(17 days)
The BASIC Dental Implant System Post & Core - Thin Attachment is indicated for attaching artificial teeth to a dental implant.
The Post and Core - Thin Attachment is a one-piece attachment. The base is cemented into a dental implant. Artificial teeth are then attached to the Post and Core - Thin using conventional techniques.
The provided document is a 510(k) summary for the BASIC Dental Implant System Post and Core - Thin Attachment, submitted to the FDA in 2002. This summary states that no performance data or results of clinical studies were provided for this device. Instead, the submission concluded that the device is "substantially equivalent to other existing Post and Core attachments in commercial distribution."
Therefore, based solely on the provided information, it is not possible to describe acceptance criteria or a study proving the device meets those criteria, as none were included in this 510(k) summary.
In such a scenario for a 510(k) submission, the FDA's determination of substantial equivalence often relies on:
- Comparison to a Legally Marketed Predicate Device: The current device (Post and Core - Thin Attachment) is compared to a predicate device (BASIC Dental Implant System Post and Core Attachment, K960868). The assumption is that if the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness, then the performance data of the predicate device (or lack thereof, if also cleared through substantial equivalence without new performance data) is deemed sufficient.
- Existing Standards: While not explicitly mentioned here, for certain device types, compliance with recognized industry standards might be cited in lieu of novel performance studies.
To answer your specific questions based on the provided text, the response would be as follows:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document. The basis for clearance was substantial equivalence to a predicate device, not meeting predefined performance criteria from a new study.
- Reported Device Performance: No performance data was reported or provided in this 510(k) summary.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no performance studies were conducted or provided for this submission.
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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 as no performance studies were conducted or provided for this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no performance studies were conducted or provided for this submission.
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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 a mechanical dental implant accessory, not an AI-assisted diagnostic tool. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical dental implant accessory, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable as no performance studies were conducted or provided for this submission.
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The sample size for the training set
- Not applicable as no computational or AI-based device was involved. No training set was used.
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How the ground truth for the training set was established
- Not applicable as no computational or AI-based device was involved. No training set was used.
§ 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.