(311 days)
IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).
IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles.
The provided text describes information for a 510(k) premarket notification for the "IH Implant System" by Sewon Medix Inc. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.
Therefore, many of the requested elements for a study proving device acceptance against specific criteria are not explicitly present in the provided text. The document details bench testing, specifically fatigue testing and biocompatibility, to show equivalence.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" in this 510(k) pertains to demonstrating that the new device is as safe and effective as a legally marketed predicate device. For the non-clinical testing performed, the acceptance criteria are generally "in compliance with" or "similar to" established standards and predicate device characteristics, rather than specific performance thresholds.
Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)
| Test | Acceptance Criteria | Reported Device Performance ("IH Implant System") |
|---|---|---|
| Biocompatibility (Fixture) | In compliance with applicable international and US regulations (similar to predicate) | Cytotoxicity (OK), Sensitization (OK), Intracutaneous Reactivity (OK), Acute Systemic (OK), Implantation (OK), Genotoxicity (OK) |
| Biocompatibility (Prosthetic) | In compliance with applicable international and US regulations (similar to predicate) | Cytotoxicity (OK), Sensitization (OK), Irritation (OK), Acute Systemic (OK), Genotoxicity (OK) |
| Roughness of SLA Surface (Ra) | 2.5~3.0 μm (similar to Osstem product catalog) | 2.861 ± 0.262 μm |
| Sterilization Validation | VDmax 25 SAL 10-6 (similar to predicate) | VDmax 25 SAL 10-6 |
| Packaging Validation (Shelf life) | 8 years (predicate device shelf life) | 5 years |
| Fatigue Testing | In compliance with "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2007 (similar to predicate) | Results are in compliance and were similar to previously cleared predicate devices. |
Study Details (as far as available in the text)
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of a clinical study or human performance evaluation.
- For biocompatibility and fatigue testing, the sample sizes are not explicitly stated. These are typically bench tests performed on a representative number of devices.
- Data provenance: For Fatigue Testing, it was "conducted according to... ISO 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario." For Biocompatibility, it states "Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations." The text does not provide country of origin or whether it was retrospective/prospective data, as these are non-clinical lab tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes non-clinical bench testing for substantial equivalence, not a study requiring human expert ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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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 is not an AI-assisted device or an MRMC study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental implant system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the sense of clinical ground truth. For non-clinical tests (biocompatibility, fatigue, surface roughness), the "ground truth" or reference is established by international standards (e.g., ISO 14801, ASTM F67-06), regulatory guidance, and the characteristics of the legally marketed predicate devices.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/machine learning product.
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How the ground truth for the training set was established:
- Not applicable for the same reason mentioned above.
In summary: The provided 510(k) focuses on demonstrating substantial equivalence of a physical dental implant system through non-clinical laboratory testing. It does not present a clinical study with human subjects, associated acceptance criteria as performance metrics, or the human-involved "ground truth" and reader performance details common in studies for diagnostic devices or AI algorithms. The "acceptance criteria" here refer to meeting established safety and performance standards via bench testing to show similarity to predicate devices.
§ 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.