(86 days)
BioHorizons Single-stage Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.
BioHorizons Single-stage Implants may be restored immediately with a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.
BioHorizons Single-stage Implants are machined titanium, screw-form endosseous implants supplied in 3.5mm, 4.0mm, 5.0mm, 6.0mm diameters across lengths of 9mm, 10.5mm, 12mm and 15mm. Implant material is titanium alloy as specified ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-6, validated in compliance to ANSI / AAMI / ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The BioHorizons Single-stage Implant System includes a series of implant catalog item numbers with Laser-Lok® technology applied to the implant collar to provide additional treatment options for the dental implant clinician.
The provided document is a 510(k) Premarket Notification for the BioHorizons Single-stage Implant System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed study results as one might find for a novel drug or a high-risk medical device.
Therefore, the document does not contain the specific information requested regarding acceptance criteria, a standalone study to prove meeting acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.
Here's why and what information can be extracted:
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No Acceptance Criteria or Performance Metrics: For a 510(k) submission, the primary goal is to show that the new device (BioHorizons Single-stage Implant System in this case) is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (materials, design, intended use, sterilization methods) and citing existing regulatory approvals for the predicate device, rather than setting and meeting new performance acceptance criteria through a specific study in the way a drug or novel biologic might.
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No Dedicated "Study" in the Requested Format: The document doesn't describe a stand-alone prospective or retrospective study designed to test the device against specific performance acceptance criteria. Instead, it relies on the established safety and effectiveness of the predicate devices.
Let's address the specific points based on what can be inferred or what is explicitly stated in the document, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal for 510(k): Substantial Equivalence to Predicate Devices | The BioHorizons Single-stage Implant System is deemed "substantially equivalent" to its predicate devices (BioHorizons Single-stage Implant System K053152 and BioHorizons Tapered Internal Implant System K071638). This implies that its safety and effectiveness are comparable to devices already legally marketed. |
| Material Composition | Acceptance: Conforms to ASTM F136 (Wrought Titanium-6Aluminum-4Vanadium ELI Alloy) and ASTM F1185 (Composition of Ceramic Hydroxylapatite for Surgical Implants) for coatings. |
| Performance: Uses titanium alloy as specified and may have tricalcium phosphate or hydroxylapatite coating conforming to these standards. | |
| Sterility Assurance Level (SAL) | Acceptance: Minimum SAL of 10^-6. |
| Performance: Validated in compliance with ANSI / AAMI / ISO 11137-1 for a minimum SAL of 10^-6. | |
| Intended Use | Acceptance: Use in mandible/maxilla as artificial root for single tooth replacement, fixed bridgework, and dental retention. Also, immediate restoration with temporary prosthesis (not in functional occlusion) or when splinted/stabilized by multiple implants. |
| Performance: The new device shares the same intended use. | |
| Technological Characteristics | Acceptance: Substantially equivalent to predicate in terms of materials, suppliers, processing, packaging, sterilization, and the Laser-Lok feature. |
| Performance: All these aspects "remain the same as for the predicate" or the Laser-Lok feature is "substantially equivalent." | |
| Safety and Effectiveness | Acceptance: To be as safe and effective as the predicate devices. |
| Performance: The FDA's substantial equivalence determination implies it meets this criterion, based on the comparison to predicate devices. |
The subsequent points (2-9) are largely not applicable in the context of this 510(k) submission, as it isn't a clinical trial demonstrating performance against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No dedicated "test set" or clinical study with a specific sample size is mentioned. The submission relies on the established performance of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set was established as part of this submission framework.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or expert adjudication process is described here.
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: Not applicable. This device is a dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a new performance study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and clinical use.
8. The sample size for the training set: Not applicable. No "training set" is mentioned as this is not an algorithm being developed.
9. How the ground truth for the training set was established: Not applicable. Same as above.
§ 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.