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The Ellipse Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDA-cleared sterilization wrap using the following cycle:

Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time

The the worst case validated sterilization load is:

-One (1) Supplemental Instruments (total weight: 10.0 Ibs.) and one (1) Supplemental Reamer Tray with instruments (total weight: 13.1 lbs.); in a non-stacked configuration.

The worst case loading configuration included the 12 instruments supplied with the Supplemental Instrument Tray with the following worst case lumen dimensions:

Supplemental Instrument Tray (Model SIT1-000)

The worst case loading configuration included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions:

Supplemental Reamer Tray (Model SRT1-000):

Do not exceed a maximum load of 12 instruments (10.0 lbs.) in the Supplemental Instrument Tray. Do not exceed a maximum load of 18 instruments (13.1 lbs.) in the Supplemental Reamer Tray.

The Ellipse Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray and a Supplemental Reamer Tray. These trays are designed to organize, protect, and transport instruments during steam sterilization and subsequent storage. The trays are composed of a lid and base tray with handles and are perforated for steam penetration. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth), and is designed to hold 12 instruments. The Supplemental Reamer Tray has the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth), and is designed to hold 18 flexible reamer instruments. An insert tray with the following dimensions is used with the Supplemental Reamer Tray: 497 mm (length) x 240 mm (width) x 52 mm (depth). The Ellipse Supplemental Instrument Trays are reusable and are used to store instruments prior to, during, and after the sterilization process. The trays are made of anodized aluminum and have medical grade, Class VI Silicone instrument holders with stainless steel mounting hardware which are used to secure, separate, and organize the instruments within the trays. The tray handles are also encased in medical grade, Class VI Silicone.

The document provided describes the Ellipse Supplemental Instrument Trays and their intended use for organizing, protecting, and transporting instruments during steam sterilization. It also details the performance testing conducted to demonstrate their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a single consolidated table of all acceptance criteria with corresponding performance results in a formal way. Instead, it discusses various validation tests and their outcomes. I've extracted the relevant information and organized it into the following table, synthesizing acceptance criteria from the descriptions of the tests performed.

2. Confirmation of the absence of moisture on the trays and sterilization wrap.
3. No more than 3% difference in weight prior to and after sterilization. (for 40 minutes dry time) | Met: "The dry time validation was successful in determining an effective dry time of 40 minutes for the validated pre-vacuum steam sterilization cycle. Acceptance criteria below were met during validation of the dry time: 1) Autoclave data showing appropriate dwell time at 132°C (+3°C) for each full cycle; 2) Confirmation of the absence of moisture on the trays and sterilization wrap; 3) No more than 3% difference in weight prior to and after sterilization." |
   | Material Durability | Function and physical construction of trays and components maintained after 100 sterilization cycles. | Met: "Performance testing was conducted to demonstrate that the function and physical construction of the Ellipse Supplement Trays and its components are maintained after exposure to 100 sterilization cycles."
   "The materials used in the Ellipse Supplemental Instrument Trays were exposed to 100 sterilization cycles and no material degradation was observed. All materials maintained their integrity and remained fully functional." |
   | Material Compatibility | Materials of construction are compatible with steam sterilization. | Met: "Performance testing demonstrated that the materials of construction are compatible with steam sterilization." |
   | Biocompatibility | Materials of construction are biocompatible (non-cytotoxic). | Met: "Extracts of test article (polymeric component) on L-939 mouse fibroblast cells in MEM elution assay did not display a cytotoxic response and is considered non-cytotoxic. Testing demonstrated that the materials of construction are biocompatible." |
   | Shipping Validation | All acceptance criteria for package performance testing were met. | Met: "Shipping validation was performed on the Ellipse Supplemental Instrument Trays. The package performance testing results demonstrated all acceptance criteria were met." |
   | Cleaning Validation | Hemoglobin, Micro BCA protein, and TOC test results meet all acceptance criteria for both manual and automated cleaning processes. | Met: "The Ellipse Supplemental Instrument Trays have been validated to be cleaned using both a manual and automated process. Hemoglobin, Micro BCA protein, and TOC test results met all acceptance criteria." |

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

The document does not explicitly state a "test set" in the context of an AI/algorithm. This device is a physical medical instrument tray, not a software algorithm. Therefore, the concept of a "test set" for data provenance, country of origin, or retrospective/prospective data as typically used for AI/ML models does not apply here.

For the physical device, the "samples" would be the trays and instruments themselves. The performance testing mentions:

• 100 sterilization cycles for material durability. This implies that the trays were subjected to at least 100 cycles to assess their physical integrity and functionality.
• Worst-case validated sterilization load: This involved one (1) Supplemental Instrument Tray (10.0 lbs) and one (1) Supplemental Reamer Tray (13.1 lbs) in a non-stacked configuration, loaded with specific instruments (12 in the Instrument Tray, 18 in the Reamer Tray), including those with worst-case lumen dimensions.

The provenance of the data would be from laboratory testing performed on the physical trays and associated instruments.

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

This question is not applicable as the device is a physical instrument tray, not an AI/ML model for which "ground truth" would be established by experts. Performance is determined by objective physical and biological tests (e.g., SAL, material integrity, dryness, cleaning efficacy).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for evaluating human-expert disagreement for ground truth in AI/ML studies. For a physical device, performance is measured against predefined objective standards and test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. This is a physical medical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

As this is a physical device, the "ground truth" for its performance is established by objective laboratory and scientific testing against established standards and protocols. For example:

• Sterilization Efficacy: Measured by indicator organisms and testing to achieve a specific SAL (10⁻⁶). This is a microbiology-based ground truth.
• Dryness: Measured by the absence of visible moisture or weight difference, which are empirically verifiable physical properties.
• Material Integrity/Durability: Measured by physical inspection for degradation and functional testing after repeated cycles.
• Biocompatibility: Determined by in vitro cytotoxicity assays (e.g., L-939 mouse fibroblast cells).
• Cleaning Efficacy: Measured by chemical assays for residual contaminants (Hemoglobin, Micro BCA protein, TOC).

These are all objective, quantifiable measures rather than human expert consensus, pathology, or outcomes data in the sense of a diagnostic medical device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model.

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