(184 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 bridges applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® BLX SRAs and Antomic Abutments: Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.
The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. There are two available prosthetic platforms identified as RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in various sizes.
Straumann® BLX SRAs are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent screw-retained single or multi-unit restorations. They are provided sterile by gamma radiation and are available in various sizes and angulations.
Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cement-retained single or multi-unit restorations. They are provided non-sterile and are available in various sizes and angulations. They are delivered with the corresponding basal screw. Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.
The provided text describes a 510(k) premarket notification for the Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study to establish new acceptance criteria. Therefore, the information requested in your prompt (Acceptance Criteria and study design for proving it) is not explicitly present in the provided document in the way one might find it for a novel device undergoing clinical trials.
However, based on the performance testing section, we can infer some aspects that act as "acceptance criteria" for demonstrating substantial equivalence to the predicate devices. The study conducted is primarily a series of bench tests and validation studies rather than a clinical trial or a study designed to prove new acceptance criteria.
Here's an attempt to structure the answer based on the provided text, highlighting what is implicitly or explicitly stated about "acceptance" in the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, explicit "acceptance criteria" as pass/fail thresholds for a novel claim are not presented. Instead, the performance tests aimed to show that the subject device performs equivalently to the predicate devices and meets relevant industry standards. The "performance" column here reflects the outcome of those equivalence demonstrations.
| Acceptance Criterion (Inferred from Equivalence Testing) | Reported Device Performance |
|---|---|
| Sterilization Validation: Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137-1:2006. | Validated to SAL of 10-6 using the over kill bioburden method in accordance with ISO 11137-2:2013 for BLX implants and SRAs. |
| Shelf Life: Packaging and materials prevent adverse effects over time. | Shelf life of 5 years demonstrated as packaging is equivalent to predicate/reference devices, and materials are not adversely affected by time. |
| End-User Sterilization (Anatomic Abutments): Validation according to ISO 17665-1 and ISO 17665-2. | Recommended sterilization method has been validated for BLX Anatomic Abutments. |
| Pyrogenicity: Meets pyrogen limit specifications (e.g., LAL Endotoxin Analysis with testing limit of 20 EU/device). | Device meets pyrogen limit specifications as determined by LAL Endotoxin Analysis with a testing limit of 20 EU/device (for blood contacting and implanted devices). |
| Biocompatibility: Equivalent to predicate/reference devices per ISO 10993-1:2009 and FDA Guidance. | Biological assessment shows the subject devices have equivalent body contact, duration, material formulation, and sterilization methods compared to predicate/reference devices. No new testing performed due to equivalence. |
| Dynamic Fatigue & Static Strength: Equivalent to predicate/reference devices as per FDA guidance for root-form endosseous dental implants. | Dynamic fatigue and static strength tests were performed on both RB and WB platforms (worst-case considerations) and shown to be equivalent to the reference devices. |
| Insertion Torque: Allows for suitable implant insertion torques. | Insertion torque tests were conducted on worst-case BLX implants (Ø3.75 mm) and demonstrated that the implants and related cutting instruments allow reaching suitable implant insertion torques. |
2. Sample size used for the test set and the data provenance
- Sterilization Validation: The document states that the validation was in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, specifically mentioning the "over kill bioburden method." These standards outline protocols for sample size determination, but the exact sample sizes used for the sterilization validation are not specified in this document.
- Bench Testing (Dynamic Fatigue, Static Strength, Insertion Torque): The document mentions that "worst-case considerations" were used for testing various platforms (RB and WB) and implant sizes (e.g., Ø3.75 mm for insertion torque). Specific sample sizes for these bench tests are not provided.
- Data Provenance: All data appears to be prospective bench testing and validation studies conducted by or for the manufacturer (Institut Straumann AG / Straumann USA, LLC). No country of origin for the data is specified beyond it being conducted by the applicant's entity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The studies described are engineering and materials science tests (sterilization, biocompatibility, mechanical strength), not studies involving human interpretation or clinical outcomes that would require "experts to establish ground truth." The ground truth for these tests is based on established scientific and engineering principles, international standards (ISO), and FDA guidance documents.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies that involve human interpretation and potential disagreements, such as image reading studies. The described studies are objective engineering tests.
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 information is not applicable and not provided. The device is an endosseous dental implant system, not an AI-powered diagnostic tool or image analysis software. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. As stated above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the various tests described is derived from:
- International Standards: e.g., ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2, ISO 10993-1.
- FDA Guidance Documents: Such as "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile."
- Engineering Principles: For mechanical testing like fatigue, strength, and torque.
- Predicate Device Performance: The underlying "ground truth" for a 510(k) submission is that the new device is "substantially equivalent" to predicate devices, meaning it performs as safely and effectively without raising new questions of safety or effectiveness.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. 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.