(259 days)
The KJ Submerged System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading.
The KJ Submerged System replaces the root of a missing tooth and is made from surgical grade titanium alloy(Ti-6Al-4V) to exacting specifications. The KJ Submerged system is comprised of only two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture. KJ Submerged System's locking taper provides a tight seal at the implant to abutment interface, minimizing the gap. The sloping shoulder affords felxibility at time of implant placement.
The provided text describes a 510(k) premarket notification for a medical device, the "KJ Submerged System," which is a dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria tied to human or AI performance. Therefore, many of the requested elements for a study proving device performance against acceptance criteria for AI/human reader performance are not applicable here.
However, I can extract the relevant information regarding the non-clinical testing performed and the basis for substantial equivalence.
Here's a breakdown of the requested information based on the provided text, with explanations for why certain sections are not applicable:
Acceptance Criteria and Study Details for KJ Submerged System (Dental Implant)
This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria for diagnostic performance or AI effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Strength appropriate for intended use (conformance to ISO 14801) | Results confirmed the strength of the system. (Implied acceptance based on conformance to standard) |
| Same intended use as predicate device | Has the same intended use (Confirmed through comparison) |
| Same operating principle as predicate device | Uses the same operating principle (Confirmed through comparison) |
| Same basic design as predicate device | Incorporates the same basic design (Confirmed through comparison) |
| Same material and surface treatment as predicate device | Incorporates the same material and the surface treatment (Confirmed through comparison) |
| Similar range of physical dimensions to predicate device | Encompass the similar range of physical dimensions, including diameter and length of the implants, and diameter and height of the abutments (Confirmed through comparison) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study or AI model evaluation. The "testing" referred to is non-clinical, specifically mechanical fatigue testing. The sample size for ISO 14801 Dentistry - Implants - Dynamic fatigue tests is not explicitly stated in the provided text, but such standards typically prescribe a minimum number of samples.
- Data Provenance: Not applicable as this is a non-clinical, in-vitro mechanical test, not data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in this context would refer to objective measurements from mechanical testing, not expert interpretation of diagnostic images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There was no adjudication of expert opinions; the testing was mechanical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. This device is a dental implant, and the submission is for substantial equivalence based on non-clinical testing and comparison to predicate devices, not an evaluation of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This is a physical medical device (dental implant), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was objective physical measurements and adherence to specified performance metrics as defined by the ISO 14801 standard for dynamic fatigue tests of endosseous dental implants.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this context, as it's a physical device and not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device submission.
§ 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.