(123 days)
The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.
The FIXTURE ORIGINAL consists of 4 implants, diameter 3,75 mm, and length from 8,5 to 15 mm.
The provided text describes a 510(k) submission for the "FIXTURE ORIGINAL" endosseous implant. However, it does not include detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the way typically expected for performance-based medical device submissions.
Instead, this submission primarily relies on substantial equivalence to a predicate device (Nobel Biocare AB standard fixture RP with a diameter of 3.75 mm). The core argument is that because the FIXTURE ORIGINAL is similar in material, dimensions, and intended use to the predicate device, further testing "will not raise new issues of safety and efficacy."
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined with specific metrics) | The submission argues that due to substantial equivalence in material, dimensions, and intended use to the predicate device, the FIXTURE ORIGINAL performs similarly. The predicate device (Nobel Biocare Standard Fixture) is indicated "To be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patients chewing function." The FIXTURE ORIGINAL has an identical intended use statement. |
- Explanation: The document does not define specific performance acceptance criteria (e.g., minimum tensile strength, fatigue life, osseointegration rates, etc.) for the FIXTURE ORIGINAL itself, nor does it present specific performance data against such criteria. The entire premise of the submission is that the device's characteristics are so similar to a legally marketed predicate that specific new performance testing is deemed unnecessary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided. The submission relies on substantial equivalence and does not describe a new performance test set for the FIXTURE ORIGINAL.
- Data Provenance: Not applicable / Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No new test set or ground truth determination described for the FIXTURE ORIGINAL.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No new test set or ground truth determination described.
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
- MRMC Study: No. This is a submission for an endosseous implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for the FIXTURE ORIGINAL itself in this submission. The "ground truth" for the submission's argument is the established safety and effectiveness of the predicate device based on its existing regulatory clearance.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of the Submission's Approach:
The K021355 submission for the Brånemark Integration AB FIXTURE ORIGINAL relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nobel Biocare Standard Fixture, K925765). The argument is built on the following points:
- Identical Intended Use: Both devices share the same intended use for permanent anchorage of prosthetic devices and restoring chewing function.
- Similar Dimensions: The FIXTURE ORIGINAL's dimensions (diameter 3.75mm, length 8.5-15mm) fall within the range of the predicate device (diameter 3.75mm, length 7-20mm).
- Similar Material: Although not explicitly stated as "identical material" in the provided text, the phrase "substantially equivalent to Nobel Biocare Standard Fixture in material, dimensions, and intended use" strongly implies material similarity.
- Previous Testing of Predicate: The submission refers to existing "mechanical testing requested for Screw-type Endosseous Implants as described in the Guideline 'Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants', dated December 9, 1996," completed for the predicate device.
The conclusion drawn by Brånemark Integration AB is that "further testing will not raise new issues of safety and efficacy" because of this substantial equivalence. The FDA concurred with this assessment, granting 510(k) clearance based on this argument, not on new performance data for the FIXTURE ORIGINAL.
§ 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.