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Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

• Custom Titanium Abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements.
• Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
  Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants.
  Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.

The Custom Legacy Titanium Abutments and Custom InterActive Titanium Abutments (collectively the "Custom Titanium Abutments") are one-piece hex type engaging abutments comprised of Titanium 6AL-4V ELI, which serve as a final abutment upon which a prosthetic dental restoration will be fitted.
The Custom Legacy Abutments are offered in 3.0mm, 3.5mm, and 5.7mm diameters that correspond to the platform diameters of the Legacy Implant System; the Custom InterActive Abutments are offered in 3.0mm and 3.4mm diameters that correspond to the InterActive Implant System. The devices are supplied with fixation screws that are placed through the abutment to secure it to the implant's reciprocal hex platform. The Custom Abutments are provided with a large amount of modifiable material to accommodate the digital workflow used for device customization. Customization of the final abutment is performed in Implant Direct's Custom Direct laboratory under Implant Direct's manufacturing control, where the devices are milled to meet individual patient specifications. The digital workflow uses the following additional devices:

• 3Shape Abutment Design Software (K151455)
• Dental System Control Panel
• Dental Designer
• Lab Scanner (3Shape D700 and 3Shape Scan-it Restoration Dental System (510(k)-exempt, Product Code NOF)
• Intra-oral scanners
• 3M True Definition Scanner (K122467)
• Itero Scanner Software (K131101)
  The Custom Abutments are patient-specific and may be modified within the following parameters:
• Maximum angle of 30° from the axis of the implant
• Minimum wall thickness of 0.4mm
• Minimum post height of 4mm
  The Custom Abutments are available using either a Design-and-Mill or Mill-only digital workflow. With the Design-and-Mill process flow, the patient's dentition information (impression or intraoral scan) is sent to Implant Direct. Implant Direct will design an abutment and forward the design to the end user for approval prior to manufacturing. With the Mill-only process flow, the end user uses intra-oral scanners and lab scanners to design the abutment using the 3Shape software. The abutment design file (.stl) is sent to Implant Direct for manufacturing.
  The Custom Abutments are single-use and supplied non-sterilization by the end user. They are externally-communicating devices which come in permanent contact (>30 days) with a patient's tissue/bone.

This document is related to a 510(k) premarket notification for dental implant abutments, which are physical medical devices, not AI/software-based devices. Therefore, the concepts of "acceptance criteria for an AI model," "study proving the device meets acceptance criteria" (in the context of algorithm performance), "test set," "training set," "ground truth establishment," "experts," "adjudication," and "MRMC studies" are not applicable here.

The document discusses performance data for the physical dental abutments, but this refers to traditional engineering and biological testing, not AI model validation.

Here's a breakdown of why your desired information isn't present in this document:

• Device Type: The device is "Custom Legacy and Custom InterActive Titanium Abutments," which are physical, custom-milled dental prosthetics. They are not AI algorithms.
• Study Purpose: The studies mentioned (Biocompatibility, Fatigue Testing, Steam Sterilization, Software Verification and Validation) are engineering and biological tests designed to ensure the physical device is safe and performs its mechanical function, and that the design software adheres to specified parameters. They are not studies to evaluate the diagnostic or predictive performance of an AI model.

However, I can extract information related to the device's technical specifications and how its engineering performance was validated:

Acceptance Criteria and Device Performance (in a physical device context):

The document details various non-clinical tests performed to support the device's safety and performance, acting as "acceptance criteria" for a physical medical device. The "reported device performance" is that the device passed these tests, indicating it performs as intended and is substantially equivalent to predicate devices.

Table of "Acceptance Criteria" and "Reported Device Performance" (adapted for a physical device K192218):

Regarding the other points, as they pertain to AI/ML, they are not applicable to this physical device submission:

1. Sample size for the test set and data provenance: Not applicable. This document refers to the number of physical abutment samples tested for biocompatibility and fatigue, not a test set for an AI model.
2. Number of experts and qualifications for ground truth: Not applicable. Ground truth for an AI model's performance on medical images is irrelevant for this physical device.
3. Adjudication method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which is not relevant here.
5. Standalone (algorithm only) performance: Not applicable. The device itself is a physical object; there's no "algorithm-only" performance to evaluate in this context. The software mentioned (3Shape Abutment Designer) is a design tool, not a diagnostic or predictive AI.
6. Type of ground truth used: Not applicable. Ground truth for AI (e.g., pathology, outcomes) is not relevant for testing the mechanical and biological properties of a dental abutment.
7. Sample size for the training set: Not applicable. There is no AI training set for this physical device.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document thoroughly covers the engineering and biological validation required for a Class II physical medical device, demonstrating its substantial equivalence to predicate devices through well-defined tests, but it does not contain information about AI model validation.

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The InterActive Complete 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 sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:

• (1) Prevaccum Steam At 132℃ for 4 minutes with a 20 minutes dry time.
• (2) Gravity Steam At 132% for 15 minutes with a 30 minutes dry time.
• The trays are intended for sterilization of non-porous loads.
• The trays are recommended not to be stacked during sterilization.
• The Complete Surgical Tray represents the worst case validated load due to the number of components) and the weight of 608.05 grams.
• Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray.
• The tray will be marketed in following variations.

The InterActive Complete 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 insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and ratchet. The tray is available in only one size of approximately 7.2 inches X 5.6 inches X 2.4 inches and will be marketed in four different variations – (1) InterActive Complete Surgical Tray (ICST) containing 34 instruments, (2) InterActive Basic Surgical Tray (IBST) containing almost half the number of instruments as ICST, (3) InterActive Surgical Tray (IST), empty tray containing no instruments, and (4) Complete Surgical Tray (CST), containing 45 instruments.

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 cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the 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 K052992 and K012105. Radel R 5000 CL 301 is used for the lid, and Radel R 5100 NT15 is used for base and insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain the 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 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 tray are all non-porous devices and include dental surgical drills and tools. The tools are class I exempt and the drills have Class II pre-market notification clearance.

The provided text describes the performance testing for the InterActive Complete Surgical Tray, a device designed to hold dental surgical drills and tools for steam sterilization and transport. The relevant sections for acceptance criteria and the study proving it meets these criteria are primarily found under "7. Non-Clinical Performance Testing" and "TABLE 2: Substantial Equivalence: Comparison with Predicates on Performance Testing".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical targets in a dedicated table format. Instead, it refers to compliance with specific standards and successful conduct of tests. The reported device performance is indicated by "Yes" for meeting the test requirements.

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

The document does not explicitly state the sample size used for each specific non-clinical performance test. It only confirms that the tests were conducted.

The data provenance is retrospective, as these are non-clinical (laboratory/engineering) tests conducted on the device to demonstrate its performance against established standards. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. and international standards.

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 to this type of non-clinical device testing. "Ground truth" established by experts is typically relevant for studies involving human interpretation (e.g., diagnostic imaging studies). For this device, compliance is measured against engineering and sterilization standards.

4. Adjudication Method for the Test Set:

This information is not applicable to this type of non-clinical device testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving multiple human interpreters to resolve disagreements in expert opinions.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a device or AI on human reader performance, usually in a diagnostic context. The document describes non-clinical performance testing for a sterilization tray and does not involve human readers interpreting cases.

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

Yes, standalone performance testing was done. The entire "Non-Clinical Performance Testing" section describes the performance of the device itself (the sterilization tray) under various conditions (steam sterilization, cleaning, transport, biocompatibility) without human intervention in its primary function.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests is defined by the acceptance criteria within the cited national and international engineering and sterilization standards. For example:

• Sterilant Penetration: Successfully killing biological indicators or defined sterility assurance levels (SALs) as per AAMI/ANSI/ISO 17665.
• Toxicological Properties: No cytotoxic effects observed as per ISO 10993-5.
• Cleaning: Reduction of bioburden/soil to acceptable levels as per AAMI TIR 30.
• Packaging Integrity: Maintenance of package integrity after transport simulations as per ASTM D4169.

8. The Sample Size for the Training Set:

This information is not applicable. The device described is a physical medical device (sterilization tray), not an AI algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for this physical device.

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