(266 days)
ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring function.
ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:
Implants:
- 3i Internal Connection: D3.4, D4.1, D5, D6
- Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5
- Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
- Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm
- Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm)
- Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm)
- Zimmer Screw Vent: D3.5, D4.5, D5.7
Abutments:
- 3i Low Profile Abutment
- ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
- ASTRA TECH 20° and 45° UniAbutment
- Astra Tech UniAbutment EV 3.6
- Friadent XiVE MP D3.8, D4.5, D5.5
- Friadent XiVE TG D3.8,D 4.5, D5.5
- Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
- Straumann Bone Level Angled Abutment: 4.0 mm
- Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
- Straumann RN (4.8 mm), WN (6.5 mm)
- Zimmer Tapered Abutment: 4.5 mm
ATLANTIS™ ISUS is a custom restorative device that is intended to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of ATLANTIS™ ISUS is fabricated using computer-assisted manufacturing (CAM) to produce a custom patient specific device.
ATLANTIS™ ISUS is available in four design types: Bar, Bridge, Hybrid, and 2 in 1. It also features Angulated Screw Access (ASA) allowing the screw-channel opening to be angled up to 30° off the implant/abutment axis.
The provided text describes a medical device called ATLANTIS™ ISUS, an implant suprastructure. The document is primarily a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design for a new device.
Therefore, the document does not contain the detailed acceptance criteria and a study specifically designed to prove the device meets those criteria in the way one would for a new AI/software device. The information provided is for a physical medical device (dental implant suprastructure).
However, I can extract the information related to the device's "performance" characteristics and the testing performed to demonstrate its safety and effectiveness, which serves a similar purpose to acceptance criteria and performance data for this type of device.
Here's an interpretation based on the provided text, structured to align with your request for acceptance criteria and study information, noting the differences due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are not framed as statistical thresholds for an AI algorithm's output, but rather as meeting specific physical and mechanical performance standards comparable to legally marketed predicate devices. The "reported device performance" refers to the results of non-clinical bench testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Mechanical Strength (Fatigue Performance): The ATLANTIS™ ISUS implant suprastructures must withstand dynamic loading conditions without failure, comparable to predicate devices and suitable for their intended use. | Non-Clinical Performance Data: Static and dynamic compression-bending testing was conducted according to ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants (2007). |
| Result: "Results of the fatigue testing support substantial equivalence in fatigue performance." | |
| Screw Torque Reliability (Angulated Screw Access): For designs incorporating Angulated Screw Access (ASA), the system must allow for sufficient and reliable application of torque to the prosthetic screws. | Non-Clinical Performance Data: Torque testing was performed for situations with angulated screw access. |
| Result: "Screw torque testing shows that sufficient torque can be applied in situations with angulated screw access." | |
| Biocompatibility: The materials used in ATLANTIS™ ISUS must be biocompatible and safe for long-term contact with human tissue. | Biocompatibility Testing: "The results of biocompatibility testing conducted for the predicate device, ISUS Implant Suprastructures (K122424) are valid, therefore, no additional biocompatibility testing has been performed." (This indicates reliance on predicate device's proven biocompatibility). |
| Material Composition Equivalence: The materials selected for the suprastructure and screws must be equivalent or similar to those of predicate devices, with established safety profiles for dental implants. | Material Specification: Suprastructure: Titanium, Cobalt Chromium (equivalent to predicate devices). Screw: Titanium alloy (equivalent to predicate devices). |
| Design and Manufacturing Process Equivalence: The device's design principles and manufacturing process (CAD/CAM) must be consistent with established methods for dental implant suprastructures, particularly those of the predicate devices. | Description of Device: "ATLANTIS™ ISUS is a custom restorative device that is intended to dental implants or abutments... The design... is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD)... fabricated using computer-assisted manufacturing (CAM)." |
| Technological Characteristics: "Fabricated using computer-assisted design (CAD)... Milled using computer-assisted manufacturing (CAM)... Fabricated from homogenous, single-block raw material (CPTi or CoCr alloy)." | |
| Dimensional Compatibility: The device must be compatible with the specified implant and abutment systems, including platform diameters and connection types. | Specification: Platform Diameter: 3.0 - 6.5 mm. Connection: Internal. (These specifications are compared in Table 6.1 to predicate devices, showing substantial equivalence or justified differences.) |
The following points refer to your specific questions, which are more tailored to AI/software validation studies. Given that this is a physical medical device submission (dental implant suprastructure), some of these questions are not directly applicable or the information is not present in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the non-clinical tests (e.g., how many units were fatigue tested). It refers to "testing" in general.
- Data Provenance: Not applicable for non-clinical bench testing of physical devices. The testing was conducted as part of the submission package for FDA clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in this context would implicitly be the established engineering standards (like ISO 14801) and accepted dental restoration principles, not expert consensus on image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for non-clinical bench testing. Performance is measured against physical specifications and standard test methods.
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. This is a physical dental implant suprastructure, not an AI/software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance assessment described is "standalone" in the sense that it's the physical device alone being subjected to tests. However, it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is based on:
- International Standards: ISO 14801 (for dynamic fatigue testing).
- Engineering Principles/Specifications: Performance against specified torque requirements, material properties, and dimensional compatibility.
- Equivalence to Predicate Devices: The ultimate "truth" for 510(k) is demonstrating that the device is as safe and effective as a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This device is manufactured using CAD/CAM based on patient dental models and clinician prescriptions. There is no explicit "training set" in the machine learning sense. The "design" is based on established engineering principles and dental prosthetics knowledge, and the "manufacturing" is automated.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" in the AI sense. The design process (CAD) uses patient-specific data to create a custom device according to pre-defined parameters and dental restoration best practices, rather than learning from a dataset.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)