(282 days)
SuperLine 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. SuperLine is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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This document is a 510(k) clearance letter for a dental implant device called "SuperLine." It mostly contains regulatory information and does not describe any specific studies or performance criteria in the detail requested. The 510(k) process primarily confirms substantial equivalence to a predicate device, not necessarily extensive clinical performance testing with defined acceptance criteria in the manner of a new drug or novel medical device requiring broad clinical trials.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- This document does not contain a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, AUC, or similar statistical measures. The 510(k) clearance process often relies on testing for substantial equivalence, which may involve bench testing and comparisons to a predicate device's design and materials, rather than detailed clinical performance metrics with defined acceptance criteria against a ground truth as would be seen in AI/CADe device submissions.
2. Sample size used for the test set and the data provenance:
- Not specified. The document does not describe a clinical test set or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe a test set or ground truth establishment.
4. Adjudication method for the test set:
- Not specified. The document does not describe a test set or adjudication method.
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 device is an endosseous dental implant, not an AI or CADe system designed to assist human readers. Therefore, an MRMC study with AI assistance is not relevant to this product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used:
- Not specified. The document does not describe any ground truth. For a physical implant, "ground truth" related to its performance would typically involve measures of biocompatibility, mechanical strength, osseointegration, and clinical success over time, which are implied by substantial equivalence to a predicate device rather than explicitly detailed here.
8. The sample size for the training set:
- Not applicable/Not specified. This document is for a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. This document is for a physical medical device, not an AI model.
In summary: The provided document is a regulatory clearance letter for an endosseous dental implant. It confirms the device's substantial equivalence to a legally marketed predicate device, enabling its market access. It does not contain the kind of detailed study design, acceptance criteria, or performance data typically associated with a new AI/CADe device or a clinical trial report. The information requested aligns more with performance evaluations of diagnostic software or AI-powered medical devices.
§ 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.