(135 days)
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
The subject devices represent a line extension of the previously cleared Bone Level implants of the Straumann Dental Implant System (K062129, K083550 and K121131). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC) the same lengths (8 to 14 mm), the same materials (CP Ti and Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified predicate devices. The subject devices differ in that the apical aspect of the implants incorporate a tapering thread form, the apical aspect of the implants incorporate three cutting flutes, an additional length of 16mm and the transfer piece is of a new design.
The provided text is a 510(k) premarket notification for a medical device, specifically dental implants. It focuses on demonstrating substantial equivalence to existing predicate devices rather than providing acceptance criteria and performance data in the traditional sense of a study proving performance against defined metrics.
Therefore, much of the requested information cannot be extracted directly from this document because it describes a different type of regulatory submission. This document aims to establish that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific, quantifiable performance targets with a detailed clinical study.
However, I can extract information related to the device characteristics and the type of evidence provided for substantial equivalence.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided as requested. The document doesn't define explicit "acceptance criteria" against which the device performance is measured in a quantitative manner, like sensitivity, specificity, accuracy, or a specific failure rate.
- Instead, for dental implants, "performance" is demonstrated through technological characteristics and non-clinical bench studies (specifically dynamic fatigue testing) to show "substantial equivalence" to predicate devices.
- The comparison table provided (Page 6) shows technological characteristics of the subject device (Straumann® Bone Level Tapered Implants) versus predicate devices. This implicitly suggests that being similar or equivalent in these characteristics is the "acceptance criteria" for substantial equivalence.
| Feature | Acceptance Criteria (Predicate Characteristics) | Reported Device Performance (Subject Device Characteristics) |
|---|---|---|
| Implant-to-Abutment Connection | Narrow CrossFit® (NC), Regular CrossFit® (RC) | Narrow CrossFit® (NC), Regular CrossFit® (RC) |
| Implant Diameter | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm |
| Implant Length | 8, 10, 12, 14mm | 8, 10, 12, 14, 16mm (Note: new 16mm length added) |
| Coronal Thread Form | Constant major and minor thread diameters (parallel wall), 0.8mm thread pitch | Constant major and minor thread diameters (parallel wall), 0.8mm thread pitch |
| Apical Thread Form | Constant major and minor thread diameters (parallel wall), 0.8mm thread pitch | Angled major and minor thread diameters (tapered wall), with differing major/minor diameters such that depth increases toward apical end, with cutting flutes. 0.8mm thread pitch. (Note: This is a design difference from the predicate, justified by equivalence to Nobel predicates with tapered forms and cutting flutes.) |
| Surface Finish | SLA, SLActive | SLA, SLActive |
| Transfer Piece | Thread mount transfer piece | Snap fit mount Loxim™ transfer piece (Note: new design, but serves same intended function) |
| Material | Commercially pure grade 4 titanium & Titanium-13Zirconium alloy (Roxolid®) | Commercially pure grade 4 titanium & Titanium-13Zirconium alloy (Roxolid®) |
| Primary Package SLActive | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE, implant holder of Grilamid TR70 polyamide, filled with aqueous NaCl solution. | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE, implant holder of Grilamid TR70 polyamide, filled with aqueous NaCl solution. |
| Sterilization | Gamma Irradiation, 25 kGy minimum, Validated per ISO 11137-1 and ISO 11137-2 to an SAL of 1 x 10^-6 | Gamma Irradiation, 25 kGy minimum, Validated per ISO 11137-1 and ISO 11137-2 to an SAL of 1 x 10^-6 |
| Dynamic Fatigue Performance | Consistent with FDA guidance and ISO 14801 (implied successful performance by predicates) | Data shows that the subject devices provide performance that is substantially equivalent to the identified predicate devices (demonstrated through bench studies per ISO 14801 and FDA guidance). This is the key "performance" reported to meet substantial equivalence. The specific numerical acceptance criteria for fatigue are not detailed here, only that the subject device meets the criteria that the predicates met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document refers to "bench studies" for dynamic fatigue testing (Page 7). This typically involves mechanical testing rigs, not human or animal subjects, so terms like "test set," "data provenance," "retrospective/prospective" in a clinical sense are not applicable. The sample size for materials testing would be part of the ISO 14801 standard and the specific test protocols, which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is relevant for studies involving human interpretation or pathology, which is not the case for this technical submission based on bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 device is a dental implant (a physical medical device), not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench testing (dynamic fatigue), the "ground truth" or standard for acceptable performance would be defined by ISO 14801 standards and FDA guidance for dental implants. Success is failure to fracture or deform beyond acceptable limits under specified loading conditions.
- For the overall substantial equivalence determination, the "ground truth" is typically the performance of the legally marketed predicate devices. The new device aims to be as safe and effective as these established devices.
8. The sample size for the training set
- Not applicable. This device is hardware, not an AI algorithm requiring a training set in the computational sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.