(247 days)
The OsseoSpeed implants 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 o
- 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
- together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer
- with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.
Astra Tech Implant System implants are intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The new components of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically designed for soft bone applications. All other features and procedures of OsseoSpeed TX implants remain the same as those for OsseoSpeed implants.
The purpose of this submission is to add the OsseoSpeed TX implants to the present product line and expand device claims regarding primary stability of Astra Tech Implant System implants.
The provided text describes a 510(k) premarket notification for the Astra Tech Implant System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria for a novel device. Therefore, the "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood for a new therapeutic or diagnostic device (e.g., specific clinical endpoints, sensitivity/specificity thresholds) are not explicitly present in the document in the format requested.
Instead, the submission's goal is to show the new OsseoSpeed TX implants (with a narrower tapered apex design and modified drilling protocol for soft bone) are substantially equivalent to existing legally marketed devices. The "acceptance criteria" in this context would be the successful demonstration of this substantial equivalence, and the "study" is the comparison testing performed to support this claim.
Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" for a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as demonstrated) |
|---|---|
| Intended Use: Device has the same intended use as predicate devices. | The OsseoSpeed implants are intended to replace missing teeth, for immediate placement, and for one- and two-stage surgical procedures. Claims expanded for soft bone applications and immediate loading protocols where appropriate. This aligns with or expands upon the predicate devices' intended uses. |
| Technological Characteristics: Device has the same operating principle, basic design, materials, packaging, and sterilization methods as predicate devices. | Implants are made of commercially pure titanium (ASTM F67) and encompass similar physical dimensions. Packaged in similar materials and sterilized using similar methods. The OsseoSpeed TX implants have a narrower tapered apex design compared to OsseoSpeed implants (K053384) but are considered an evolution within the same system. |
| Performance: Demonstrated equivalence in performance characteristics relevant to the intended use, particularly for the new design features. | Testing was performed to compare OsseoSpeed TX implants (new drilling protocol) with OsseoSpeed implants (standard drilling protocol). Calculations were made to determine bone-to-implant contact. The design of OsseoSpeed TX implants, combined with the soft bone drilling protocol, results in improved primary mechanical stability of the implant. This supports the expanded claims for soft bone applications. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised. | The FDA’s clearance letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This implies that the FDA concurred that no new safety or effectiveness concerns were raised that would prevent market clearance. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Testing was performed to compare OsseoSpeed TX implants using the new soft bone drilling protocol with OsseoSpeed implants using the standard drilling protocol. Calculations also were made to determine bone to implant contact for the two implant/drilling protocol combinations."
- Sample Size: The exact sample size for this comparative testing is not specified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/non-clinical testing given the nature of comparing drilling protocols and bone-to-implant contact for implants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information (expert review for ground truth) is typically relevant for diagnostic devices interpreting medical images or data. For a dental implant's mechanical stability and bone-to-implant contact, the "ground truth" would be established through direct physical measurements, imaging, or histological analysis, rather than expert consensus on interpretation. Therefore, this information is not applicable and not provided in the document for an implant device.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are primarily used in studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the "testing" described involves comparing implant performance characteristics (mechanical stability, bone-to-implant contact) through presumably laboratory or animal studies, an adjudication method in this sense is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for comparing the performance of human readers, typically with and without AI assistance for diagnostic tasks. This submission is for a dental implant, which is a therapeutic device, not a diagnostic one involving human interpretation of cases. Therefore, this type of study was not done and is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This question is also relevant for diagnostic devices, specifically AI algorithms. The Astra Tech Implant System is a physical dental implant, not an algorithm. Therefore, a standalone algorithm performance study was not done and is not applicable.
7. The Type of Ground Truth Used
For the performance testing described ("compare OsseoSpeed TX implants... with OsseoSpeed implants... Calculations also were made to determine bone to implant contact"), the ground truth would be based on:
- Direct measurements/experiments: For primary mechanical stability and bone-to-implant contact, this would typically involve biomechanical testing (e.g., insertion torque, removal torque, pull-out strength tests) and potentially histological analysis or micro-CT imaging to quantify bone-to-implant contact in animal models or ex vivo samples.
- The document implies these were obtained through calculations and comparative testing, which points to direct experimental data rather than expert consensus, pathology (in the clinical sense for a patient), or outcomes data (long-term clinical results).
8. The Sample Size for the Training Set
This question is applicable to machine learning algorithms. Since the Astra Tech Implant System is a physical medical device (dental implant) and not an AI/ML algorithm, there is no training set and therefore no specified sample size for it.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 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.