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31 dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, arc placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.

The 3i Nano CaP OSSEOTITE Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nano-crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled /straight designs, and each design provides offerings for either external hex or internal connections.

This is a 510(k) premarket notification for a modification to a dental implant, the 3i Nano CaP OSSEOTITE® Dental Implants. The provided document does not contain acceptance criteria for device performance in the form of specific quantitative metrics or a study demonstrating that the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

• Similar Design Features and Functions: The device is stated to have similar design features and functions to existing OSSEOTITE, OSSEOTITE NT, OSSEOTITE Certain, OSSEOTITE Certain NT, Prevail Implants, and 3i Innovative Implants and Cover Screws. The specific enhancement, the deposition of nano-crystals of calcium phosphate, is compared to already available Hydroxylapatite (HA) Coated Endosseous Dental Implants.
• Performance Testing: The document briefly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II Special Controls Root-form Endosseous Dental Document: Guidance Implants and Endosseous Dental Abutments." It also mentions "Risk analysis was conducted in accordance with ISO 14971."

Therefore, many of the requested criteria cannot be extracted from this particular 510(k) summary. This type of 510(k) relies heavily on comparing the new device's characteristics and performance to existing, legally marketed devices, rather than establishing new, specific acceptance criteria for performance in a clinical study.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document refers to "Laboratory testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a dental implant, performance testing would likely involve mechanical, material, and biocompatibility testing, not expert interpretation of data in the way, for example, a diagnostic AI would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided.

5. 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:

• No. This is not an AI/software device; it's a physical dental implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is not an AI/software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For the "Performance testing" mentioned, the ground truth would typically be established by engineering specifications, material standards, and biocompatibility testing protocols. This would involve objective measurements against predefined limits for mechanical strength, fatigue resistance, surface characteristics, and biological response, rather than expert consensus on a clinical outcome in this context.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of this device's regulatory submission.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. There is no "training set" in the context of this device's regulatory submission.

In summary: This 510(k) primarily demonstrates substantial equivalence through similarity to predicate devices and general statements about laboratory testing confirming functionality and conformance to design requirements and special controls guidance, rather than presenting specific quantitative acceptance criteria or detailed study results.

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3i Dental Implant Systems are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Implant Innovation's dental implant systems are available in a wide range of diameters and lengths. 3i implants include screw-form (i.e., threaded) or cylinder; are manufactured from titanium; and are coated or non-coated. The OSSEOTITE® brand implants have a special dual acid-etched treatment process to increase surface roughness.

The provided text is a U.S. FDA 510(k) summary for a dental implant system. It outlines the device, its indications for use, and a comparison to predicate devices, ultimately leading to a substantial equivalence determination.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification, not a clinical study report. It focuses on demonstrating substantial equivalence to existing devices, which is a different type of evaluation than proving a device meets specific performance criteria through a dedicated study.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

The proposed OSSEOTITE® implants are identical to the predicate implants currently on the market, K983347, K980549, K935544.

The provided 510(k) summary for the OSSEOTITE® Dental Implants does not describe an AI/ML powered device, therefore, many of the requested details about acceptance criteria, study methods, and ground truth are not applicable. This document is a summary for a traditional medical device (dental implants) and focuses on substantial equivalence to predicate devices rather than performance metrics typically associated with AI.

However, I can extract the relevant information presented in the document pertaining to the closest equivalent of "acceptance criteria" and the study that supports it.

Acceptance Criteria and Reported Device Performance

Detailed Study Information (where applicable and extractable)

1. Sample size used for the test set and the data provenance:

   • Sample size: Not explicitly stated. The document refers to a "meta-analysis of clinical data" and "a second analysis" but does not provide the number of patients or implants included in these analyses.
   • Data provenance: Not explicitly stated. It is inferred that the data is clinical, but the country of origin, whether retrospective or prospective, is not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. The "ground truth" here is implied to be clinical outcomes (implant survival), which would be derived from patient data, not expert consensus on an image or diagnostic output.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or diagnostic assessments. This study relies on clinical outcomes data.

4. 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 is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

   • Clinical outcomes data (specifically, long-term cumulative survival of dental implants).

7. The sample size for the training set:

   • Not applicable/Not provided. Dental implants do not typically have "training sets" in the context of AI/ML. The "meta-analysis of clinical data" would represent the overall dataset analyzed for the study.

8. How the ground truth for the training set was established:

   • Not applicable. The "ground truth" (clinical survival) would have been established through follow-up observations of patients who received the implants in clinical studies. The details of how this was measured (e.g., specific criteria for survival, follow-up period) are not provided in this summary.

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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.

Not Found

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.

• 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):

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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."

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