(143 days)
Implants:
OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:
- · To replace missing teeth in single or multiple unit applications within the mandible or maxilla
- · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
- · For both one- and two-stage surgical procedures
- · Especially well in soft bone applications where implants with other implant surface treatments may be less effective
- · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants.
OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations.
To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Astra Tech Implant System Plus:
Important Note: This 510(k) summary is for a dental implant system. The information provided is typical for medical devices that aim to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing efficacy from scratch. Therefore, many of the typical "AI/algorithm performance study" criteria you listed (like MRMC studies, training set details, or ground truth establishment for a test set in the AI context) are not applicable to this type of device submission.
The "study" in this context refers to performance testing designed to show that the new device's technological changes do not raise new issues of safety or efficacy compared to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved by showing that the subject device has the same intended use, technological characteristics, materials, and provides similar performance without raising new issues of safety or efficacy. The specific performance test mentioned is compliance with ISO 14801.
Reported Device Performance:
The document states: "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801."
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Same intended use as predicate devices. | The Astra Tech Implant System Plus implants and abutments have the same intended use as the predicate devices: replacing missing teeth, immediate placement, one- and two-stage procedures, soft bone applications, and supporting crowns/bridges/overdentures. |
| Same operating principle as predicate devices. | The device "uses the same operating principle" as predicate devices. | |
| Same basic design (with minor modifications not raising new safety/efficacy concerns). | The device "incorporates the same basic design." The main technological change is a new anti-rotation feature (keyway cross section) which is "similar to the cam anti-rotation mechanism of the CAMLOG Implant System." This difference "does not raise new issues of safety or efficacy." | |
| Same materials as predicate devices. | The device "incorporates the same materials." | |
| Similar packaging and sterilization methods as predicate devices. | The device "has similar packaging and is sterilized using the same materials and processes." | |
| Mechanical Performance | Compliance with ISO 14801 (Dynamic loading for endosseous dental implants). | "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801." (The specific results of this testing are not detailed in this summary, but the inclusion of this testing is noted.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the summary. For mechanical testing under ISO 14801, a specific number of implants would be tested, but this number is not disclosed in the provided text.
- Data Provenance: The testing was conducted by or for Astra Tech AB, a Swedish company. The summary doesn't specify if the testing itself was performed in Sweden or elsewhere, nor does it specify if human data (e.g., retrospective or prospective patient data) was used. Given it's ISO 14801, it is almost certainly bench-top mechanical testing, not human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the "test set" in this context refers to mechanical performance testing, not human-interpreted data requiring expert consensus or ground truth establishment in the way it would be for an AI algorithm.
4. Adjudication Method for the Test Set
This information is not applicable for mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic or screening devices, especially those involving human interpretation of images, to assess reader performance with and without an AI aid. This 510(k) is for a physical medical implant device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is a physical dental implant, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the mechanical performance testing (ISO 14801), the "ground truth" would be the objective measurements of force, cycles to failure, or displacement as defined by the standard, measured by calibrated equipment. It is not expert consensus, pathology, or outcomes data in the usual sense.
8. The Sample Size for the Training Set
Not Applicable. This 510(k) is for a physical medical device, not an AI algorithm. Therefore, 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 an AI algorithm, this question is irrelevant to this device submission.
§ 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.