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510(k) Data Aggregation
(88 days)
BT-Tite CV3: It is intended to be used in maxilla or mandible, for post-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.
Mini Implant: It is intended to be used in maxilla or mandible for immediate and long-term stabilization of removable prosthesis.
Mini Single: It is intended to be used in maxilla or mandible in anterior narrow sites of dental arch, to replace lateral teeth, dental agenesis and inferior incisors.
Slot implant: It is intended to be used as temporary intra-oral anchorage unit in the orthodontic treatment in the superior or inferior arch or extra arch in case of edentulous patients, when necessary teeth for the anchorage are absent or the next teeth are compromised from a parodontal point of view. It facilitates the orthodontic movement of teeth. It is removed after orthodontic treatment has been completed. Slot implants are intended for single use only.
BTLock implant are 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. The main feature of BTLock implant system is an original and patented connection (US patent n° 6659700 B2 dated December 9th 2003, attachment nº 11). This connection has no compatibility with other systems. All prosthetic components and accessories are exclusive for BTLock implant system. It included BT-Tite CV2 and BT-Tite Standard lines which have been approved by the FDA with the 510(K) number 073458.
BT-Tite CV3 is an implant line which includes fixture and abutment joined together by a through screw. CV3 fixture is machined from titanium, with a deep thread, micro-grooves on the collar, 6 longitudinal long grooves along the body till the collar, DMA surface and a platform designed for the platform-switching. The surface treatment called DMA (which stands for doppia mordenzatura acida, that is double acid-etching) is obtained by the combination of sand-blasting and double acid-etching. This treatment is absolutely equivalent to BT-Tite (no material is added, no changes in the material used for the treatment: just acid-etching is performed twice instead than once).
This line features a conical-cylindrical shape as the other fixtures of BTLock system. Therefore, because of this equivalence, I submitted the same tests carried for the other lines (BT-Tite One, BT-Tite CV2, BT-Tite Standard).
It is available in 3 diameters (3,75 - 4,5 - 5,5 mm) and 5 lengths (8 - 10 - 11,5 - 13 -16 mm). The technical details of the product are included in its own drawing (see attachment nº 18).
Mini Implant: The fixture of the mini implant line is machined from titanium and self-threading. They are available in 3 diameters (2 - 2,5 - 3 mm) and 3 lengths (11,5 - 13 - 16 mm). The implant length includes the machine-cut collar (1,5 mm) and the threaded part which features a surface treatment called BT-Tite, which is obtained by the combination of sand-blasting and acid-etching.
Mini Single: It is a self-threaded and tapered implant made of titanium alloy. The fixture's body features BT-Tite as surface treatment (already approved by FDA, see K073458). This implant has a one-piece design, that is the abutment is integrated to the implant, and an anatomic design. The implant and the abutment are made of the same material.
It is available in 2 diameters (2,5 - 3 mm) and 4 lengths (10 - 11,5 - 13 - 16 mm).
Slot Implant: This device is made of titanium alloy, has a tapered and self-tapping shape. The head has 2 slots, one hole and one neck. The neck is polished (in order not to interfere with soft tissue). It can be loaded immediately.Its smooth threaded surface allows easy removal at the end of treatmet: as a matter of fact because complete osteointegration is neither expected nor desired with this anchorage system because its utilization is temporary.
It is available in 2 diameters (1,6 - 2 mm) and 3 lengths (6 - 7,5 - 9 mm).
The BTLock dental implants (BT-Tite CV3, Mini Implant, Mini Single, Slot Implant) were approved through the 510(k) pathway, which establishes substantial equivalence to legally marketed predicate devices rather than proving device performance against specific acceptance criteria in a standalone study. Therefore, the information typically requested regarding acceptance criteria and performance studies in the context of an AI/ML device is not directly applicable to this submission.
However, based on the provided document, here's an attempt to extract relevant information that might loosely align with your request, focusing on the studies conducted to support the safety and effectiveness for substantial equivalence:
Summary of Information from K083869 for BTLock Dental Implants:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in a discrete table format with acceptance criteria and corresponding performance metrics for the device itself. The submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent if the materials, treatments, and mechanical properties are substantially similar, and if the biocompatibility and mechanical tests are passed.
The document mentions several tests performed:
| Test Category | Specific Test | Outcome (Implied Acceptance) | Notes |
|---|---|---|---|
| Biocompatibility | Citotoxicity Evaluation test | Within acceptable limits (Attachment nº 49) | |
| Skin sensitization test | Within acceptable limits (Attachment nº 49) | ||
| Salmonella typhirium reverse mutation assay | Within acceptable limits (Attachment nº 49) | ||
| Intramuscular implantation test | Within acceptable limits (Attachment nº 49) | ||
| Intracutaneous reactivity test | Within acceptable limits (Attachment nº 50) | ||
| Pyrogenicity test (USP 151) | Within acceptable limits (Attachment nº 51) | ||
| Sterility (ISO 11737-2) | Sterile (Attachment nº 52) | ||
| Systemic toxicity test | Within acceptable limits (Attachment nº 53) | ||
| Evaluation of sterilization efficacy fixture | Effective sterilization (Attachment n° 54) | Also referred to as Bioburden test in the document. | |
| Evaluation of sterilization efficacy abutment | Effective sterilization (Attachment n° 55) | ||
| Mechanical Tests | Performed by Milan University | Demonstrated effectiveness prior to commercialization | Specific criteria and results are not detailed in the summary (Attachments nº 38, 39 are referenced). |
| Clinical Study | Multi-centred Clinical Study | Proved effectiveness prior to commercialization | Further details on outcomes or specific metrics are not provided in the summary (Attachment nº 40 is referenced). |
| Material/Surface | DMA (Double Acid-Etching) for BT-Tite CV3 | Equivalent to BT-Tite surface (no material added, no changes in material, just acid-etching performed twice). | This is a description of the surface treatment for BT-Tite CV3 and its equivalence to previously approved surfaces. |
| BT-Tite surface for Mini Implant | Obtained by sand-blasting and acid-etching (approved by FDA with K073458) | This describes the surface treatment for Mini Implants. | |
| BT-Tite surface for Mini Single | Approved by FDA (K073458) | This describes the surface treatment for Mini Single implants. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Biocompatibility & Mechanical Tests: Sample sizes are not explicitly stated in the provided summary.
- Clinical Study: Mentioned as a "multi-centred clinical study" (Attachment nº 40). The sample size, country of origin, and whether it was retrospective or prospective are not specified in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this 510(k) submission, as it relates to evaluating device performance against a "ground truth" typically seen in ML/AI studies. For mechanical and biocompatibility tests, validated test methods are used, and for the clinical study, patient outcomes would be observed and assessed by medical professionals, but not in the sense of "ground truth establishment" for an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable to this type of device submission. Adjudication methods are typically used in studies where human readers are establishing "ground truth" or evaluating AI output, which is not the primary focus here.
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 is not applicable. This is a submission for dental implants, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed in the context of human readers improving with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is an endosseous dental implant; there is no algorithm or AI component involved to perform a standalone evaluation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For biocompatibility tests, ground truth would be established by standard biological assays and thresholds (e.g., cell viability, immune response, pyrogenicity limits).
- For mechanical tests, ground truth would be established by engineering specifications and failure criteria.
- For the clinical study, the "effectiveness" would be assessed through outcomes data in patients, such as successful osseointegration, stability of prostheses, chewing function restoration, and absence of adverse events, monitored by dental professionals.
8. The sample size for the training set:
This is not applicable as there is no AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established:
This is not applicable for the same reason mentioned in point 8.
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(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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