(129 days)
Hahn Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
The Hahn Tapered Implant System consists of dental implants, abutments, screws, and surgical instruments. They are manufactured from Titanium alloy, grade 23. The implant is designed with an internal hex connection and a tapered body to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched to facilitate osseointegration. The Implants are design with two (2) platform connection geometries; they are available in the following diameters: 3.0mm, 3.5mm, 4. 3mm, 5.0mm, and 7. 0mm diameter is available in the following lengths: 8mm, 10mm, 11.5mm, 13mm, and 16mm. The dental implants are provided sterile (gamma radiation).
The document describes the Hahn Tapered Implant System, a dental implant system from Prismatik Dentalcraft, Inc. The submission is a 510(k) premarket notification, which means the company is demonstrating that their device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating this substantial equivalence through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly that the new device performs at least as well as the predicate device in specified non-clinical tests. The reported performance is that the device met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance demonstrated to be "as safe, as effective, and performs as well as the predicate device(s)" in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" | "The testing performed established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." |
| "All differences between the predicate and proposed devices have been evaluated per the testing described in section F (non-clinical testing) and the proposed device has performed as well as the predicate; the devices are substantially equivalent." | |
| Reliability Calculation (as per FDA Guidance) | Performed; device found to be substantially equivalent to predicate. |
| Fatigue Testing of finished assembled implant/abutment systems (as per FDA Guidance) | Performed; device found to be substantially equivalent to predicate. |
| Static Load Failure Testing of finished assembled implant/abutment systems (as per FDA Guidance) | Performed; device found to be substantially equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that non-clinical testing was used.
- Sample Size: The document does not specify the exact number of samples used for reliability calculation, fatigue testing, or static load failure testing. It generally states that "Non-clinical test data was used."
- Data Provenance: The data is from non-clinical (laboratory/mechanical) testing, not human patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" don't apply in the traditional sense for clinical studies. It would be generated in a lab setting by the manufacturer or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the study described is a non-clinical, mechanical performance study, not one requiring expert review of data like medical images or clinical outcomes. Ground truth for mechanical tests usually comes from standardized test methods and established engineering principles.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is a non-clinical, mechanical performance study, not one requiring adjudication of human-interpreted results.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (dental implant system), not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This submission is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this non-clinical study would be the physical and mechanical properties and performance characteristics of the dental implants as measured by standardized engineering test methods (e.g., measuring load to failure, fatigue life). The acceptance criteria are based on performing at least as well as the predicate device in these objective, measurable parameters, guided by FDA special controls guidance.
8. The Sample Size for the Training Set
This information is not applicable. This is a non-clinical (mechanical) study of a physical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
§ 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.