(175 days)
SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Customized 3D Pre-Formed Titanium Membrane. SMARTbuilder System (SB1) is the nonabsorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder System (SB1) is made of pure titanium metal and supplied sterile.
The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd. SMARTbuilder System (SB1). This document states that no clinical studies were submitted and no biocompatibility evaluation was conducted for the SMARTbuilder System (SB1) because it has the same material and manufacturing process as its predicate device and uses Pure Titanium Grade 2 (ASTM F67), which is widely used as a dental material. Therefore, the device's acceptance criteria and studies demonstrating its adherence to these criteria are not detailed in this document.
The submission focuses on establishing substantial equivalence to a predicate device (SMARTbuilder System, K120951) based on shared materials, intended use, and similar design and technological characteristics.
Here is a summary of the requested information based only on the provided text, with many fields necessarily left blank or marked as "Not Applicable (N/A)" due to the absence of clinical study data:
Acceptance Criteria and Device Performance Study Summary for SMARTbuilder System (SB1)
This 510(k) submission, K130840, relies on substantial equivalence to a predicate device and does not include clinical study data to demonstrate the device meets specific acceptance criteria. Therefore, most of the requested information regarding performance metrics, sample sizes, and ground truth establishment is Not Applicable (N/A) in this context.
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical studies were submitted, there are no specific performance-based acceptance criteria or reported device performance metrics in this document. The "performance" assessment is based on demonstrating substantial equivalence to the predicate device in terms of material, intended use, and similar design.
| Feature/Criterion | Acceptance Criteria (Not explicitly stated as performance metrics due to reliance on substantial equivalence) | Reported Device Performance (N/A, as no clinical study data is provided) |
|---|---|---|
| Material | Pure Titanium Grade 2 (ASTM F67) (Same as predicate) | Meets Material Specification (Implicit through substantial equivalence) |
| Intended Use | To stabilize and support bone graft in dento-alveolar bony defect sites (Same as predicate) | Meets Intended Use (Implicit through substantial equivalence) |
| Sterilization | Sterile (Same as predicate) | Sterile (Implicit through substantial equivalence) |
| Shelf Life | 8 years (Proposed device); 5 years (Predicate device) | Not explicitly evaluated as a performance metric in a study. |
| Design | Scallop shape with dimensions (Similar to predicate in design and technological characteristics) | Design as specified (Implicit through substantial equivalence) |
| Other Performance Metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility) | Not Applicable (N/A) | Not Applicable (N/A) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not Applicable (N/A) - No clinical studies or test sets with patient data were submitted.
- Data Provenance: Not Applicable (N/A) - No clinical data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A) - No clinical studies requiring expert-established ground truth were performed or submitted.
4. Adjudication method for the test set
- Not Applicable (N/A) - No clinical studies were performed.
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 (N/A) - This device is a physical medical implant (bone plate/membrane), not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A) - This device is a physical medical implant, not an algorithm or software. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (N/A) - No clinical studies requiring ground truth were performed or submitted.
8. The sample size for the training set
- Not Applicable (N/A) - No machine learning or AI components are involved, and thus no training set was used.
9. How the ground truth for the training set was established
- Not Applicable (N/A) - No training set was used.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.