(231 days)
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on singletooth, bar and bridge applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants by the corresponding abutment components.
The Straumann BLX Ø3.5 mm Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The BLX connection is identified as conical fitting with Torx style engaging feature (TorcFit connection). There are two available prosthetic platforms identified for BLX Implants: RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform with a TorcFit internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in the following sizes:
Platform: RB, Maximium outer Ø (mm): 3.5, Length (mm): 8, 10, 12, 14, 16, 18
The provided text describes the Straumann BLX Ø3.5 mm Implants, a medical device for endosseous dental implantation. The information required to describe acceptance criteria and associated studies is extracted below.
1. Table of acceptance criteria and reported device performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit quantifiable acceptance criteria as a standalone device. However, the performance testing section details the types of tests conducted and implicitly states that the results demonstrated equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization: Sterility Assurance Level (SAL) of 10^-6 | Achieved a SAL of 10^-6, validated according to ISO 11137-1:2006 (development, validation, and routine control of sterilization process) and ISO 11137-2:2013 (establishing sterilization dose) using the over kill bioburden method. |
| Pyrogenicity: Meets pyrogen limit specifications | Met pyrogen limit specifications, with a testing limit of 20 EU/device, determined by LAL Endotoxin Analysis. |
| Shelf Life: | 5 years, due to packaging equivalent to predicate devices and materials not adversely affected by time. |
| Biocompatibility: Compliant with ISO 10993-1 and FDA Guidance | Biological assessment performed according to ISO 10993-1:2009 and FDA Guidance Document "Use of International Standard ISO 10993-1". No new testing performed as subject devices have equivalent nature of body contact, contact duration, material formulation, and sterilization methods compared to predicate devices. (This implies that the established biocompatibility of the predicate is assumed to apply). |
| Dynamic Fatigue: Equivalent to predicate devices | Dynamic fatigue tests were conducted in 0.9% NaCl at 37°C and "demonstrated the Straumann BLX Implant System is equivalent to the predicate devices." (No specific numerical acceptance criteria or performance metrics are provided for the subject device or predicate, only a qualitative statement of equivalence.) |
| Static Strength: Equivalent to predicate devices | Static strength tests were conducted alongside dynamic fatigue tests and "demonstrated the Straumann BLX Implant System is equivalent to the predicate devices." (No specific numerical acceptance criteria or performance metrics are provided for the subject device or predicate, only a qualitative statement of equivalence.) |
| Insertion Torque: Allows reaching suitable implant insertion torques. | Insertion torque tests were conducted on the "worst cases" for BLX Ø3.5 mm implants and "demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques." (No specific numerical acceptance criteria or performance metrics are provided, only a qualitative statement of suitability.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sterilization Validation: The validation method used was the over kill bioburden method. While details on the number of samples for bioburden testing are not specified, it would typically involve a statistically significant number of samples to establish the bioburden and then validate the sterilization process. Data provenance is not specified.
- Pyrogenicity: The number of devices tested for LAL Endotoxin Analysis is not specified. Data provenance is not specified.
- Bench Testing (Dynamic Fatigue, Static Strength, Insertion Torque): The sample sizes for these tests are not explicitly stated in the document. Data provenance is not specified.
- Clinical Data: No device-specific clinical data has been submitted.
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. This submission relies on substantial equivalence and bench testing, not clinical studies requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication by experts was used.
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, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The equivalence is based on physical and biological testing against established standards and predicates, not clinical ground truth derived from patients.
8. The sample size for the training set:
Not applicable. This device is a physical product, not a software algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable as there is no training set for this device.
§ 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.