(35 days)
The Lifecore Stage-1 Angled Abutment is intended to attach to an endosseous implant and provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required.
The Lifecore Stage-1 Angled Abutment System is designed for use with endosseous implants to provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required. The Stage-1 Angled COC Abutment and Screws will facilitate ideal tooth positioning due to lack of available bone, access limitation, or to correct angulation of implant placement. The system consists of 15 and 20 degree angled abutments, angled abutment screw, and angled abutment try-ins. One angled abutment is packaged together with an angled abutment screw to allow the clinician to have the components required for clinical use. The angled abutments and angled abutment screw are manufactured from titanium alloy (Ti 6Al-4V E.L.) which conforms to ASTM Standard Specification F136.
The provided text describes the Lifecore Stage-1 Angled Abutment System, a Class III medical device intended for dental implant support and retention where angle correction is required.
However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics that would typically be reported for the device's clinical or algorithmic performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technological characteristics.
Therefore, I cannot fulfill most of your request directly from the provided text. I will, however, extract the information that is present.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., "accuracy > 90%") and their corresponding device performance values are not provided, this table cannot be fully populated. The document only states that the device has "met the design criteria" for various tests.
| Criteria | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Static Loads Performance | (Not specified) | Met the design criteria |
| Fatigue Loads Performance | (Not specified) | Met the design criteria |
| Corrosion Resistance | (Not specified) | Likely to resist corrosion; found to be within acceptable limits |
| Dimensional Specifications | (Routinely inspected) | Routinely performed and found to be within acceptable limits |
| Electrochemical Corrosion (Uncoupled) | (Not specified) | Found to be within acceptable limits |
| Electrochemical Corrosion (Galvanic) | (Not specified) | Found to be within acceptable limits |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document refers to "testing to verify design specifications" but does not detail the sample sizes for these tests (e.g., number of abutments tested for static load) or the provenance of any data beyond indicating it's related to the device's design verification. It appears to refer to in-vitro non-clinical tests rather than human or real-world data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient outcomes to establish ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the non-clinical tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document describes non-clinical engineering and material tests, not studies comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device (an abutment system), not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been the pre-defined engineering specifications and ASTM standards for static loads, fatigue loads, corrosion resistance, and dimensional accuracy. The device's performance was compared against these established technical benchmarks.
8. Sample Size for the Training Set
Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and regulatory standards, not by iterative training on a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 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.