extracts, with a score of 0 indicating no cytotoxicity).
These are objective, scientifically defined metrics and methods, not expert consensus or pathology in the human diagnostic sense.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" for a physical medical device. The device itself is manufactured, and its performance is validated through specific tests, not "trained" on a dataset.

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

This question is not applicable, as there is no training set for this type of device.

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