(300 days)
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:
| Acceptance Criterion (Implicitly for SE) | Device Performance (Reported) |
|---|---|
| Intended Use | OssBuilder System: "used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site." This is compared to the predicate's intended use for fixing and stabilizing non-resorbable barrier membranes for tissue regeneration. The submission argues equivalence despite linguistic differences, viewing them as a whole system. |
| Principle of Operation | OssBuilder System (Tenting Screw): "is placed in maxilla or mandible bone area to be combined with OssBuilder (non-resorbable titanium membrane) and Healing Cap or Cover Cap. It helps to support and prevent the mobility of the membrane during the bone regeneration." This is compared to the predicate's "temporary dental implant ... to be combined with titanium membrane and cover screw or cover cap. It helps to support the membrane." Again, linguistic differences are noted but equivalence asserted. |
| Material | OssBuilder System: Ti-6Al-4V ELI (ASTM F136). Predicate (Neo GBR): Ti-6Al-4V ELI (ASTM F136). (Identical) |
| Dimensions (Tenting Screw) | OssBuilder System: Head Diameter: 3.0mm; Major Thread Diameter: 2.1mm; Length: 8.5, 10.0, 11.5, 13.0mm. Predicate (Neo GBR): Head Diameter: 2.85mm; Major Thread Diameter: 2.0mm; Length: 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2mm. (Similar, differences noted but deemed acceptable). |
| Dimensions (Healing Cap) | OssBuilder System: Diameter: 4.0, 5.0mm; Height: 7.0, 8.0mm. Predicate (K172354): Diameter: 4.0, 5.0mm; Height: 7.0, 8.0mm, 4.3mm (for Cover Cap). (Identical for healing cap). |
| Sterilization | OssBuilder System: Gamma Sterilization. Predicate: Gamma Sterilization. (Identical) |
| Shelf Life | OssBuilder System: 8 years. Predicate (Neo GBR): Unknown. Predicate (K172354): 8 years. (Similar/Identical to one predicate) |
| Biocompatibility | Evaluation conducted per ISO 10993-1. Deemed necessary as the OssBuilder System is made of same material, chemical composition, manufacturing process, and body contact with the predicate devices. (No additional testing required due to substantial equivalence in these factors). |
| Sterilization Validation & Shelf-life | Considered by leveraging data from prior submissions. |
| Mechanical Properties | Bench tests conducted per ASTM F543 (fracture load, insertion torque, axial pullout strength, torsional strength, breakage angle, removal torque, self-tapping force). Results found substantially equivalent to the predicate device for worst-case insertion in block material representing hard/soft bone. |
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.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.