(27 days)
The 3.0mm One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The 3.0mm One-Piece implant must be splinted if two or more are used adjacent to each other. The 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The Zimmer One-Piece Implant, 3.0mm, Angled is a one-piece endosseous implant which is a combination of implant and abutment sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion is angled by 17 degrees. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant implantation and with facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.
This document is a 510(k) Pre-Market Notification for a medical device (Zimmer® One-Piece Implant, 3.0mm, Angled) and details its equivalence to already marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of performance metrics that would typically be associated with AI/ML medical devices (sensitivity, specificity, etc.).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The "device performance" in this context refers to its ability to function as intended, similar to the predicate devices, and its safety and effectiveness.
Here's a breakdown of why the requested information cannot be fully provided based on the input:
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Acceptance criteria and reported device performance (Table):
- The document does not explicitly list quantitative acceptance criteria (e.g., specific accuracy thresholds) for the device's performance in the way an AI/ML study would.
- The "device performance" is primarily established through a comparison to predicate devices, asserting that the new device is "equivalent in design" and uses the "same materials, general structure, and function" as the predicate cleared in K052997, particularly noting a dimensional modification (17-degree angle).
- No specific performance metrics like sensitivity, specificity, F1-score, or similar clinical performance measures are reported.
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Sample size for the test set and data provenance:
- Not applicable in this document. This is a pre-market notification for a physical medical device, not a study evaluating an AI/ML algorithm on a dataset. The "test set" would be implied through mechanical testing or clinical use (which might be covered in separate studies not included here or prior for the predicate devices).
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Number of experts used to establish ground truth and qualifications:
- Not applicable. Ground truth, in the context of an AI/ML study, refers to the definitive correct answer for a given input (e.g., disease presence). For a physical implant, "ground truth" relates to its engineering specifications, biocompatibility, and functional integrity, which are established through manufacturing controls, material science, and prior clinical experience with similar devices.
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Adjudication method:
- Not applicable.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- Not applicable. This is not an AI/ML device; it's an endosseous dental implant.
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Standalone performance (algorithm only):
- Not applicable. This is not an algorithm.
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Type of ground truth used:
- For a physical medical device like this, the "ground truth" for its safety and effectiveness is established through adherence to design specifications, material standards, biocompatibility testing, mechanical stress testing, and clinical data (often from predicate devices or general clinical experience with similar implant types). The document implies that the device conforms to established standards and performs comparably to the predicate.
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Sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the type of AI/ML-specific performance metrics, study design, or data-related information requested. The "proof" is the comparison to existing, already cleared 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.