(191 days)
For 3.0mm Intra-Lock® OP Dental Implants:
The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function.
For 3.75mm, 4.0mm & 4.75mm Intra-Lock® OP Dental Implants:
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
The Intra-Lock® OP Dental Implants are threaded dental implants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, with an integrated straight abutment (implant and abutment arc one piece).
The provided text is a 510(k) Summary for the Intra-Lock® OP Dental Implants. This type of document is for medical device regulation and describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. It outlines performance testing performed, but it does not detail specific acceptance criteria or report performance data against those criteria in a quantitative manner that would be typical for an AI/ML device study.
Therefore, I cannot fulfill all parts of your request based on the provided text, particularly those related to a study proving the device meets acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device. The document describes mechanical and material testing for an implant, not an AI software.
However, I can extract the information that is present, especially regarding the performance testing performed and the general approach.
Here's the closest I can get to your request based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria or specific numerical performance metrics. Instead, it lists the types of performance testing that were conducted to support the device's intended use and demonstrates substantial equivalence to predicate devices which have implicitly met regulatory acceptance.
| Acceptance Criteria Category (Implied) | Reported Device Performance / Assessment |
|---|---|
| Functional / Mechanical Integrity | Static / Dynamic Fatigue: Testing was reviewed to support the performance. (No specific numerical results or criteria are provided, but the implication is that the implants withstood relevant forces to establish substantial equivalence.) |
| Material Biocompatibility | Material: TI6AL4V, CP Titanium (These are well-established biocompatible materials for dental implants, aligning with predicate devices.) Differences in material (Titanium Alloy vs. TI6AL4V, CP Titanium) are presented but deemed not to raise new issues of safety or effectiveness. |
| Surface Properties | Surface Analysis: Testing was reviewed (No specific numerical results are provided, but implied to be acceptable and comparable to predicate 'Blasted' or 'Zimmer MTX Surface'). |
| Sterility | Sterilization Validation: Validation performed (Method: Gamma Irradiation, consistent with predicate devices, implying sterile product). |
| Longevity / Stability | Shelf Life: 5 years (Consistent with predicate devices, implying long-term stability of the packaged, sterile product). |
| Design Equivalence | Design Features: Comparisons with predicate devices (Zimmer® One-Piece Implant, MILO® Implant System, Intra-Lock® Implant System with Blossom™) indicate similar materials, intended use, indications, sterilization, and shelf life. "The minor differences between these designs and principals of operation raise no new issues of safety or effectiveness." This implies that the design performs acceptably for its intended use, analogous to the predicate devices. This includes thread patterns, diameter/length sizes, and abutment design. |
| Risk Mitigation | Risk analysis: Performed. (No specific details, but standard regulatory practice to identify and mitigate risks). |
| Intended Use Fulfillment | The device's indications for use are described, and the performance testing is stated to "support performance... for their intended use." This is an overarching criterion. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML study, nor does it provide sample sizes for the performance testing mentioned (risk analysis, shelf life, sterilization validation, surface analysis, static/dynamic fatigue).
The data provenance is not mentioned. These are likely lab-based engineering and biological tests rather than clinical data from human subjects or retrospective/prospective medical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical implant, not an AI/ML diagnostic or predictive device that relies on expert interpretation of data to establish ground truth for a test set. The validation is based on engineering and material science principles, and comparison to established predicate devices.
4. Adjudication method for the test set
Not applicable for the reasons stated above.
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. This is not an AI-assisted diagnostic or interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental implant).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" is established through:
- Engineering Standards: Compliance with recognized international and national standards for static and fatigue strength (e.g., ISO standards for dental implants, though not explicitly cited, they are implicit in such submissions).
- Material Specifications: Verification of material composition and properties against established biocompatible requirements.
- Sterilization Validation: Confirmation that the sterilization process achieves a predefined sterility assurance level (SAL).
- Bench Testing: Physical testing results (e.g., fatigue cycles, surface roughness measurements) are compared against safety and performance thresholds derived from predicate devices and regulatory guidance.
- Biocompatibility Testing: (Though not explicitly listed in "Performance Testing" for this specific summary, it's a standard requirement for implants and would involve testing for toxicity, sensitization, etc., against biological ground truth).
8. The sample size for the training set
Not applicable. There is no AI/ML component or "training set" in the context of this device.
9. How the ground truth for the training set was established
Not applicable for the reasons stated above.
§ 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.