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510(k) Data Aggregation
(329 days)
Rhein'83 SRL
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 following implant systems: (list of compatible implant systems follows)
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. The device is intended for use in healthcare facilities/hospitals.
The sphere OT Equator technology represents a prosthetic abutment solution for "overdenture". 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 abutments are for straight use only and are recommended for placement on straight implant bodies with no divergence or need for angle corrections.
The OT Equator is manufactured of titanium Ti-6Al-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.
This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the OT Equator dental implant abutment. It is a regulatory document and does not contain information about the acceptance criteria or study performance of an AI/ML device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study effect size
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence of the OT Equator device to previously cleared predicate devices based on materials, design, intended use, and manufacturing processes, rather than presenting a study related to an AI/ML device and its performance metrics. The non-clinical tests mentioned (biocompatibility, sterilization validation, reverse engineering analysis) are performed on the physical dental implant abutment and its interaction with implant systems, not on an AI system.
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(183 days)
RHEIN'83 SRL
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 following implant systems: NOBEL BIOCARE AB - NobelActive NP 3.5 NOBEL BIOCARE AB - NobelActive RP 4.3 - 5 NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5 NOBEL BIOCARE USA INC - Replace Select Straight TiUnit RP 4.3 NOBEL BIOCARE USA LLC - Replace Select Straight TiUnit WP 5 NOBEL BIOCARE AB - Brânemark System Mk III TiUnite NP 3.3 NOBEL BIOCARE AB - Brånemark System Mk III Shorty RP 4,1 NOBEL BIOCARE AB - Brånemark System Mk III TiUnite WP5 6 Straumann USA - Bone level NC 3.3 Straumann USA - Bone level RC 4.1 - 4.8 Straumann USA - Tissue level RN 4,8 Straumann USA - Tissue level WN 6.5 Zimmer Dental Inc. - Tapered Screw-Vent 3.5. 4.5. 5.7 Zimmer Dental Inc. - Spline 3.25. 3.75 - 4, 5 ASTRA TECH AB - OsseoSpeed™ TX 3.5-4, 4.5-5 DENTSPLY INTL., INC. - ANKYLOS C/ 3,5 DENTSPLY INTERNATIONAL, INC. - FRIALIT plus Stepped Screw 3.4, 3.8, 4.5, 5.5, 6.5 BIOMET 3i - Certain 3.25, 4.1, 5, 6 IMPLANT DIRECT LLC - Legacy 3, 3.75, 4.7 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT SYBRON MANUFACTURING LLC - Swish Plus3.7, 4.1 - 4.8 MIS - IMPLANT TECHNOLOGIES LTD. - SEVEN 3.3, 3.75, 4.2, 5, 6 MIS - IMPLANT TECHNOLOGIES LTD. - C1 3.3, 3.75, 3.9, 4.2, 4.3, 5 MEGAGEN CO., LTD. - ANYRIDGE 3.5, 4, 4.5, 5, 5.5 NEODENT USA, INC. - CM Titamax 3.5, 3.75, 4, 4.3, 5 NEODENT USA, INC. - CM Drive 3.5, 3.75, 4, 4.3, 5 NEOSS, LTD. - ProActive 3.5, 4, 4.5, 5, 5.5, 6 BIOHORIZONS IMPLANT SYSTEMS, INC. - Laser-lok® 3.0 BIOHORIZONS IMPLANT SYSTEMS, INC. - Tapered internal 3.5, 4.5, 5.7 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM SD 3.5 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM RD 4.1 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM WD 5
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. The device is intended for use in healthcare facilities/hospitals.
The sphere OT Equator technology represents a prosthetic abutment solution for "overdenture". 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 compatible prosthetic restoration.
The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.
This document is a 510(k) premarket notification for the "OT EQUATOR" device, an endosseous dental implant abutment. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance metrics through clinical trials. As such, the information typically found in acceptance criteria and detailed study results for novel devices is not explicitly provided in the same format.
However, based on the provided text, we can infer how the device meets acceptance criteria through its demonstrated substantial equivalence to the predicate.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the legally marketed predicate device (OT EQUATOR, K142211). The "reported device performance" for the new submission (OT EQUATOR, K160382) is its equivalence to these characteristics.
| Feature/Acceptance Criterion (Implied by Predicate) | Reported Device Performance (Submitted OT EQUATOR K160382) |
|---|---|
| Indications for Use | "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." (Same as predicate) |
| Intended Users | Adequately trained dental technicians and dentists. (Same as predicate) |
| Material (Abutment) | Titanium 6Al-4V (Same as predicate) |
| Material (Male socket) | Rilsan, Pebax, Kepital (Same as predicate) |
| Material (Housing) | Stainless Steel AISI303 (Same as predicate) |
| Platform Diameter | According to the compatible implant (see table above, indication for use) (Same as predicate) |
| Surface treatment | TiN coating only for the head part of the abutment (Same as predicate) |
| Cuff Width | 1mm - 2mm - 3mm - 4mm - 5mm - 6mm- 7mm (Same as predicate) |
| Height | 2 mm (Same as predicate) |
| Components | OT EQUATOR PROFILE kit contains: Ot Equator Profile abutment, metal housing, retentive caps, protective disk. (Same as predicate) |
| Sterilization | Marketed non sterile, to be sterilized before insertion in patient's mouth. (Same as predicate) |
| Reusable | No (Same as predicate) |
| Biocompatibility | Meets standards for permanent duration (> 30 days), mucosal membranes contacting device (demonstrated by predicate). |
| Sterilization Validation | Achieves SAL of 10-6 (demonstrated by predicate). |
| Coupling with compatible implant | Successful coupling as validated by reverse engineering analysis (results reported in a chart form, not detailed in text). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on non-clinical tests to demonstrate substantial equivalence. For the reverse engineering analysis:
- Sample Size: "a statistically significant number of OEM implant systems" were used. The exact number is not specified.
- Data Provenance: Not explicitly stated, but the company (Rhein'83 SRL) is based in Italy. The testing would have been performed on commercially available implant systems. It is not a clinical study, so terms like retrospective/prospective don't directly apply.
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)
Not applicable. This submission concerns a physical device and its material/design characteristics validated against a predicate device and engineering standards, not diagnostic performance requiring expert interpretation of medical images or conditions. The "ground truth" for the non-clinical tests (like reverse engineering) would be the technical specifications of the implants and the device, measured by calibrated instruments, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies with subjective interpretations. The non-clinical tests described (biocompatibility, sterilization validation, reverse engineering) rely on objective measurements and established standards.
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. This device is a dental implant abutment, not an AI-powered diagnostic tool, and no MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Ground truth is established by international standards (e.g., ISO 10993 series, though not explicitly detailed here, it's implied by the reference to "permanent duration (> 30 days), mucosal membranes contacting device").
- Sterilization Validation: Ground truth is established by international standards (e.g., ISO 17664 and ISO 11737-1/-2) for a Sterility Assurance Level (SAL) of 10-6.
- Reverse Engineering Analysis: Ground truth is the precise dimensions and specifications of the compatible OEM implant systems. These are objective engineering measurements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set exists.
Ask a specific question about this device
(470 days)
Rhein '83 SRL
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.
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(156 days)
RHEIN 83 SRL
QUICK COUPLING DEVICE FOR DENTAL PROSTHESES
Not Found
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for dental prostheses, which primarily focuses on substantial equivalence to predicate devices rather than the specifics of a performance study with acceptance criteria.
The letter acknowledges the device's clearance for marketing but does not include:
- A table of acceptance criteria or reported device performance metrics.
- Information on sample sizes, data provenance, number of experts for ground truth, or adjudication methods.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used, training set size, or how ground truth was established for a training set.
The document is a regulatory approval, not a technical report on device performance validation.
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