(65 days)
The intended use of the Replace HA Coated Implants is for restoring chewing function by serving as anchorage for dental restorations. The Replace HA Coated Implant is both for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Replace™ HA Coated Implant is to serve as a support for prosthetic devices to restore a patient's chewing function. The available diameters are 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with lengths of 10 mm, 13 mm, and 16 mm. The titanium alloy implant has an HA coating on the root form portion to within approximately 2 mm of the top.
The provided text describes a 510(k) summary for the Replace™ HA Coated Implant by Nobel Biocare USA, Inc. The document focuses on establishing substantial equivalence for an expanded Indications for Use of an already marketed device, rather than introducing a completely new device or new technology. Therefore, the information regarding acceptance criteria and a detailed study proving the device meets those criteria, as typically seen in efficacy studies for novel devices, is not present in this submission.
Here's a breakdown of the available information in relation to your request, highlighting what is present and what is not:
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Acceptance Criteria and Reported Device Performance: This section is not applicable in the traditional sense of a clinical performance study with predefined primary and secondary endpoints. The submission is for an expanded indication of an existing device.
- Acceptance Criteria: No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are stated. The "acceptance criterion" in this context is the FDA's determination of substantial equivalence, meaning the expanded indications are "as safe and effective as the original Indications for Use."
- Reported Device Performance: The document states, "Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use." No specific performance metrics (e.g., success rates, complication rates) are provided in this summary.
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Sample Size, Ground Truth, and Adjudication for Test Set: This information is not provided in the 510(k) summary. A 510(k) summary for an expanded indication, particularly for a device like a dental implant, often relies on existing clinical data from the predicate device and potentially post-market surveillance data, rather than a new, dedicated, prospective clinical trial with a specific test set.
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MRMC Comparative Effectiveness Study: An MRMC study is not applicable here as this is a physical medical device (dental implant), not an AI/software-based diagnostic tool.
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Standalone Performance: Not applicable for a physical medical device.
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Type of Ground Truth Used: The term "ground truth" is not explicitly used or defined in the context of this submission. The "clinical results" mentioned imply a reliance on real-world outcomes associated with the predicate device and potentially additional clinical observations supporting the expanded indications.
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Sample Size for Training Set: Not applicable in the context of a 510(k) for a physical medical device's expanded indications.
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How Ground Truth for Training Set Was Established: Not applicable.
Summary of available information as per your request:
| Information Category | Details from the Document |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | Acceptance Criteria: "Substantial equivalence" to the currently marketed device regarding safety and effectiveness for the expanded Indications for Use. |
| Reported Performance: "Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use." (No specific numerical data provided in this summary) | |
| 2. Sample size and data provenance for test set | Not provided. The submission refers to "Clinical results" without specifying the test set details. |
| 3. Number of experts and qualifications for ground truth (test set) | Not provided. |
| 4. Adjudication method for the test set | Not provided. |
| 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study | Not applicable; this is a physical dental implant, not an AI/software device. |
| 6. Standalone (algorithm only) performance study | Not applicable; this is a physical dental implant. |
| 7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) | Implied: "Clinical results" and potentially outcomes data from the predicate device. Specific methodology for establishing "ground truth" in this context is not detailed. |
| 8. Sample size for the training set | Not applicable; this submission is for an expanded indication of an existing physical device, not an AI model. |
| 9. How ground truth for the training set was established | Not applicable. |
In conclusion, this 510(k) summary focuses on demonstrating that an expanded indication for an existing dental implant is as safe and effective as the original indication, relying on existing "clinical results" rather than a new, detailed clinical study with specific acceptance criteria and performance metrics for a novel technology.
§ 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.