(163 days)
The GBR System is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.
The GBR System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The GBR System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V). The device screw is available in three different types, Auto Screw, Tenting Screw and GBR Screw. The device plate is provided in two different types, mesh plate and GBR mesh plate. The device system also includes various manual surgical instruments, such as mesh puncher, screwdriver handle, screw block, driver shaft and drill bit. The GBR System is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The GBR System is provided as silver color which is casted according to the anodizing technique while apply 5 V ~ 10 V electric energy to the titanium.
The provided text describes a 510(k) summary for the "GBR System" medical device, which consists of bone plates and screws. The submission aims to demonstrate substantial equivalence to a predicate device, the "Jeil Bone Fixation System" (K050669).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum tensile strength), but rather implies that the device is acceptable if its performance is "equivalent" to the predicate device. The performance is assessed through non-clinical testing based on ASTM standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent Driving torque per ASTM F543-13 (Screws) | Testing indicates GBR System is equivalent to predicate device. |
| Equivalent Axial pull-out test per ASTM F543-13 (Screws) | Testing indicates GBR System is equivalent to predicate device. |
| Equivalent Torsion test per ASTM F543-13 (Screws) | Testing indicates GBR System is equivalent to predicate device. |
| Equivalent Tensile Strength (Plates) | Testing indicates GBR System is equivalent to predicate device. |
| Equivalent material (Plates) | Unalloyed Titanium (ASTM F67) - Same as predicate. |
| Equivalent material (Screws) | Titanium Alloy (Ti-6Al-4V) (ASTM F136) - Same as predicate. |
| Equivalent sterilization method | Non-sterile, Steam sterilization prior to use - Same as predicate. |
| Equivalent single use | Yes - Same as predicate. |
| Equivalent intended use | Stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity - Same as predicate. |
| No significant differences that would adversely affect use | "No significant differences between the Model GBR System and the predicate device that would adversely affect the use of the proposed device." |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many screws were tested for driving torque). It states that the evaluation was based on ASTM F543-13. The data provenance is presumed to be from laboratory testing conducted by Jeil Medical Corporation. There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's non-clinical lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by objective engineering measurements against ASTM standards, not by expert interpretation.
4. Adjudication method for the test set
This information is not applicable. Since the testing is non-clinical and objective, there is no need for adjudication by experts.
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 was no MRMC comparative effectiveness study done. This device is a physical medical implant (bone plates and screws) and not an AI-assisted diagnostic tool or software, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The GBR System is a physical medical device, not an algorithm or software. Therefore, standalone algorithm performance is not a relevant concept for this submission.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the objective measurements against the established ASTM standards for mechanical properties (driving torque, axial pull-out, torsion, tensile strength). For material, it's compliance with ASTM F67 and ASTM F136 specifications.
8. The sample size for the training set
This information is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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.