(84 days)
The plates are intended for use in patients requiring craniofacial reconstruction of the internal orbit. These plates provide structure and support to the orbital walls and/or floor when anatomical reconstruction of the internal orbit is necessary.
The Orbital Reconstruction Plates are a series of plates made from titanium with different configurations and thicknesses. The configurations vary to accommodate the level of reconstruction required or the patient's anatomy. The difference in thickness provides the necessary support for the internal orbit based on the type and extent of reconstruction required. The screws used with plates were previously cleared under various premarket notifications.
This 510(k) submission (K973982) for Orbital Reconstruction Plates does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way described in your request.
Medical devices such as these orbital reconstruction plates, which are cleared via the 510(k) pathway, usually demonstrate substantial equivalence to a legally marketed predicate device. This typically involves comparing the new device's intended use, materials, design, and operational principles to those of the predicate device, rather than conducting a new effectiveness study with specific acceptance criteria as you've outlined.
Here's a breakdown of why your specific questions cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This document explicitly states, "The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to other predicate devices...". It does not describe any specific performance metric, acceptance criteria, or a study that measures and reports the device's performance against such criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, clinical data, or study data is mentioned.
- 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): No ground truth establishment or expert review is mentioned, as no study was described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or study is described.
- 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: This device is a passive implantable medical device (bone plates), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI assistance are not relevant to this product.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no study or ground truth establishment is described.
- The sample size for the training set: Not applicable, as no training set or machine learning components are involved.
- How the ground truth for the training set was established: Not applicable, as no training set or machine learning components are involved.
In summary: The provided 510(k) summary for the Orbital Reconstruction Plates focuses on establishing substantial equivalence to predicate devices based on design and intended use, not through performance studies with predefined acceptance criteria. This is a common approach for many Class II medical devices, especially those that are analogous to existing technologies.
{0}------------------------------------------------
510(k) Summary
July 12 1998
| Proprietary Name: | Orbital Reconstruction Plates |
|---|---|
| Common Name: | Bone Plates |
| Classification Name | Single/Multiple Component Metallic Bone Fixation |
| Reference: | Appliances and Accessories (21 CFR 888.3030) |
| Proposed Regulatory Class: | II |
| Device Product Code: | 87HRS |
Vivian Kelly For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
The Orbital Reconstruction Plates are a series of plates made from titanium with different configurations and thicknesses. The configurations vary to accommodate the level of reconstruction required or the patient's anatomy. The difference in thickness provides the necessary support for the internal orbit based on the type and extent of reconstruction required. The screws used with plates were previously cleared under various premarket notifications.
The plates are intended for use in patients requiring craniofacial reconstruction of the internal orbit. These plates provide structure and support to the orbital walls and/or floor when anatomical reconstruction of the internal orbit is necessary.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to other predicate devices used for orbital reconstruction plates such TiMesh's Titanium Mesh Tilghman Orbit Liner and Synthes' Universal Orbital Floor Plate.
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, with three abstract shapes that could be interpreted as wings or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Ms. Vivian Kelly · Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K973982 Orbital Reconstruction Plates Trade Name: Regulatory Class: II Product Code: HRS Dated: October 16, 1997 Received: October 20, 1997
Dear Ms. Kelly:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{2}------------------------------------------------
Page 2 - Ms. Vivian Kelly
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 ene rogalacion Chercross, "Mobianany" (2) 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Calvin M. Whittier, Ph.D., M.
-Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): |<973982
Device Name: Orbital Reconstruction Plates
Indications for Use:
The plates are intended for use in patients requiring craniofacial reconstruction of the internal orbit. These plates provide structure and support to the orbit walls and/or floor when anatomical reconstruction of the internal orbit is necessary.
(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 General Restorative Devices
| 510(k) Number | K973902 |
|---|---|
| --------------- | --------- |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.