(163 days)
The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment. The implant abutments fit Nobel Biocare Brånemark System®. Nobel Biocare (Steri-Oss®), Keystone (Lifecore), 3i Implant Inovations®, Sterngold-ImplaMed®, Interpore IMZ™, Osstem, Zimmer (Paragon, Centerpulse), OIC, IMTEC Corporation®, MIS Implants, Minimatic/Stryker, Bud, Straumann, Biolok International, INNOVA, Implant Direct, Zimmer (Calcitek® Centerpulse), BioHorizons®. See table 1 for platform compatibility.
There are seven (7) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [A], [B], [C], [S], [X], [X], [Z]. Table 1 specifies which dental implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant. The devices are supplied non-sterile, therefore there is no shelf life.
The provided text describes the SFI Bar® Implant Abutments, a medical device for dental use. It outlines the device's characteristics and its equivalence to predicate devices, supported by non-clinical performance data.
Here's an analysis of the acceptance criteria and study information, based only on the provided text, and noting what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sufficiently large safety margin for fracture to occur when tightening. | "Torque test results indicated that there is sufficiently large safety margin for fracture of the SFI Bar® Implant Abutments specified on this submission to occur when tightening." |
| No risk or possibility of harm to the patient (related to torque). | "There is no risk or possibility of harm to the patient." |
| Performance characteristics equivalent to predicate SFI Barto. | "Testing has shown that the SFI Bar® Implant Abutments included in this application are equivalent in performance characteristics to the predicate SFI Barto." |
| Acceptance criteria were met. | "The acceptance criteria were met." |
2. Sample size used for the test set and data provenance:
- Sample size: Not specified. The text only mentions "Test samples torqued above 50 Ncm".
- Data provenance: The studies were non-clinical tests conducted by the manufacturer, Sterngold Dental, LLC. The country of origin is not explicitly stated. It is a retrospective analysis of the device's performance against established standards and predicate devices.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of experts: Not applicable for this type of testing. The 'ground truth' for mechanical performance tests like torque is typically defined by engineering specifications and industry standards rather than expert consensus on subjective evaluations.
- Qualifications: Not applicable.
4. Adjudication method for the test set:
- Not applicable. Mechanical tests for medical devices are typically assessed against pre-defined quantitative thresholds and standards, not through adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for diagnostic imaging or similar devices where human readers interpret results. This device is a dental implant abutment, and its performance is evaluated through mechanical testing.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Yes, in essence. The testing described ("Torque tests, application and functional testing") is a standalone assessment of the physical device's performance characteristics. This is a mechanical device, not an algorithm, so the "standalone" concept translates to evaluating the device itself without human intervention affecting its inherent mechanical properties.
7. The type of ground truth used:
- Engineering specifications and regulatory guidance. The ground truth for this device's performance, particularly torque, is based on "implant manufacturer's recommended torque value" and likely general engineering standards for mechanical strength and durability. The evaluation also refers to "FDA guidance 'Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'"
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" here would refer to the design and manufacturing processes, which are guided by established engineering principles and past experience with similar devices (the predicate devices).
9. How the ground truth for the training set was established:
- Not applicable. As noted above, this is not an AI/ML algorithm. The "ground truth" for the design and manufacturing of such a device is rooted in engineering principles, material science, and regulatory standards for dental implants and abutments. The text states, "The implant abutments were designed and developed, and manufactured according to manufacturer's specifications and controlled procedures," and they conform to "ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy."
§ 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.)