(79 days)
The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.
The PreFormance Post will be shaped similar to the currently marketed GingiHue Post. However, the PreFormance Post will be made of PEEK with a titanium insert. The posts will be available in straight and 15° pre-angled configurations. The collar height on the PreFormance Post will be 4mm and 6mm and the post height will be 7mm.
This 510(k) Premarket Notification for the PreFormance™ Post from Implant Innovations, Inc. is for a dental abutment, which is a mechanical device. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through design characteristics and performance testing in a laboratory setting, rather than clinical study data involving human or AI performance.
Therefore, many of the typical elements of an acceptance criteria and study description related to AI or diagnostic device performance, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable here.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for performance metrics like sensitivity, specificity, or accuracy, as it pertains to a mechanical device. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to existing predicate devices (GingiHue Abutments and GingiHue Pre-Angled Abutments) and conformance to relevant standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Design features similar to predicate devices (GingiHue Posts) | The PreFormance Post is "shaped similar to the currently marketed GingiHue Post." The PreFormance Posts are "identical in terms of size, biocompatibility, performance characteristics and basic design" to the proposed and currently marketed devices (GingiHue Posts). Key difference noted: PreFormance Post will be made of PEEK with a titanium insert. |
| Material composition meets biocompatibility and functional requirements | Made of PEEK with a titanium insert. (PEEK and titanium are common biomaterials in dentistry, implying biocompatibility and strength). The document states, "identical in terms of... biocompatibility." |
| Conforms to FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments | "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." |
| Risk Analysis conducted in accordance with ISO 14971 | "Risk Analysis was conducted in accordance with ISO 14971." |
| Functionality equivalent to predicate devices | "Laboratory testing was conducted to determine device functionality..." The PreFormance Posts are "equivalent to the GingiHue Conclusion Posts which provide similar functionality." |
2. Sample size used for the test set and the data provenance
This is not applicable. The "Performance Testing" described is laboratory testing of the mechanical device, not a study involving patient data or clinical samples. There is no mention of a "test set" in the context of diagnostic performance or AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth as typically understood for diagnostic or AI studies (e.g., expert consensus on medical images) is not relevant for this type of mechanical device submission. The "ground truth" here is the engineering specifications, material properties, and functional performance measured against established standards.
4. Adjudication method for the test set
This is not applicable, as there is no "test set" in the context of human or AI assessment requiring adjudication.
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 is not applicable. The device is a dental abutment, not an AI software or a diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Engineering specifications and design input requirements: The device is rigorously designed to meet specific dimensions, material properties, and functional characteristics.
- Performance standards: Conformance to relevant national and international standards applicable to dental implants and abutments (e.g., FDA Class II Special Controls Guidance Document, ISO 14971 for risk management).
- Predicate device characteristics: The GingiHue Posts serve as a benchmark for "similar functionality" and "identical...performance characteristics."
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI or machine learning device. The design, manufacturing, and testing processes for mechanical devices do not involve a training set in this context.
9. How the ground truth for the training set was established
This is not applicable. (See #8).
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Implant Innovations, Inc.
510(k) Premarket Notification - PreFormance™ Post
ﮯ
510(k) Summary
2006 FER 1
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | Implant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410 |
|---|---|
| Contact | Jim BanicRegulatory Affairs SpecialistImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6932Fax. 561-514 6316Email jbanic@3implant.com |
| Date Prepared | November 11, 2005 |
| Device Name | PreFormance Post |
| Classification Name | Dental Abutments |
| Device Classification | Class IIDental Devices Panel21 CFR § 872.3630 |
| Predicate Devices | GingiHue Abutments -> K871954GingiHue Pre-Angled Abutments -> K932123 |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act. |
| Device Description | The PreFormance Post will be shaped similar to thecurrently marketed GingiHue Post. However, thePreFormance Post will be made of PEEK with a titaniuminsert. The posts will be available in straight and 15° pre-angled configurations. The collar height on thePreFormance Post will be 4mm and 6mm and the post |
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Implant Innovations, Inc. 510(k) Premarket Notification - PreFormance™ Post
Technological Characteristics height will be 7mm.
· The PreFormance Abutment Posts are intended for use as Indications for Use an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing. The prostheses can be screw or cement retained to the abutment.
Substantial equivalence of the PreFormance Posts is based on:
-
Design features which are similar to the currently available GingiHue Posts. The PreFormance Posts are made of PEEK with a titanium insert
-
Performance testing. The proposed and currently marketed devices are identical in terms of size, biocompatibility, performance characteristics and basic design.
Laboratory testing was conducted to determine device Performance Testing functionality and conformance to design input requirements, as well as FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk Analysis was conducted in accordance with ISO 14971.
The PreFormance Posts are equivalent to the GingiHue Conclusion Posts which provide similar functionality.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a stylized image of an eagle with three heads, which is a common symbol used by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2006
Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K053170 Trade/Device Name: PreFormance Posts Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 13, 2006 Received: January 17, 2006
Dear Mr. Banic:
This letter corrects our substantially equivalent letter of February 1, 2006.
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 (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. Banic
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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): K053170
Device Name: PerFormance Posts
Indications for Use:
The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert S. Betz, DDS for Dr. Susan Runner
cion Sign-Ctr)
sion of Anesthesiology, General Hospital,
Cction Control, Dental Devices
Number: K053170
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)