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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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INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The INNO SLA Submerged Implant System offers the following components.

1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
Ø 1.95 x 9.3 mm
12 Multi Cylinder Screw Ø 2.25 x 5 mm
13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
14 Temporary Abutment Ø 4.5 x 10 mm
15 Multi Titanium Cylinder Ø 4.5 x 9 mm

The provided document is a 510(k) premarket notification for a medical device (INNO SLA Submerged Narrow Implant System). This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness or meeting specific performance acceptance criteria through a dedicated study.

Therefore, the document does not contain any information regarding:

• Acceptance criteria in the traditional sense of a clinical or performance study with numerical targets for metrics like sensitivity, specificity, accuracy, etc.
• The study that proves the device meets acceptance criteria (as no such study with performance metrics is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Ground truth type for a performance study.
• Sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence through:

1. Performance Data (Non-Clinical):

The performance testing listed focuses on engineering and material characteristics, leveraging previous clearances and established standards.

• Gamma radiation sterilization and shelf-life: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Steam sterilization of abutments: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K201323.
• Five-year shelf life and packaging: Leveraged from Cowellmedi Co., Ltd's previous clearance K132242.
• SLA surface treatment: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Fatigue test in accordance with ISO 14801: This is an engineering test to ensure the mechanical integrity of the implant system. The document states: "We have performed the fatigue test to make sure the differences do not raise and the test result of the test supported substantial equivalence." However, no specific numerical acceptance criteria or results are provided in the summary.
• Biocompatibility endpoints: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Non-clinical worst-case MRI review: Performed using scientific rationale and published literature to evaluate displacement force and torque.

2. Substantial Equivalence Discussion and Comparison Chart:

This section directly compares the subject device (INNO SLA Submerged Narrow Implant System) with various predicate and reference devices, highlighting similarities in:

• Intended Use
• Material (Titanium Grade 4 or Ti-6Al-4V ELI)
• Principle of Operation
• Design
• Surface Treatment (SLA, TiN Coating)
• Sterility (Gamma Sterilization, Non-sterile with terminal sterilization via moist heat/autoclave, End User Sterilization)
• Shelf Life (5 years)

The document asserts that slight differences, such as in abutment size options or diameter ranges, do not affect substantial equivalence or raise concerns about safety or performance.

In summary, for a traditional clinical or AI/ML performance study as requested, all fields would be "Not Applicable" or "Not Provided" based on the content of this 510(k) summary. The "acceptance criteria" here are implicitly that the device performs equivalently to the listed predicates based on the non-clinical tests and functional comparisons detailed.

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