(168 days)
The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).
The EM Provisional is a dental implant made of titanium alloy (Ti-6Al-4V) and is supplied sterile. The surface is machined finished and is intended to be surgically placed in the bone of the upper or lower jaw arches.
This document is a 510(k) Premarket Notification from Hiossen, Inc. for their dental implant device, EM Provisional. According to the provided text, this submission argues for "substantial equivalence" of the EM Provisional to existing predicate devices, rather than presenting a study proving a device meets specific performance criteria through a clinical or non-clinical study that would generate the kind of data typically found in an AI/software as a medical device (SaMD) submission.
Therefore, the requested information, specifically regarding acceptance criteria, device performance from a test set, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, is not available in this document. This document primarily focuses on demonstrating that the new device (EM Provisional) is structurally and functionally equivalent to already cleared devices, meaning it does not pose new or increased risks and performs similarly.
Instead of performance metrics from a new study, the document makes the following arguments for substantial equivalence:
1. Acceptance Criteria and Device Performance (as presented in this substantial equivalence argument, not a performance study):
The "acceptance criteria" here relate to the device being substantially equivalent to its predicate. The "performance" is demonstrated by asserting similarity in design, materials, and manufacturing, rather than through measured accuracy, sensitivity, or specificity.
| Acceptance Criteria (for Substantial Equivalence Claim) | Reported Device "Performance" (Comparison to Predicate) |
|---|---|
| Intended Use Equivalence | The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s). This is identical to the Intended Use of the primary predicate device (MS System (Provisional) K072871). |
| Technology/Design Equivalence | Both EM Provisional and the predicate MS System (Provisional) are: |
- Screw form
- One-piece fixture and abutment
- Available in diameters: Ø1.8, Ø2.5 mm
- Available in lengths: 10.0, 13.0, 15.0 mm |
| Material Equivalence | Both EM Provisional and the predicate MS System (Provisional) are made of Titanium alloy Ti-6Al-4V (ASTM F 136). |
| Surface Finish Equivalence | Both EM Provisional and the predicate MS System (Provisional) have a machined finished surface. |
| Sterilization Equivalence | Both EM Provisional and the predicate MS System (Provisional) are Radiation Sterile, and the EM Provisional uses the same manufacturing process, material, and sterilize barrier system as the predicate. |
| Packaging Equivalence | EM Provisional packaging is consistent with the predicate: Secured in plastic ampule, housed in Tyvek-lidded blister tray, placed in a tamper-evident outer package (predicate uses "outer box" but intent is the same). The reference device (Hiossen Implant System K140934) also uses similar packaging. |
| Risk Equivalence | The proposed device does not pose any new or increased risks as compared to the legally marketed predicate and reference devices. Asserted due to identical manufacturing processes, materials, and design to the predicate, making re-testing for biocompatibility, sterilization validation, surface treatment characterization, fatigue, compressive strength, and pull-out unnecessary per the "least burdensome principle." No clinical performance reports were submitted, reinforcing reliance on equivalence to existing devices. |
2. Sample size used for the test set and the data provenance:
Not applicable. There was no "test set" in the context of an AI/SaMD performance study. The submission relies on pre-existing data and knowledge of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new ground truth was established for a performance study. Equivalence is asserted based on engineering and material comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication process for a test set was performed.
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 device is a physical dental implant, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical dental implant, not an AI/SaMD.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. Ground truth as typically understood for SaMD performance studies is not relevant here. The ground for "equivalence" is based on established performance and safety profiles of the predicate device.
8. The sample size for the training set:
Not applicable. This device is a physical dental implant, not an AI/SaMD.
9. How the ground truth for the training set was established:
Not applicable. This device is a physical dental implant, not an AI/SaMD.
In summary, this document demonstrates substantial equivalence of a physical dental implant to a legally marketed predicate device based on similarities in design, materials, and intended use, rather than through a novel performance study proving it meets specific acceptance criteria typically associated with SaMD or other complex medical devices requiring such studies.
§ 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.