(98 days)
SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. SimpleLine II is for single stage surgery
The SimpleLine II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
This document describes a 510(k) submission for the SimpleLine II endosseous dental implant, seeking clearance based on substantial equivalence to a predicate device. The information provided focuses on the physical characteristics and performance testing of the device, rather than a clinical study evaluating an AI algorithm's performance. Therefore, many of the requested categories related to AI study design, ground truth, and expert evaluation are not applicable to this document.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Device Performance (Dental Implant)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Limit of Predicate Device (Implantium II) - specific N value is implied to be > 250N | The fatigue limit of SimpleLine II is over 250N. (Fracture, cracks, or severe distortion of any parts were not detected). |
| No Fracture, Cracks, or Severe Distortion of Any Parts after specified fatigue testing conditions | Fracture, cracks, or severe distortion of any parts were not detected. |
| Same device characteristics as predicate device (Implantium II) regarding material, surface treatment, design. | SimpleLine II has the same device characteristics as the predicate device Implantium II. The material, surface treatment is the same, and the design and use concept are similar. (Note: The document also states "The differences between them are shape and shelf life," which contradicts the claim of "same design.") |
Explanation: The acceptance criteria for this dental implant are based on a direct comparison to a legally marketed predicate device (Implantium II) for fatigue characteristics and general design parameters. The primary performance test is a fatigue test.
Study Details (Based on the Provided Text)
Given the nature of the document (510(k) summary for a physical medical device, not an AI algorithm), the following information is either not applicable or can only be inferred in the context of device testing (not a clinical or AI study).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the fatigue test. It is implied that at least one specimen was tested, as it refers to "specimen" in the singular ("Tilting angles of specimen is 30"). However, standard engineering tests typically involve multiple samples to ensure statistical validity. The exact number of implants tested isn't provided.
- Data Provenance: The device company, Dentium Co., Ltd., is located in Suwon-si, Gyeonggi-do, Korea. The testing was presumably conducted there or at a contracted facility. The fatigue testing is prospective, as it's a test performed on the device itself.
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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)
- N/A. This is not an AI or diagnostic study requiring expert ground truth for interpretation of images or patient outcomes. The "ground truth" for a fatigue test is the physical outcome of the test (fracture, deformation, cycles to failure).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically used in clinical trials or diagnostic studies involving human interpretation or uncertain outcomes. The fatigue test results are objective mechanical measurements.
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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
- N/A. This is not a study involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical device undergoing mechanical testing, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Mechanical Test Results: The "ground truth" is the objective physical state of the implant after the fatigue test: whether fracture, cracks, or severe distortion occurred, and the applied load at which it was still intact. This is based on direct observation and measurement, not expert consensus or pathology in a medical sense.
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The sample size for the training set
- N/A. This is not an AI algorithm, so there is no training set.
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How the ground truth for the training set was established
- N/A. This is not an AI algorithm, so there is no training set ground truth.
§ 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.