(263 days)
The Slim Onebody System is intended for immediate loading in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase (maximum six months) of permanent endosseous dental implants.
The Slim Onebody System is a mini implant made of Ti-6A1-4V ELI alloy(ASTM F136) and Pure Titanium Gr4(ASTM F67). It serves as a temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implantation. Its surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched). It is comprised of diameter ranging from 2.0 - 3.0mm and lengths ranging from 10mm -14mm. The product consists of a FIX type and a Ball Type implant.
The provided document describes a 510(k) summary for the "Slim Onebody System," an endosseous dental implant. This submission focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific acceptance criteria for performance metrics typically found in AI/ML device evaluations.
Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance (Not applicable in the AI/ML sense)
The document does not define specific performance metrics like sensitivity, specificity, or AUC with acceptance thresholds. Instead, it relies on demonstrating that the device meets established engineering and biocompatibility standards, and compares its physical and material properties to a predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Not AI/ML specific) | Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO7405 (2008) standards for dental devices | Non-toxic, non-sensitizing to biological tissues |
| - ISO Cytotoxicity Negative | Passed | |
| - ISO Systemic toxicity Negative | Passed | |
| - ISO Pyrogenicity Negative | Passed | |
| - ISO Sensitization Negative | Passed | |
| - ISO Intracutaneous reactivity Negative | Passed | |
| - ISO Irritation Negative | Passed | |
| Mechanical Performance | Withstand anticipated forces (FDA guidance) | |
| - ISO Fatigue | Strong enough | |
| - ISO Static compressive | Strong enough | |
| - Torque Force | Strong enough | |
| Substantial Equivalence | Similar raw material, mechanical/physical properties, shape, and intended use as predicate device | "Slim Onebody System is substantial equal with the predicate devices." |
Study that Proves the Device Meets Acceptance Criteria
The studies conducted were non-clinical bench tests and biocompatibility evaluations.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. Standard practice for these tests involves a certain number of samples, but the exact count isn't in this summary.
- Data Provenance: The tests were conducted on the "Slim Onebody System" itself, presumably by Dentium Co., Ltd., which is based in Korea.
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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. For non-clinical bench and biocompatibility testing, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and validated testing methodologies, rather than expert consensus on interpreted data like in AI/ML. Labs performing these tests are accredited and their staff qualified, but this isn't documented as "expert" ground truth in the traditional sense for these evaluations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 (where multiple experts independently assess and an arbitrator resolves disagreements) are relevant for subjective interpretations, often in clinical imaging or diagnostic studies. Non-clinical tests typically have objective pass/fail criteria based on quantitative 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:
- No. This is not an AI/ML device. It is a physical medical device (dental implant).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Ground truth is established by the test results themselves demonstrating compliance with ISO standards (e.g., cell viability in cytotoxicity, lack of systemic reaction in systemic toxicity).
- For mechanical testing: Ground truth is established by quantitative measurements meeting specified force/fatigue thresholds derived from FDA guidance and engineering principles.
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The sample size for the training set:
- Not applicable. This device does not have a "training set" as it is not an AI/ML product.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set.
§ 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.