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UniFit Dental Implant System is intended for surgical placement in the maxillary and or mandibular arch to support crowns, bridges or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.

UniFit short implants (6 mm L) are intended to be used only with straight abutments.

All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.

Adin's UniFit Dental Implant System is a new model that provides an additional connection platform to Adin's legally marketed Dental Implant Systems, indicated for use in surgical and restorative applications for placement in the maxillary and/or mandibular arch to provide support for prosthetic devices such as crowns, bridges, or overdentures in order to restore masticatory function.

This new UniFit model is identical to Adin's cleared Touareg™ CloseFit (RP- Regular Platform, and WP- Wide Platform) and Adin's Touareg™-S implant systems (cleared under K112585 and K081751, respectively) except for the "Star" (Torx) connection and new 6mm length for specific diameters.

The UniFit Dental Implant System includes dental implants, screws and prosthetic components for CAD/CAM restorations.

The UniFit dental implants are tapered core implants with a spiral tap, and a dome apex and double lead thread design.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the UniFit Dental Implant System.

Please Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict numerical acceptance criteria against a pre-defined performance target. The studies described are primarily to ensure safety, functionality, and equivalence to already cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission focused on substantial equivalence to predicate devices rather than meeting a specific performance target for AI, the "acceptance criteria" here refer to meeting the established performance standards of the predicate devices and general safety/performance testing for the type of medical device. The document does not provide a traditional table of AI-specific acceptance criteria (e.g., sensitivity, specificity, AUC) or corresponding numerical performance for the device's AI component. Instead, it describes a series of engineering and biocompatibility tests to ensure the new device is as safe and effective as previously cleared devices.

The "device performance" reported is that the device successfully meets the internal protocols and relevant ISO/ASTM standards, indicating it performs comparably to the predicate devices and is safe for its intended use.

No AI is mentioned in the provided text for the UniFit Dental Implant System. The document describes a physical dental implant system and components, not a software or AI-driven medical device. Therefore, the subsequent questions regarding AI-specific criteria (sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable based on this document.

• Pyrogenic Material-Mediated and chemical extractions conducted.
• Biocompatibility tests were conducted in accordance with referenced standards. |
  | Connection Design Effectiveness | Stable connection and all measurements within component's specification, following tolerance analysis. | All tested specimens showed stable connection and all measurements were found to be within each component's specification. |
  | Maximal Applicable Torque Resistance (Implant) | Withstand maximal insertion torque as predefined in implant specification, considering safety margins and device design. | Test conducted in accordance with internal protocol; implies meeting criteria (no explicit numerical value reported as metric). |
  | Tool to Implant Connection Lifetime Performance | Maximal applied torque and deformation test met predefined acceptance criteria; no mechanical or visual damages observed at end of reusable tool's recommended lifetime. | Met predefined acceptance criteria; no mechanical or visual damages observed. |
  | Implant-Abutment Connection Degree of Rotation | Predefined acceptance criterion for degree of free rotation after applying closure torque. | All tested specimens met the predefined acceptance criterion. |
  | Abutment Screw Performance - Maximum Applicable Torque | Torque resistance of connecting screw such that breakage occurs above acceptance criteria and at the desired location (under the screw head/groove). | All tested screws failed in values above the acceptance criteria and at the desired location. |
  | Screw Loosening and Abutment Extraction by Retrieval Tool | Ability to screw and loosen with no deformation or fracture; abutment easily retrieved from implant under lateral pressure; screw retrieval torque withstands predefined torque. | All tested screws and abutments were successfully unscrewed and retrieved; screw retrieval torque withstood predefined torque. |
  | Regular Platform Dynamic Loading (Fatigue) | Meet requirements of ISO 14801:2016 for fatigue load (fatigue limit) for endosseous dental implants under "worst case" conditions and prosthetic components. | All of the success criteria were met. |
  | Torsion Testing | Meet acceptance criteria for torsional performance as per YY0315:2016 for torsional yield strength and maximum torque of worst-case implant/connecting part joints. | All tested specimens met acceptance criteria for UniFit implant system torsional performance per YY0315:2016. |
  | 6.00mm Implants Pull-Out Test | Axial pull-out strength comparable to or better than predicate devices (MIS short implants K103089), per ASTM F543. | The test met its acceptance criteria (comparison with legally marketed device). |
  | Comparative Surface Area Analysis (before treatment) | UniFit Short Implant's actual surface area (before surface treatment) greater than or equivalent to legally marketed reference item (MIS short implants K103089) at worst-case implant variation. | The total surface area measurements of the tested items were greater than the legally marketed reference item, the acceptance criteria was met. |
  | Comparative Bone to Implant Contact (BIC) Surface Area Analysis | Test article (Adin's UniFit short implant, 6.0 mm) BIC volume and surface area comparable to or exceeding reference item (MIS SEVEN MF7-06420) for Hard Bone (Type I) and Soft Bone (Type IV) conditions. | Test article, at both conditions of the bone, exceeded the MIS reference item in terms of B.I.C. volume and surface area. |
  | Single TMA Fatigue Rationale | Fatigue limit of Single TMA abutments assembled to designated Dental Implants (including compatible screw) conforms to ISO 14801:2016, and does not present new worst-case compared to existing and approved TMA system. | The Single TMA and designated superstructures do not present any new worst-case when compared to the existing and approved TMA system (Rationale provided). |
  | Fatigue testing of TiBase Abutments | Worst-case combination of subject device implants, TiBase abutments, and zirconia superstructure is strong enough for clinical application per ISO 14801. | Tested according to ISO 14801; implies meeting strength requirements (no explicit numerical value reported as metric). |
  | Gamma Irradiation Sterilization | Assurance of SAL (Sterility Assurance Level) of 10^-6 using VDmax 20kGy according to ISO 11137-2:2013 and ISO/TS 13004. | Sterilization validated in accordance with ISO 11137-2:2013, assuring SAL of 10^-6. |
  | Cleaning and Steam Sterilization (End-User) | Assurance of SAL of 10^-6 for steam sterilization (for non-sterile components) using full cycle approach as detailed in Annex D4 of ISO 17665-1:2006, in accordance with ISO 17665-1:2006 and ISO 17665-2:2009. | Steam sterilization validated in accordance with ISO 17665-1:2006 and ISO 17665-2:2009, assuring SAL of 10^-6. |
  | Disinfection (End-User) | Disinfection process validated in accordance with ISO 17664-1:2021 and AAMI TIR12:2020. | Disinfection process validation conducted with accordance with ISO 17664-1:2021 and AAMI TIR12:2020. |
  | Shelf-Life, Packaging and Transportation | Ensure 5 years shelf life under accelerated and real-time aging, and confirmed sterility throughout shelf life and after packaging/transportation per ISO 11607-1. | Shelf-life tests conducted to ensure 5 years shelf life, confirming sterility after packaging and transportation. |

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

As no AI component is described, this question is not directly applicable. The performance data section describes various engineering tests.

• Test Set Description: The "test set" for the engineering evaluations consists of physical samples of the UniFit Dental Implant System.
• Sample Sizes:
  • For most tests (connection design effectiveness, torque resistance, tool life, rotation, screw performance, screw loosening/extraction, torsion testing, fatigue testing of TiBase abutments), the document states "All tested specimens" or "All tested screws," implying all manufactured or a representative sample of components tested met the criteria. It does not provide specific numerical counts for these "specimens" or "screws."
  • For the UniFit 6.00mm Implants Pull-Out test, comparison was made to "proposed predicate devices MIS short implants (K103089)." The sample size for UniFit is not explicitly stated but implies sufficient numbers for comparison.
  • For Comparative Surface Area Analysis and Comparative Bone to Implant Contact Surface Area Analysis, comparison was made against "legally marketed devices (MIS short implants cleared under 510(k) K103089) at worst case implant variation" and "MIS's SEVEN MF7-06420." Again, specific sample sizes for the UniFit components are not given, but "tested items" is used.
• Data Provenance: The data comes from internal testing conducted by Adin Dental Implant Systems Ltd. (implied by "Adin internal protocol") and potentially external accredited labs for biocompatibility and sterilization (e.g., "Tests have been conducted at MDT Medical Device Testing GmbH"). The tests are in accordance with international standards (ISO, ASTM, YY) and FDA guidance. The implants are compared to predicate devices already marketed in the US.

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

This question is not applicable as the document does not describe the use of experts to establish a "ground truth" for an AI algorithm's performance on a test set. The validation is through engineering, materials, and biocompatibility testing against established standards and comparisons to predicate devices, which generally do not involve human "experts" establishing ground truth in the AI sense.

4. Adjudication Method for the Test Set

Not applicable, as there is no AI component or subjective human interpretation of results requiring adjudication for ground truth.

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, as no AI component is described.

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

Not applicable, as no AI component is described.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, "ground truth" is established through:

• Compliance with International Standards: Adherence to ISO and ASTM standards for material properties, mechanical performance, fatigue, sterility, and biocompatibility.
• Comparison to Predicate Devices: Performance characteristics (e.g., implant design, connection types, material, dimensions, sterilization methods, clinical indications) are compared against several legally marketed predicate and reference devices (e.g., Adin's Touareg™ CloseFit Dental Implant System, MIS C1 implants, Straumann BLX System, etc.). The "ground truth" implicitly aligns with the documented safety and effectiveness of these predicate devices.
• Internal Protocols: Performance data is generated and evaluated against Adin's internal protocols and specifications.

8. The Sample Size for the Training Set

Not applicable, as no AI component or machine learning model is described that would require a training set.

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

Not applicable, as no AI component or machine learning model is described that would require a training set with established ground truth.

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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.

MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.

MIS LOCKiT abutments are provided in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: . 1, 3, 5 mm

MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).

b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.

Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: 1, 3, 5 mm .

MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

The provided text is a 510(k) Premarket Notification from the FDA for dental implant abutments. It details the device, its intended use, and how it is substantially equivalent to legally marketed predicate devices. The document explicitly states that no clinical performance data was required or conducted for this device submission. Instead, the substantial equivalence was demonstrated through non-clinical performance data, primarily mechanical testing (fatigue testing), and comparisons to predicate devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance (human-in-the-loop, MRMC, expert ground truth, training/test sets for AI models, etc.) is not applicable to this document. The device in question is a physical dental abutment, not an AI/software device that would typically undergo the kind of clinical validation described in the prompt.

However, I can extract the acceptance criteria and performance data for the mechanical testing which was used to demonstrate substantial equivalence:

Acceptance Criteria and Reported Device Performance (Non-Clinical / Mechanical Testing)

Regarding the other points of the prompt, as applied to this document:

2. Sample size used for the test set and the data provenance: For mechanical testing, the "test set" would be the physical samples of the abutments and implants. The document mentions "worst case implants and abutments" being chosen for testing, such as "narrowest implants loaded with the abutments which have the maximum gingival height." The exact number of samples tested for each configuration is not explicitly stated in this summary, but would be detailed in the full test reports. The provenance is the manufacturer, MIS Implants Technologies Ltd., located in Israel. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement and engineering standards (e.g., ISO 14801:2016 for fatigue testing), not expert consensus.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/software for diagnostic imaging interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used: For mechanical testing, the ground truth is defined by the performance standards (e.g., ISO 14801:2016) and direct physical measurement of fatigue, tensile strength, etc.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) submission focuses on demonstrating substantial equivalence through non-clinical (mechanical and biocompatibility) testing, as is typical for Class II physical medical devices like dental abutments. It does not involve AI/software validation or human-reader studies.

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