(88 days)
The BioHorizons Maestro System™ is indicated for use as an artificial root structure for single tooth replacement or as abutments for bridgework and denture retention in the mandible and maxilla.
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 bone growth and interface maintenance over the long-term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, and D4) and bone volume classification (Division A, B, and C-h) in the mandible and maxilla. Four implant designs, corresponding to each bone density and bone volume classification, are available in 3.5, 4.0,and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, is available in several lengths and may feature a titanium plasma-spray (TPS) or hydroxyapatite (HA) coating.
The provided text describes a 510(k) premarket notification for the BioHorizons Maestro System™, an endosseous implant system. The evaluation details focus on mechanical testing, not on clinical performance or AI algorithm effectiveness. Therefore, many of the requested criteria cannot be directly addressed.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes product evaluation consisting of "mechanical testing of the implant and bioactive coating mechanical tests." It then states that these analyses "indicate The Maestro System™ should be safe and effective when used as intended."
However, the document does not explicitly state specific acceptance criteria in a quantitative or qualitative manner (e.g., minimum tensile strength, maximum wear rate). It also does not provide a table of reported device performance metrics against such criteria. The closest information to performance is the general statement about biomechanical performance optimization, but no specific data is presented.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "mechanical testing of the implant and bioactive coating mechanical tests."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable in this context. The "ground truth" for mechanical testing in device evaluation would typically refer to established engineering standards and measurements, not expert clinical interpretation.
4. Adjudication Method for the Test Set:
This question is not applicable in this context as the evaluation involved mechanical testing, not human-read test sets requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study was mentioned. The device is a physical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone algorithm performance study was done. The device is a physical implant, not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device evaluation would be based on engineering standards and measurements derived from mechanical testing, ensuring the implant meets specified strength, fatigue, and other material properties for its intended use. The document doesn't explicitly name the specific standards or measurements used (e.g., ASTM standards for implant materials), but implies their use through the mention of "mechanical testing."
8. The Sample Size for the Training Set:
This question is not applicable. The device is a physical implant; there is no "training set" in the context of AI development. The design of the implants is based on biomechanical principles and bone density classifications, which would stem from scientific understanding and potentially prior clinical data, but not in the sense of an AI training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as above.
Summary of what cannot be addressed from the provided text:
Due to the nature of the device (a physical endosseous implant) and the type of evaluation described (mechanical testing for safety and effectiveness), most of the questions relating to AI performance metrics, expert adjudication, ground truth establishment for AI models, and training/test set sample sizes (in the context of AI) are not applicable. The document focuses on the physical and material properties of the implant system and its substantial equivalence to previously cleared devices.
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SEP 1 6 1997
BioHorizons Implant Systems, Inc. 510(K) Notification June 18, 1997
510(k) Summary of Safety and Effectiveness
Proprietary Name 4 1 .
The Maestro System™
Common Name - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Uncoated and titanium plasma spray coated screw-form implants
Classification Name
Endosseous implants, surgical components, and prosthetic attachments
Classification
Class III
Official Contact
R. Steven Boggan, M.S., M.B.A. President and Chief Operating Officer BioHorizons Implant Systems, Inc. 2129 Montgomery Highway Birmingham, AL 35209 (205) 871-1345 FAX (205) 870-0304
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Device Description
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 bone growth and interface maintenance over the long-term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, and D4) and bone volume classification (Division A, B, and C-h) in the mandible and maxilla.
Four implant designs, corresponding to each bone density and bone volume classification, are available in 3.5, 4.0,and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, is available in several lengths and may feature a titanium plasma-spray (TPS) or hydroxyapatite (HA) coating. The following table provides a comprehensive summary of implant diameter, length, and coating.
| Diameter (mm) | Design | Lengths (mm) | Coating |
|---|---|---|---|
| $3.5 | D2 | 9, 12, 14 | Uncoated |
| D3 | 9, 13, 15 | TPS | |
| $4.0 | D1 | 10, 12 | Uncoated |
| D2 | 9, 11, 13 | Uncoated | |
| D3 | 9, 12, 14 | TPS | |
| D4 | 9, 13, 15 | HA | |
| $5.0 | D1 | 9, 11 | Uncoated |
| D2 | 9, 10, 12 | Uncoated | |
| D3 | 9, 11, 13 | TPS | |
| D4 | 9, 12, 14 | HA |
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Product Evaluation
Evaluation of The Maestro System™ consisted of mechanical testing of the implant and bioactive coating mechanical tests. These analyses indicate The Maestro System™ should be safe and effective when used as intended.
Indications
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.
Substantial Equivalence Information
The Maestro System™ is substantially equivalent in all features which could affect safety or effectiveness to the BioHorizons Dental Implant System (K964330) and the Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants.
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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. R. Steven Boggan President and Chief Operating Officer BioHorizons Implant Systems, Incorporated 2129 Montqomery Highway Birmingham, Alabama 35209
Re: K972313 The Maestro System™ Trade Name: Requlatory Class: III Product Code: DZE Dated: June 18, 1997 Received: June 20, 1997
Dear Mr. Boggan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Boggan
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricio Cucurella ffc
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K9723)3
Device Name: BioHorizons Maestro System™
Indications for Use:
The BioHorizons Maestro System™ is indicated for use as an artificial root structure for single tooth replacement or as abutments for bridgework and denture retention in the mandible and maxilla.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rump
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use
(per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.