(349 days)
KAT Implant System Dental Implants are indicated for restoration of edentulous 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 implants can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.
KAT Implant System Straight Abutment devices are intended to be used with KAT Implant System Dental Implants to aid in prosthetic rehabilitation.
KAT Implant System (Dental Implants and Straight Abutment) is indicated for the restoration of edentulous areas in maxilla and mandible.
KAT Implant System Dental Implants (with outside diameters 6.0mm, 7.0mm and 8.0mm) and KAT Implant System Straight (Prepable) Abutments (with outside diameters 4.2mm, 4.6mm, 5.0mm, 5.4mm, and 6.4mm) are root-form, endosseous dental implant and implant abutment devices intended to be distributed as part of the KAT Implant System platform. KAT Implant System currently consists of implants, abutments, and Class I accessory instrumentation cleared for marketing under Traditional 510(k) Prc-marketing Notification # K083544.
Like the predicate KAT Implant System Dental Implant with outside diameter 5.0mm, the KAT Implant System Dental Implants which are subject of this 510(k) are provided in lengths of 6.0mm, 8.0mm, and 10.0mm. External V-shaped thread is similarly utilized in these new sizes of KA I Implant System Dental Implants in order to screw the implants into the bone. Horizontal fins are also placed between the thread and the abutment receiving portion of these dental implants. The abutment receiving portion of all KAT Implant System Dental Implants consists of a 3.1mm outside diameter post with a 1.5 degree taper. All KAT Implant System Dental Implants are intended to be used with previously cleared KAT Implants System Implant Abutments, as stated in Instructions for Use.
Like the predicate KAT Implant System Implant (Indexed) Abutments with outside diameters 4.2mm, 4.7mm, 5.5mm and 6.5mm, the KAT Implant Straight (Prepable) Abutments which are subject of this 510(k) consist of outside diameters within the predicate's range of outside diameters, and are 6.5mm in length. KAT Implant System Straight (Prepable) Abutments are similarly retained by the KAT Implant System Dental Implants through the abutmentreceiving post. A locking-taper connection activates the seating of the abutment to the implant with the help of a torque wrench.
This document is a 510(k) summary for a dental implant system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study with acceptance criteria and performance data in the traditional sense of an AI/ML device submission.
As such, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and ground truth is largely not applicable or not explicitly detailed in this type of submission for a physical medical device like a dental implant.
However, I can extract the relevant information and approximate answers where possible based on the provided text, primarily focusing on the comparison to the predicate device.
Here's the breakdown of the information you requested:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the format of specific quantitative benchmarks. Instead, it demonstrates substantial equivalence based on a comparison of technological characteristics and performance testing to a legally marketed predicate device. The "performance" here refers to the outcomes of bench testing designed to show comparable safety and efficacy to the predicate.
| Acceptance Criteria (Implied from Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|
| Materials: Same as predicate (Titanium-6Aluminum-4Vanadium ELI alloy per ASTM F136-2(a), biocompatibility per Class II Special Control Guidance Document). | The subject devices are manufactured using the same Titanium-6Aluminum-4Vanadium ELI alloy, certified to meet ASTM F136-2(a) and biocompatibility requirements of the Class II Special Control Guidance Document. |
| Surface Treatment: Same as predicate (aluminum oxide grit-blasting, alkaline ultrasonication, nitric acid passivation per ASTM F86-04). | The subject devices undergo the same aluminum oxide grit-blasting (compliant with Class II Special Control Guidance Document) and same surface preparation processes (alkaline ultrasonication and nitric acid passivation per ASTM F86-04). |
| Packaging: Same as predicate (material and process requirements of ISO 11607:2006). | The subject devices are packaged with the same size and material primary packaging, conforming to ISO 11607:2006. |
| Sterilization: Same as predicate (radiation sterilization per ISO 11137:2006 with SAL = 10^-6). | The subject devices are sterilized using the same sterilization process and sterility assurance level (SAL = 10^-6) per ISO 11137:2006. |
| Implant/Abutment Rotation/Loosening Performance: Comparable to predicate. | Predicate: Insertion of abutment with force not less than 15 N-cm (torque wrench) or tapping force. Rotation/loosening prevented by frictional fit and engagement between implant post grooves and key's protrusions. |
| Subject Device (Implant): Same results as predicate (characterization performed as implant/abutment system). | |
| Subject Device (Abutment): Insertion with force not less than 25 N-cm (torque wrench) or tapping force. Demonstrated better resistance to rotation/loosening compared to predicate device. Justification for 25 N-cm torque provided in Section 18, Performance Testing. | |
| Implant/Abutment Fatigue Performance: Meets guidance for fatigue testing per Class II Special Control Guidance Document, comparable to predicate. | Predicate: Meets guidance for Fatigue testing per Class II Special Control Guidance Document (tested on 3.5mm diameter implant). Has substantial equivalence with the predicate in terms of fatigue performance, if not better. |
| Subject Device (Implant): Same results as predicate (characterization performed as implant/abutment system). | |
| Subject Device (Abutment): Same results as subject device implant (characterization performed as implant/abutment system). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes bench testing (non-clinical) rather than a clinical study.
- Sample Size: Not explicitly stated in terms of the number of units tested for each specific performance characteristic (e.g., how many abutments were tested for rotation/loosening, or how many implant-abutment systems were tested for fatigue). The document refers to "Testing performed on Implant/Abutment System as presented in Section 18, Performance Testing – Bench." Section 18 is not provided in this excerpt, but it would typically contain the specific number of test articles.
- Data Provenance: Bench test data originating from the manufacturer (KAT Implants LLC, Portsmouth, NH 03801, USA). This is non-clinical data, not patient data, so "country of origin of the data" and "retrospective or prospective" are not applicable in the patient data sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is a physical medical device 510(k) submission, not an AI/ML device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic interpretation is not applicable. The "ground truth" for this device's performance is established by engineering and materials science testing standards (e.g., ASTM, ISO standards, and FDA guidance documents like the Class II Special Control Guidance Document for Root-form Endosseous Dental Implants). These standards define how to objectively measure properties like material composition, strength, fatigue resistance, and sterilization effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of physical device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human experts are interpreting data (e.g., images) to establish "ground truth" or resolve disagreements. Here, the "truth" is determined by objective physical measurements according to established engineering protocols.
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. MRMC studies are specific to diagnostic devices (often AI-powered) where human readers (e.g., radiologists) interpret cases, and the study evaluates the impact of an AI tool on their performance. This document is for a physical dental implant system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on:
- Compliance with material specifications (e.g., ASTM F136-2(a) for alloy, ASTM F86-04 for surface preparation).
- Compliance with packaging and sterilization standards (ISO 11607:2006, ISO 11137:2006).
- Results from mechanical bench testing (e.g., for rotation/loosening, fatigue) against benchmarks implied or referenced by the FDA's "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and comparison to the predicate device's established performance.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a "training set."
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is 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 a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.