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The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.

Device Description

The proposed Washtrays are used to store and organize dental implant surgical instruments needed during implant surgery, as well as hold instruments during cleaning and sterilization. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or sterilization container.

The proposed Washtrays consist of a stainless-steel perforated tray equipped with baskets and a lid with a handle. The large basket comprises instrument holders inserted in an anodized aluminum alloy Overlay printed with visual symbols for correct positioning of the designated instruments such as drills and taps.

The designated instruments are placed in the Overlay in the Instrument holders which are made with PEEK and have a stainless steel spring to hold the instruments in place. The Overlay guides the user through the surgical protocol for implant placement. The small basket with its own small lid and silicone mat inside is used to store the instruments which can be disassembled prior to cleaning. The metal grid base has silicone feet to prevent the Washtrays from slipping/sliding when placed on a surface.

The outer dimensions for all Washtrays is the same, 10.83 x 2.32 inches. The inner arrangement of the baskets varies between the Washtrays.

AI/ML Overview

The device being described is a set of "Washtrays" intended for organizing, cleaning, sterilizing, and storing surgical instruments.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Acceptance Criteria	Reported Device Performance
Sterilization Cycle Validation	Sterility assurance level (SAL) of ≤ 10⁻⁶	Pass
Drying Validation	No visible moisture; ≤ 3% weight gain of packaging and absorbable materials	Pass
Cleaning (Manual Pre-Cleaning and Automated Cleaning)	No visible soil; Protein < 6.4 µg/cm²; Hemoglobin < 2.2 µg/cm²	Pass
Reprocessing of Trays (cleaning and sterilization)	No signs of flush rust, rust corrosion, deformation, or damage	Pass
Simulated Use of Trays	No significant wear of the holders	Pass
Transportation Testing	No visible damages; Instruments fixed inside the Washtray and instrument holders	Pass
Load Test Handle	No permanent deformation of the handle or the lid with a load of 40N	Pass
Cytotoxicity	Inhibition of cell proliferation must be at or below 30% compared to untreated cultures	Pass

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

The document does not explicitly state the exact sample sizes (number of trays or instruments) used for each specific test. However, it does indicate:

Reprocessing of Trays: Trays were tested for "up to 200 reprocessing cycles."
Simulated Use of Trays: "Five hundred (500) repeated positionings have been simulated for each holder."

The provenance of the data is non-clinical testing data, performed internally by Dentsply Sirona or their supplier Aesculap AG according to various international standards (e.g., ANSI/AAMI/ISO, AAMI TIR, ISO, ASTM, DIN EN ISO, ISTA) and internal test methods. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical studies, as these are non-clinical (laboratory/bench) tests.

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

This section is not applicable as the provided document describes non-clinical performance data for physical medical devices (Washtrays), not diagnostic software or AI algorithms that require expert consensus for ground truth. Ground truth for these tests is established through objective measurements against scientific and regulatory standards (e.g., SAL of ≤ 10⁻⁶ for sterilization, specific µg/cm² limits for protein/hemoglobin, physical integrity assessments).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This section is not applicable for the same reason mentioned in point 3. Adjudication methods are typically used in clinical studies with human readers to resolve discrepancies in diagnoses or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy or decision support systems involving human interpretation, which is not the nature of the "Washtrays" device.

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

No, a standalone (algorithm-only) performance study was not done. The "Washtrays" are physical devices, not software algorithms requiring standalone performance evaluation.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is derived from established scientific and regulatory standards and objective measurements. Examples include:

Sterilization: Sterility Assurance Level (SAL) of ≤ 10⁻⁶, a widely accepted microbiological standard.
Cleaning: Measurable limits for residual protein and hemoglobin (e.g., Protein < 6.4 µg/cm², Hemoglobin < 2.2 µg/cm²).
Drying: Absence of visible moisture and a specific weight gain percentage.
Mechanical Integrity/Durability: Absence of deformation, damage, rust, or significant wear.
Biocompatibility: Inhibition of cell proliferation compared to untreated cultures for cytotoxicity.

8. The Sample Size for the Training Set:

This section is not applicable as the "Washtrays" are physical devices undergoing performance testing, not an AI or machine learning model that requires a training set.

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

This section is not applicable for the same reason mentioned in point 8.

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