(75 days)
The intended use of the external fixation device is the same as that expressed in the predicate device 510k.
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Here's an analysis of the provided text regarding acceptance criteria and study information for the Avanta Orthopaedics External Fixator.
Important Note: The provided document is a 510(k) summary for a medical device (external fixator). 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies in the way an AI/ML device or a novel therapeutic might. Therefore, many of the requested fields related to AI/ML device evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies) will not be applicable to this traditional device submission.
Acceptance Criteria and Device Performance for Avanta Orthopaedics External Fixator
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Avanta Orthopaedics) |
|---|---|---|
| Intended Use | Unilateral external fixation for limb lengthening, osteotomies, arthrodesis, fracture fixation, and other amenable bone conditions (as per EBI/Orthofix K831576 predicate). | Same as predicate device. |
| Device Type | External Fixator | External Fixator |
| Pin Type | Implantable | Implantable |
| Compression/Distraction | Allows for application of both compression and distraction. | Yes, allows for application of compression or distraction. |
| Pin Length Range | 80-160 mm (EBI/Orthofix) | 50-90 mm (Avanta Orthopaedics) - This is a difference noted but deemed acceptable for substantial equivalence. |
| Components | Includes various size frames, bars, pin clamps, pins, accessories, and instruments to accommodate anatomies and injuries. | Includes various size frames, bars, pin clamps, pins, accessories, and instruments. |
| Material | Smooth or threaded metallic bone fixation fastener. | Smooth or threaded metallic bone fixation fastener (implied, as this is a general characteristic of the product code). |
| Classification | Class II (Orthopaedic, Product Code JWD) | Class II (Orthopaedic, Product Code JWD) |
Study Proving Device Meets Acceptance Criteria:
The document describes a substantial equivalence determination based on a comparison to a predicate device, not a specific study proving performance against pre-defined acceptance criteria in a clinical trial sense. The "study" here is essentially the 510(k) submission itself, which argues that the Avanta Orthopaedics External Fixator is as safe and effective as the legally marketed predicate device (EBI/Orthofix K831576).
The key findings from the comparison table (provided in the document) are:
- The Avanta device and the predicate device have similar design characteristics and intended use.
- The primary difference noted is the pin length range, which is 50-90 mm for Avanta compared to 80-160 mm for EBI/Orthofix. Despite this difference, the FDA determined the device to be substantially equivalent, implying that this difference does not raise new questions of safety or effectiveness for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving a "test set" of data in the context of an AI/ML device. The "test set" in this case would be the Avanta Orthopaedics External Fixator itself, compared against the predicate device's established performance and characteristics. The "provenance" is the device's design and manufacturing specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert labels on medical images) is not relevant for this type of 510(k) submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process as described for AI/ML validation was performed.
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
Not applicable. This is a traditional medical device, not an AI/ML-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an AI/ML algorithm, which is not what this device is.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device (EBI/Orthofix K831576), which has been legally marketed in interstate commerce prior to May 28, 1976, or has been reclassified. This is based on the history of that predicate device's use and regulatory clearances.
8. The Sample Size for the Training Set
Not applicable. No "training set" in the context of AI/ML algorithms was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. No "training set" was used.
{0}------------------------------------------------
A V A N T A
ORTHOPAEDICS
MAR 16 1998
K974911
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
December 30, 1997 Prepared:
Avanta Orthopaedics, Inc. Applicant: 9369 Carroll Park Drive, Suite A San Diego, CA 92121
619-452-8580 Telephone: 619-452-9945 Fax: Louise M. Focht Contact:
Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number
Product Code: Accessories Predicate Device:
External Fixator External Fixator Class II Orthopaedic 888.3040 Smooth or threaded metallic bone fixation fastener. JWD
EBI/Orthofix K831576
Device Description:
The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Intended Use:
The intended use of the external fixation device is the same as that expressed in the predicate device 510k.
{1}------------------------------------------------
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
Comparison to Predicate Device:
The table below summarizes similarities and differences between the EBI/Orthofix and the Avanta Orthopaedics external fixator.
| Feature | EBI/Orthofix | Avanta Orthopaedics |
|---|---|---|
| Pins | Implantable | Implantable |
| Allows for application ofcompression or distraction | Yes | Yes |
| Pin Length | 80-160 mm | 50-90 mm |
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Louise M. Focht Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, California 92121
MAR 1 6 1998
Re: K974911 External Fixator II Regulatory Class: Product Code: JWD Dated: December 30, 1997 December 31, 1997 Received:
Dear Ms. Focht:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Ms. Louise M. Focht
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.
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
{4}------------------------------------------------
Intended Use:
The intended use of the external fixation device is the same as that expressed in the predicate device 510k.
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
5
§ 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.