(99 days)
The Straumann® CARES® Screw-retained Bridge Titanium and Straumann® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) Ø4.8mm and Wide Neck (WN) Ø6.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Straumann® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants.
The Straumann® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants.
Straumann CARES Screw-retained Bridge, Titanium (Ti) and Straumann CARES Dolder Bar Titanium (Ti) are dental restorative devices intended to be attached directly to dental implants by basal screws. Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant with prosthetic platforms Regular Neck (RN) Ø4.8mm and Wide Neck (WN) Ø6.5mm.
The implant positions and oral situation are recognized by a scan of a dental master model with implant analogs and scanbodies. Based on the scan data, the dental technician selects the proper implant interfaces and designs the bar or bridge according to a dentist's prescription. Once the Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti is designed the digital dataset is sent to Straumann CADCAM by internet connection where the bridge or bar is milled from a Titanium-based blank.
Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti allow for individual customization regarding function and esthetics. They attach directly to Straumann dental implants. The device is intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. The devices are CADderived, CAM-produced and have a scanner as its data source.
The milling blanks used for the manufacture of Straumann CARES Screwretained Bridge Ti and Straumann CARES Dolder Bar Ti are manufactured from Titanium, grade 4, which is biocompatible for its intended use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti:
Acceptance Criteria and Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Minimal body testing | Meet or Exceed Predicate Device | Passed |
| Free hanging bridge | Meet or Exceed Predicate Device | Passed |
| Free end pontic bridge | Meet or Exceed Predicate Device | Passed |
| Metal-Ceramic bond testing (ISO 9693) | Requirements Satisfied | Performed (Result not explicitly stated as "Passed" but implied by overall conclusion) |
Note: The document states that the Metal-Ceramic bond testing was "in accordance with ISO 9693: Metal-ceramic dental restorative systems: requirements satisfied." The overall conclusion explicitly states that the device "met the pre-determined acceptance criteria," which implies satisfactory results for this test as well.
Study Information
The provided document describes performance testing, primarily bench testing, rather than a clinical study involving human subjects or AI-driven analysis of medical images. Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the type of verification and validation performed for this device.
Here's an breakdown based on the provided text:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the fatigue tests or bond testing. The testing type implies physical samples of the devices were used.
- Data Provenance: Not applicable. The testing was bench testing of manufactured devices.
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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. Ground truth in the context of expert review for diagnostic accuracy is not relevant here. The "ground truth" for these performance tests would be the established engineering standards and predicate device performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or diagnostic studies. This document describes mechanical performance testing.
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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:
- No. An MRMC comparative effectiveness study was not done. This device is a physical dental restorative component, not an AI or diagnostic imaging device that uses human readers.
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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 physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this performance testing is adherence to established engineering standards (ISO 14801:2007, ISO 9693) and direct comparison to the performance of the legally marketed predicate device. The acceptance criteria explicitly state "Meet or Exceed Predicate Device."
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The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set.
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How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or a training set.
Summary of the Study:
The study described is a series of bench performance tests to demonstrate the substantial equivalence of the proposed Straumann CARES Screw-retained Bridge Ti and Dolder Bar Ti to their predicate devices. The tests focused on:
- Fatigue Testing: Performed according to the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2007 ("Dentistry-Implants-Dynamic fatigue test for endosseous dental implants"). This included "Minimal body testing," "Free hanging bridge," and "Free end pontic bridge" configurations. The acceptance criterion for these tests was to "Meet or Exceed Predicate Device," which the proposed devices "Passed."
- Metal-Ceramic Bond Testing: Performed in accordance with ISO 9693 ("Metal-ceramic dental restorative systems: requirements satisfied"). The document states the requirements were satisfied.
The conclusion drawn from this performance testing was that the devices "function as intended and met the pre-determined acceptance criteria," indicating substantial equivalence to the predicate device and confirming their safety and effectiveness for intended use.
§ 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.)