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510(k) Data Aggregation
(68 days)
DSI Dental Implant System
DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.
DSI Dental Implant System is an internal hex implant system with one model of implant at this time, Premium Spiral is a slightly tapered spiral internal hex implant with micro-rings at the implant neck which comes in 3.5, 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. The 6.0 diameter implant does not come in lengths of 13 or 16mm. All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface. Loc-in abutments are anodized. All types of abutments can be used with all implants. Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. The system also includes abutment fixation screws. Straight abutments come in 7, 9, or 11mm lengths and shouldered straight abutments come 1, 2, 3, or 4mm in gingival height. Wide straight shoulder abutments come in gingival heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 7, 9, 11 mm. Straight wide abutments come in lengths of 9 or 11 mm. 15° anatomic angulated abutments come in gingival heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in gingival heights of 1, 2, or 3mm. Straight multi-unit abutments, Loc-in abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Loc-in abutments come in collar heights of 0.5, 1, 2, 3, 4, 5, and 6 mm. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in gingival heights of 0.5, 1.5 mm. Overdenture abutments are used with removable dentures and partial dentures. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Multi-unit abutments are used for fixed restorations. Straight multi-unit mounted dentures can only be removed by the dentures mounted on flat abutments, overdentures or ball attachments can be removed by the patient. The UCLA is 4.5mm in diameter and is for making gold restorations which are taller than 4mm. Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in gingival heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in gingival heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in gingival heights of 2, 3, 4, and 5 mm.
The provided text describes a 510(k) premarket notification for the DSI Dental Implant System, asserting its substantial equivalence to legally marketed predicate devices. The document details the device, its indications for use, and a summary of testing conducted to support this claim.
It does not describe an AI/ML powered medical device, nor does it present acceptance criteria and a study proving the device meets those criteria in the way typically expected for such products (e.g., performance metrics like sensitivity, specificity, AUC). Instead, the "acceptance criteria" for this dental implant system are framed in terms of demonstrating substantial equivalence to a predicate device, primarily through materials, design, and fatigue performance.
Therefore, many of the requested points regarding AI/ML device performance (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document as it pertains to a traditional medical device (dental implants).
However, I can still extract information related to the device's performance testing and comparison to predicates, interpreting "acceptance criteria" in the context of demonstrating substantial equivalence for a non-AI device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (DSI Dental Implant System) |
|---|---|
| Mechanical Strength (Fatigue Performance) | Run out limit about the same or higher than other implant systems (predicates). |
| Biocompatibility | Surface treatment does not adversely change cytotoxicity. Materials are common in dental implants and meet ASTM F136. |
| Sterilization Efficacy | Implants sterilized according to ISO 11137-1, ISO 11137-2, and ISO 11137-3. |
| Abutment steam sterilization done according to ISO 17665-1 and ISO 17665-2. | |
| Package Integrity & Shelf Life | Package integrity testing and accelerated aging conducted. |
| Endotoxin Content | Endotoxin testing according to USP 161 conducted. |
| Indications for Use (Similarity) | Substantially equivalent to SpiralTech Dental Implant System. |
| Material (Similarity) | Ti6Al4V, same as predicate devices. |
| Design/Connection (Similarity) | Internal Hex connection, similar to predicate devices. Slight differences in geometry and size are considered minor. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test (e.g., how many implants were fatigue tested) or the provenance (country of origin, retrospective/prospective) of any clinical data, as this is primarily a non-clinical, performance-based submission. The testing appears to be lab-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of AI/ML evaluation by experts is not relevant here. The evaluation is against engineering standards and comparison to predicate devices, which is typically conducted by engineers and regulatory experts.
4. Adjudication method for the test set
Not applicable for this type of device and submission.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference for evaluating this device's performance is based on recognized international standards (ISO, ASTM, USP) for medical devices, specifically dental implants, and comparison to legally marketed predicate devices. For example, mechanical strength is compared against the run-out limits established by ISO 14801.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable.
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