(84 days)
BTI Dental Implant Tiny® 3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
The BTI Dental Implant Tiny® Ø3.0 is a self tapping, threaded, root- form dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameter: 3.0mm and lengths: 11.5, 13, 15mm
The provided text is a 510(k) summary for the BTI Dental Implant Tiny® Ø3.0. This document primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for an AI/software device evaluation.
Dental implants, like the one described, are typically evaluated through:
- Mechanical Testing: To ensure strength, fatigue resistance, and fracture toughness. Standards like ISO 14801 (Fatigue Test for Endosseous Dental Implants) are common.
- Biocompatibility Testing: To ensure the material is safe for implantation. Based on ISO 10993.
- Animal Studies or Clinical Performance Data: Especially for new designs or materials, to demonstrate osseointegration and long-term success.
The 510(k) summary only mentions "Technological Aspects: A comparison of the device features, intended use and other information demonstrate that the BTI Dental Implant Tiny® Ø3.0 substantially equivalent to the predicate devices." This implies that the device's performance is assumed to be similar to its predicate devices, which have already gone through their own testing and regulatory approval processes.
Therefore, I cannot fill in the table or answer most of your questions as the requested information (acceptance criteria, specific performance studies, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone studies) is not present in the provided text.
The closest I can get is extracting the intended use and device description, but these are not "acceptance criteria" in the sense of a quantitative performance metric.
Here's what I can extract from the provided text, acknowledging that it doesn't align with your request for AI/software-specific evaluation:
1. Table of (Implied) Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Implied by Substantial Equivalence and Device Description) |
|---|---|
| Material: Biocompatible and suitable for long-term implantation, as demonstrated by predicate devices. | Made of titanium. Assumed to meet biocompatibility requirements due to substantial equivalence. |
| Form/Design: Root-form, threaded, and self-tapping, with specific dimensions comparable to predicate devices. | Self-tapping, threaded, root-form dental implant. Diameter: 3.0mm, Lengths: 11.5, 13, 15mm. |
| Intended Use: Capable of restoring missing teeth and/or fixing overdentures in partially or fully edentulous patients, specifically for maxillary lateral incisors and mandibular lateral and central incisors, with suitability for immediate loading under good primary stability and appropriate occlusal load. | Intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures. Specifically for maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading recommended under specific conditions. |
The following questions cannot be answered from the provided text as they pertain to a different type of device evaluation (e.g., AI/software performance) than what is presented in a dental implant 510(k) summary based on substantial equivalence:
2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The 510(k) relies on substantial equivalence to predicate devices, not a test set in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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: Not applicable/Not provided, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided in the context of device performance testing for substantial equivalence. Clinical outcomes data for predicate devices would implicitly support their safety and effectiveness.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided document is a regulatory submission for a dental implant, detailing its intended use and features to demonstrate substantial equivalence to existing devices. It does not include the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that would be found in submissions for AI/software-based medical devices.
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510(k) Summary As Required By 21 CFR 807.92 5.
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| Submitter: | Biotechnology Institute, SL.Parque Tecnológico de AlavaC/Leonardo Da Vinci 14B, 1B.01510 Miñano (Alava)Spain | OCT - 6 2009 |
|---|---|---|
| Contact Person: | Alfredo GómezRegulatory Affairs DepartmentBiotechnology Institute, SL.Parque Tecnológico de AlavaC/Leonardo Da Vinci 14B, 1B.01510 Miñano (Alava)Spain | |
| Date Prepared: | July 09, 2009 | |
| Device Trade Name: | BTI Dental Implant Tiny® Ø3.0 | |
| Common Name: | IMPLANT, ENDOSSEOUS, ROOT-FORM | |
| Substantial Equivalence: | K022258 BTI Dental Implant SystemK053355 BTI Interna Dental Implant SystemK080396 OsseoSpeedTM Narrow | |
| Device Description: | The BTI Dental Implant Tiny® Ø3.0 is a self tapping, threaded, root-form dental implant intended for restoring missing teeth in partiallyor fully edentulous patients to restore the chewing capacity ofpatients. It is made of titanium and offers a variety of sizes includingdiameter: 3.0mm and lengths: 11.5, 13, 15mm | |
| Intended Use: | BTI Dental Implants Tiny® Ø3.0 are intended to be used to restoremissing teeth in partially or fully edentulous patients and/or thefixation of overdentures to restore or enhance the chewing capacityof patients.These implants shall be used only to replace maxillary lateral incisorsand mandibular lateral and central incisors.Immediate loading is recommended when there is good primarystability and an appropriate occlusal load. | |
| Technological Aspects: | A comparison of the device features, intended use and otherinformation demonstrate that the BTI Dental Implant Tiny® Ø3.0substantially equivalent to the predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its wing, representing service, science, and protection. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Alfredo Gómez Regulatory Affairs Specialist B.T. I. Biotechnology Institute, S.L. Parque Tecnológico de Alava Leonardo Da Vinci, 14B 01510 Miñano (Alava) SPAIN
OCT - 6 2009
Re: K092112
Trade/Device Name: BTI Dental Implant Tiny® 3.0 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 22, 2009 Received: September 24, 2009
Dear Mr. Gomez:
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.
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.
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Page 2- Mr. Gómez
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 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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reporta Problem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):_K092112
Device Name:_BTI Dental implant Tiny® 3.0
Indications For Use:
BTI Dental Implant Tiny® 3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Nulley for WSR
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092112
§ 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.