(85 days)
The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
DIO Protem Implant System consists of Protem Implants, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm). The superstructures consist of Protem Cemented Abutment, Ball Cap and Healing Cap. The Protem Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of fixture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
The provided text describes a 510(k) premarket notification for the "DIO Protem Implant System (2.0/2.5mm)". This submission is for a medical device (endosseous dental implant system) and not for an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC) and associated studies (MRMC, standalone, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods) is not applicable here.
Instead, the "acceptance criteria" for a medical device like this in a 510(k) submission typically revolves around demonstrating substantial equivalence to a previously legally marketed predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to performance testing (bench testing) and a thorough comparison against the predicate device to show that the new device is as safe and effective.
Here's how to interpret the information provided in the context of a traditional medical device 510(k) submission:
Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The "acceptance criteria" for the DIO Protem Implant System (2.0/2.5mm) is demonstrating substantial equivalence (SE) to its predicate device, the DIO Protem Implant System (K06710568). This is the primary criterion for clearance under a 510(k).
The "study" or evidence provided to prove the device meets this acceptance criterion is a substantive comparison of its technological characteristics and intended use to the predicate device, supported by laboratory testing.
1. Table of Acceptance Criteria and the Reported Device Performance (interpreted for medical devices, not AI):
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance / Characteristics (Subject Device) | Predicate Device (K06710568) |
|---|---|---|
| Intended Use: Identical to the predicate device's intended use. | Identical to predicate devices | The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. |
| Material: Same material as the predicate device. | Titanium alloy | Titanium alloy |
| Screw Threads: Presence of screw threads as in the predicate. | YES | YES |
| Implant Thread Diameter: Within the range of the predicate device. | 2.0 and 2.5 mm | 2.0 and 2.5 mm |
| Lengths: Within the range of the predicate device. | 8-14 mm | 8-14 mm |
| Surface Treatment: Same type of surface treatment as the predicate device. | Sanded (also mentions sandblasted, RBM treated) | Sanded |
| Sterilization: Sterilized in the same manner as the predicate. | YES (gamma sterilized for implants) | YES |
| Functionality & Conformance to Design Input Requirements: Demonstrated through laboratory testing. | Laboratory testing was conducted to determine device functionality and conformance to design input requirements. | (Implied to meet similar standards as predicate) |
| Components: Similar overall system components (implants, superstructure, prosthetics, surgical instruments). | Protem Implants, Superstructure, Prosthetics, Surgical Instruments. | (Implied similar, as it's the same system, with information being changed. The 510(k) summary is for changing some information of the prior submission, not for a brand new system). |
2. Sample size used for the test set and the data provenance:
Not applicable for this type of medical device submission. The evaluation relies on the physical and material characteristics of the device, as well as bench testing to verify performance, rather than a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for AI/ML device performance is not relevant here.
4. Adjudication method for the test set:
Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:
Not applicable. This is not an AI/ML powered 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 powered device.
7. The type of ground truth used:
Not applicable in the context of AI/ML. For a physical device, the "ground truth" would be established by engineering specifications, material science standards, and performance test results. For instance, the stated dimensions (e.g., diameter, length) are verified directly against engineering drawings and manufacturing tolerances.
8. The sample size for the training set:
Not applicable. There is no AI/ML algorithm being "trained."
9. How the ground truth for the training set was established:
Not applicable.
§ 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.