(256 days)
The A Plus Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. It is intended for delayed loading.
The A Plus internal fixtures are made with Grade 4 titanium. The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options.
The devices covered by this submission are A Plus internal fixture, screw, abutment and some accessories. The diameters of A Plus internal fixtures are 3.4 mm, 3.8 mm, 4.3 mm, 4.8 mm, and 5.3 mm, and the lengths are 8 mm, 10 mm, 12 mm, and 14 mm.
This document describes a 510(k) premarket notification for a medical device called the "A Plus Internal Fixture System," which is an endosseous dental implant. The core of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness through extensive studies as might be required for a novel device. Therefore, the information provided focuses on non-clinical performance and design similarity rather than complex clinical trial data or AI performance metrics.
Based on the provided text, the device itself is an endosseous dental implant, not an AI-powered diagnostic or assistive tool. Consequently, questions related to AI performance, human reader improvement with AI assistance, expert consensus for ground truth establishment in a diagnostic context, and training/test set sample sizes for algorithms are not applicable to this submission.
Here's an analysis based on the information provided, addressing the relevant points and noting the non-applicability of others:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Test | Not explicitly stated, but implied to meet general medical device sterilization standards. | "leveraged from own K070562 predicate" - implies compliance with predicate's sterilization validation. |
| Shelf Life Test | Not explicitly stated, but implied to demonstrate stability over the intended shelf life. | "leveraged from own K052369 predicate" - implies compliance with predicate's shelf life validation. |
| Biocompatibility Testing | Not explicitly stated, but implied to meet ISO standards for biocompatibility for implantable devices (Cytotoxicity, Intracutaneous Reactivity, Maximization Sensitization, Systemic Injection, Pyrogen, 90-Day Bone Implantation). | "leveraged from own K052369 predicate" - implies biological compatibility equivalent to the predicate. |
| Fatigue Test | Compliance with ISO 14801 standards for dynamic fatigue testing of endosseous dental implants. | "Test results comply with ISO14801." - device meets the specified fatigue standard. |
| RBM Surface Coating (Cleaning Validation & SEM/EDX Analysis) | Verification that any particles or chemicals used to remove particles have been washed from the surface. | "cleaning validation test and SEM/EDX analysis have been conducted on the proposed device to verify that any particles or chemicals used to remove particles have been washed from the surface." - implies successful verification. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the non-clinical tests. For mechanical and material tests like fatigue and surface analysis, samples of the physical device components are tested according to the relevant ISO standards, but a "test set" in the context of clinical or AI validation is not applicable here.
- Data Provenance: The device manufacturer is T-Plus Implant Tech. Co., Ltd. in New Taipei City, Taiwan. The non-clinical testing was performed either directly by the manufacturer or by a contracted lab, with the results provided as part of the 510(k) submission. No information on the country of origin of "data" in a patient or imaging context is relevant or provided. The studies are not clinical human studies; they are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. "Ground truth" established by experts is relevant for diagnostic devices, especially those using AI, where a human expert's interpretation (e.g., radiologist's reading) is compared to the device's output. For an endosseous dental implant, "ground truth" is established by engineering specifications, material science standards, and the results of physical and chemical tests (e.g., measuring forces, observing material degradation, analyzing surface composition).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or multi-reader studies to resolve discrepancies among expert readers when establishing a "ground truth" for a diagnostic task. The tests performed for this dental implant are non-clinical bench tests (e.g., fatigue, biocompatibility), where results are determined by objective measurements against predefined standards.
5. 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
- This question is not applicable. The "A Plus Internal Fixture System" is a physical dental implant, not an AI-powered diagnostic or assistive device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed or is relevant to its substantial equivalence determination.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. The device is an endosseous dental implant, not an algorithm. There is no "standalone algorithm" performance to report.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on established engineering standards, material specifications, and regulatory requirements. For example, for the fatigue test, the "ground truth" is that the implant must withstand a certain number of load cycles at a specified force as per ISO 14801. For biocompatibility, the "ground truth" is that the materials must not elicit adverse biological reactions as defined by ISO 10993 series for medical devices. For surface coating, the "ground truth" is the absence of residual particles.
8. The sample size for the training set
- This question is not applicable. There is no "training set" for this type of device, as it is not a machine learning or AI-based system.
9. How the ground truth for the training set was established
- This question is not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.