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The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.

The One Plus Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance chracteristics, The surface of this system has been treated with R.B.M and the abutment part has TiN coating on it. The One Plus Implant System is available in the following sizes. Sizes: 3.00mm (Dia.) x 11.5/13/14.5 3.75mm (Dia.) x 11.5/13/14.5 4.50mm (Dia.) x 11.5/13/14.5 5.25mm (Dia.) x 11.5/13/14.5

The provided document is a 510(k) premarket notification for the "One Plus Implant System," a dental implant device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria and results as typically seen for novel medical device approvals or AI/algorithm-based devices.

Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics. It is a regulatory submission for a physical device, and the "testing" mentioned is primarily related to manufacturing, sterility, and material properties to ensure safety and performance equivalence, not a clinical performance study as would be conducted for a diagnostic AI.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses "substantial equivalence" based on design, materials, intended use, and manufacturing processes, not on a set of clinical performance metrics with pre-defined acceptance criteria. The non-clinical testing mentioned (sterilization, shelf life, chemical/SEM analysis) is to ensure the product itself is safe and functions as intended, not to measure a clinical performance against a threshold.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of clinical performance data in this submission. The non-clinical testing refers to lab tests on the device itself.

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. There is no ground truth established by experts for clinical performance in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 physical dental implant, not an AI-powered diagnostic tool for human readers.

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 (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here would be established procedures for manufacturing and testing of medical devices (e.g., sterility standards, material composition verification).

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "testing" and "performance":

The document states under "8. Non-Clinical Testing":

• Sterilization validating testing: Performed in accordance with ISO 11137-1, ISO 11137-2, and ISO 11137-3. This demonstrates that the device can be effectively sterilized.
• Accelerated shelf life testing: Performed in accordance with ASTM1980-07, ISO 11607-1, ISO 11737-1, ISO 11737-2. This demonstrates the stability of the device over its intended shelf life.
• Chemical and SEM image analyses: Performed to verify no residual material after RBM treatment on the fixture. This ensures the surface treatment is properly applied and safe.

The "acceptance criteria" for these tests would be the specific standards and thresholds defined within the cited ISO and ASTM documents. The "reported device performance" would be that the device met these standards, allowing the conclusion of substantial equivalence for these aspects. However, these are not clinical performance metrics.

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The OsseoFuse 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 terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

The OsseoFuse Dental Implant System includes Hexa-Plus S fixture, Hexa-Plus S abutment, and Hexa-Plus S Lab Components. This system made of Titanium intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. It is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of this system has been treated with R.B.M (Resorbable Blast Media).

The provided text is a 510(k) summary for the OsseoFuse Dental Implant System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria, device performance metrics, or any clinical studies (retrospective, prospective, standalone, or comparative effectiveness) that would typically be conducted for a medical device that claims to meet specific performance criteria based on a study.

Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K110577, also named "OsseoFuse Dental Implant System" by KJ Meditech Co., Ltd.). The provided text explicitly states:

• "Based n a risk analysis of the modifications, no additional testing was added for this submission." (Page 3)
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (Page 4)
• "When compared with predicate device, no new questions of safety or effectiveness have been raised." (Page 2)

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study, as such information is not present in the provided document. The basis for clearance is substantial equivalence, not a direct demonstration of performance against predefined acceptance criteria through new testing.

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