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Avinent Sterilization Cassettes are 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 the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes.

The Avinent Sterilization Cassettes are 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 of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The trays in this submission are Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. 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 them to be effective for 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 wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K191566. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

The provided text is related to the FDA 510(k) premarket notification for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The document details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical testing.

However, the questions you've asked are typically relevant to studies evaluating the performance of AI/ML-driven medical devices (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details).

Since the Avinent Sterilization Cassettes are a physical medical device (sterilization trays), and not an AI/ML software or diagnostic tool, many of the requested data points (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, ground truth types related to expert consensus or pathology, etc.) do not apply to this type of submission.

The "studies" described are validation tests for the physical properties and functionality of the sterilization cassettes themselves (e.g., cleaning validation, steam sterilization validation, cycle life, cytotoxicity).

Let's adapt the answer based on the information available and the nature of the device:

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

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The Avinent Surgical 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 the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Surgical Tray. -The tray will be marketed in the variations found in the following table.

The Avinent Surgical Tray 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 of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. 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 them to be effective for 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 wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K142519. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

This document describes the non-clinical testing performed for the Avinent Surgical Tray (K191566) to demonstrate its safety and effectiveness. The information provided heavily focuses on the validation of the tray's ability to be cleaned and sterilized, along with its durability and biocompatibility, as opposed to an AI/ML device. Therefore, many of the requested criteria related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and expert qualifications for independent evaluation, are not applicable to this submission.

Here is the breakdown of the acceptance criteria and study results based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact "sample sizes" in terms of number of devices tested for each validation (e.g., how many trays were subjected to cleaning validation, sterilization, or 100 cycles). It refers to "the tray" being tested.

• Data Provenance: The studies were conducted by AVINENT Implant System, S.L.U. or a contracted lab to validate the device's performance. The origin of the data is implied to be from laboratory testing related to the device itself. It is inherently prospective as these are validation tests conducted specifically for this 510(k) submission. No information on country of origin for the data is explicitly stated, but the company is located in Spain.

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

This information is not applicable as the testing described is related to physical and biological performance of a medical device (sterilization tray), not an AI/ML algorithm. Ground truth here is established through objective laboratory measurements and standardized biological and physical tests (e.g., visible soil, specific chemical limits, microbial growth, visual inspection criteria for durability, cytotoxicity scores). No human experts are described as contributing to "ground truth" in terms of interpretation or consensus for these specific tests.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The results are based on objective measurements and established pass/fail criteria for cleaning effectiveness, sterility, durability, and biocompatibility.

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

Not applicable. This device is a surgical tray for sterilization, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth for these tests is based on:

• Objective Measurements: e.g., precise levels of hemoglobin and protein for cleaning validation, absence/presence of microbial growth for sterilization, visual inspection against pre-defined criteria, and quantitative scores for cytotoxicity.
• Standardized Criteria: Adherence to established scientific and regulatory standards (e.g., ISO 10993-5, and general sterility and cleaning validation principles).
• Pass/Fail Criteria: Predetermined thresholds for acceptable performance in each test.

8. The Sample Size for the Training Set

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

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

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The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.

AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.

Implants are intended for immediate loading on single-tooth and/or multiple tooth applicationswhen good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied.

Specific indications for small diameter (03.3 mm implants):

Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary lateral incisors or mandibular central and lateral incisors.

The implant system serves as anchorage for dental prosthetic restorations. Implants are placed in the bone of the upper or lower jaw. Abutments are placed into the dental implant to provide support for the prosthetic reconstruction including abutments for cemented restorations to achieve better esthetics, Abutments can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The proposed devices are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are titanium alloy 6Al 4V, feature internal and external hex implant to abutment connection options and are available with modified surfaces (TO2 layer) to promote improved osseointegration. Implant abutments are also titanium alloy 6A1 4V. Instruments and accessories necessary to place implants and abutments also form part of the system.

The provided text is a 510(k) Premarket Notification for the AVINENT Implant System. It describes the device, its intended use, a comparison with predicate devices, and concludes with a substantial equivalence determination. However, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the format typically associated with performance metrics like sensitivity, specificity, accuracy, or clinical endpoints.

Instead, this document focuses on demonstrating substantial equivalence to already legally marketed predicate devices based on:

• Material composition: Titanium Grade 5 (TiAl6V4 ELI) and PEEK, consistent with predicate devices.
• Form/Features: Root-form, tapered, microthread, self-tapping with hexagonal internal/external connections, mirroring features in predicate devices.
• Dimensions: Diameters, lengths, and prosthetic connections are within the range of predicate devices.
• Surface Treatment: BAS (Biomimetic Advanced Surface) which is described as shot-blasted and anodized to form a titanium oxide layer, compared to TiUnite® and RBT surfaces in predicates. The key is the functionality of promoting osseointegration.
• Abutment Material: Titanium Grade 5 (TiAl6V4 ELI) and PEEK, aligning with predicate devices.
• Implant/Abutment Connection: External Hex and Internal Hex, matching predicate devices.
• Abutment forms/Features: Straight and angled up to 30°, similar to predicate devices.

The "study" that supports this submission is explicitly stated as non-clinical bench testing:

SUMMARY DISCUSSION OF NON-CLINICAL DATA:
"The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Bench testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including mechanical performance (fatigue) testing taking account of the level and duration of contact with the body, surface finish testing, packaging validation and sterilization process validation."

Therefore, the requested information elements related to clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not present in this document, as the device's clearance was based on substantial equivalence through non-clinical bench testing.

Here's a summary of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not applicable. The submission is based on non-clinical bench testing and comparison to predicate devices, not a clinical test set.
• Data Provenance: Non-clinical bench testing. No country of origin for clinical data is applicable. Retrospective or prospective study design is not applicable.

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

• Not applicable. Human expert ground truth is not relevant for this type of submission.

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

• Not applicable.

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:

• Not applicable. This device is a dental implant, not an AI-powered diagnostic tool.

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

• Not applicable.

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

• Not applicable in the context of clinical "ground truth." The "ground truth" for demonstrating substantial equivalence rests on adherence to material standards, mechanical performance benchmarks, and functional similarity to predicate devices, verified through non-clinical testing.

8. The sample size for the training set:

• Not applicable. There is no AI component or training set involved.

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

• Not applicable.

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