(123 days)
Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.
Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:
| Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| Nobel Biocare NobelActive® | 3.5 | 3.5 (NP) |
| Nobel Biocare NobelActive® | 4.3, 5.0 | 3.9 (RP) |
| Straumann Bone Level | 3.3 | 3.3 (NC) |
| Straumann Bone Level | 4.1, 4.8 | 4.1, 4.8 (RC) |
| Zimmer TSV | 3.7, 4.1 | 3.5 |
| Zimmer TSV | 4.7 | 4.5 |
| Zimmer TSV | 6.0 | 5.7 |
Sherlock is a dental implant abutment system that is being expanded to include two (2) new abutment designs compatible with three (3) OEM implant systems. The Subject device implant platform diameters range from 3.3 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm. The Subject device includes the following two-piece abutment designs: Titanium Base with angulated screw channel (ASC) and are provided with corresponding abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile.
In final, finished form, the Subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (titanium base) with a cemented/bonded CAD-CAM zirconia top-portion. Each patientspecific zirconia superstructure is individually prescribed by the clinician and manufactured milling center.
All Subject device abutments are provided in a straight design with no angulation in the titanium base post and with an indexed/engaging implant connection for crowns or a non-engaging/non-indexed implant connections for bridges. The standard Titanium base abutments are provided in gingival heights ranging from 0.25 mm and abutment post lengths of 8 mm or 10 mm. The ASC Titanium Base abutments are provided in gingival heights ranging 0.8 mm to 1.8 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC Titanium Base abutments are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard Titanium Base and ASC Titanium Base posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.
All digitally designed zirconia copings (mesostructures) for use with the Subject device titanium base abutments will be made at an Open Implants validated milling center under FDA quality system regulations, and the zirconia material will conform to ISO 13356.
The overall design parameters for the two-part Standard and ASC CAD/CAM Titanium Base customized abutments with zirconia mesostructure are:
Minimum Zirconia Wall Thickness – 0.5 mm Minimum Post Height for single-unit restoration – 4.0 mm for Straumann implant line Minimum Overall Gingival Height – 0.5 mm (titanium base plus zirconia) Maximum Overall Gingival Height – 5 mm Maximum Correction Angle - 30°
The recommended cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.
This document is an FDA 510(k) clearance letter for the Sherlock dental implant abutment system. It outlines the device's intended use, technological characteristics, and a comparison to predicate and reference devices to demonstrate substantial equivalence.
Based on the provided text, the "device" in question is a dental implant abutment. The approval is based on a demonstration of substantial equivalence to previously cleared predicate devices, rather than a clinical study proving new performance claims. Therefore, the typical structure of acceptance criteria and a study proving those criteria for a novel device, especially an AI/ML system, is not directly applicable here.
However, I can extract information related to the non-clinical performance data used to support the substantial equivalence claim, which serves as a form of "acceptance criteria" for this type of submission.
Here's a breakdown of the information requested, adapted to what is available in the provided FDA 510(k) letter:
1. Table of Acceptance Criteria and Reported Device Performance
For this submission, the "acceptance criteria" are implied by the regulatory requirements for demonstrating substantial equivalence for dental implant abutments, primarily relying on non-clinical testing and comparison to predicate devices, rather than specific performance metrics from a human-in-the-loop or standalone AI study.
| Acceptance Criteria (Implied by Regulatory Pathway) | Reported Device Performance (as per Non-Clinical Data) |
|---|---|
| Mechanical Performance (Static and Fatigue Testing): Safety and durability under typical loading conditions, meeting ISO 14801 standards. | Worst-case constructs of each compatible implant system were subjected to static and fatigue testing according to ISO 14801. (Performance results not quantified in this summary, but implied to meet standards). |
| Material Biocompatibility: Materials (Ti-6Al-4V ELI alloy, Zirconia) are safe for implantation. | Biocompatibility cytotoxicity testing to ISO 10993-5 for titanium bases leveraged from K193335 (Reference device). Zirconia material conforms to ISO 13356. |
| Cleaning Validation: Ability of the device to be appropriately cleaned. | Cleaning validation testing to AAMI TIR30 for a titanium and zirconia construct leveraged from K193335. |
| Sterilization Validation (End-User): Device can be safely sterilized by the end-user. | Sterilization validation testing to ISO 14937 for a titanium and zirconia construct leveraged from K193335. Device to be sterilized by the end-user using same methods as K212664 (Predicate device). |
| MRI Safety: Compatibility with Magnetic Resonance (MR) environment. | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al. 2019), addressing magnetically induced displacement force and torque. |
| Compatibility with OEM Implant Systems: Proper fit and function with listed implant systems. | Reverse engineering studies of OEM implant bodies and abutment screws leveraged from K193335 and K212664. Compatibility supported by predicate/reference devices and non-clinical performance testing. |
| Equivalent Intended Use: Consistent with predicate and reference devices. | Indications for Use Statement (IFUS) is "substantially equivalent" and "highly similar" to K212664 (Predicate) and reference devices K193335, K212108. |
| Equivalent Technological Characteristics: Similar design principles, materials, abutment/implant interface, prosthesis attachment, and restoration types to predicate/reference devices. | Subject device described as "highly similar" in technological characteristics to predicate and reference devices, with minor differences not impacting safety or effectiveness. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human data for an AI/ML system. The "test set" here refers to physical devices and materials subjected to non-clinical testing. The text refers to "worst-case constructs" for mechanical testing, but does not provide specific sample numbers for these tests.
- Data Provenance: The data provenance for this submission is primarily non-clinical bench testing (static and fatigue testing, biocompatibility, cleaning, sterilization, MRI review) and comparison to previously approved devices (leveraging data from K193335 and K212664). No human clinical data was included in this premarket notification. The tests are general, and therefore, "country of origin" of data or "retrospective/prospective" does not directly apply to the non-clinical tests themselves, although the regulatory submission is for the U.S. market.
3. Number of Experts for Ground Truth and Qualifications:
- Not applicable. This submission does not involve an AI/ML system that requires expert human annotation for ground truth establishment for a diagnostic or similar task. The ground truth for the device's performance is established through established engineering standards (ISO, AAMI) and material science principles, confirmed via laboratory testing.
4. Adjudication Method for the Test Set:
- Not applicable. There is no human reading or diagnostic task involved that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements from bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This device is a physical dental implant abutment, not an AI/ML software for data interpretation or diagnosis. Therefore, no MRMC study was performed or required.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- Engineering Standards and Bench Test Results: The "ground truth" for this device's safety and effectiveness is based on compliance with established international standards (e.g., ISO 14801, ISO 10993-5, ISO 13356, ISO 14937, AAMI TIR30) demonstrated through physical and chemical testing. "Reverse engineering studies" are also mentioned, implying a comparison against the physical characteristics of existing OEM implant systems.
8. Sample Size for the Training Set:
- Not applicable. There is no AI/ML system involved that would require a "training set." The CAD/CAM customizations refer to design parameters for manufacturing, not a machine learning training process.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As no AI/ML training set is used, this question is not relevant.
In summary: This FDA 510(k) clearance is for a physical medical device (dental implant abutment) and relies on demonstration of substantial equivalence through non-clinical bench testing and comparison to existing predicate devices. It does not involve AI/ML technology, human readers, or clinical data that would necessitate the types of "acceptance criteria" and "study proofs" typically associated with AI/ML-driven diagnostic devices.
§ 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.)