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The Southern Implants Instrument Tray is 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 one of the following cycles:

• · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time.
• · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time.

The trays are not intended for sterilization of non-porous loads.

The trays are recommended not to be stacked during sterilization.

The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).

Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.

The device 'instrument trays' is 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 three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches.

The lid, base and insert are made of Radel R-5000. This material is a polymer resin.

The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools.

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 it to be effective for sterilization and be able to withstand the environment of repeated steam 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 sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents

The provided text describes the acceptance criteria and the results of a study for the "Southern Implants Instrument Trays" device.

Here's an analysis of the requested information:

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

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

The document does not explicitly state the sample sizes used for each test set. It mentions "The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams)." This implies testing was done on these configurations, but not specific sample numbers for individual tests. The data provenance (country of origin, retrospective/prospective) is not specified.

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 to the type of device and tests described. The "ground truth" here relates to objective performance criteria for sterilization, cleaning, biocompatibility, and physical durability, which are assessed through laboratory testing against established standards, not through expert human interpretation of medical images or conditions.

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

Adjudication methods like 2+1 or 3+1 consensus are typically used for subjectively assessed data, such as in clinical trials or image interpretation. This is not mentioned and is not applicable to the engineering and biological performance tests described 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

An MRMC comparative effectiveness study is not relevant to this device. This type of study applies to diagnostic AI devices involving human readers. The Southern Implants Instrument Trays are physical medical devices for sterilization and organization.

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

This refers to the performance of an AI algorithm alone. The device in question is a physical instrument tray, not an AI algorithm. Therefore, this question is not applicable.

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

The "ground truth" in this context is based on:

• Established scientific principles and standards: For sterilization effectiveness (6 log reduction), cleaning efficacy (protein and hemoglobin levels), cytotoxicity (morphological grade), and physical durability (no damage).
• Standardized test methods: Such as ISO 17665-1, ISO 17664, AAMI TIR 12, AAMI TIR 30, ISO 10993-5, and ASTM D 4169.
• Measurement of physical and biological parameters: e.g., bacterial reduction, chemical residue levels, cell viability, physical integrity, temperature readings.

8. The sample size for the training set

This device is not an AI algorithm that requires a training set. Therefore, this question is not applicable.

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

This question is not applicable as there is no AI training set for this device.

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