(90 days)
An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. This submission provides information and animal/clinical data to support a clinical performance claim of "Enhanced Performance in Poor Quality Bone".
Screw type implant with a "Defined Surface Structure".
The provided text describes a 510(k) submission for the "Osseotite" Dental Implant System, focusing on a claim of "Enhanced Performance in Poor Bone" due to a "Defined Surface Structure." It does not present acceptance criteria in the typical sense of quantitative targets for performance metrics from a formal validation study. Instead, it relies on demonstrating that the "Osseotite" surface performs at least as well as, and in some cases better than, other "non-Osseotite" surfaced implants, particularly in areas with poor quality bone.
Here's an attempt to extract and interpret the information based on your request, understanding that the structure of a 510(k) summary is different from a clinical trial report.
Acceptance Criteria and Reported Device Performance
The document doesn't define explicit numerical acceptance criteria for a new, unproven device's safety and efficacy because it's a 510(k) submission seeking substantial equivalence to a predicate device. The primary "acceptance criterion" for marketing approval through 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, which the "Osseotite" implants had already achieved in terms of design and materials in an earlier K submission (K935544).
This particular submission (K980549) is to support a marketing claim of "Enhanced Performance in Poor Bone" based on new data, not to re-establish fundamental safety and efficacy. Therefore, the "acceptance criteria" here implicitly relate to the sufficiency of evidence to support this performance claim rather than a predefined set of performance thresholds for device approval.
However, we can infer performance indicators and reported findings:
| Acceptance Criterion (Inferred from marketing claim) | Reported Device Performance |
|---|---|
| Performance at least as good as "non-Osseotite" surfaced implants. | "Osseotite" surface performs overall, at least as well as other "non-Osseotite" surfaced implants. |
| Improved or enhanced performance in areas of poor quality bone (e.g., posterior maxilla). | Appears to offer improved or enhanced performance in areas of the oral cavity known to have poor or poorer quality bone. |
| Increased bone-to-surface contact (animal studies). | Animal studies demonstrate an increase in bone-to-surface contact for "Osseotite" compared to machined surfaced implants. |
| Increased resistance to countertorque extraction (animal studies). | Animal studies demonstrate an increase in resistance to countertorque extraction for "Osseotite" compared to machined surfaced implants. |
| Improved life table curves in poor quality bone (clinical trials). | Life table curves are approximately 8.8% greater for "Osseotite" vs "non-Osseotite" machined surface implants at 24 months when surgically placed in areas known to have poor quality bone. |
Study Details to Support "Enhanced Performance" Claim
The document describes several types of studies and data used to support the "Enhanced Performance" claim:
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Sample size for the test set and data provenance:
- Animal studies: Unspecified number of animals. Likely from research institutions where the studies were "published." Provenance not specified, but typically animal studies are prospective.
- Clinical trials: Two ongoing prospective clinical trials. The sample size for the clinical trials is not explicitly stated in this summary, but they track "Osseotite" vs "non-Osseotite" (machined surface) implants. The "8.8% greater" outcome is reported for "similar implants at 24 months" in areas of poor quality bone. The specific countries of origin for these clinical trials are not mentioned.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- The document mentions "Numerous academic and clinical researchers are involved with a variety of studies." It does not specify the exact number of experts involved in establishing ground truth for individual animal or clinical study outcomes.
- Expert qualifications are inferred from the context of "academic and clinical researchers" but are not explicitly detailed (e.g., years of experience, specific certifications).
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Adjudication method for the test set:
- Not specified. This level of detail is typically found in full study protocols or publications, not a 510(k) summary.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study in the typical sense (e.g., human readers interpreting images with and without AI assistance) was not done. The "Osseotite" is a physical dental implant, and the studies assess its direct performance (e.g., osseointegration, stability, survival rates) rather than observational interpretations.
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Standalone (algorithm only without human-in-the-loop performance) study:
- This is not applicable as the device is a physical dental implant, not an AI algorithm. The studies assess the implant's standalone biological and mechanical performance in vivo.
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Type of ground truth used:
- Animal studies: Likely direct measurement of biological response (e.g., histology for bone-to-surface contact, mechanical testing for countertorque extraction).
- Clinical trials: Clinical outcomes directly observed and measured (e.g., implant survival, success/failure based on established dental implant criteria, which might include absence of mobility, absence of pain/infection, etc.). These outcomes serve as the ground truth.
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Sample size for the training set:
- Not applicable in the typical sense of a machine learning model's training set. The "training" for this physical device would be the iterative design, manufacturing, and preclinical testing phases, which are not specifically quantified as a "training set" here.
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How the ground truth for the training set was established:
- Not applicable as described above. The ground truth for evaluating the device's performance (as described in points 1 and 6) is based on direct biological and clinical measurements and observations.
§ 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.