(66 days)
KAT Implant 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 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 3.0mm implant is indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artifical 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. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.
KAT 2.5mm is a self-tapping titanium alloy threaded screw indicated for transitional and long-term intra-bony applications, such as providing support for transitional and crowns, bridges and dentures. KAT 2.5mm may also be used for inter-rollul br transitional application.
KAT implant system consists of dental implants, implant abutments, healing abutments, temporary abutments, screw retained framework abutment, spacer, cylinder, healing collar and the instruments for placement and restoration of the implants. KAT implants are supplied in 2.5, 3.0, 3.5, 4.3 and 5.0mm diameters. KAT 2.5 and 3.0mm implants are supplied in 10, 12 and 14mm length. IAAT 3.5mm is supplied in 8, 10, 12 and 14mm length. KAT 4.3 and 5.0mm inplants are supplied in 6, 8, 10, 12 and 14mm length. External V-shaped thread is utilized to screw the implants into the bone. Horizontal fins are placed in between the thread and the abutment receiving portion of 3.5, 4.3 and 5.0mm implace All implants have 3.1mm diameter 1.5 degree taper abutment receiving post. KAT abutments are available in 4.2, 4.7, 5.5 and 6.5mm diameter. KAT abutments can be attached to any KAT implant via locking taper connection.
The KAT Implant System was found substantially equivalent to predicate devices based on similarities in intended use, operating principles, basic design, materials, and sterilization processes. No specific acceptance criteria with quantifiable metrics were provided in the document. The study described is a submission for substantial equivalence to legally marketed predicate devices, not a study evaluating specific performance metrics against pre-defined acceptance criteria.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of explicit acceptance criteria with quantifiable performance metrics. The FDA clearance is based on a determination of substantial equivalence to predicate devices. This means the device is considered as safe and effective as a legally marketed device and doesn't introduce new questions of safety or effectiveness.
The document states:
- "KAT Dental Implant System has the same intended use as, and technological characteristics similar to the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety and effectiveness."
Therefore, the "reported device performance" is essentially that the device is, by virtue of substantial equivalence, expected to perform similarly to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of performance evaluation with a specific sample size. The submission is focused on demonstrating substantial equivalence to existing devices through comparison of design, materials, and intended use, rather than presenting results from a performance study using a test set of implants in patients or a cadaver study.
Therefore, no information on sample size or data provenance (country of origin, retrospective/prospective) for a test set is available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no performance study with a "test set" is described, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As no performance study with a "test set" is described, there is no information on adjudication methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was described or performed in this submission. The submission relies on demonstrating substantial equivalence to predicate devices, not on showing efficacy through direct comparison of human readers with or without AI assistance.
6. If a Standalone Performance Study Was Done
No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was described. The device is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the substantial equivalence determination is the established safety and effectiveness of the legally marketed predicate devices. The new device is compared against these existing devices.
The predicate devices mentioned are:
- LaminOss® Osteocompressive Dental System (K982925)
- Bicon Dental Implant 4.5 x 6.5mm (K050712)
- IMTEC Sedax MDI 1.8mm (K031106)
- OsseoSpeed 4.0S-6mm (K063779)
- OsseoSpeed Narrow (K080396)
8. The Sample Size for the Training Set
Since this is a submission for a physical medical device (dental implants) and not a machine learning algorithm, the concept of a "training set" is not applicable and therefore no sample size is provided.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not applicable here.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)