(117 days)
The Thommen SPI® EASY Ø 4.0 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.
The design of the SPI EASY Abutment System has been modified to add additional abutments to fit the 4.0 platform components.
This document is a 510(k) Summary for a medical device modification, specifically the "SPI® EASY Ø 4.0 Abutment." It does not include acceptance criteria or a study that proves the device meets those criteria in the typical sense of a performance study for a diagnostic or AI device.
Instead, this submission is focused on demonstrating substantial equivalence to an existing predicate device, primarily through a comparison of design, materials, and intended use for a modified dental implant abutment.
Here's an analysis based on your request, highlighting where the requested information is not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in this context. For a 510(k) submission seeking substantial equivalence for a modified device (especially a Class II dental abutment), the "acceptance criteria" are typically related to mechanical properties, biocompatibility, and sterilization, ensuring they are equivalent or superior to the predicate. Performance is demonstrated through comparison to the predicate, not a clinical efficacy study with specific metrics like sensitivity/specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not describe a clinical performance study with a "test set" of patients or data. The "test" for this device is likely engineering bench testing (e.g., fatigue, torque strength), which would be compared against established standards or predicate device performance. These details are not typically provided in the 510(k) Summary but would be in the full submission.
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 ground truth establishment by clinical experts is mentioned, as this is not a diagnostic device requiring interpretation of clinical data in a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical study involving expert adjudication is described.
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 a hardware modification for a dental implant abutment, not an AI or diagnostic imaging device. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. There is no "ground truth" in the clinical sense mentioned in this 510(k) summary. Performance would be assessed through engineering and materials testing against specifications and comparison to the predicate.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth is applicable here.
Summary of what the document does provide regarding "acceptance" for this specific device:
The "acceptance" in this context is meeting the criteria for substantial equivalence to a predicate device. The document explicitly states the similarities to the unmodified predicate SPI EASY Dental Implant Abutment:
- Intended Use: Same
- Operating Principle: Same
- Basic Design: Same
- Materials: Same
- Packaging: Same
The modification is described as "to add additional abutments to fit the 4.0 platform components." The FDA's letter (Page 2-3) confirms they have reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market subject to general controls.
This is a regulatory acceptance based on equivalence, rather than a performance acceptance based on clinical study metrics.
§ 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.)