(343 days)
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.
The document then lists various components of the system including Transfer Abutment, Angled Abutment, Link Abutment for Cerec, Temporary Abutment, Multi Angled Abutment, Multi NP-Cast Cylinder, Multi Combination Cylinder, Convertible Angled Cylinder, Stud Abutment, O-ring, O-ring Retainer Cap, Port Abutment, Port Angled Abutment, Port Angled Abutment Head, Port Male, Port Extended Male, Port Male Cap, Port Male Kit, Abutment Screw, Cylinder Screw, Esthetic-low Temporary Cylinder, and Temporary Cap (Narrow Ridge), along with their descriptions, materials, and dimensions.
The provided document is a 510(k) premarket notification for the Osstem Abutment System. It outlines how the device is considered substantially equivalent to already marketed predicate devices, rather than providing a performance study against specific acceptance criteria for a new AI/software device.
Therefore, many of the requested details, such as those related to AI/algorithm performance (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance), are not applicable to this type of submission. The document focuses on material properties, design, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in the typical sense of performance metrics for an AI/software device (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is claimed based on similarities in:
- Intended Use
- Technology (design principles)
- Material Composition
- Performance Characteristics (mechanical properties, biocompatibility, sterilization)
The performance is "reported" by demonstrating that the device is equivalent to known predicate devices through non-clinical testing (biocompatibility, sterilization validation, mechanical properties, specifically fatigue testing and retention testing). The document states: "Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence."
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicates) | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Biocompatibility | Evaluted following FDA Guidance Document ISO 10993-1 and ISO 10993 suite of standards. (Implies compliance, but no specific numerical results or pass/fail thresholds are provided in this summary.) |
| Sterilization Validation | Considered according to ISO 17665-1 (for non-sterile delivery). (Implies validation, but no specific numerical results or pass/fail thresholds are provided. Products are provided non-sterile, so this refers to validation of sterilization methods for the end-user.) |
| Mechanical Properties (Fatigue Testing) | Considered according to FDA Guidance Document "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 standard with worst-case scenario. (Implies testing was performed and passed, but no specific numerical results or pass/fail thresholds are provided.) |
| Mechanical Properties (Retention Testing for Dental Attachments) | Conducted. (Implies testing was performed and passed, but no specific numerical results or pass/fail thresholds are provided.) |
| Indications for Use | "Identical, with the exception of the addition to the Subject Indications for Use Statements language regarding the Link Abutment for CEREC. This language is identical to the Indications for Use Statement of the Reference Device being used for the Substantial Equivalence comparison for the Link Abutment for CEREC." (Demonstrated through comparison tables in Section 6). |
| Material Composition | "Identical" or "Within the range of the predicates" for most components. (Demonstrated through comparison tables in Section 6). |
| Design/Dimensions | "Identical" or "Similar" or "Within the range of the predicates" with explanations for minor differences and why they don't affect safety/effectiveness. (Demonstrated through comparison tables in Section 6). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The submission relies on non-clinical (laboratory) testing for mechanical properties and biocompatibility, as well as comparison to predicate devices, not on a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set or human expert review of "truth" data for diagnostic performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This is not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and designs as measured in laboratory tests, and compared against established industry standards (ISO 14801) and FDA guidance for dental abutments. For biocompatibility, it's adherence to ISO 10993 standards. No clinical ground truth from patients is established or used for this 510(k) submission.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)