(179 days)
Fixture OsseoSpeed and Fixture MicroMacro are intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements. partial and total fixed detachable bridges and overdentures. One or two stage surgical procedure can be used. When using the one stage surgical protocol, immediate loading may be applied in the anterior mandibular region (between the mental foramina) if at least four implants are splinted with a bar, or other continuous suprastructure.
The Fixture OsseoSpeed is a root-form threaded dental implant made of Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.5, 4.0, 4.5 and 5.0 mm. and lengths from 8mm to 19mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delayed.
Fixture MicroMacro is of similar design and construction and is available in diameters 3.5 and 4.0mm, and lengths from 8mm to 19mm.
This document is a 510(k) summary for a dental implant, focusing on substantial equivalence to predicate devices and expanding the indications for use. It primarily discusses the design, materials, and intended use of the Astra Tech Fixture OsseoSpeed and Fixture MicroMacro.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it refers to "Performance testing" conducted to "determine device functionality and conformance to design input requirements." For the "immediate loading claims," it states these were "supported by clinical data."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functionality and conformance to design input requirements | Achieved. Laboratory testing confirmed functionality and conformance. |
| Immediate loading claim for Fixture OsseoSpeed and Fixture MicroMacro | Supported by clinical data. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "clinical data" but does not specify the sample size, country of origin, or if the data was retrospective or prospective.
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)
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This document describes a medical device (dental implant), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
As this is a physical medical device (dental implant), the concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "immediate loading claims," the ground truth was established through "clinical data." The specific nature of this clinical data (e.g., success rates, stability measurements, patient outcomes) is not detailed.
8. The sample size for the training set
This document does not specify a training set or its sample size. This is typical for a 510(k) submission for a physical device, which relies more on engineering testing, material science, and clinical performance data rather than machine learning models.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is mentioned or implied.
§ 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.