(85 days)
The NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.
The NobelPerfect Abutments are direct replacement abutments for the Replace Scalloped Margin Implant System which was marketed under the trade name NobelPerfect. The NobelPerfect Abutments consist of both healing and definitive abutments. Both abutment types are co-packed with the necessary clinical screw. The NobelPerfect Abutments are available for the narrow platform (NP), regular platform (RP), and wide platform (WP). The definitive abutments are 12.0 mm height from the base of the abutment and have no angulation. Both the healing and definitive abutments are made of titanium vanadium alloy.
This FDA 510(k) summary describes Nobel Biocare AB's NobelPerfect Abutments and asserts their substantial equivalence to a predicate device, the Replace Scalloped Margin Implant System (K021584). The document does not contain acceptance criteria or study results that prove the device meets acceptance criteria for performance metrics often associated with AI/ML-driven medical devices (e.g., accuracy, sensitivity, specificity).
Instead, the document focuses on demonstrating substantial equivalence primarily through comparison of technological characteristics and leveraging existing data from predicate devices for aspects like sterilization, packaging, shelf life, and biocompatibility.
The only "performance data" mentioned is the fatigue limit determination for the NobelPerfect Abutment using ISO 14801. However, the document does not provide the acceptance criteria for this test nor the reported results.
Therefore, I cannot provide the requested information regarding acceptance criteria and study results for device performance in the context of typical AI/ML medical device evaluation. The information provided in the document is for a traditional medical device (dental abutments) seeking 510(k) clearance based on substantial equivalence to a predicate, not for an AI-driven device with performance metrics like accuracy or sensitivity.
If the request assumes this is an AI/ML device, that assumption is incorrect based on the provided document.
However, assuming the intent of the request is to extract any available "performance data" or evidence of meeting standards, even if not explicitly stated as "acceptance criteria" for an AI model, I can highlight what is present:
Missing Information/Not Applicable in this Document:
- Acceptance Criteria for AI Performance Metrics: Not applicable as this is not an AI/ML device description.
- Reported Device Performance (for AI metrics): Not applicable.
- Sample size for test set, data provenance: Not applicable.
- Number of experts, qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone algorithm performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set, ground truth for training set: Not applicable.
Information that could be broadly interpreted as "performance" or "meeting criteria" in this specific document:
The document focuses on demonstrating that the NobelPerfect Abutments are substantially equivalent to the predicate device, K021584, based on technological characteristics and non-clinical testing.
1. A table of (implied) acceptance criteria and the reported device performance:
The document doesn't present acceptance criteria in a table format with specific quantitative thresholds. Instead, it relies on demonstrating consistency with or improvement upon the predicate device's characteristics and meeting established standards for certain tests.
| Characteristic / Test | Implied Criteria (How it's "met") | Reported Device Performance / Conclusion |
|---|---|---|
| Fatigue Limit | Determined using ISO 14801 | Fatigue limit was "determined" (result not provided, but implies satisfactory determination for substantial equivalence) |
| Sterilization | Same method (Gamma radiation); validated to ANSI/AAMI/ISO 11137 | Validation in accordance with ANSI/AAMI/ISO 11137; no additional testing required |
| Device Packaging | Same as predicate (thermoform tray with peel-top lid) | No additional testing required |
| Shelf Life | Same packaging as predicate; 3-year expiration date; real-time aging used | Determined by real-time aging; no additional testing required |
| Biocompatibility | Same material, manufacturing, intended use, patient contact as predicate | No additional testing required |
| Material | Titanium vanadium alloy (ASTM F1472, ASTM F136) | Meets specification (same as predicate) |
| Design Features | Compatible with specific implant platforms (NP, RP, WP) | Matches predicate's compatible platforms |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Fatigue Limit (ISO 14801): The sample size for this test is not specified in the summary document. Data provenance is not specified.
- Other tests (Sterilization, Packaging, Shelf Life, Biocompatibility): No new testing was performed for the subject device. Existing data from the predicate device (K170135, K021584), validated to relevant international standards (e.g., ANSI/AAMI/ISO 11137), was leveraged. The provenance of this leveraged data is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to
- the type of medical device (physical implant components)
- the type of evaluation performed (substantial equivalence to a predicate based on material, design, and non-clinical engineering tests like fatigue).
There is no concept of "ground truth" established by human experts in the context of this 510(k) submission for dental abutments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the reasons stated in point 3.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "truth" in this context is the adherence to material specifications, validated manufacturing processes, and performance against engineering standards (like ISO 14801), rather than a diagnostic or interpretive ground truth.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
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December 14, 2017
Nobel Biocare AB Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K172854
Trade/Device Name: NobelPerfect Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 19, 2107 Received: September 20, 2017
Dear Charlemagne Chua:
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.
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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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K172854 |
|---|---|
| Device Name | NobelPerfect Abutments |
| Indications for Use (Describe) | The NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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da ുട്ടുകൂട്ടു വിട്ടുകളുടെ പ്രശസ്തുക
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I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: December 13, 2017
II. DEVICE
Name of Device: NobelPerfect Abutments Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Product Code: NHA
III.PREDICATE DEVICE
Primary Predicate Replace Scalloped Margin Implant System (K021584)
Reference Predicate: TREFOIL System (K170135) NobelActive Wide Platform (K133731)
IV. DEVICE DESCRIPTION
The NobelPerfect Abutments are direct replacement abutments for the Replace Scalloped Margin Implant System which was marketed under the trade name NobelPerfect. The NobelPerfect Abutments consist of both healing and definitive abutments. Both abutment types are co-packed with the necessary clinical screw.
A.4.
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The NobelPerfect Abutments are available for the narrow platform (NP), regular platform (RP), and wide platform (WP). The definitive abutments are 12.0 mm height from the base of the abutment and have no angulation. Both the healing and definitive abutments are made of titanium vanadium alloy.
V. INDICATIONS FOR USE
The NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.
Comparison of Predicate and NobelPerfect Abutments Indications for Use
| Technologicalcharacteristics | Subject Device | Predicate (primary) |
|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin ImplantSystem (K021584) | |
| Indication forUse1 | The NobelPerfect Abutments are pre-manufactured prosthetic componentsdirectly connected to the endosseousdental implant and are intended for useas an aid in prosthetic rehabilitation. | The Replace™ Scalloped Margin ImplantSystem is an implant with a scallopedcoronal margin, designed for single stageor two stage surgical procedures. TheReplace™ Scalloped Margin ImplantSystem is intended for use to restorechewing function in edentulous and/orpartially edentulous patients. |
1 - Note: K021584 does not include a separate indications for use statement for the abutments included in the Replace Scalloped Marqin Implant System. Therefore, an abutment specific indications for use statement was created for the subject devices which falls within the intended use of the primary predicate and the indications for restoring chewing function. "
VI. Comparison of Technological Characteristics
Comparison of Predicate and NobelPerfect Abutment Technological Characteristics
| Technologicalcharacteristics | Subject Device | Predicate (primary) | |
|---|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin ImplantSystem (K021584) | ||
| Design Features | CompatibleImplantPlatform | Replace Scalloped Margin Implants(renamed NobelPerfect Implants)- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP) | Replace Scalloped Margin Implants(renamed NobelPerfect Implants)- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP) |
| DeviceMaterial | Titanium vanadium alloy (ASTM F1472,ASTM F136) | Titanium vanadium alloy (ASTM F1472,ASTM F136) | |
| Abutmentdesign | Single piece design with scalloped sidesand base extension. | Single piece design with scalloped sides |
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| Technologicalcharacteristics | Subject Device | Predicate (primary) | |
|---|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin ImplantSystem (K021584) | ||
| Abutmentheight | 12.0 mm from base | 7.5 mm from base | |
| Abutmentwidth | NP – 3.39 x 3.035 mmRP – 3.75 x 3.09 mmWP – 4.255 x 3.50 mm | NP – 3.32 x 3.035 mmRP – 3.75 x 3.09 mmWP – 4.255 x 3.5 mm | |
| AbutmentAngulation | No angulation | No angulation |
Comparison of Predicate and NobelPerfect Healing Abutment Technological Characteristics
| Technologicalcharacteristics | Subject Device | Predicate (primary) | |
|---|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin ImplantSystem (K021584) | ||
| Design Features | CompatibleImplantPlatform | Replace Scalloped Margin Implants(renamed NobelPerfect Implants)- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP) | Replace Scalloped Margin Implants(renamed NobelPerfect Implants)- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP) |
| DeviceMaterial | Titanium vanadium alloy (ASTM F1472,ASTM F136) | Delrin - White | |
| Abutmentdesign | Single piece design with scallopedimplant interface and base extension | Single piece design with scallopedimplant interface | |
| Abutmentheight | NP – 3.86 mm from baseRP – 4.51 mm from baseWP – 4.28 mm from base | 4.95 mm from base | |
| Abutmentdiameter(major) | NP – 4.305 mmRP – 5.065 mmWP – 5.775 mm | NP – 4.3 mmRP – 5.08 mmWP – 5.775 mm | |
| Scalloptaper | NP - 0°RP - 4.8°WP - 5.2° | 0° |
Analysis of Differences Between Subject Device and Predicate
The NobelPerfect Abutments are replacement abutments for the existing NobelPerfect implant system. Both the definitive and healing abutments have been redesigned to include some improvements. The definitive abutments differ from the predicate abutments in that they have a base extension that extends into the implant that is intended to improve abutments stability. The abutments are also longer than the predicate to facilitate more restorative options. The healing abutments are made of titanium alloy instead of Delrin plastic as the predicate is. The RP and WP platform healing abutments have a slight scallop taper whereas the predicate is straight.
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Summary:
The design differences between the subject and predicate were evaluated. Differences in technology were evaluated through performance testing.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the reference predicate device TREFOIL System (K170135) was leveraged in the following aspects of the 510(k).
- -Sterile Device Information
- o The sterilization method for the subject device is the same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- -Device Packaging
- o The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
- -Shelf Life
- The packaging for the subject device is the same as the predicate and o is labeled with a 3 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- -Biocompatibility
- The subject device is manufactured from the same material as the o predicate, uses the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.
The fatigue limit of the NobelPerfect Abutment was determined using ISO 14801.
VIII. CONCLUSIONS
The NobelPerfect Abutments were evaluated for substantial equivalence using standard testing. In cases where the NobelPerfect Abutments could be shown to not represent a worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the NobelPerfect Abutments have been shown to be substantially equivalent to the Replace Scalloped Margin Implant System (K021584).
§ 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.)