(176 days)
The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment, an abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous or partially edentulous patient) can be attached, yet remain retrievable.
How device functions: The Steri-Oss Lingual Bio-Esthetic Indirect Abutment is designed to be used in conjunction with endosseous implants as part of a system to provide support for prosthetic appliances to restore patient chewing function, and includes utilization of a lingual refaining screw for abutment retention which allows retrievability.
Scientific concepts; Natural dentition is composed of a root (subgingival) and a crown (supragingival). Implant system designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The abutment must be securely fastened to the implant. A lingual retaining screw may be used for this purpose, while retaining retrievability.
Characteristics: The Bio-Esthetic Indirect Abutment is a conventional abutment designed for use with a lingual screw which, when tightened, retains the abutment in place.
Here's a breakdown of the requested information based on the provided 510(k) summary for the Bio-Esthetic Indirect Abutment:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Predicate Device (Friatec's "Frialit MH-6 Abutment") | New Device (Steri-Oss' Bio-Esthetic Indirect Abutment) | Acceptance Criteria (Implicit from Substantial Equivalence Claim) |
|---|---|---|---|
| Abutment and Screw Material | Titanium alloy | Titanium alloy | Same as predicate (Titanium alloy) |
| Retaining Screw Collar Material | Gold alloy | Gold alloy | Same as predicate (Gold alloy) |
| Abutment Design | Cylindrical shape | Oval cylinder shape with and without angulation | Considered acceptable if it provides similar function and safety to predicate |
| Height (mm) | 0.130 in. to 0.256 in. | 0.350 in. to 0.0359 in. | Considered acceptable if it provides similar function and safety to predicate |
| Maximum Diameter (mm) | 0.067 in. to 0.110 in. | 0.230 in. to 0.283 in. | Considered acceptable if it provides similar function and safety to predicate |
| Abutment Angulation | Straight | Straight and 15° | Considered acceptable if it provides similar function and safety to predicate |
| Packaging | Unknown | Chevron pouch in plastic case | Not explicitly stated as a comparative performance metric for function, but assumed to be adequate for device protection and sterility maintenance if applicable. |
| Sterility | Unknown | Provided Sterile | Assumed to meet applicable sterility standards. |
Study Proving Device Meets Acceptance Criteria:
The 510(k) submission states: "Performance Data: Not applicable." This explicitly indicates that no performance study (clinical or non-clinical) was conducted or provided to demonstrate that the device meets specific acceptance criteria in the traditional sense of a study with defined endpoints and statistical analysis.
Instead, the submission relies on the concept of substantial equivalence to a predicate device (Friatec's "Frialit-2 MH-6 Abutment"). The acceptance criteria are implicitly met by demonstrating that the new device has the same or similar technological characteristics and intended use as the legally marketed predicate device, and does not raise different questions of safety and effectiveness.
Therefore, the "study" that proves the device meets the acceptance criteria is the comparison to the predicate device as presented in Table 6.1 and the accompanying textual description. The FDA's issuance of the 510(k) clearance signifies their agreement that, based on this comparison, the new device is substantially equivalent to the predicate.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable, as no performance study with a test set was conducted.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no performance study with a test set requiring ground truth establishment was conducted.
4. Adjudication method for the test set:
- Not applicable, as no performance study with a test set was conducted.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This device is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable, as no performance study requiring ground truth was conducted. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as this is a physical medical device, not a machine learning model.
§ 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.)