(26 days)
The Bioplate® Riqid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The supplementary label/labeling material will be used for training and promotional purposes and does not affect the intended use of the devices.
The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and are used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.
The provided text is a 510(k) premarket notification for a medical device – The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery. This document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a robust clinical trial with AI would.
Therefore, many of the requested sections (e.g., AI performance, MRMC study, ground truth for training data) are not applicable to this type of submission. The document relies on a comparison of characteristics and intended use to predicate devices that were already legally marketed.
Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or device performance measurements in the typical sense of a clinical study. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the predicates.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Same Indications for Use as predicate devices | "The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surqery has the same indications for use as the Bioplate, Inc., Walter Lorenz, Synthes USA, Osteomed Corp., and KLS-Martin predicate devices." |
| Similar Technological Characteristics to predicate devices | "All of the technical characteristics of the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are substantially equivalent to the corresponding characteristics of the predicate devices." |
| No New Issues of Safety and Efficacy | "...any minor differences raise no new issues of safety and efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission does not describe a clinical "test set" in the context of evaluating a new performance claim or an AI algorithm’s accuracy. Substantial equivalence is typically demonstrated through bench testing (mechanical properties, material composition, etc.) and comparison to predicate devices, rather than a prospective clinical study with a patient test set for performance comparison. The document does not provide details on specific bench tests conducted or the data generated from them beyond general statements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As there is no "test set" for performance evaluation against a ground truth in the context of an AI device, this information is not provided. The 'ground truth' here is essentially established by the historical performance and regulatory approval of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No "test set" and corresponding adjudication method are described for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a physical medical implant (bone plating system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in the context of this 510(k) submission is the established safety and efficacy of the predicate devices already on the market. The Bioplate® system is deemed safe and effective because it is substantially equivalent to these already accepted devices. This is a regulatory "ground truth" rather than a clinical ground truth like pathology or outcomes data for a novel performance claim.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI algorithm or training set for this device.
In summary, this 510(k) submission for The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery demonstrates substantial equivalence to existing predicate devices by showing it has the same intended use and similar technological characteristics, raising no new safety or efficacy concerns. The requested information regarding acceptance criteria, study details, and AI performance metrics are primarily relevant for AI/ML-based medical devices or devices demonstrating novel clinical performance, which this implantable device is not.
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Summary of Safety and Effectiveness
Submitter's name, address, telephone number and contact person:
Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA 90016 (310) 815-2100 (310) 815-2126 (fax)
Carol E. Jones Contact Person:
Trade Name of Device
- The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Common name
Bone plates and bone screws
Classification name
Bone Plate (21 CFR 872.4760)
Predicate Devices
- Walter Lorenz Surgical Instruments, Inc. (1) Lorenz Self Drilling Screw K013954
- Synthes (USA) (2) Self Drilling Screw K983485
- KLS-Martin L.P. (3) Centre-Drive Drill Free Screw K971297
- Osteomed Corp. (4) Auto-Drive Bone Screw K974785
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- (5) Bioplate. Inc.
Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surqery K972463/K022890
Description of the device
The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and are used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.
Intended used of the device
The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation, and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The supplementary label/labeling will be used for training and promotional purposes and does not affect the intended use of the devices.
Comparison of the devices' technological characteristics with those of predicate devices
The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surqery has the same indications for use as the Bioplate, Inc., Walter Lorenz, Synthes USA, Osteomed Corp., and KLS-Martin predicate devices. All of the technical characteristics of the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 8 2003
Ms. Carol E. Jones Chief Operating Officer Bioplate, Incorporated 3643 Lenawee Avenue Los Angeles, California 90016-4310
Re: K030806
Trade/Device Name: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 12, 2003 Received: March 13, 2003
Dear Ms. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Jones
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Suser Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K030806 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
The Bioplate® Rigid Fixation Bone Plating System for Device Name: Craniomaxillofacial Surgery.
Indications for Use:
The Bioplate® Riqid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The supplementary label/labeling material will be used for training and promotional purposes and does not affect the intended use of the devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use_(Optional Format 1-2-96) |
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Anesthesiology, General Hospital, | |||
| Infection Control, Dental Devices | |||
| 510(k) Number. | K030806 |
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.