(185 days)
The implant is indicated for use in the mandible and maxilla for use as an artificial root structure for abutments for bridgework and denture retention.
The Steri-Oss implant functions by serving as a replacement for the root portion of natural dentition, upon which a prosthetic may be constructed. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implant is threaded with a 3.8 mm width and an 8, 10, 12, 14, 16 and 18 mm length. The superior aspect is flat. Half of the implant is coated with hydroxylapatite.
This document, K960398, is a 510(k) summary for a medical device called the "Steri-Oss Apical Implant". This particular submission does not contain information about acceptance criteria and a study proving the device meets them as would be relevant for an AI/ML device. Instead, it describes a conventional dental implant and its comparison to a predicate device.
Therefore, most of the requested information regarding acceptance criteria, study design, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth establishment, and sample sizes for training and testing is not applicable or available in this document.
Here's the breakdown of what can be extracted from the provided text, and where gaps exist:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of measurable performance for a diagnostic/AI device. The submission focuses on demonstrating substantial equivalence to a predicate device based on material, coating configuration, dimensions, design, packaging, and sterility.
- Reported Device Performance: Instead of a performance study against acceptance criteria, the document states: "Static tensile, static 90° transverse, static 30° compression and 30° compression fatigue were conducted on the predicate." This refers to mechanical testing on the predicate device, not the new Apical Implant, as a basis for equivalence. No specific performance results from these tests are provided for either device in this summary.
Acceptance Criteria (Inferred from Substantial Equivalence) Reported Device Performance (N/A for new device, based on predicate) Material: Titanium alloy Titanium alloy and HA (Apical Implant) Coating: All but 1-2mm neck 50% of apical threads (Apical Implant) Width (mm): 3.8 Same (3.8mm) Length (mm): 8, 10, 12, 14, 16, 18 Same (8, 10, 12, 14, 16, 18mm) Design: Threaded root form with flat superior aspect Same Packaging: Double vial Same Sterility: Sterile Same Mechanical Performance as predicate Static tensile, 90° transverse, 30° compression, 30° compression fatigue conducted on predicate. No results for new device. -
Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data for an AI/ML device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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Adjudication method for the test set: Not applicable.
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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 document does not describe a study involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used: Not applicable. The "ground truth" here is the design and material specifications compared to a predicate device, and the mechanical properties of the predicate device.
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The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.