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The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.

The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.

Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.

Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.

Here's an breakdown of the information present and what's missing, based on the prompt's requirements:

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

• Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
  • Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
  • Cytotoxicity testing (per ISO 10993-5 and USP ): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
  • Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
  • LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP , ): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
  • Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
• Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.

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

• Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
• Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.

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

• Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.

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

• Missing: Not applicable to the presented data.

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:

• Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.

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

• Missing: Not applicable.

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

• Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
• Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.

8. The sample size for the training set:

• Missing: Not applicable, as this is not an AI/ML device.

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

• Missing: Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.

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KAT Implants System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implant can be placed in extraction sites or healed alveolar ridges. KAT Implants System 2.5mm implants are self-tapping titanium alloy threaded screws indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT Implants System 2.5mm implants may also be used for inter-radicular transitional application.

KAT Implants System 3.0mm implants are indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artificial teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate.

KAT Implants System Abutments are intended to be used with KAT Implants System Dental Implants aid in prosthetic rehabilitation of the edentulous areas in maxilla and mandible.

Like the predicate KAT Implants 2.5mm and 3.0mm KAT Implants System Onepiece implants 2.5mm and 3.0mm display the following characteristics: a) have a threaded body and a tapered post with an internal threaded bore, b) have the same indications, c) are manufactured from the same material (Ti6Al4V ELI alloy), c) have the same diameters (2.5 and 3.0mm) and implant body lengths (10, 12 and 14mm), d) are packaged with the same materials and undergo the same sterilization process. KAT Implants System One-piece implants 2.5mm and 3.0mm implants are not designed to receive any abutments; they are designed to receive the crowns directly via cementation procedure. KAT Implants System One-piece implants are blasted with a soluble tricalcium phosphate blasting media. All materials and manufacturing processes are the same for all KAT Implants System Dental Implants. The fatigue testing was executed per ISO 14801:2007, Dentisty - Implants - Dynamic fatigue testing on endosseous dental implants on a 4.2mm width by 8.5mm length abutment with 20 ° angularity and a 3.0mm diameter implant, which is considered worst-case representation for KAT Implants System implants having 3.0mm or greater diameter. In view of a fatigue test results (samples were able to withstand 440 N of force over 5 million cvcles) and considering the fact that KAT Implants System One-piece Implants 3.0 and predicate KAT Implants System 3.0mm implants (K083544) have identical dimensions, no further fatigue testing was deemed necessary.

Predicate one-piece implant devices (IMTEC Sedax MDI 1.8mm and Maximus 3.0mm Diameter Implant) are the same as One-piece implants 2.5 and 3.0 in respect to material composition, surface treatment, diameters and lengths (for the exception of One-piece implant 3.0 x 10). Predicate Maximus 3.0mm Diameter Implant is not provided in 10 mm length, but another predicate - KAT 3.0mm implant cleared under K083544 is provided in 10 mm length.

Since predicate KAT Implants System 2.5mm implants (K083544) are approved for use with abutments of KAT Implants System, and considering the fact that KAT Implants System Onepiece Implants 2.5 and predicate KAT Implants System 2.5mm implants (K083544) have identical dimensions, no further fatigue testing was deemed necessary.

KAT Implants System Angled Abutments are implant abutment devices intended to be distributed as part of the KAT Implants System. KAT Implants System currently consists of implants, abutments, and Class I accessory instrumentation cleared for marketing under Traditional 510(k) Pre-marketing Notification # K083544 and K101201. All dental abutments of the KAT Implants System are a) used for the same indication, b) are manufactured with the same Ti-6AI-4Va ELI alloy, c) undergo the same surface treatment and sterilization, d) packaged and labeled using the same packaging materials and Instructions for Use, and e) are intended to be assembled together during surgery utilizing the same locking-taper implant post/abutment connection, with the aid of the same KAT Implants System Class 1 accessories and instruments.

Like the predicate KAT Implants System Straight (Prepable) Abutments with outside diameters 4.2mm 4.6mm and 5.4mm (all available only in 6.5mm length), KAT Implants System Angled Abutments which are subject of this 510(k), consist of a same-dimension internal hollow bore on one end for connection with the abutment-receiving post of the KAT Implants System Dental Implants. Like the abutment predicate, they are similarly designed to be retained by the KAT Implants System Dental Implants through the abutment-receiving post. A locking-taper connection is activated with a torque wrench set at 25 Ncm.

KAT Implants System Ball Abutments are implant abutment devices intended to be distributed as part of the KAT Implants System.

Like the predicate KAT Implants System Straight (Prepable) Abutments with outside diameters 4.2mm, 4.6mm and 5.4mm (all available only in 6.5mm length), KAT Implants System Ball Abutments which are subject of this 510(k), consist of a same-dimension internal hollow bore on one end for connection with the abutment-receiving post of the KAT Implants System Dental Implants. Like the abutment predicate, they are similarly designed to be retained by the KAT Implants System Dental Implants through the abutment-receiving post. A locking-taper connection is activated with a tapping force – the same method used to activate locking taper connection on the other predicate - KAT Implants System Implant Abutment 4.2x6.5.

The material of construction (Ti-6Al-4Va ELI Alloy), all surface preparation, all packaging, labeling and sterilization of KAT Implants System Angled Abutments and Ball Abutments are the same as previously cleared KAT Implants Straight and Implant Abutments. The outside diameters are the same, however, dimensional characteristics which differ from KAT Implant System Straight Abutments predicate duly noted below:

Angled Abutments: outside diameter availability in 4.6mm, and 5.4mm (within the range of previously cleared KAT Implant System Straight Abutments outside diameters), all with an 8.5mm length at 10° and 20° angulation. Mesial-distal width of Angled Abutment 4.2 10° and Angled Abutment 4.2 20° is 4.2mm.

Ball Abutments: outside diameter availability in 4.2mm (within the range of previously cleared KAT Implant System Straight Abutments outside diameters), and lengths between 6.5 and 8.5mm at 0°, 10° and 20° angulation.

The dimensional properties arising from differences in length between KAT Implants System Angled and Ball Abutments and the predicate KAT Implants System Straight Abutments were investigated by fatigue testing on KAT Implants System Angled Abutment 4.2mm x 8.5mm (20 ° anqularity) samples. The testing was executed per ISO 14801:2007, Dentistry - Implants -Dynamic fatique testing on endosseous dental implants. The use of a 4.2mm width by 8.5mm length Angled Abutment with 20° angularity is considered worst-case scenario representation for KAT Implants System abutments.

All KAT Implants System Dental Implant and Abutment devices which are subject of this 510(k) and the listed predicate devices are substantially equivalent because they are:

Manufactured using the same Titanium-6Aluminum-4Vanadium ELI alloy (certified to meet ASTM F136. Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications and biocompatibility requirements of Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments);

Packaged with the same size and material primary packaging (in conformance with material and process requirements of ISO 11607, Packaging for Terminally-Sterilized Medical Devices and ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials);

Are sterilized using the same sterilization process and sterility assurance level with SAL = 10-6 (per ISO 11137, Sterilization of Healthcare Products - Radiation).

Have the same Indications for Use.

Do not present any new dimensions and operating technology from endosseous dental implants and abutments already present in the market.

The only modifications that were made are:

1. Angle of the predicate Straight Abutments was changed from 0° to 10° and 20°;

2. Length of the predicate Straight Abutments was changed from 6.5mm to longer lengths. New abutment devices were named Angled Abutments 4.2 20°, 4.6 20°, 4.2 10°, 4.6 10°, 5.4 10°.

3. Internal thread of the Straight Abutments was removed and a ball element was added. New abutment devices were named Ball Abutments 3.5, 4.5, 5.5, 3.5 10°, 4.5 10°, 4.5 20°, 4.5 20°, 4.5 20°,

4. Abutment receiving post of the predicate KAT Implants 2.5 and 3.0 was made longer. New implant devices were named One-Piece Implants 2.5 and 3.0;

5. Implant blasting media was changed from aluminum oxide to a soluble tricalcium phosphate. All KAT Implants System Implants will be blasted with soluble tricalcium phosphate and will retain original names.

The document describes the K112758 submission for KAT Implants System components. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the fatigue testing, the acceptance criterion implicitly comes from the predicate device and the ISO standard. The document states that the samples were able to withstand a certain force over a specified number of cycles. The fatigue testing for the new devices aims to show equivalent performance to maintain safety and effectiveness.

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

• Sample Size for Fatigue Testing: Not explicitly stated as a number, but refers to "samples" being able to withstand the force. For the "worst-case representation," a 4.2mm width by 8.5mm length Angled Abutment with 20° angularity and a 3.0mm diameter implant were tested. Without specific numbers, it is difficult to determine if statistical significance was met.
• Data Provenance: The studies are non-clinical (mechanical testing) conducted by the manufacturer, KAT Implants LLC. There is no information regarding country of origin of data (likely US, given the submission to FDA) or if it's retrospective or prospective (typically, this type of testing is prospective for new or modified devices).

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

This information is not applicable to this submission type. The studies described are non-clinical (mechanical and material testing), not involving human reader studies or expert ground truth generation for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable as there are no human reader studies described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

This information is not applicable as there are no human reader studies described, and the device is a physical dental implant system, not an AI-based diagnostic tool.

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

This information is not applicable as the device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by recognized engineering standards and specifications:

• Fatigue Testing: ISO 14801:2007 (Dentistry - Implants - Dynamic fatigue testing on endosseous dental implants).
• Biocompatibility: ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications) and biocompatibility requirements of the Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
• Packaging: ISO 11607 (Packaging for Terminally-Sterilized Medical Devices) and ASTM F88 (Standard Test Method for Seal Strength of Flexible Barrier Materials).
• Sterilization: ISO 11137 (Sterilization of Healthcare Products - Radiation).

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.

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