(28 days)
SPI® ART Abutment is intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
SPI ART Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.
The design of the SPI ART Abutment System has been modified to add additional abutments to fit the 3.5 mm and 4.0 mm platform components.
This 510(k) summary for the SPI® ART Abutment describes the device and its intended use, but it does not include any acceptance criteria or details of a study that proves the device meets specific performance criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed predicate device. This means the manufacturer is asserting that the new device is as safe and effective as the predicate, based on similarities rather than new performance testing against specific criteria for this modification.
Therefore, I cannot populate the table or answer most of the questions as the requested information is not present in the provided text.
Here's a breakdown of what can be said based on the provided text:
Acceptance Criteria and Device Performance (Not Provided)
- The document does not describe specific numerical or qualitative acceptance criteria for the SPI® ART Abutment's performance.
- There are no reported device performance metrics against any such criteria.
Study Information (Not Applicable for this Submission Type)
This submission describes a modification to an existing device (adding new sizes). The primary "study" or justification for equivalence is based on the similarities to the predicate device, not new performance testing in the way typical for a de novo device.
- Sample size used for the test set and the data provenance: Not applicable. No new performance testing on a "test set" is described. The basis for equivalence is the similarity to the predicate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described for performance testing of this modification.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a dental implant abutment, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Equivalence Claimed:
The manufacturer states the SPI® ART Abutment (specifically the 3.5 mm and 4.0 mm platform components) is substantially equivalent to the unmodified predicate SPI® ART Abutment because they:
- Have the same intended use.
- Use the same operating principle.
- Incorporate the same basic design.
- Incorporate the same materials.
- Are packaged using the same materials and processes.
This 510(k) is a Special 510(k) for a device modification, which typically relies on demonstrating that the change does not significantly affect the safety or effectiveness, often by showing it retains the characteristics of the predicate device. It is not a submission that would typically include new, extensive performance testing data against specific acceptance criteria for the modified device itself.
§ 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.)