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The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.

(2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.
The tray is intended for sterilization of non-porous loads.
Do not stack trays during sterilization.
The tested Tray represents the worst case validated load of 667.52 grams.
Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

Device Description

The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.

The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray.

The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the "Standard Sterilizable Tray." It outlines the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The document describes non-clinical testing for a sterilization tray, which is a physical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects for AI/ML device performance (like "human readers improve with AI," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," and "training set details") are not applicable to this submission. The information provided focuses on the physical and functional performance of the sterilization tray.

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

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity	Observe the cytotoxicity potential of the device extract.	Morphological Grade 2 (mild) or better	Pass
ISO 17664: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices	Verify the continued performance of the device during its useful life.	No visual degradation, silicone retention performance	Pass
TIR30 & TIR 12: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices; Designing, testing and labeling reusable medical devices for reprocessing in health care facilities	Verify the effectiveness of the recommended cleaning process.	< 12 µg/cm² of TOC recovered from devices; < 6.4 µg/cm² of protein recovered from devices.	Pass
ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices	Verify the ability of the sterilization process to adequately sterilize the load.	6 log reduction at half-cycle	Pass
ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems	Verify the durability of the device during transportation.	No damage	Pass

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

The document specifies the types of tests conducted (e.g., biocompatibility, cleaning validation, sterilization validation, transport simulation) but does not provide specific sample sizes (e.g., number of units tested) for each test.

Data Provenance: The tests are described as non-clinical laboratory tests performed by the manufacturer (Implant Direct Sybron Manufacturing, LLC) to demonstrate the device's performance. The document does not specify the country of origin of the data beyond being associated with this manufacturer's testing, nor does it classify the data as "retrospective" or "prospective" in the typical sense for clinical studies; these are laboratory validation studies.

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

This question is not applicable to this type of device and study. The "ground truth" for a sterilization tray's performance is established by objective measurements and standardized test methods (e.g., chemical analysis for cleanliness, biological indicators for sterilization efficacy, visual inspection for degradation/damage, etc.), not by expert interpretation of images or clinical outcomes.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, where multiple human experts interpret data to create a consensus ground truth. For the physical and functional testing of a sterilization tray, results are typically determined by objective measurements and adherence to pass/fail criteria.

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 is designed for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission concerns a physical medical device (sterilization tray) and its non-clinical performance characteristics, not an AI/ML algorithm.

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

This question is not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no "algorithm only" performance to evaluate.

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

The "ground truth" for this device's performance is established by adherence to recognized international and industry standards (ISO, ASTM, TIR) and specific measurable criteria outlined within those standards for:

Biocompatibility (cytotoxicity)
Durability and continued performance over useful life (reprocessing cycles)
Cleaning efficacy (residual protein and TOC)
Sterilization efficacy (6-log reduction of biological indicators)
Transportation durability (no damage)

These are objective, quantifiable measures derived from standardized laboratory tests, not subjective interpretations or clinical outcomes data.

8. The sample size for the training set

This question is not applicable. This is a submission for a physical medical device, not an AI/ML algorithm. There is no "training set."

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

This question is not applicable for the same reasons as #8.

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