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510(k) Data Aggregation
(116 days)
BT-Tite Standard (or VSM) It is intended to be used in maxilla or mandible, and for every kind of reconstruction, preferably not immediately loaded. It is intended to be used in a single stage or two stage surgical procedure.
BT-Tite One (or CV1) It is intended to be used in maxilla or mandible, for extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure.
BT-Tite CV2 (or CV2) It is intended to be used in maxilla or mandible. It is indicated in any situation for extraction sites, where the implant would be immediately loaded and where the bone crest is stable. In case of post-extraction sites, it has to be inserted some millimetres under the bone. It is intended to be used in a single stage or two stage surgical procedure.
BTLock implant system is composed by a fixture and an abutinent, joined together by a through screw. Main feature of BTLock implant system is an original and patented internal connection (US patent nº 6659700 B2 dated December 9th 2003). This connection has not compatibility with other system. All prosthetic components and accessories are exclusive for BTLock implant system,
BTLock implants are threaded, root-form dental implants, intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients.
BTLock implants are machined from titanium and available tapered. The implants may a) have a surface that consists of a titanium oxide layer, i. e. TiUnite implants (BT-Tite Standard Line); b) be coated with hydroxyapatite powder, i. e. HA Coated implants, (HA Coated Standard Linc); or c) Acid-Etched (Acid-Etched Standard Line).
BTLock implant lines may differ also for the kind of thread (One or Standard), while keeping always the same kind of connection. All prosthetic components are indecd compatible with same-sized diameter of all lines.
BTLock implants may be placed in the oral cavity using cither a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.
Here's a breakdown of the acceptance criteria and study information for the BTLock Implant System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the clinical study. Instead, it states that "BTLock carried on both biocompatibility and mechanical testings and a multi-centered clinical study to proove the effectiveness of the devices before commercialisation." and later, "We don't see relevant differences with respect to predicate devices. Anyway. BTLock carried on both mechanical testings (by Politconico di Milano, Milan University) adn a multi-centered clinical study over its products." This implies that the acceptance criteria for the clinical study were likely related to demonstrating effectiveness and substantial equivalence to existing, legally marketed predicate devices rather than meeting pre-defined specific performance metrics in terms of success rates or specific clinical outcomes. A typical measure of effectiveness for dental implants in such studies would be long-term survival rates and stability, but these are not quantified here.
The document primarily focuses on demonstrating the device's materials, design, and manufacturing processes are comparable to legally marketed predicates, and that biocompatibility and mechanical properties are satisfactory.
Therefore, the table will reflect the general nature of the claims made:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effectiveness: Demonstrate ability to restore chewing function and support prosthetic devices. | A "multi-centered clinical study" was conducted to "prove the effectiveness of the devices before commercialization." The 510(k) submission states, "We don't see relevant differences with respect to predicate devices." This implies the study findings supported the claim of effectiveness comparable to predicate devices. Specific quantitative outcomes (e.g., success rates, marginal bone loss) are not provided in the summary. |
| Biocompatibility: Demonstrate the materials are safe for use in the human body. | Biocompatibility testing included: Citotoxicity Eluation test, Skin sensitization test, Salmonella typhirium reverse mutation assay, Intramuscular implantation test, Intracutaneous reactivity test, Pyrogenicity test (USP 151), Sterility (ISO 11737-2), Systemic toxicity test. These tests were notably conducted on implants with a "riskier" plasma spray coating in 2001, and considered valid for current products. The device materials (Titanium grades II, IV, V, and Stainless Steel AISI 316 L) are described, implicitly demonstrating their established biocompatibility. |
| Mechanical Properties: Demonstrate structural integrity and durability. | Mechanical testings were carried out by Politecnico di Milano, Milan University. The document mentions "taber testings" over a similar coating (Osprovit) to the HA coating (K630), with a letter from the supplier explaining mechanical equivalence. This suggests the mechanical properties were found to be adequate and comparable. Specific quantitative results (e.g., fatigue strength, fracture resistance) are not provided in the summary. |
| Substantial Equivalence: Demonstrate similarity to legally marketedPredicate devices. | The submission explicitly aims for substantial equivalence to K041661 (NOBEL BIOCARE ENDOSSEOUS IMPLANTS) and K051461 (3I OSSEOTITE DENTAL IMPLANTS). The general tone of the submission is that there are "no relevant differences" and that materials and general mechanical properties are "substantially equivalent." The FDA granted 510(k) clearance, confirming substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions a "multi-centered clinical study."
- Data Provenance: Not specified, other than the study being "multi-centered." The company is based in Italy, so it's plausible the study was conducted in Europe, but this is not explicitly stated. The study was prospective as it was "carried on... to prove the effectiveness of the devices before commercialisation."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a clinical study on dental implants, ground truth would typically be established by the treating clinicians and follow-up examinations (e.g., radiographs, clinical assessments), but the details of who assessed these outcomes and their qualifications are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study focuses on imaging interpretation and reader performance, which is not applicable to a dental implant device itself. The clinical study mentioned is for device effectiveness in patients.
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 AI algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The ground truth for the clinical study would have been based on clinical outcomes data from the "multi-centered clinical study." This would include assessments like implant stability, absence of infection, successful osseointegration, successful prosthetic restoration, and possibly radiographic evidence of bone levels. However, the exact nature and specific measurements of this clinical outcomes data are not detailed in the provided text.
For the biocompatibility tests, the ground truth was established by recognized laboratory standards and protocols (e.g., ISO, USP 151).
8. The Sample Size for the Training Set
Not Applicable. As this is a physical medical device, not a machine learning model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set for this type of device.
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