(137 days)
The Cotec Dental Implant 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 not intended for immediate loading.
Cotec Dental Implant System is composed of two types of fixtures, internal and submerged and abutments. The sizes of the fixtures in both internal and submerged type are identical, and made of titanium meta! intended to be surgically placed in the bone of the upper or lower jar arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. This system is made from pure titanium, and the surface treatment of fixtures is done with R.B.M. whereas abutments are not surface treated. The submerged type implant has an internal morse tapered connection with abutment for stronger engaging and dispersed stress distribution. This means that marginal bone can be perfectly preserved for safety in long term use. There are two types of submerged implant, straight and tapered type. Fixture diameter is Ø3.8, Ø4.2, Ø4.7, Ø5.2mm and the length is 8.0, 10.0, 12.0, 14.0mm. Fixture and cover screw are made of CP, Ti, Gr4 (ASTM-F67). The abutment is made of Ti6Al4V,ELI(ASTM-F136), and its diameters are 3.8 - 5.2 mm and the length is 5.5 -- 7.5mm.
The provided text is a 510(k) summary for the Cotec Dental Implant System. It describes the device's technical specifications, intended use, and claims substantial equivalence to predicate devices (SQ IS System and SQ IT System by Neobiotech Co., Ltd.). The document outlines various performance tests conducted to demonstrate the safety and effectiveness of the device.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Purpose of Test) | Reported Device Performance |
|---|---|
| Acute systematic toxicity (safe without any systematic toxicity) | Test samples are safe without having any systematic toxicity. |
| Appearance (no fracture, deformation, crack) | No fracture, deformation, crack has been found. Test samples are safe. |
| Cytotoxicity (safe to be used) | The test samples are indicated to be safe to be used. |
| Intracutaneous reactivity (safely acceptable rate for intracutaneous reactivity) | Test samples are proved to be safely acceptable rate for intracutaneous reactivity. |
| Pyrogen test (safe with higher than body temperature) | This test proved that the test samples are safe with higher than body temperature. |
| Sensitization test (no indications of erythema or oedema on guinea pig skin) | Test samples are proved to be safe with having no indications of erythema or oedema on guinea pig skin. |
| Sterility test (no indications of bacterial activity) | No indications of bacterial activity, thus the test samples are proved to be safe to be used. |
| Overall safety and effectiveness (as safe and effective as predicate devices, no new safety/effectiveness questions) | Substantially equivalent to predicate devices, demonstrating safety and effectiveness; differences do not raise new questions. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document refers to "test samples" for each test but does not specify the exact number, quantity, or characteristics (e.g., number of implant fixtures, specific sizes tested) of the samples used for any of the individual performance studies.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that the tests were "conducted."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. The studies described (toxicity, appearance, cytotoxicity, etc.) are laboratory-based performance and biocompatibility tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth in the same way an AI-driven diagnostic would. Therefore, the concept of "experts establishing ground truth" in this context is not relevant.
4. Adjudication Method for the Test Set:
- Not Applicable. As these are laboratory performance tests, there is no "adjudication method" involving multiple reviewers to establish ground truth as would be seen in clinical or image-based diagnostic studies. The results would be objectively measured or observed based on established laboratory protocols and standards (e.g., ASTM standards for material properties, specified test methods for biocompatibility).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted. This device is a dental implant system (a physical medical device), not a diagnostic algorithm or AI system that assists human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant here.
6. Standalone Performance Study:
- Yes (inherently). The performance studies listed (acute systematic toxicity, appearance, cytotoxicity, intracutaneous reactivity, pyrogen, sensitization, sterility) are all standalone tests of the device itself, performed without human-in-the-loop assistance. The results directly assess the intrinsic properties and biological safety of the Cotec Dental Implant System.
7. Type of Ground Truth Used:
- The "ground truth" for the tests performed is derived from the established scientific and regulatory standards for medical device biocompatibility and performance. For example:
- Biocompatibility tests (Toxicity, Cytotoxicity, Reactivity, Pyrogen, Sensitization): Ground truth is defined by the absence of adverse biological reactions as per ISO 10993 series of standards (which typically underpin such tests, though not explicitly cited here, it's implied by the FDA guidance document reference) and specific pass/fail criteria for each test according to regulatory guidelines.
- Material properties and physical integrity (Appearance): Ground truth is based on visual and physical inspection against predefined quality standards (e.g., absence of visible defects).
- Sterility: Ground truth is the absence of microbial growth as determined by standard microbiological culture methods.
8. Sample Size for the Training Set:
- Not applicable. The Cotec Dental Implant System is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. The device's design and manufacturing are based on established engineering principles and material science, not trained data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for this physical device, this question is irrelevant. The "ground truth" for the design and manufacturing of the device is rooted in engineering specifications, material standards (e.g., ASTM-F67, ASTM-F136), and regulatory requirements for dental implants.
§ 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.