(178 days)
UD Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
UD Implant System is a dental implant system made of titanium (Fixture: ASTM F136 / Prosthetic Abutment: ASTM F136, ASTM F67 Gr 4) intend to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. This device may be used to replace one or more missing teeth. Its material, structure and intended use are substantial equivalence with the predicate device.
The provided text describes a 510(k) summary for the "UD Implant System," a dental implant device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving a device meets specific acceptance criteria based on performance metrics.
Therefore, many of the requested sections about clinical study details (sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set) cannot be answered. The provided text outlines non-clinical testing conducted to validate safety, but not performance-based acceptance criteria against clinical outcomes.
Here's a breakdown of what can be extracted and what cannot, based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in terms of performance metrics or acceptance criteria for clinical efficacy. The summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, and provides a list of non-clinical tests for safety and physical characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance is mentioned as this is a 510(k) submission focusing on substantial equivalence through non-clinical testing and comparison to a predicate device.
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)
Not applicable. No clinical test set or ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is mentioned.
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. This device is a dental implant, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable for clinical performance. The "ground truth" or basis for acceptance in this submission relates to the adherence to standards for materials, mechanical properties, and biocompatibility in non-clinical testing, and the substantial equivalence to a predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Evidence Presented (based on available information):
Device: UD Implant System (Endosseous Dental Implant)
Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Hero II and IS Dental Implant System by KJ Meditech Co., Ltd. K121047) to market the device.
Evidence for Substantial Equivalence:
- Intended Use: Identical to the predicate device.
- Operating Principle: Same.
- Basic Design: Same.
- Material: Titanium (ASTM F136 / ASTM F67 Gr 4) - similar to the predicate's Titanium 6Al 4V ELI Alloy.
- Surface Treatment: R.B.M. (Same as predicate).
- Structure: Internal Hexagon connection, self-taping cutting edge threads (Same as predicate).
- Dimensions: Similar range of diameters and lengths for fixtures and abutments.
- Surgery Type: One stage, Two stages (Same as predicate).
- Sterilization: Gamma radiation (Same as predicate).
- Shelf-life: 5 years (Same as predicate).
Non-clinical Testing Conducted (for safety, not performance against clinical acceptance criteria):
- Physical tests: visual, packaging, packaging seal efficacy, dimension, sterility (direct transfer method).
- Surface treatment tests: roughness average, developed surface area ration, surface characteristics (SEM), surface composition analysis (EDX).
- Mechanical properties tests: adaptation accuracy (Implant to abutment comparability), 35° compressive loads, torsional breaking force, removal torque force, fatigue test.
- Sterilization validation and shelf life tests.
- Biocompatibility tests (in accordance with ISO10993 series).
The 510(k) summary concludes that the UD Implant System is substantially equivalent to the predicate device based on these comparisons and non-clinical tests. It does not contain information about clinical performance studies with specific acceptance criteria that would typically be associated with AI/software medical devices or new device types requiring de novo clinical validation.
§ 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.