(470 days)
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
The OT Equator abutments are indicated for use with the implant systems listed in Attachment B.
The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial denture retained in whole or in part by endosseous implants in the mandibula or maxilla.
OT Equator technology represents a prosthetic abutment solution for "overdenture". The sphere The emerging profile, specifically designed to accommodate the relative interchangeable copings OT Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation.
The OT Equator is manufactured of titanium Ti-6AI-4V (meets ASTM Standard F-136) and it is designed to retain any prosthetic restoration.
The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.
The approval of the OT Equator device is based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria from a standalone study. Therefore, the information provided does not contain a table of acceptance criteria and reported device performance in the traditional sense, nor details of a study directly designed to prove the device meets such criteria.
Instead, the submission focuses on non-clinical tests (biocompatibility, mechanical strength, fatigue, sterilization validation, and reverse engineering analysis) to show that the OT Equator is as safe and effective as its predicate devices, despite minor dimensional differences.
Here's an breakdown of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there isn't a table of acceptance criteria with corresponding performance metrics like sensitivity/specificity for this type of device (an endosseous dental implant abutment). The regulatory approval is based on demonstrating substantial equivalence. The "performance" is implicitly demonstrated through non-clinical testing that aligns with relevant standards and shows comparable structural integrity and biocompatibility to the predicate device.
"Performance" as demonstrated by Non-Clinical Tests (Implicit Acceptance):
| Test Category | Implicit "Acceptance Criteria" (Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Materials are identical to the predicate device, conform to FDA recognized standards (e.g., ASTM F-136), and are manufactured using the same process as the predicate. | All materials, including the TiN coating, are identical to the predicate (Sphero-Block, K033630). Conforms to ASTM F-136. No additional biocompatibility testing was conducted as current materials are considered substantially equivalent. |
| Mechanical Strength | Product demonstrates adequate strength, meeting design requirements and demonstrating substantial equivalence to declared predicate devices when tested against FDA Guidance and ISO 14801. | Compression tests (static and dynamic) were performed to check various connections. Results demonstrate substantial equivalence performance to declared predicate devices, adhering to FDA Guidance Document: "Root-form Endosseous Dental Implants and Endosseous Dental Abutments, 2004" and ISO 14801 standard, "Dentistry- implants- dynamic Fatigue Test For Endosseous Dental Implants." |
| Fatigue | Product demonstrates substantial equivalence performance to declared predicate devices according to ISO 14801. | Fatigue tests were performed according to ISO 14801 on OT Equator models, using the smallest compatible implant as the worst-case scenario. Test results provide evidence of substantial equivalence performance compared to the predicate devices. |
| Sterilization | Demonstrates a Sterility Assurance Level (SAL) of 10^-6 related to the abutments, in accordance with ISO 17664, ISO 11737-1, and ISO 11737-2. | Steam sterilization validation test was conducted according to ISO 17664, ISO 11737-1, and ISO 11737-2. The test demonstrated an SAL of 10^-6 for the OT Equator abutments. The device is marketed non-sterile and requires sterilization before insertion. |
| Reverse Engineering | Abutment can be perfectly coupled with related compatible implants, with features critical to fit, dimensions, and tolerances identified and confirmed. | Reverse engineering analysis was conducted on OEM implant systems (statistically significant number). Implant dimensions, threaded hole dimensions, tolerances, and maximum depth were detected using stereo microscopes, calibrated plugs, "go/no go" threaded gauges, and profile projectors. Report included critical features, dimensions, tolerances, and CAD images showing assembled devices and interface gaps. Analysis demonstrated compatibility of the abutment to identified dental implant bodies. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: No specific sample size mentioned as no new testing was performed. Reliance on predicate device's prior clearance and material standards.
- Mechanical Strength & Fatigue: The document states "the smallest compatible implant was chosen as worst case" for fatigue testing, and compression tests were run on "various connections." For reverse engineering analysis, "tests were conducted on a statistically significant number of OEM implant systems." Specific numerical sample sizes are not provided for these tests.
- Sterilization Validation: No specific sample size mentioned. Standard validation protocols (ISO 17664, ISO 11737-1/-2) would imply a predetermined sample size based on the specific sterilization method and validation plan.
- Data Provenance: The document does not specify country of origin for the test data, nor whether the tests were retrospective or prospective. It is implied these were prospective tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device does not typically involve "ground truth" derived from expert consensus in the clinical sense (e.g., radiologist reads of images). The "ground truth" for non-clinical engineering tests is established by adherence to recognized standards and objective measurements. Experts involved would be engineering and material science professionals carrying out the laboratory tests. Their specific numbers and qualifications are not detailed in this submission.
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation scenarios for consensus on diagnoses.
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. The OT Equator is a physical dental implant abutment, not an AI-powered diagnostic device or software. Therefore, MRMC studies and AI assistance metrics are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As a physical medical device, the concept of "standalone algorithm only" performance does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on:
- Material Standards: Conformance to ASTM Standard F-136 for titanium.
- Mechanical Testing Standards: Adherence to FDA Guidance Document: "Root-form Endosseous Dental Implants and Endosseous Dental Abutments, 2004" and ISO 14801 standard for dynamic fatigue.
- Sterilization Standards: Conformance to ISO 17664 and ISO 11737-1/-2.
- Objective Engineering Measurements: Dimensions, tolerances, and fit confirmed through various calibrated instruments during reverse engineering analysis.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.)