(267 days)
The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/ lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic Dental Implants are only to be used with straight abutments.
The Promimic Dental Implant consists of 4 implants, diameter 3.75 mm, and length from 8.5 to 15.0 mm.
Here's a breakdown of the acceptance criteria and study information for the Promimic Dental Implant, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative "acceptance criteria" for the Promimic Dental Implant's performance. Instead, it uses a substantial equivalence (SE) approach, comparing its characteristics to previously cleared predicate devices. The "acceptance" is based on demonstrating that the new device's technological characteristics are similar to the predicates and that any differences do not raise new questions of safety or effectiveness.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Promimic Dental Implant Performance (Reported and Compared) |
|---|---|---|
| Indication for Use | Surgical placement into upper/lower jaw arches as permanent support for prosthetic attachment, to restore masticatory function. | Surgical placement into upper/lower jaw arches as permanent support for prosthetic attachment, to restore masticatory function. |
| Dimensions | Similar range to predicates (e.g., diameters 3.25-6 mm, lengths 8-19 mm) | Diam. 3.75 mm, length 8.5 - 15 mm |
| Material | Commercially pure Titanium or Ti alloy grade 5 | Commercially pure Titanium |
| Threaded | Yes | Yes |
| Surface | Various surface treatments (e.g., Plasma sprayed HA, Anodized Ti, Ti blasted) | Spin coated nanometer scale HA |
| Surgical Technique | One - two stage | One - two stage |
| Sterilization Method | Radiation | Radiation |
| Abutment Connection | Various types (e.g., External hex, Internal trilobe, Conical internal) | External hex |
| Abutment Screw | M2 or similar for compatible platforms | M2 |
| Mechanical Properties | In accordance with "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004" guideline. | In accordance to the guideline (no specific values given, but stated to be in conformity) |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not report specific sample sizes for a "test set" in the context of clinical or performance data for the Promimic Dental Implant itself. The performance testing mentioned refers to mechanical testing, not clinical trials on human subjects.
- The data provenance pertains to mechanical testing performed by Promimic AB to demonstrate the physical properties of the device. There's no mention of country of origin for clinical data or whether it's retrospective or prospective, as clinical data for this specific device is not presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable or not provided in the context of this 510(k) summary. The "ground truth" for showing substantial equivalence relies on comparing the device's technical specifications and mechanical testing results to established predicate devices and recognized standards, not on expert adjudication of clinical outcomes for a test set.
4. Adjudication Method for the Test Set
- This information is not applicable or not provided. There is no mention of a clinical "test set" requiring adjudication by experts.
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
- This is not applicable. The Promimic Dental Implant is a physical medical device (dental implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- This is not applicable. As stated, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the substantial equivalence determination is the technical specifications and established performance characteristics of legally marketed predicate devices and compliance with recognized mechanical testing guidelines (specifically, "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004").
8. The Sample Size for the Training Set
- This information is not applicable or not provided. There is no "training set" in the context of developing this physical medical device. The manufacturing processes and design are based on established engineering principles and materials science.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable or not provided. There is no "training set" or corresponding ground truth for this type of device submission.
§ 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.