(261 days)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Unitite Slim, Unitite, Unitite Compact, Strong SW CM S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.
Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.
The purpose of this submission is to add labeling claims for a surface treatment designated HA™®, which is applied to implants of the S.I.N. Dental Implant System, as previously cleared in K170392. K193096. K200992, K211921, K221453, and K222231. The new labeling claims and the information supporting the claims are shown below in Performance Data.
The following information is a summary of the designs of the subject device implants, as they have been previously cleared with the HA"" surface treatment. Note that there are no changes to any aspect of the design, nor to the HA" surface treatment, as described in the respective 510(k) Premarket Notifications referenced above.
The previously cleared implants that are the subject of this submission includes eleven (11) product lines from six (6) 510(k)s. Implant body diameters, platform diameters and lengths for each product line are shown below in Table 10.1 Summary of Subject Device Designs and Sizes.
K170392: Unitite Slim, Unitite, Unitite Compact K193096: Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus K200992: Strong SW Plus K211921: Epikut Plus CM, Epikut Plus HE K221453: Epikut Plus CM (additional lengths) K22231: Epikut S Plus
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The HA1000 surface treatment is identical to that cleared in K211921.
The provided text is a 510(k) Premarket Notification from the U.S. FDA for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices by comparing their indications for use, designs, materials, and manufacturing processes, with an emphasis on adding new labeling claims related to a surface treatment.
Crucially, this document states: "No clinical data were included in this submission." This means that the device's performance was not proven through a study involving human subjects or artificial intelligence (AI). The document relies on non-clinical data such as in vitro testing, animal testing referenced from published literature, sterilization, endotoxin, shelf-life, biological evaluation, MR compatibility, and fatigue testing to support the claims and substantial equivalence.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and specific performance metrics for an AI/device study cannot be extracted from this document.
However, I can extract the information related to the non-clinical performance data presented to meet the criteria for substantial equivalence to predicates.
Here's a breakdown of what can be extracted and an explanation of why other requested information is not present:
Information that CANNOT be extracted from this document (and why):
- A table of acceptance criteria and the reported device performance (for clinical/AI studies): Not applicable as no clinical or AI study was performed. The acceptance criteria relate to demonstrating substantial equivalence through non-clinical data, not specific performance metrics against a ground truth for a diagnostic claim.
- Sample sizes used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set: Not applicable as no clinical study or diagnostic AI was evaluated.
- The sample size for the training set: Not applicable (not an AI device).
- How the ground truth for the training set was established: Not applicable (not an AI device).
What CAN be extracted/inferred regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission:
The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to existing legally marketed devices (predicates). The "study that proves the device meets the acceptance criteria" in this case refers to the non-clinical tests and comparisons performed to show this equivalence and support the new labeling claims.
1. A table of acceptance criteria and the reported "device performance" (in terms of non-clinical criteria):
The acceptance criteria for this 510(k) submission are implicitly met by demonstrating that the subject device is as safe and effective as the predicate devices and that the new labeling claims are supported by scientific evidence. The "performance" here refers to meeting specific engineering, biological, and material standards, not diagnostic accuracy.
| Acceptance Criterion (Implicitly required for 510(k) & specific claims) | Reported Device "Performance" (Evidence provided) |
|---|---|
| Equivalence in Intended Use | Subject device's Indications for Use (IFUS) are identical or substantially similar to those of predicate and reference devices (K170392, K193096, K200992, K211921, K221453, K222231). This includes general placement, loading conditions, specific length limitations for delayed loading, and angulation requirements for longer implants. |
| Equivalence in Design/Physical Characteristics | The design (body/platform diameters, lengths, implant/abutment interface) of the subject device implants (including the new HA™® surface) is identical to those previously cleared in predicate/reference 510(k)s (K170392, K193096, K200992, K211921, K221453, K222231). |
| Equivalence in Materials | Subject device is manufactured from unalloyed titanium conforming to ASTM F67, identical to predicate devices. The HA™® surface treatment is identical to that cleared in K211921. |
| Sterilization Efficacy | Demonstrated by gamma irradiation sterilization to a sterility assurance level of 10^-6 by VDmax25 method, according to ISO 11137-1 and ISO 11137-2 (referenced from K211921). |
| Absence of Pyrogens/Endotoxins | Bacterial endotoxin testing (LAL test) according to ANSI/AAMI ST72 on manufacturing water (weekly) and sterilized product (quarterly) demonstrated all sterile product meets a limit of |
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.