Search Results

The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.

OssBuilder System is consisted of metal devices, OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw, and is intended for use to stabilize and support of bone graft in dento-alveolar bony defect sites.

Tenting Screw, a product in the OssBuilder System product group, is a temporary dental implant that can be implanted in the bone defect site of the alveolar bone to fix the guided tissue regeneration material.

Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration.

This document describes the premarket notification (510(k)) for the OssBuilder System, an intraosseous fixation device. It asserts substantial equivalence to predicate devices based on non-clinical performance testing. Due to the nature of this submission, which focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical study, many of the typical elements expected for evaluating AI/algorithm performance (e.g., ground truth establishment with experts, MRMC studies, training/test set details) are not applicable or provided.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are not reported as specific performance metrics like accuracy, sensitivity, or specificity, which would be common for diagnostic AI/software. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through:

• Identical or similar design, operating principle, and intended use as predicates.
• Identical or similar materials.
• Successful non-clinical performance testing (bench tests) demonstrating comparable mechanical properties.
• Validated sterilization and shelf-life.
• Biocompatibility evaluation.

The reported device performance heavily relies on comparisons to predicate devices in the following aspects:

2. Sample Size for the Test Set and Data Provenance

This submission does not involve an AI/algorithmic device that would typically have a "test set" of patient data for performance evaluation. The "tests" performed are bench tests on the physical device components.

• Sample Size: Not explicitly stated as a number of devices/units tested, but refers to "Bench tests evaluated for OssBuilder System according to ASTM F543" for "worst-case insertion in block material." The assumption is that standard engineering testing practices for mechanical properties were followed.
• Data Provenance: The tests are laboratory-based bench tests, not patient data from a specific country. They are likely conducted at the manufacturer's facility or a contracted testing lab. The submission is made by a company based in the Republic of Korea (Osstem Implant Co., Ltd.) with a US correspondent (Hiossen Inc.).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. As this is a physical medical device submission demonstrating substantial equivalence through non-clinical testing, there is no "ground truth" derived from human experts interpreting medical images or data. The "ground truth" for mechanical properties is established by the specifications defined in standards like ASTM F543 and the performance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Mechanical properties are measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device, and therefore, no MRMC comparative effectiveness study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the performance specifications and characteristics of the legally marketed predicate devices and generally accepted industry standards (e.g., ASTM F543) for mechanical properties testing, along with established biocompatibility guidelines (ISO 10993-1). The manufacturer demonstrates that the new device meets or is "substantially equivalent" to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, 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.

Ask a specific question about this device

OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. It is consisted of OssBuilder, Healing Cap, Cover Cap, and OB Anchor. The OssBuilder System is not indicated for permanent implantation.

The provided text is a 510(k) summary for the OssBuilder System, a dental device intended to stabilize and support bone grafts. It does not describe a clinical study in the traditional sense, but rather a set of non-clinical performance tests to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested categories for clinical studies will not be applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that the mechanical properties of the OssBuilder System were found to be "substantially equivalent" to predicate devices. The acceptance criteria are implied to be that the proposed device performs at least as well as the predicate device in relevant mechanical tests and maintains biocompatibility and sterility.

2. Sample size used for the test set and the data provenance

For the non-clinical performance testing (biocompatibility, sterilization, shelf-life, mechanical properties), specific sample sizes are not explicitly mentioned in the provided text. The data provenance is also not detailed beyond stating they are "non-clinical testing data" and "bench tests." It can be inferred that these tests were conducted by the manufacturer, Osstem Implant Co., Ltd., likely in their Korean facilities or outsourced to testing laboratories. The nature of these tests (e.g., material testing, sterilization validation) means they are not retrospective or prospective studies in the sense of clinical trials, but rather laboratory-based evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the document describes non-clinical performance testing (material properties, sterilization, etc.), not a study requiring expert readers or ground truth establishment for diagnostic accuracy.

4. Adjudication method for the test set

This question is not applicable for the same reasons as #3.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. The OssBuilder System is a physical dental device, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the OssBuilder System is a physical dental device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described:

• Biocompatibility: The ground truth is based on the well-established biocompatibility of titanium and Ti-6Al-4V alloys, which are widely used in medical implants, and the equivalence to predicate devices made of the same materials.
• Sterilization Validation: The ground truth for sterility is established by industry standards (ISO 11137).
• Shelf-life: The ground truth for shelf-life is established by internal testing and leveraging data from prior submissions for packaging materials durability.
• Mechanical Properties: The ground truth for mechanical properties (Tensile Strength, Yield Strength, Elongation) is derived from standardized material testing methods and comparison to the known properties of the predicate devices.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of a physical medical device's non-clinical performance testing.

9. How the ground truth for the training set was established

This question is not applicable for the same reasons as #8.

Ask a specific question about this device