(81 days)
External Fixation is useful in many areas of orthopedic surgery. Following are the major categories of application:
-
- Limb salvage from traumatic injury.
-
- Fracture treatment (i.e. long bone fracture, including the tibia, femur, humerous, radius, and ulnar bones).
-
- Reconstruction of extremities with deformity and dysfunction.
- Arthrodesis.
The surgeon must carefully evaluate the purpose for external fixation in the individual patient if the treatment is to be successful. Consideration should be given to the following factors necessary for the successful application of an external fixator. Fracture osteotmy stability, soft tissue viability, adjacent function or injury, and functional demands of the patient.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Alphatec Wire External Fixation System. This type of document declares "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a device already on the market.
It is important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not necessarily on presenting a comprehensive study with acceptance criteria and a detailed performance study in the way a Premarket Approval (PMA) application would.
Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, and detailed study methodologies is not explicitly present in the provided FDA letter or its enclosed "Indications for Use" statement. The letter refers to the "510(k) premarket notification" as containing the description of the device and how it was deemed substantially equivalent. The detailed study data would be within that notification, not in the FDA's summary letter itself.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the FDA letter. For a 510(k), compliance with predicate device characteristics and relevant standards (e.g., mechanical strength, biocompatibility) would be assessed. The letter does not specify quantitative acceptance criteria or reported device performance metrics in a tabular format.
2. Sample size used for the test set and the data provenance:
This information is not provided in the FDA letter. 510(k) submissions typically include bench testing, and sometimes animal or limited clinical data if necessary to demonstrate equivalence or address specific safety concerns. The letter does not detail any such specific study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the FDA letter.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the FDA letter.
5. 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 is not applicable to the Alphatec Wire External Fixation System, which is a physical orthopedic device, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as it's a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the FDA letter. For a 510(k) for a physical device, substantial equivalence is often based on design, materials, and performance characteristics compared to a predicate, as well as adherence to relevant standards. The "ground truth" would implicitly be the established safety and efficacy of the predicate device under its intended use.
8. The sample size for the training set:
This information is not provided in the FDA letter. As this is a physical device, there would not be a "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established:
This information is not provided in the FDA letter. Again, this concept is not directly applicable to a physical medical device.
In summary, the provided FDA letter for the Alphatec Wire External Fixation System is a declaration of substantial equivalence based on a 510(k) submission. It does not contain the detailed study data, acceptance criteria, or performance metrics in the format you've requested. Such information would be contained within the larger 510(k) submission document itself, which is not provided here. The letter confirms that the device is deemed substantially equivalent to legally marketed predicate devices for the stated "Indications for Use" (limb salvage, fracture treatment, reconstruction of extremities, arthrodesis). The approval assumes compliance with good manufacturing practices and other general controls.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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متر
MAY 2 7 1998
Mr. Dan L. Pastrick Director of Operations Alphatec Manufacturing, Inc. 42-160 State Street Palm Desert, California 92211
K980788 Re : Alphatec Wire External Fixation System Trade Name: Requlatory Class: II Product Code: JDW Dated: March 2, 1998 Received: March 2, 1998
Dear Ms. Pastrick:
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 enolosure) 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. ਜੋ 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 regulations.
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Page 2 - Mr. Dan L. Pastrick
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 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,
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
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510 (k) NUMBER (IF KNOWN): K980788
DEVICE NAME: Alphatec Wire External Fixation System
INDICATIONS FOR USE:
External Fixation is useful in many areas of orthopedic surgery. Following are the major categories of application:
-
- Limb salvage from traumatic injury.
-
- Fracture treatment (i.e. long bone fracture, including the tibia, femur, humerous, radius, and ulnar bones).
-
- Reconstruction of extremities with deformity and dysfunction.
- Arthrodesis. ----------
The surgeon must carefully evaluate the purpose for external fixation in the individual patient if the treatment is to be successful. Consideration should be given to the following factors necessary for the successful application of an external fixator. Fracture osteotmy stability, soft tissue viability, adjacent function or injury, and functional demands of the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use N (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
cooe
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980788
.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.