(90 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.
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.
Here's an analysis of the provided text regarding the Nobel Biocare Replace™ HA Coated Implant (K020646) and the study proving its acceptance criteria:
Summary of Device and Acceptance Criteria Information:
The provided documents are a 510(k) summary and the FDA's clearance letter for the Nobel Biocare Replace™ HA Coated Implant. It describes the device, its intended use, and the FDA's determination of substantial equivalence to previously marketed devices. This clearance (K020646) is specifically for an expanded indication for use, rather than for a new, de novo device.
This means that the acceptance criteria are primarily related to demonstrating that the expanded indication (immediate placement and function in good quality bone) is as safe and effective as the original indications for use, without significant changes to the device's technological characteristics. The "study that proves the device meets the acceptance criteria" is a clinical study that assesses the safety and effectiveness of the device under this expanded indication.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as predicate devices for expanded indications. | "Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use." (K020646, page 1) The FDA clearance letter's determination of substantial equivalence (K020646, page 2) implies that the device meets safety standards for its expanded use. |
| Effectiveness: Device is as effective as predicate devices for expanded indications. | "Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use." (K020646, page 1) The device is cleared for its stated indications: "restoring chewing function by serving as anchorage for dental restorations," now including immediate placement and function. |
| Technological Characteristics: No significant change in device design or materials. | "The technological characteristics of the Replace HA Coated Implants remained unchanged. No design modification was made." (K020646, page 1) |
Important Note: The provided document is a 510(k) summary, which is a high-level overview. It typically does not contain the detailed data of the clinical study itself, but rather summarizes its conclusions. The specific quantitative metrics for "safety" and "effectiveness" (e.g., survival rates, bone loss thresholds) would be found in the full 510(k) submission, which is not publicly available in this snippet. The FDA's clearance implicitly confirms these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states "Clinical results show...", but does not specify the sample size of the clinical study (test set) conducted.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study for FDA clearance, it's highly likely to be a prospective clinical trial, though this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the test set. This type of detail is typically found in the full clinical study report, not in the 510(k) summary.
4. Adjudication Method for the Test Set:
- The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance:
- This question is not applicable to the provided document. The device is an endosseous dental implant, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance. The "study" here refers to clinical performance of the physical implant in patients.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- This question is not applicable. The device is a physical dental implant, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for a dental implant clinical study would be direct clinical observations and measurements over time, typically including:
- Clinical outcomes data: Implant survival rates, success rates (based on criteria like absence of mobility, absence of peri-implant radiolucency, absence of pain/infection).
- Radiographic analysis: Bone level changes around the implant.
- Patient-reported outcomes: Functionality, comfort, aesthetics.
- Pathology (if applicable): Though less common for a full study, biopsies might be used in specific research scenarios.
- The document generically refers to "Clinical results," implying a collection of these types of direct clinical performance measures.
8. The Sample Size for the Training Set:
- This question is not explicitly applicable in the context of this 510(k) for a physical medical device. "Training set" usually refers to data used to train an AI algorithm. For a physical implant, there isn't a "training set" in the same sense.
- However, if interpreted as previous clinical experience/data that informed the device's design and original indications, the document states the device builds upon earlier models (K962845 and K973423), implying a history of clinical data from these predicate devices. The clinical data informing the current expanded indication would be from the study mentioned under item 1.
9. How the Ground Truth for the Training Set Was Established:
- Similar to item 8, this question is not directly applicable to a physical implant. The "ground truth" for the predicate devices would have been established through their own clinical trials and post-market surveillance.
§ 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.