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The BV Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The proposed devices, dental implant system consists of dental implants, abutments and healing cap, it is used in one or two-stage dental implant placement and restoration. The dental implants are available in Mini and Regular two types. The implant is made from titanium and the surface of the implants are treated with Sandblasting and Acid etching. The implants are provided in lengths from 7.0-15.0 and in diameter from 3.7 to 6.8.

The abutments in this submission include transfer abutment, temporary abutment, multi abutment, multi angled abutment, equator abutment and Esthetic-low Temporary Cylinder. The abutment is also available in mini and regular two types to match with the corresponding implant. The abutment is made from titanium alloy.

The healing cap in this submission include cover screw, healing abutment and equator healing abutment.

The provided document is a 510(k) premarket notification letter and summary for the BV Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel AI/ML-driven device.

Therefore, the document does not contain the specific information required to answer the questions regarding acceptance criteria and a study that proves a device meets those criteria for an AI/ML device.

Specifically, the document does not include the following information relevant to AI/ML device evaluation:

1. A table of acceptance criteria and the reported device performance: The tables provided are for comparison of the proposed dental implant system with predicate devices, outlining product codes, indications for use, and physical characteristics. There are no performance metrics related to an AI/ML component.
2. Sample size used for the test set and data provenance: Not applicable as there is no AI/ML component or a test set described.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this is not an AI/ML device. The document explicitly states "No clinical study is included in this submission." (Page 6).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document details non-clinical tests conducted to demonstrate substantial equivalence for a dental implant system:

• Biocompatibility test: Leveraged previous tests on K150388 (same applicant) for the implant. Cytotoxicity testing was performed for the abutment, showing no cytotoxicity.
• Surface test: Leveraged previous tests on K150388.
• Bacteria Endotoxin Test: Conducted per USP 85, with results showing endotoxin less than 20EU per device.
• Mechanical test: Performed on the proposed and predicate device, showing no significant difference.
• Sterilization: Radiation sterilization for implants (validated per ISO 11137-1 and -2) and steam sterilization for abutments and healing caps (validated per ISO 17665-1 and -2).

The document is a traditional 510(k) submission for a physical medical device (dental implant system), not an AI/ML device, and therefore the requested information is absent.

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