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510(k) Data Aggregation
(422 days)
ABC Dental Implant System
The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.
ABC Dental Implant System is an internal hex implant system with one model of implant at this time. ABC dental implant is a slightly tapered cylindrical internal hex implant with micro-rings at the implant neck, which comes in 3.3. 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13, and 16. The 5.0 and 6.0 diameter implants do not come in a length of 16mm. All implants and abutments are made of ASTM F136 Ti 6A1 4V ELI. The implants have a grit blasted and acid etched surface. All types of abutments can be used with all implants. Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. Straight abutments come in 5. 7, 9, or 11mm leneths and shouldered straight abutments come 1, 2, 3, or 4mm in height. Wide straight shoulder abutments come in heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 5, 7, 9, 11 mm. Smooth straight wide abutments come in lengths of 5, 7, 9, and 11 mm and the grooved version comes only in 9mm. 15° anatomic angulated abutments come in heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in heights of 1, 2, or 3mm. Straight multi-unit abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in heights of 0.5, 1.5, or 2.5 mm. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Straight multi-unit mounted dentures can only be removed by the dentist, but dentures mounted on flat abutments or ball attachments can be removed by the patient. Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in heights of 2, 3, 4, and 5 mm.
The provided text does not describe an AI/ML powered device, but rather a dental implant system (ABC Dental Implant System). Therefore, the information typically requested for AI/ML device studies (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable here.
The document pertains to a 510(k) premarket notification for a Class II medical device, the ABC Dental Implant System. The acceptance criteria and the "study" proving the device meets these criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing and comparison of characteristics.
Here's an interpretation of "Acceptance Criteria" and "Device Performance" based on the provided 510(k) summary, reframed to fit the context of a dental implant system:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)
The "acceptance criteria" for a dental implant system in a 510(k) submission are generally to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is primarily shown through non-clinical performance testing and a detailed comparison of characteristics.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (ABC Dental Implant System) |
|---|---|
| Functional Equivalence: The device should perform its intended function similarly to the predicate. | Indications for Use: "The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Also indicated for immediate loading when good primary stability is achieved..." This matches the predicate and reference devices. |
| Material Equivalence/Biocompatibility: Materials should be safe and biologically compatible for their intended use. | Made of ASTM F136 Ti 6Al 4V ELI (Grade 5), which is common in dental implants. Biocompatibility testing (according to ISO 10993-5) showed no cytotoxic potential. |
| Mechanical Strength/Fatigue Life: The implant and abutment system must withstand chewing forces over time. | Dynamic fatigue testing according to ISO 14801 was conducted. "ABC implants exhibited a run out limit about the same or higher than other implant systems." |
| Surface Treatment Properties: The surface treatment should be safe and not adversely affect cytotoxicity or performance. | Grit blasted and acid etched surface. Surface analysis showed the treatment "does not adversely change the cytotoxicity of the materials." |
| Sterility & Packaging Integrity: The device must be sterile and maintain sterility until use. | Sterilization was conducted on implants (Gamma Radiation). Abutment steam sterilization was done. Package integrity testing and accelerated aging were conducted. Endotoxin testing performed according to USP 161. |
| Design/Dimensional Equivalence: Key design features and dimensions should be comparable to support substantial equivalence. | Detailed comparison table shows similar dimensions (diameter and length ranges), internal hex connection, screw-shaped design, and available abutment types and dimensions to the predicate (Alpha-Bio Tec® Dental Implant System) and reference devices (ARDS Dental Implants). |
| Manufacturing/Quality Control: Device production should follow good manufacturing practices. | While not explicitly detailed as "acceptance criteria" performance, the 510(k) process implicitly requires adherence to Quality System (QS) regulation (21 CFR Part 820). The letter mentions "good manufacturing practice requirements." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable. The "test set" here refers to non-clinical laboratory testing (e.g., fatigue testing, biocompatibility testing) of the device itself, not a clinical study involving a dataset of patient images or outcomes. The data provenance would be the manufacturing site (Israel) and the testing laboratories that conducted the non-clinical tests. These are physical device tests, not data analysis tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or measurements from patient data. For a dental implant system, the "ground truth" for the device's performance is established by standardized material and mechanical testing protocols (e.g., ISO standards), not by human experts adjudicating clinical cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there's no clinical "test set" requiring adjudication.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device. The "standalone performance" is the mechanical and material performance of the physical implant device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for proving its safety and effectiveness is primarily established through:
- Standardized Non-Clinical Testing: Adherence to established international standards (e.g., ISO 14801 for fatigue testing, ISO 10993-5 for biocompatibility).
- Material Specifications: Conformance to recognized material standards (e.g., ASTM F136 for Ti-6Al-4V ELI).
- Comparison to Predicate Device: Demonstrating that the new device's characteristics (design, materials, indications for use, performance) are sufficiently similar to a predicate device that has already been cleared by the FDA.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable.
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