(159 days)
The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.
The Retrograde Femoral Nail is made of wrought Ti-6Al-4V conforming to ASTM F136. The diameter of the nail tapers from 4.0 mm to 3.6mm with 6 lengths ranging from 19 to 29 cm. Both the proximal and distal ends are bent to provide 3 point fixation. The entire nail is fluted for rotational stability. One end of the nail is threaded to allow for an axial end screw or smooth attachment cap.
This document describes the Retrograde Pediatric Nail, a femoral nail made of wrought Ti-6Al-4V. The information provided is primarily related to its regulatory submission (510(k)) and its substantial equivalence to predicate devices, rather than a detailed study proving its performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested elements for a comprehensive study description are not available in the provided text. The document focuses on the design specifications and mechanical test results as evidence for substantial equivalence, rather than clinical performance data.
Here's an attempt to extract and infer information based on the provided text, highlighting what is present and what is missing:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for the Retrograde Pediatric Nail
The provided document, a 510(k) summary for the Retrograde Pediatric Nail (K980854), focuses on demonstrating substantial equivalence to predicate devices. This regulatory pathway typically relies on comparing design, materials, indications for use, and mechanical performance to legally marketed devices, rather than requiring extensive clinical trials with pre-defined acceptance criteria for efficacy and safety against a defined ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" are implied by the performance of the predicate devices and the physical properties required for functional intramedullary nails. The reported device performance is based on mechanical testing.
| Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Retrograde Pediatric Nail) |
|---|---|
| Comparable bending stiffness | 145 lb-in² |
| Comparable torsional stiffness | 112 lb-in² |
| Same Indications for Use | Fractures of the femur, tibia, and humerus with retrograde applications in patients where the growth plate would not be compromised. |
| Similar Geometry | Tapers from 4.0 mm to 3.6 mm, 6 lengths (19 to 29 cm), proximal and distal ends bent for 3-point fixation, fluted for rotational stability, threaded end for axial end screw/cap. (Described as similar, not explicitly quantified against a criterion here, but implied to be within acceptable physiological ranges) |
| Material | Wrought Ti-6Al-4V conforming to ASTM F136 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" for a clinical test set. The reported performance relates to mechanical testing of the device itself.
- Data Provenance: The document does not provide information on the country of origin or whether the data for mechanical testing was retrospective or prospective. It is standard for mechanical testing to be conducted in a laboratory setting. There is no patient data involved in the provided "Test Results" section.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the provided information. The "ground truth" here is based on engineering standards and mechanical properties of the device, not clinical outcomes evaluated by medical experts. The FDA review process involves internal experts (e.g., engineers, medical officers) determining substantial equivalence, but they are not establishing a "ground truth" for a test set in the sense of clinical data interpretation.
4. Adjudication Method for the Test Set
This question is not applicable as there is no human-adjudicated clinical test set described.
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 question is not applicable. The device is a physical orthopedic implant, not an AI software. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical orthopedic implant, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the reported performance (bending stiffness and torsional stiffness) is based on mechanical engineering principles and testing standards relevant to orthopedic implants. For the substantial equivalence determination, the ground truth is the established safety and effectiveness of the identified predicate devices, as determined by the FDA prior to May 28, 1976, or subsequent reclassifications.
8. The Sample Size for the Training Set
This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical medical device. Device design and manufacturing parameters guide the creation of the product.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set described.
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AUG | | | |998
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Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: Retrograde Pediatric Nail
Common Name: Femoral Nail
Classification Name: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030.
The Retrograde Femoral Nail is made of wrought Ti-6Al-4V conforming to Description: ASTM F136. The diameter of the nail tapers from 4.0 mm to 3.6mm with 6 lengths ranging from 19 to 29 cm. Both the proximal and distal ends are bent to provide 3 point fixation. The entire nail is fluted for rotational stability. One end of the nail is threaded to allow for an axial end screw or smooth attachment cap.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include same indications for use and similar geometry.
Test Results: The nail is designed with a bending stiffness of 1451b-in2 and a torsional stiffness of 1121b-in2.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 11 1998
Ms. Debbie De Los Santos Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
Re: K980854 Retrograde Pedicatric Nail Requlatory Class: II Product Code: HTY Dated: July 9, 1998 Received: July 13, 1998
Dear Ms. De Los Santos:
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. ਜ 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 requlatory action. In addition, FDA may publish further announcements 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 requlations.
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Page 2 - Ms. Debbie De Los Santos
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,
Stephen Rhodes
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):
Retrograde Pediatric Nail Device Name: Indications For Use:
Retrograde Pediatric Nail Indications For Use
The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Stipt Rhodes
Division Sign Off Division of General Restorative Devices (980854 510(k) Number.
§ 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.