(15 days)
The Maestro System™ may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention. The Indication/Intended use of the modified device, the Maestro System™, as described in its labeling has not changed.
The proposed Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 4.0 mm and 5.0 mm, and in active thread area lengths of 9 mm, 12 mm, and 15 mm. The implant will have a polished collar length of 2 mm. The implant raw material is titanium alloy as specified in ASTM F136 -Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. The device is further processed by treating the surface with resorbable blast media (RBM) or coating with synthetic hydroxylapatite (HA). The product is packaged using materials known in the industry to be appropriate for medical device packaging and will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10°. The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality. Following five years of clinical use, this submission proposes offering an additional polished collar length and threaded area length to assist the dental practitioner in treatment planning and ease of use with the product. Three base implant designs, corresponding to each bone density classification (D1/D2, D3 and D4) will be available in 4.0 mm and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, will be available in three lengths and may feature a Resorbable Blast Media (RBM) surface treatment, or hydroxylapatite (HA) coating.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information, formatted as requested.
Important Note: The provided document (K020645) is a 510(k) summary for a dental implant. These summaries are primarily focused on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed clinical study proving specific acceptance criteria in the way a novel AI or diagnostic device might. Therefore, many of the requested fields (like sample size, number of experts, adjudication methods for ground truth, MRMC studies, standalone performance details, training set specifics) are not typically found in this type of document for a dental implant and are marked as "Not Applicable," "Not Provided," or "Not Relevant" below. The primary "study" for this device is testing to demonstrate equivalence in mechanical properties and biocompatibility.
Acceptance Criteria and Device Performance
There are no explicit "acceptance criteria" tables with numerical targets and corresponding "reported device performance" in the sense of a diagnostic algorithm's sensitivity or specificity. Instead, the acceptance is based on demonstrating substantial equivalence to a previously cleared predicate device. This substantial equivalence is established by showing that the modified device (The Maestro System™ with a 2mm polished collar length) has the same intended use, fundamental scientific technology, and similar technological characteristics (materials, design principles, manufacturing, sterilization) as the predicate. The "performance" is implicitly deemed acceptable if this substantial equivalence is established and the device maintains safety and effectiveness.
The document highlights the following characteristics of the proposed device, which, by virtue of being similar to the predicate, establish its "performance" for substantial equivalence:
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be the same as the predicate device: "may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention." | "The Indication/Intended use of the modified device, the Maestro System™, as described in its labeling has not changed." The device is intended for "mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention." |
| Fundamental Tech. | Must be the same as the predicate device. | "The Fundamental Scientific Technology of the modified device has not changed." It remains a screw-type dental implant. |
| Materials | Must be the same as or equivalent to the predicate, conforming to established standards. (e.g., ASTM F136 for Titanium alloy). | "The proposed Maestro System screw-type dental implant is a machined titanium, screw-form implant... The implant raw material is titanium alloy as specified in ASTM F136 -Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications." Coatings (RBM, HA) are also consistent with previously cleared devices. |
| Design Principles | Implants are designed to "optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term" based on bone quality (D1/D2, D3, D4). These principles are consistent across predicate and new device. | The "Three base implant designs, corresponding to each bone density classification (D1/D2, D3 and D4) will be available in 4.0 mm and 5.0 mm diameters." These designs are consistent with the "comprehensive system" described for the predicate. |
| Sterilization | Must sterilize to a minimum sterility assurance level of 10⁻⁶ and comply with relevant standards (ANSI/AAMI/ISO 11137). | "The product... will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10⁻⁶." |
| Change Specific | The new device must safely incorporate a 2mm polished collar length while maintaining overall length and other characteristics comparable to the predicate. | The "only change has been to increase the polished collar length to 2 mm. The overall length of the implant will remain unchanged." "All materials, suppliers, processing, packaging and sterilization methods remain the same." |
Study Details
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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: Not applicable/Not provided. This 510(k) is for a dental implant, not a diagnostic algorithm. The "test set" would primarily refer to bench testing for mechanical properties and biocompatibility. Details of such testing (e.g., number of implants tested for fatigue or tensile strength) are not included in this summary document.
- Data Provenance: Not applicable/Not provided in this summary. Bench testing data is typically generated in a lab setting. Clinical data, if any were submitted (which is generally not required for 510(k) substantiation based on minor design changes and substantial equivalence), would need specific provenance.
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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: Not applicable/Not provided. For a dental implant's mechanical and material properties, "ground truth" is established through standardized engineering tests and material specifications, not expert consensus on interpretations. The regulatory body (FDA) evaluates the submitted test data and documentation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not relevant. This type of adjudication is typically used for reconciling differing expert opinions in labeling or image interpretation, which is not the primary mode of evaluation for a physical medical device like an implant in a 510(k).
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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:
- MRMC Study: No. This is a physical dental implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI improvement metrics are not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a physical dental implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: For a dental implant, the "ground truth" for demonstrating safety and effectiveness for a 510(k) typically involves:
- Biocompatibility: Conformance to ISO 10993 series through testing or material equivalency.
- Mechanical Performance: Bench testing (e.g., fatigue, static strength, torque strength) according to relevant ISO/ASTM standards, demonstrating performance equivalent to or better than the predicate.
- Material Specifications: Conformance to ASTM or ISO standards for the raw materials.
- Sterilization Validation: Conformance to ISO 11137.
- The "Type of Ground Truth" here is primarily the adherence to these recognized standards and demonstrated performance in engineering and biological testing.
- Ground Truth Type: For a dental implant, the "ground truth" for demonstrating safety and effectiveness for a 510(k) typically involves:
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The sample size for the training set:
- Training Set Sample Size: Not applicable/Not relevant. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable/Not relevant. As this is not an AI device, there is no training set or associated ground truth.
§ 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.