(71 days)
The BioHorizons O-Ring Abutment System is intended to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.
The O-ring Abutment System is either a one-piece or a two-piece restorative prosthesis that provides a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.
This document describes a 510(k) submission for the BioHorizons O-Ring Abutment System, a Class III medical device. The submission focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, the information provided below will reflect this specific regulatory pathway.
Acceptance Criteria and Device Performance
The provided document does not specify quantitative acceptance criteria with corresponding reported device performance metrics in the format of a typical performance study for AI/software devices. Instead, the "acceptance criteria" can be inferred from the regulatory requirement of demonstrating substantial equivalence to predicate devices, and the "reported device performance" is a qualitative affirmation of meeting the stated intended use.
Inferred "Acceptance Criteria" and "Reported Device Performance" from the 510(k) Summary:
| Acceptance Criteria (Inferred from Intended Use and Equivalence Claim) | Reported Device Performance (from "Product Evaluation" Section) |
|---|---|
| Provides a direct attachment for tissue-supported overdentures. | "found to provide a direct attachment for tissue-supported overdentures" |
| Retains overdentures with two or more implants. | "retained by two or more implants" |
| Accommodates implants with up to a 10-degree divergence. | "with up to a 10-degree divergence" |
| Safe when used as intended. | "should be safe... when used as intended." |
| Effective when used as intended. | "should be effective... when used as intended." |
| Substantially equivalent in all features affecting safety and effectiveness to predicate devices (Lifecore Biomedical, SteriOss, and Implant Innovations O-Ring Abutment Systems). | "substantially equivalent in all features that could affect the safety and effectiveness to the Lifecore Biomedical, SteriOss, and Implant Innovations, O-Ring Abutment Systems." |
Study Information
The provided document describes a 510(k) premarket notification for a Class III device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to establish novel performance metrics against pre-defined acceptance criteria with quantified results like sensitivity/specificity for AI/software.
Based on the provided text, the "study" conducted was primarily a product evaluation focused on demonstrating that the device meets its stated intended use and is substantially equivalent to existing predicate devices.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify a quantifiable "test set" sample size in terms of number of patients or abutments. The evaluation involved "laboratory conditions" and feedback from "consulting implantologists and oral and maxillofacial surgeons." This suggests a qualitative, rather than quantitative, assessment related to real-world usage and expert opinion.
- Data Provenance: Not explicitly stated, but the evaluation by "consulting implantologists and oral and maxillofacial surgeons" implies a clinical context, likely within the US given the submission to the US FDA. The evaluation would have been prospective in nature, as it involved evaluating the new device.
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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: The document refers to "consulting implantologists and oral and maxillofacial surgeons" (plural), indicating more than one expert. A specific number is not provided.
- Qualifications: "Implantologists and oral and maxillofacial surgeons" are highly qualified clinical specialists in the field of dental implants and associated prosthetics. Their experience level is not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe a formal adjudication method for ground truth establishment, which is typical for qualitative evaluations in 510(k) substantial equivalence submissions for mechanical devices. The phrase "and has been found" suggests a consensus or agreement among the evaluators, rather than a structured adjudication process.
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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 MRMC study was done. This is a mechanical medical device (dental abutment), not an AI/software device. Therefore, a multi-reader, multi-case comparative effectiveness study with or without AI assistance is not applicable and was not performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a mechanical component (an abutment for dental implants) and does not involve any algorithms or AI. "Standalone performance" in the context of AI does not apply here.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was established through expert consensus/opinion by "consulting implantologists and oral and maxillofacial surgeons" combined with laboratory conditions (likely bench testing or mechanical evaluations). The goal was to confirm the device's ability to perform its intended mechanical function.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. Therefore, there is no "training set" in the conventional sense. Device design and development are based on engineering principles and preclinical testing, not on data training.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/machine learning model, this question is irrelevant to the BioHorizons O-Ring Abutment System.
§ 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.