(90 days)
The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.
The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.
This document (K243272) is a 510(k) premarket notification for a dental device, the LOCATOR Angled Abutment. It is important to note that this document does not describe the performance of software or an AI device. Instead, it describes a mechanical dental implant component and its substantial equivalence to previously cleared predicates.
Therefore, many of the requested categories related to AI/software performance criteria, expert adjudication, MRMC studies, ground truth establishment for AI/ML, and training set information are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding the acceptance criteria (in terms of performance testing for a mechanical device) and how the device meets them:
1. Table of Acceptance Criteria (for a mechanical device) and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Verification (Fit and Performance with OEM Implants) | Critical features of OEM implant bodies, abutments, and abutment fixation screws were identified and measured using calibrated equipment. Specifications for the design were created based on this data. All critical tolerances were verified functionally in OEM implants, demonstrating that the abutments fit and perform as intended. |
| Fatigue Resistance (ISO 14801:2016) | Fatigue testing was performed for the tallest abutment cuff height LOCATOR Angled Abutment with the smallest diameter OEM implant. While no specific numerical acceptance threshold for fatigue cycles is explicitly stated, the implication is that the device met the performance requirements for substantial equivalence to the predicate, which would include passing this test. |
| TiN Coating Performance (ASTM F1044, ASTM F1147) | The Titanium Nitride (TiN) coating performance was tested per ASTM F1044 and ASTM F1147. This indicates that the coating, identical to the predicate device, meets the specified standards for performance. |
| Packaging and Shipping Validation | Packaging and shipping validation testing was completed. The LOCATOR Angled Abutment (worst-case device and packaging) was undamaged after the test, meeting the desired outcome. |
| Cleaning and Sterilization Efficacy | The cleaning and sterilization methods are identical to the predicate device (K233587), implying they meet established efficacy standards. |
| MR Compatibility (ASTM F2052-21, F2213-17, F2182-19, F2119-07 and FDA Guidance) | MR compatibility testing (Force, Torque, Heating (RF & Gradient field), Image Quality, Vibration) was previously conducted on similar Ti-6Al-4V components. An engineering analysis established that the LOCATOR Angled Abutment does not create a new worst-case scenario for MR compatibility, thus meeting the criteria based on existing data. |
| Biocompatibility (ISO 10993-1, ISO 10993-5) | Biocompatibility assessment was conducted using testing from K072878 and additional cytotoxicity testing per ISO 10993-5 (cleared under K233587). This indicates the device materials and design are biocompatible and safe for use in the human body. |
Study Details (for a mechanical device):
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Sample sizes used for the test set and the data provenance:
- Specific quantitative sample sizes for each mechanical test (e.g., number of abutments fatigued, number of coatings tested) are not detailed in this summary.
- The data provenance is from non-clinical performance testing conducted by the manufacturer, Zest Anchors, LLC. This is typically internal laboratory testing.
- The nature of the tests (fatigue, coating, packaging, functional fit) indicates this is prospective testing performed specifically to support this regulatory submission. Country of origin for data is not specified but is implicitly from the manufacturer's testing facilities (likely USA, given the submission location).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a mechanical device is established through objective engineering measurements and standardized performance tests (e.g., ISO, ASTM standards), not by human expert consensus on interpretations. The "experts" involved would be qualified engineers and technicians performing the tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers/experts in AI/medical image analysis. For mechanical device testing, the results are objectively measured and compared against predefined performance specifications.
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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. This device is a mechanical dental abutment, not an AI or software product. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical abutment, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established engineering principles, material science specifications, and adherence to international standards (e.g., ISO 14801, ASTM F1044, ASTM F1147, ISO 10993). Functional fit was verified against OEM implant specifications through direct testing.
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The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning model. There is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, no training set exists for this type of device.
In summary, the provided document explicitly states that the submission aims to demonstrate substantial equivalence of the new LOCATOR Angled Abutment variations to existing predicate devices. This is achieved by showing that the new abutments share the same intended use, principles of operation, materials, manufacturing processes, and fundamental design, and they meet the same functional and performance characteristics through non-clinical testing. The "acceptance criteria" here refer to the successful completion and passing of these engineering and material performance tests against established standards.
§ 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.)