(105 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 and to restore a patient's chewing function.
With use of OSSEOTITE® implants, the time between surgical implant placement and evaluation for prosthetic loading may be reduced from previously recommended four months (mandible) and six months (maxillary) to, two months for either mandibular or maxillary sites, when such evaluation confirms appropriate conditions for prosthetic attachment and masticatory loading.
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The provided document is a 510(k) summary for the OSSEOTITE® Dental Implant System, detailing its substantial equivalence to previously marketed devices and a performance claim for reduced healing time. It describes the scientific basis for this claim but does not provide specific details about a formal study with acceptance criteria and statistical analysis as would typically be found in a clinical trial report.
Therefore, many of the requested sections below cannot be fully answered or will be marked as "Not Applicable" or "Not Provided" based on the information available in this 510(k) summary.
Acceptance Criteria and Device Performance for OSSEOTITE® Dental Implant System
The acceptance criteria for the OSSEOTITE® Dental Implant System, as presented in this 510(k) summary, revolve around demonstrating a reduced healing time for prosthetic loading compared to historical recommendations. The document focuses on achieving "adequate healing" within two months, regardless of the implant site.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Primary Performance Claim | Reduced time from implant placement to clinical evaluation for prosthetic loading: |
- Mandible: Reduced from 4 months to 2 months.
- Maxilla: Reduced from 6 months to 2 months.
("provided all healing or integration criteria are met") | "Interim results from ongoing clinical studies demonstrate OSSEOTITE® implants, when placed in accordance with good clinical practice, may be reasonably expected to achieve adequate healing (integration), two months after surgical placement and consideration of prosthetic loading may be undertaken at that time."
"Proposed reduced healing time claims are substantially equivalent to claims made by other manufacturers that recognize implant surface area and morphology as relevant factors to faster healing." |
| Healing Assessment | Achievement of "adequate healing" assessed by clinical evaluation.
Radiographic confirmation of adequate healing (absence of radiolucency) after two months and prior to restoration. | "From ongoing clinical trials it has also been reported that OSSEOTITE® implants appear to attain a firm attachment, integrated with new bone in significantly less time than non-OSSEOTITE® implants for consideration of prosthetic loading."
"Clearly demonstrating an increase in resistance to countertorque extraction for OSSEOTITE® implants compared to machined surfaced implants at healing times significantly less than previously recommended." |
| Safety | No new or increased safety risks compared to predicate devices. | The 510(k) process inherently requires devices to be as safe and effective as predicate devices. The document details known adverse effects and complications common to dental implants but does not highlight any new or increased safety concerns specifically linked to the reduced healing time of OSSEOTITE®. It reinforces that "3i continues to recommend unloaded healing times" and emphasizes precautions. |
Study Details (Based on the provided K983347 510(k) Summary):
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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):
- Sample Size: Not explicitly stated. The document refers to "numerous academic and clinical researchers," "ongoing evaluations," "animal studies," and "clinical trials." No specific numbers for human subjects or animal models are provided.
- Data Provenance: Not explicitly stated. The document mentions "numerous academic and clinical researchers" which implies varied sources, but no specific countries or locations are given.
- Retrospective or Prospective: "Ongoing clinical studies" and "interim results from various ongoing evaluations" suggest a prospective nature, but details are lacking.
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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):
- Number of Experts: Not provided. The evaluation of "adequate healing" and "clinical evaluation" would typically involve dental professionals, but no details on their number or qualifications are mentioned in this summary.
- Qualifications of Experts: Not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not provided. The document refers to "clinical evaluation" and "radiographic examination" to confirm healing, but there is no description of an adjudication process for conflicting clinical assessments or interpretations.
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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:
- MRMC Study: Not applicable. This document pertains to a dental implant device and its healing properties, not an AI-assisted diagnostic or interpretation tool.
- Effect Size of AI assistance: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This document is about a physical medical device (dental implant), not an algorithm or software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for successful integration and healing appears to be based on clinical evaluation (assessment by dental professionals) and radiographic examination (absence of radiolucency suggestive of bone-implant interface issues). The mention of "resistance to countertorque extraction" from animal studies suggests a mechanical measure as well, likely correlating with bone-implant integration.
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The sample size for the training set:
- Sample Size for Training Set: Not applicable in the context of this 510(k) summary. The document describes clinical experience and ongoing studies with the OSSEOTITE® implant, which would contribute to understanding its performance, but it doesn't refer to a "training set" in the machine learning sense. The development of the OSSEOTITE® surface itself was likely informed by extensive research and prior observations, but specific "training set" data for a statistical model is not mentioned.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as no "training set" is described in the context of this device's submission. The understanding of the device's performance evolved from "market introduction," "numerous academic and clinical researchers," "ongoing evaluations," and "animal studies."
§ 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.