(99 days)
ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla.
ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are:
3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible
5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and
4.5 mm provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla.
The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement.
The technological characteristics of the modified Endopore® Anatomic Endosseous Dental Implant System also are identical to those of the predicates, except for the use of customized configurations to fit specific anatomic jaw locations, including the anterior mandible, anterior maxilla, posterior mandible and posterior maxilla, and the addition of concentric "steps" along the length of the implant's body. The dimensions of the Anatomic Implant System include diameters of 3.75 mm, 4.5 mm, and 5 mm and lengths of 8.5 mm, 10 mm, 12 mm, and 15 mm. These dimensions are within the range of those of the previously cleared Endopore® Endosseous Dental Implant System, with the addition of the 3.75 mm diameter and 15 mm length.
The provided text is a 510(k) summary for the Endopore® Anatomic Endosseous Dental Implant System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove device performance against specific acceptance criteria in the typical sense of a clinical or analytical performance study.
Therefore, many of the requested elements (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC study, standalone performance) are not applicable or not available in this type of regulatory submission.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)
For 510(k) submissions, the primary "acceptance criterion" is proving substantial equivalence to a legally marketed predicate device. Device performance is typically evaluated by demonstrating that the new device shares similar technological characteristics, intended use, and performs no worse than its predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as performance metrics in this summary. | The technological characteristics and principles of operation are identical to the predicate devices, with minor design modifications (customized configurations for anatomic jaw locations and concentric "steps" along the implant body). The dimensions are within the range of cleared devices, with new 3.75 mm diameter and 15 mm length. |
| Substantial Equivalence to predicate devices (K043190, K926354, K9711196, K032140). | The FDA found the device substantially equivalent to the predicate devices for the stated indications for use. |
Explanation: This 510(k) summary explicitly states: "The minor modification to the design of the Scalloped Endopore® Endosseous Dental Implant System and Endopore® Endosseous Dental Implant System does not alter the implant's indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicate devices." This is the core "study" and "acceptance criterion" for a 510(k) – demonstrating that the new device is as safe and effective as a legally marketed one.
Detailed Information on Studies:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This submission is based on demonstrating substantial equivalence through comparison of technological characteristics and intended use, not on a new clinical or analytical performance study with a test set of data.
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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/Not provided. No "ground truth" establishment by experts for a test set is mentioned in this substantial equivalence submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No adjudication method is mentioned as there's no disclosed test set or expert review process.
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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 dental implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (dental implant), not an algorithm or software. "Standalone performance" in this context would refer to material testing and mechanical performance, which are part of device design and manufacturing but not explicitly detailed as "standalone studies" in this summary for substantial equivalence.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of 510(k) submission, "ground truth" in the sense of a clinical benchmark for a new diagnostic or prognostic algorithm is not relevant. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices and their known performance/safety profiles.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The K052951 document is a 510(k) summary demonstrating substantial equivalence for a dental implant system. It explicitly states that the device's design modifications do not alter its fundamental scientific technology or intended use, thereby making it substantially equivalent to predicate devices. This type of submission relies on comparative analysis of specifications and intended use rather than new clinical or performance studies with separate test and training sets.
§ 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.