(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2016
T-Plus Implant Tech. Co., Ltd. Dana Cheng Quality Assurance No.41, Wuquan 6th Rd., Wugu Dist., New Taipei City, 24889 TAIWAN
Re: K152786
Trade/Device Name: A Plus Internal Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 9, 2016 Received: May 10, 2016
Dear Dana Cheng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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T-Plus Implant Tech. Co., Ltd. 510(k) Notification
A Plus Internal Fixture System
Indications for Use
510(k) Number (if known): K152786 A Plus Internal Fixture System Device Name:
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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A Plus Internal Fixture System
510(k) Summary
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of summary: | 06/06/2016 |
| 5.3 | Submitter: | T-Plus Implant Tech. Co., Ltd. |
| Address: | No.41, Wuquan 6th Rd., Wugu Dist., NewTaipei City 24889, Taiwan (R.O.C) | |
| Phone: | +886-2-22981950 | |
| Fax: | +886-2-22984353 | |
| Contact: | Dana Cheng(tplus.dana@gmail.com) |
5.4 Identification of the Device:
| Proprietary/Trade name: | A Plus Internal Fixture System |
|---|---|
| Classification Name: | Endosseous Dental Implant |
| Device Classification: | Class II |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Primary Product Code: | DZE |
| Subsequent Product Code: | NHA |
5.5 Primary Predicate Device (K070562)
| Predicate Device Name: | EZ Plus Implant System |
|---|---|
| Manufacturer: | Mega'Gen Company, Limited |
| Device Classification: | Class II |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Primary Product Code: | DZE |
| Subsequent Product Code: | NHA |
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A Plus Internal Fixture System
5.6 Reference Predicate Device (K052369)
| Predicate Device Name: | ExFeel Dental Implant System |
|---|---|
| Manufacturer: | Mega'Gen Company, Limited |
| Device Classification: | Class II |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Product Code: | DZE |
5.7 Intended Use and Indications for Use of the subject device
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.
5.8 Device Description
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.
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| Specification (mm) | Angulation | ||||
|---|---|---|---|---|---|
| Component | D | L | cuff H | Post H | range |
| A Plus Cover Screw | 3.15, 3.35 | 6.60, 7.10 | N/A | N/A | N/A |
| A Plus Healing Screw | 4.0, 5.0, 6.0 | 3.0, 4.0, 5.0,6.0, 7.0 | N/A | N/A | N/A |
| A Plus Abutment Screw | 2.3 | 10.8 | N/A | N/A | N/A |
| A Plus EZ Post Abutment | 4.0, 5.0, 6.0 | N/A | 1.0, 2.0, 3.0,4.0, 5.0 | 5.2 | N/A |
| A Plus Angled Abutment | 4.0, 5.0, 6.0 | N/A | 2.0, 3.0, 4.0,5.0 | N/A | 15°, 25° |
The range of diameters and angulations for each screw model and abutment model are provided as below:
5.9 Non-clinical Testing
A series of tests were performed to assess the proposed device is substantially equivalent to the predicate devices. All the test results demonstrate that A Plus Internal Fixture System meets the requirements of its pre-defined acceptance criteria and intended use.
-
Sterilization Test (leveraged from own K070562 predicate)
- A Shelf Life Test (leveraged from own K052369 predicate)
-
Biocompatibility testing (leveraged from own K052369 predicate):
- . Cytotoxicity Test
- . Intracutaneous Reactivity Test
- . Maximization Sensitization Test
- Systemic Injection Test (Intravenous Injection) .
- . Pyrogen Test
- . 90-Day Bone Implantation Study
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-
Performance testing:
- Fatigue test
A fatigue test is required to evaluate the stability of implant system in oral cavity. The fatigue testing has been conducted on the proposed device in accordance with ISO 14801. Test results comply with ISO14801. It approves the proposed device is substantially equivalent to the predicate devices.
- . RBM surface coating
A Plus Internal Fixtures and the predicate devices undergo an implant surface treatment of Resorbable Blast Media (RBM). The 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.
5.10 Clinical Testing
No additional clinical testing was necessary for a determination of substantial equivalence. The results of non-clinical testing indicated the device was found to be substantially equivalent to the predicate devices.
5.11 Substantial Equivalence Determination
The A Plus Internal Fixture System submitted in this 510(k) file is substantially equivalent in intended use, main materials, implant surface treatment, angulation range, safety and performance claims to the cleared EZ Plus Implant System (K070562) and ExFeel Dental Implant System (K052369). Differences of proposed device and predicate devices do not raise new issues of substantial equivalence.
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A Plus Internal Fixture System
| Proposed device | Predicate device | |||
|---|---|---|---|---|
| Item | A Plus InternalFixture System | EZ Plus ImplantSystem | ExFeel DentalImplant System | |
| Manufacturer | T-Plus Implant Tech.Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. | |
| 510(k) Number | K152786 | K070562 | K052369 | |
| Classification | Class II | Class II | Class II | |
| Intended Use | The A Plus InternalFixture System isintended to be placedin the upper or lowerjaw to supportprosthetic devices,such as artificialteeth, and to restore apatient's chewingfunction. This maybe accomplishedusing either a twostage surgicalprocedure or a singlestage surgicalprocedure. It isintended for delayedloading. | The EZ Plus ImplantSystem is intended tobe surgically placed inthe upper or lower jawto support prostheticdevices, such asartificial teeth, and torestore a patient'schewing function. Thismay be accomplishedusing either a twostage or a single stagesurgical procedure.Large angle abutments(e.g. 25°) on smalldiameter implants ofthe EZ Plus internalconnection system areintended for theanterior region of themouth and notintended for use in theposterior region of themouth due to limitedstrength of the implant. | The ExFeel DentalImplant Systems areintended to be placedin the upper or lowerjaw to supportprosthetic devices,such as artificialteeth, and to restore apatient's chewingfunction This may beaccomplished usingeither a two stagesurgical procedure ora single stage surgicalprocedure. | |
| Proposed device | Predicate device | |||
| Item | A Plus InternalFixture System | EZ Plus ImplantSystem | ExFeel DentalImplant System | |
| Material | C.P Titaniumand Titanium Alloy | |||
| Implant | surfacetreatment | RBM | RBM | RBM |
| Implant to | abutmentconnection | Internal HexConnection | Internal TripConnection | Internal and ExternalHex |
| Implant Sterile | Yes | Yes | Yes | |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Implantsize (mm) | Diameters | 3.4, 3.8, 4.3, 4.8, 5.3 | 3.3, 4.0, 5.0 | 3.75 - 5.5 |
| Lengths | 8.0, 10.0, 12.0, 14.0 | 8.0, 10.0, 11.0, 13.0,15.0, 18.0 | 7.0 - 18.0 |
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Implant
Abutment model
| Proposed device | Predicate device | ||
|---|---|---|---|
| Item | A Plus InternalFixture System | EZ Plus ImplantSystem | ExFeel DentalImplant System |
| Material | C.P Titanium andTitanium Alloy | C.P Titanium andTitanium Alloy | C.P Titanium andTitanium Alloy |
| EZ Post Abutment | |||
| Diameters (mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Cuff H | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | - |
| Post H | 5.2 | 5.2 | - |
| Angled Abutment | |||
| Diameters (mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Cuff | 2.0, 3.0, 4.0, 5.0 | 2.0, 3.0, 4.0, 5.0 | 2.0, 4.0 |
| Angulation range | 15°, 25° | 15°, 25° | 15°, 25° |
| Sterilization | None | None | None |
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Similarity and differences 5.12
The differences between the proposed device and the predicate devices are the design of implant to abutment connection and accessory components. The proposed device was tested, and the results complied with the pre-defined success criteria. Therefore, the differences of proposed device and predicate devices did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate devices in intended use, design, safety and performance claims.
5.13 Conclusion
After analyzing bench tests, device description and intended use/indications for use, it can be concluded that A Plus Internal Fixture System is substantial equivalence to the 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.