FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The IU Implant System 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, and to restore the patient's chewing function.

Device Description

The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment). The IU Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the IU Implant System, extracted from the 510(k) summary:

The provided document (K172345) is a 510(k) Summary for a new medical device, the IU Implant System. In 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to establish new safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating equivalence to established standards and predicate devices, largely through non-clinical testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IU Implant System are implicitly set by the standards and characteristics of the identified predicate and reference devices, as well as relevant ISO standards. The "performance" being demonstrated is that the subject device meets these established benchmarks, thereby showing substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Criterion Category	Specific Acceptance Criteria (Inferred from Predicate/Standard)	Reported Device Performance (IU Implant System)
Intended Use	Same intended use as predicate devices.	"The IU Implant System 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, and to restore the patient's chewing function." (Identical to primary predicate and similar to reference devices)
Technological Characteristics	Similar design, dimensions, material, surface treatment, sterilization method as predicate devices.	Similar designs, dimensions, and has the same material (Pure titanium - ASTM F67 for fixture, Titanium alloy - ASTM F136 for abutments), intended use, surface treatment (S.L.A), and technological characteristics. (Demonstrated through comparative tables)
Biocompatibility	Biocompatible according to ISO 10993-1 and ISO 7405:2008.	Biocompatibility evaluation conducted in accordance with ISO 7405:2008 and ISO 10993-1:2009/AC:2010. Specific tests performed: Cytotoxicity (Elution), Sensitization, Oral irritation, Systemic Toxicity (acute), Genotoxicity, Implantation, Endotoxin Test (LAL test) with limit below 5 EU/mL. Results demonstrated safety.
Sterilization	Achieves a Sterility Assurance Level (SAL) of 10^-6 according to ISO 11137 (gamma) and ISO 17665 (steam).	Sterilization validating testing performed following ISO 11137-1/2/3 (gamma) and ISO 17665-1/2 (steam). Test results demonstrated that the SAL of 10^-6 was achieved and all testing requirements were met.
Shelf Life	Demonstrated shelf life comparable to predicate/acceptable standards (accelerated aging).	Accelerated aging shelf life testing conducted according to ASTM F1980; real time testing is being conducted to support accelerated aging results. (No specific years stated for the subject device shelf-life, but one reference device has 8 years and the primary predicate device's shelf life is not mentioned in the table.)
Risk Analysis	Risk analysis conducted according to ISO 14971, with all risks determined to be acceptable and as low as reasonably possible.	Risk analysis for IU Implant System was conducted in accordance with ISO 14971. It was determined that all risks associated with IU Implant System were acceptable and as low as reasonably possible.
Physical Testing	Mechanical testing performed according to ISO 14801 (for predicate devices).	"Not tested/no angulation submitted for clearance" for the subject device. This indicates that direct mechanical testing of the subject's angulation characteristics wasn't performed for its own clearance but relies on similarity to predicates that performed such tests.

Study Details

Given this is a 510(k) submission, the "study" that proves the device meets the acceptance criteria is primarily a non-clinical comparative testing and documentation of material/design equivalence to predicate devices and recognized standards.

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in terms of a "test set" as one might refer to it in a clinical study. The non-clinical tests (biocompatibility, sterilization, shelf-life) would typically involve a sample of the manufactured device components. The exact number of samples for each specific test (e.g., cytotoxicity, sensitization, mechanical flexural strength) is not detailed in this summary.
Data Provenance: The biocompatibility testing was conducted according to International Standard ISO 7405:2008 and ISO 10993-1:2009/AC:2010. Sterilization testing followed ISO 11137-1/2/3 and ISO 17665-1/2. Shelf-life testing followed ASTM F1980. Risk analysis followed ISO 14971. This indicates testing against internationally recognized standards. The country of origin of the data generation isn't specified beyond the device manufacturer being WARANTEC Co., Ltd. from Korea. This is a retrospective analysis of non-clinical design and safety data against known standards and predicate devices.

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

This is not applicable in the context of this 510(k) submission. "Ground truth" in this scenario is established by adherence to recognized international standards (ISO, ASTM) and demonstrative equivalence to predicate devices, rather than expert consensus on a test set (e.g., interpretation of medical images). The experts involved would be those who conducted the laboratory tests and certified compliance with the standards (e.g., microbiologists, material scientists, toxicologists), but their number and specific qualifications are not detailed in this summary.

3. Adjudication method for the test set:

Not applicable. There is no "adjudication method" in the sense of reconciling divergent expert opinions on test data. Compliance with each standard (e.g., passing a cytotoxicity test, achieving a certain SAL) is a binary outcome based on pre-defined criteria within the standard itself.

4. 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:

No, an MRMC comparative effectiveness study was not done. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. This type of study is irrelevant for this device.

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

No, this is not an AI algorithm. This question is not applicable.

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

The "ground truth" for this P(re-market) N(otification) is
- Compliance with recognized international standards for biocompatibility (ISO 10993, ISO 7405), sterilization (ISO 11137, ISO 17665), shelf-life (ASTM F1980), and risk management (ISO 14971).
- Substantial equivalence to predicate devices in terms of intended use, materials, design, and manufacturing processes, which implicitly means the predicate devices' established safety and effectiveness serve as the benchmark.

7. The sample size for the training set:

Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device. The information refers to the manufacturing and testing of physical medical devices and their components, not machine learning models.

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

Not applicable. As stated, there is no training set for this type of device.

Summary of the "Study" (Non-Clinical Evidence):

The "study" presented is a collection of non-clinical tests and comparisons to establish substantial equivalence. It confirms:

The IU Implant System has the same intended use as the primary predicate device (Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155).
Its technological characteristics (design, dimensions, material, surface treatment, connection, sterilization method) are similar to or identical to the predicate and reference devices.
It meets all relevant biocompatibility standards (ISO 7405, ISO 10993-1) through specific lab tests (Cytotoxicity, Sensitization, Oral irritation, Systemic Toxicity, Genotoxicity, Implantation, Endotoxin).
Its sterilization process achieves the required sterility assurance level (SAL 10^-6) validated by ISO standards.
It has demonstrated shelf-life stability through accelerated aging testing (ASTM F1980).
A risk analysis was conducted according to ISO 14971, finding all risks acceptable.

Key Point from the Submission: "No clinical data were included in this submission." This explicitly states that the substantial equivalence determination relies entirely on non-clinical data and comparison to legally marketed predicate devices, as is common for many Class II medical devices in the 510(k) process.

Summary

Regulation Number and Section

§ 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.