(72 days)
The Ortho implant of the Straumann Orthosystem is an endosseous implant intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal region or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
The Ortho implant is a solid one-piece, threaded, self-tapping design made from CP titanium, Grade 4. It is available in insertion lengths of 4.0 mm and 6.0 mm. It has the same rough surface as cleared Straumann endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head.
The provided document is a 510(k) summary for the Ortho implant, which establishes substantial equivalence rather than presenting acceptance criteria and a study proving performance against them. Therefore, many of the requested details cannot be extracted directly from this document.
The document indicates that the Ortho implant is substantially equivalent to existing legally marketed devices based on its intended use, material, and design. Substantial equivalence means that a new device is as safe and effective as a legally U.S. marketed device (predicate device) and does not need to submit clinical data to prove its efficacy.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- Acceptance Criteria: Not explicitly stated. The core of this submission is establishing "Substantial Equivalence" to predicate devices, meaning it aligns with the safety and efficacy profiles already accepted for those devices. There are no specific performance metrics with acceptance thresholds (e.g., "success rate > X%") provided for the Ortho implant itself.
- Reported Device Performance: Not explicitly stated in terms of quantitative data from a new study. The document asserts that "The Ortho implant is composed of the same material and has the same surface as the ITI SLA dental implant. In addition, the design of the Ortho implant is similar to the Nobel Biocare Onplant." This implies that its performance is expected to be similar due to these shared characteristics with already cleared devices.
- Type of Ground Truth: Not applicable, as there's no new study presented to define a 'ground truth' for performance. The "ground truth" for the device's acceptability is its substantial equivalence to previously cleared devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. There is no new test set described for performance evaluation. The submission relies on comparison to predicate devices, not on a new independent study with a specific test set.
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. No new test set or expert ground truth establishment is described. The FDA (Chiu S. Lin, PhD, Director of relevant division) made the determination of substantial equivalence based on the provided documentation and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new test set requiring adjudication is described.
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 is a medical device (dental implant) submission, not an AI or imaging diagnostic device. No MRMC study was conducted or is relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device (dental implant), not an algorithm or diagnostic software.
8. The sample size for the training set
- Not applicable. No training set is described. This device is subjected to a substantial equivalence pathway, not a machine learning model's development.
9. How the ground truth for the training set was established
- Not applicable. No training set is described.
Summary based on the document:
The Ortho implant submission utilizes the substantial equivalence pathway, which is a regulatory mechanism where a new device is deemed safe and effective because it is substantially equivalent to a legally marketed predicate device. This pathway often does not require a new clinical study to prove performance against specific acceptance criteria, but rather relies on demonstrating that the new device shares fundamental technological characteristics and intended use with already approved devices.
The "study" or evidence provided to meet the acceptance criteria (which is substantial equivalence) is the comparison of the Ortho implant to the identified predicate devices:
- ITI SLA Dental Implant with Bonding Base (K971578, K973353)
- Nobel Biocare Onplant (K980460)
- Sendax Mini Dental Implant (K972351)
The document states that the Ortho implant is substantially equivalent to these devices in:
- Intended Use: "The Ortho implant has the same intended use as the Straumann bonding base used in combination with an ITI dental implant and the Nobel Biocare Onplant. Like the Onplant and the Sendax Mini Dental Implant, the Ortho implant is intended to be used as a temporary implant."
- Material: "The Ortho implant is composed of the same material [CP titanium, Grade 4] and has the same surface [rough surface for osseointegration, smooth machined surface for transmucosal part] as the ITI SLA dental implant."
- Design: "the design of the Ortho implant is similar to the Nobel Biocare Onplant. The implant has a rough surface in contact with bone for osseointegration and a smooth titanium surface in contact with mucosa. Both implants have a threaded transmucosal portion for attachment of the orthodontic anchorage appliance."
Therefore, the "acceptance criteria" here is met by successfully arguing substantial equivalence on these key points, rather than through a new, independent performance study with defined quantitative metrics.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.