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510(k) Data Aggregation
(176 days)
SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dentoalveolar bony defect sites.
The SAVE GBR consists of Healing Cap, Cover Cap and Spacer. The SAVE GBR are manufactured by Ti-6A1-4V ELI and used with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
The subject device is compatible with the OssBuilder membrane cleared in K172354.
The dimension of the device is as below:
| No. | Product | Diameter | Length |
|---|---|---|---|
| 1 | Healing Cap | Ø4.5 and 5.5 | 6.0 and 7.0mm |
| 2 | Cover Cap | Ø4.5 | 4.0mm |
| 3 | Spacer | Ø4.5 | 7.2 and 8.2mm |
The healing cap and cover cap have same functions and uses but have different design and name. The SAVE GBR are removed from the patient after such time when sufficient bone regeneration is done.
I am sorry, but the provided text (K222451_Decision_Letter[1].pdf) does NOT contain information about acceptance criteria, device performance results, sample sizes for test and training sets, expert qualifications, ground truth establishment, or any details related to an AI/ML-driven medical device study.
The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "SAVE GBR." This device is a metal component used with dental implants to stabilize and support bone grafts. The core of this FDA submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to present performance data from an AI/ML model.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI-driven device based on this input. The document focuses on material composition, dimensions, sterilization, shelf life, and intended use as compared to predicate devices, rather than AI performance metrics.
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(235 days)
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.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials (Titanium, Ti-6Al-4V) must be biologically compatible for dental use, consistent with predicate devices. | "Biocompatibility evaluation for OssBuilder System is not considered because the materials used for manufacturing OssBuilder System are titanium and titanium alloy which have been generally and widely used as a dental material such as implant for a long time. OssBuilder System is made of same material, chemical composition, and body contact with the predicated devices..." |
| Sterilization Validation | Sterility must be confirmed according to ISO 11137, with worst-case testing among subject devices. | "For the sterilization validation, it was performed accordance with worst-case chosen among subject devices and following ISO 11137." Acknowledged as performed. |
| Shelf-life | Packaging materials and device integrity must be validated for the stated shelf-life (8 years for components). | "For the shelf-life of subject devices, we considered their validation of packaging materials by leveraging the data that of our prior submissions." New shelf life of 8 years for OssBuilder, Healing Cap, Cover Cap, and OB Anchor compared to 5 years for predicates, supported by leveraging prior submission data. |
| Mechanical Properties | Tensile Strength, Yield Strength, and Elongation of components must be comparable to, or better than, predicate devices. | "Bench tests evaluated for OssBuilder System included Tensile Strength, Yield Strength, and Elongation. Mechanical properties from bench tests of OssBuilder System found substantially equivalent to the predicate device." The document explicitly states that mechanical properties were found "substantially equivalent" to predicate devices, and that the differences in design (e.g., shape, height, connection structure) or material (for some Cover Cap models) do not affect function or indication for use. |
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.
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