(207 days)
The Atlantis Abutment is intended for use as an accessory to an osseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the osseous implant.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for Zimmer Interface and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Zimmer Screw-Vent MTX and HA implants with diameters 3.3 mm, 3.7 mm, 4.7 mm; Zimmer Tapered Screw-Vent MTX and MP-1 HA implants with diameters 3.7 mm, 4.7 mm and 6.0 mm.
The provided document, K053373, describes a pre-market notification for the Atlantis™ Abutment for Zimmer Interface. This is a medical device submission seeking substantial equivalence to a predicate device, rather than a study demonstrating performance against specific acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for AI-driven devices is not applicable to this submission.
Here's a breakdown of what can be extracted from the document in relation to the questions, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is typically used for novel devices that undergo performance testing against pre-defined metrics (e.g., sensitivity, specificity, accuracy for AI/diagnostic devices). For a medical device submission seeking substantial equivalence, the "acceptance criteria" are primarily related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is assessed against the predicate device's established use and material properties, not against quantitative performance metrics in a clinical study.
Therefore, a direct table of acceptance criteria and reported device performance as typically understood for AI systems cannot be provided from this document. The "performance" is implicitly deemed acceptable if it is substantially equivalent to the predicate.
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This submission is for a dental implant abutment, not an AI or diagnostic device that would utilize a test set of data for performance evaluation. The "test set" in this context would implicitly refer to the abutment itself and its components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth establishment by experts is relevant for diagnostic or AI systems where expert annotations or interpretations serve as the reference standard. For a physical medical device like a dental abutment, "ground truth" relates to its physical and material properties, and its intended use, which are evaluated against engineering standards and clinical practice, not expert consensus on data interpretation.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as points 2 and 3. Adjudication methods like "2+1" or "3+1" are used in consensus-based ground truth establishment for diagnostic data.
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. An MRMC study is designed to evaluate the impact of a diagnostic aid (often AI) on human reader performance. This submission is for a physical dental abutment, which does not involve human "readers" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This refers to the performance of an AI algorithm independently. The Atlantis Abutment is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is its adherence to material standards (Titanium grade Ti-6A1-4V ELI meets ASTM Standard F-136) and its intended use being equivalent to predicate devices. Equivalence is also drawn from the design and performance to the predicate Atlantis Abutments (K981858) and Sulzer Dental (Zimmer) Screw-Vent Implant Systems (K011028). The FDA's substantial equivalence determination implies that the device's characteristics meet established clinical and engineering benchmarks for this class of device.
8. The Sample Size for the Training Set
Not applicable. A "training set" is used for machine learning models. This is a physical product submission.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reasons as point 8.
Summary of Relevant Information from the Document:
While the document does not fit the typical structure of an AI device study, here's a summary of the information relevant to its acceptance and equivalency:
- Device Name: Atlantis™ Abutment for Zimmer Interface
- Manufacturer: Atlantis Components Inc.
- Predicate Devices:
- Basis for Substantial Equivalence (Acceptance Criteria Implicit):
- Intended Use: The device is substantially equivalent in intended use to the predicate devices.
- Intended Use Description: As an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient, for single and multiple tooth prosthesis, in the mandible or maxilla. Prosthesis can be cement retained. Abutment screw secures the abutment to the implant.
- Material: Made from Titanium grade Ti-6A1-4V ELI, meeting ASTM Standard F-136, which is consistent with predicate devices.
- Design: Equivalent to predicate devices. The abutment is placed over the implant shoulder and mounted with a screw. Compatible with specific Zimmer Screw-Vent MTX and HA implants of various diameters.
- Performance: Implied to be equivalent through substantial equivalence claims. Performance would relate to mechanical integrity and fit, which are assumed to be met given the material and design equivalence to previously cleared devices.
- Intended Use: The device is substantially equivalent in intended use to the predicate devices.
Conclusion:
This document is a 510(k) pre-market notification for a traditional medical device (dental abutment). The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of intended use, materials, design, and performance, as required by the FDA's 510(k) pathway. It does not involve a study with primary performance endpoints suitable for the detailed questions about AI device evaluation.
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JUN J U ZUUG
VII. SECTION 10 - 510(K) SUMMARY
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
1. Applicant's Name and Address
Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 Telephone Number: 617-661-9799 Fax Number: 617-661-9063 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs
2. Name of Device
Trade Name: Atlantis™ Abutment for Zimmer Interface Common Name: Endosseous dental implant abutment Classification Name: Endosseous dental implant abutment 21 CFR 872.3630 Product code NHA
3. Legally Marketed Device to which Equivalence is claimed (Predicate Device)
| Manufacturer | Device | 510(k)Number |
|---|---|---|
| Atlantis ComponentsInc. | Atlantis Abutment and AbutmentScrew | K981858K011028 |
| Sulzer Dental (Zimmer) | Screw-Vent Implant System |
4. Description of the Device
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.
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Description of the Device (continued) 4.
The Atlantis™ Abutments for Zimmer Interface and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Zimmer Screw-Vent MTX and HA implants with diameters 3.3 mm, 3.7 mm, 4.7 mm; Zimmer Tapered Screw-Vent MTX and MP-1 HA implants with diameters 3.7 mm, 4.7 mm and 6.0 mm.
న. Intended Use of the Device
The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. Please note: Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant fixture.
6. Basis for Substantial Equivalence
The Atlantis™ Abutments for Zimmer Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858 and Sulzer Dental (currently Zimmer Dental) Screw-Vent Implant Systems cleared under K011028.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atlantis Components, Incorporated C/O Ms. Besty Brown B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K053373
Trade/Device Name: AtlantisTM Abutment for Zimmer Interface Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 7, 2006 Received: June 12, 2006
Dear Ms. Brown:
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.
JUN 3 0 2006
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Brown
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 begin 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/industry/support/index.html.
Sincerely yours,
Jhon Jurner
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
Enclosure
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Pre-market Notification Page - 000227
Indications for Use
510(k) Number (if Known)_
Device Name: Atlantis ™ Abutment for Zimmer Interface
Indication for Use:
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant.
Prescription Use V (Part 21 CFR 801 SubpartD)
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)
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§ 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.)