(231 days)
Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants. Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.
The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ANKYLOS® SynCone® Abutment 5°:
Acceptance Criteria and Study Details for ANKYLOS® SynCone® Abutment 5°
Based on the provided 510(k) summary, the device's acceptance criteria and the studies performed focus on demonstrating substantial equivalence to predicate devices. The primary criteria revolve around material composition, design, and performance characteristics compared to existing, legally marketed products.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Performance Target | Reported Device Performance |
|---|---|---|
| Material Composition Equivalence | Material for the ANKYLOS® SynCone® Abutments 5° should be the same as in the legally marketed predicate device (Ti6Al4V ELI conforming to ASTM F136). Material for tapered SynCone® 5° caps should be Gold Alloy or Titanium conforming to ASTM F67, equivalent to existing accessory components. | The ANKYLOS® SynCone® Abutments 5° are machined from Titanium Alloy (Ti6Al4V ELI) conforming to ASTM F136, the same as the predicate devices. The tapered SynCone® 5° caps are made of Gold Alloy or Titanium conforming to ASTM F67. Materials of composition for accessory components are equivalent to existing, legally marketed accessory components. |
| Design Equivalence | Similar in design, angulations, sizes, and incorporate the same technological characteristics as the predicate devices. Design of caps and abutment cover screw corresponds to the abutments. | The proposed devices are "similar in terms of design, angulations, sizes, indications for use and incorporate the same technological characteristics as the predicate devices." The design of the caps and abutment cover screw corresponds to the abutments. |
| Indications for Use Equivalence | Indications for use are the same as or comparable to predicate devices. | The indications for use are presented as: "Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants." and "Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally." These are considered equivalent in the context of substantial equivalence. A modification to the indications for use of existing ANKYLOS SynCone Abutments 4° and 6° was also implemented. |
| Biocompatibility | Biocompatibility of materials used in accessory components should be evidenced. | Biocompatibility of accessory components "has been evidenced." |
| Safety - Failure Mode, Effect, and Criticality Analysis (FMECA) | No unacceptable risks regarding the function of the ANKYLOS® SynCone® Abutments 5°. | A FMECA was performed, and "There were no unacceptable risks regarding the function of the ANKYLOS® SynCone® Abutments 5°." |
| Fatigue Performance | Meet or exceed predicate device performance when tested according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). | "Representative fatigue testing was conducted... and the results support substantial equivalence." |
| Pull Force Retention | Equivalence of taper friction retention properties compared to predicate abutments. | "Pull force testing was conducted to verify the equivalence... The results confirmed the equivalence of the performance of the new 5° abutment with that of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for the test sets in the non-clinical performance data (fatigue testing, pull force testing). It mentions "Representative fatigue testing" and "Pull force testing."
The data provenance is non-clinical bench testing, meaning it's laboratory-generated data, not from human subjects. Therefore, country of origin and retrospective/prospective designations for human data are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The ground truth for this type of submission (demonstrating substantial equivalence through non-clinical bench testing) is defined by established international standards (like ISO 14801) and direct comparison to the performance characteristics of legally marketed predicate devices. It does not involve expert adjudication of human clinical data.
4. Adjudication Method for the Test Set
This section is not applicable as the evaluation relies on objective measurements from bench testing following established standards and direct comparison to predicate device performance. No human adjudication of results is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The ANKYLOS® SynCone® Abutment 5° is a dental implant abutment, and its evaluation for this 510(k) submission relied on non-clinical performance data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical medical device (an implant abutment), not an algorithm or AI system. Its performance is inherent in its physical and mechanical properties, evaluated through bench testing, not through an algorithm's output.
7. The Type of Ground Truth Used
The ground truth used for verifying the device's performance is established engineering and material science standards and metrics, and direct comparative performance against legally marketed predicate devices.
Specifically:
- ISO 14801: Dynamic fatigue test for endosseous dental implants.
- ASTM F136 and ASTM F67: Standard specifications for titanium alloys, defining acceptable material properties.
- Performance of predicate devices: The established and accepted performance of the ANKYLOS SynCone® Abutinents 4º and 6° (K041509) and Angled ANKYLOS® Balance Base Abutments (K122268) serve as the benchmark for equivalence.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. A training set is used in machine learning to teach an algorithm. This submission is for a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as point 8.
§ 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.)