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The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization is:

INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V,

INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time

The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g.

The device dimensions are listed below for Anthogyr Surgical Cassettes:

• INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm

• INMODIGM, INMODIGMV: 76x155x47 mm

The cassettes are not intended to be stacked during sterilization process.

Anthogyr Surgical Cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment.

To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

The Anthogyr Surgical Cassettes are designed to organize, steam sterilize, and protect dental surgical instruments. They are intended for healthcare providers and must be enclosed in an FDA-cleared steam sterilizable pouch.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document describes "The worst-case cassettes were tested for performance based on critical impact factors including materials, vent to volume ratio, design complexity, weight of the loaded cassettes or the weight of the empty cassettes." Specific sample sizes for each test are not explicitly stated beyond this general description.

The data provenance is from non-clinical testing performed with the subject device. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as this is a non-clinical device performance study rather than a clinical trial.

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

This information is not applicable as the described studies are non-clinical performance tests (e.g., cleaning, sterilization, life cycle, cytotoxicity). Ground truth for these types of tests is established by objective measurements against predefined criteria, not by expert consensus.

4. Adjudication method for the test set:

This information is not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers or experts are involved in interpreting results or making diagnoses.

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 information is not applicable. The Anthogyr Surgical Cassettes are a medical device for organizing, sterilizing, and protecting dental instruments. They do not incorporate AI, nor are they interpreted by human readers in a diagnostic capacity, hence no MRMC comparative effectiveness study involving AI assistance would be relevant.

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

This information is not applicable. The device is a surgical cassette, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The type of ground truth used:

For the non-clinical tests, the ground truth is established by:

• Objective measurements and scientific standards: For cleaning validation, this involves quantitative measurements of hemoglobin and protein residuals against established thresholds, and visual inspection.
• Compliance with validated methods and standards: For sterilization validation, this involves adherence to ISO 17665-1 and observation of biological indicator growth/non-growth.
• Predefined performance criteria: For life cycle testing, the ground truth is the ability to withstand 250 cycles without functional compromise.
• Laboratory test results: For cytotoxicity testing, the ground truth is based on the measured cell proliferation inhibition percentage against a set threshold.

8. The sample size for the training set:

This information is not applicable. As a non-AI medical device, there is no "training set" in the context of machine learning. The studies described are validation tests for the physical device.

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

This information is not applicable for the same reason as in point 8.

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