(311 days)
URIS Smart Path Implant System & Prosthetic is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
All digitally designed abutments and/or coping for use with URIS Smart Path Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
URIS Smart Path Implant System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multipleunit restorations. The surface treated is SLA (Sandblasted, Large grit and Acid etched) and is provided sterile. It consists of two implant lines, the Smart Path OMNI Thread and the Smart Path extra aggressive Thread, with corresponding cover screws, healing abutments. The Smart Path implant has a tapered wall with a single thread design. The Smart Path extra aggressive Thread is straight walled with smaller threading at the coronal end, and bigger threading at the apical end.
URIS SP Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of SP Healing Abutment, SP Temporary Abutment, SP Multi-Unit Straight Abutment, SP Multi-Unit Angled Abutment, SP T-L Straight Abutment, URIS SP Base, URIS SP DS, SP Abutment Screw.
Cover screw and healing abutment are anodized in yellow or green or purple.
Fixtures and cover screw are provided sterile and other prosthetics are provided non-sterile. All non-sterile products must be sterilized by end users before use.
URIS SP Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
The provided text is a 510(k) Summary for the URIS Smart Path Implant System & Prosthetic. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.
However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, which are typically associated with the questions asked.
The document focuses on non-clinical tests to demonstrate substantial equivalence, as is common for dental implants and prosthetics. These tests are primarily related to material properties, sterilization, packaging, and mechanical fatigue.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance/accuracy studies which were explicitly stated as not included: "No clinical data were included in this submission."
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in Document) |
|---|---|---|
| Bacterial Endotoxin Testing (LAL) | In accordance with USP and USP | "met the standards" |
| Sterilization Testing | According to ISO 11137-1,-2,-3 and ISO 11737-1,-2 | "met the standards" |
| Shelf Life Testing | According to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing | "met the standards" |
| Biocompatibility Testing | Based on ISO 10993-1 | Leveraged from predicate and reference devices (K172100 and K200817) and determined to be similar based on similar materials and manufacturing processes. |
| SEM and EDS analysis for SLA surface treatment | (Implicit: demonstrate identical surface treatment characteristics as predicate/reference) | Leveraged from prior clearance for identical SLA surface treatment and manufacturing. |
| Human Factors testing (usability evaluation for aseptic presentation) | In line with ISO 11607-1:2019 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." | (Implied: met standards, no specific results reported) |
| Evaluation of broken tip at various degrees of rotation after removal from packaging | (Implicit: prevention of device damage during removal) | (Implied: met standards, no specific results reported) |
| Quality System (QS) plan for packaging design | Ensure devices conform with product specifications | (Implied: met standards, no specific results reported) |
| Fatigue testing (for endosseous dental implants) | According to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 under worst-case scenario. | "met the standards" |
| MR Environment Condition (Magnetically Induced Displacement Force and Torque on metal alloys) | Based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | (Implied: evaluated and deemed safe, no specific results reported) |
Missing Information (Not present in the provided document):
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical studies with test sets were performed. Non-clinical tests typically report sample sizes per test standard, but these are not detailed here beyond stating "worst-case scenario" for fatigue testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies requiring ground truth establishment were performed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies requiring adjudication were performed.
- 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 device is a dental implant system, not an AI-powered diagnostic tool, and no clinical studies were performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies requiring ground truth were performed.
- The sample size for the training set: Not applicable, as no AI/machine learning component requiring a training set is described.
- How the ground truth for the training set was established: Not applicable, as no AI/machine learning component requiring a training set is described.
§ 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.