(192 days)
The Guided Growth Plate is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: *valgus, varus or flexion extension deformities of the knee (femur and/or tibia) *valgus, varus or plantar flexion deformities of the ankle *valgus or varus deformities of the elbow (humerus) *radial or ulnar deviation, flexion or extension deformities of the wrist (radius)
The two hole plate features a contoured waist and low profile for pediatric usage. There is a center hole for accurate application of the plate over a temporary guide pin. This is to facilitate precise and reproducible placement of the implant relative to the adjacent growth plate that is localized radiographically.. The plate is available in two sizes (small / large) to accommodate the variations of bone size and geometry. It is transfixed to the bone using two parallel cannulated titanium screws. The Guided Growth Plate is made out of titanium which is (by design) flexible and compatible with both radiographic imaging and MRI.
The provided text is a 510(k) summary statement for a medical device called the "Guided Growth Plate Device." This type of document is for regulatory clearance, specifically demonstrating "substantial equivalence" to a predicate device, not typically for performance studies with acceptance criteria in the way you've outlined for AI/software.
Therefore, an exhaustive answer to your request, particularly concerning acceptance criteria, ground truth, training sets, and MRMC studies, cannot be fully provided from the given input. The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving a specific performance metric against a defined acceptance criterion through a clinical study for novel functions.
Here's an attempt to extract and interpret information based on your categories, given the nature of the document:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" and "reported device performance" are not presented in the context of a clinical trial demonstrating efficacy against a pre-defined metric for this device. Instead, the document focuses on regulatory acceptance based on substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (as per 510(k) submission) |
|---|---|
| Safety: Device is safely implanted and removed without undue harm. | Designed to be made of titanium, which is flexible and compatible with radiographic imaging and MRI. Applied sub-muscular but extra-periosteal. Screws diverge as deformity corrects, and implant is eventually removed. The predicate device (Blount Zimmalloy staple) has been on the market since 1950, implying a long history of safe use for similar indications. |
| Effectiveness: Device achieves its intended purpose. | Intended Use: Redirecting the angle of growth of long bone(s) to gradually correct angular deformities in growing children. Specific Indications: Correction of valgus, varus, flexion/extension deformities of the knee (femur and/or tibia), ankle, elbow (humerus), and wrist (radius). Mechanism: Inhibits longitudinal growth of the physis (growth plate) – implicitly assumed to be effective based on the predicate's known mechanism of action. |
| Material/Design Equivalence: Device materials and design are comparable to legally marketed devices. | Materials: Titanium. Features: Two-hole plate, contoured waist, low profile, center hole for guide pin, parallel cannulated titanium screws. Comparison to Predicate: Substantially equivalent to the Blount Zimmalloy staple (Zimmer, Inc.) which inhibits longitudinal growth of the physis. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a test set of data in the manner an AI/software device would. The 510(k) submission primarily relies on demonstrating equivalence through design, materials, and intended use to an existing, legally marketed device (the predicate). There is no mention of patient data, clinical trials, or any "test set" in this context.
3. 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)
Not applicable. As there is no "test set" or clinical study described for performance evaluation, there's no mention of experts establishing ground truth for data for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or clinical study 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
Not applicable. This device is a physical orthopedic implant, not an AI/software device. Hence, no MRMC studies or human reader improvement with AI assistance are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/software performance study. The "ground truth" for this device's efficacy is the clinical observation of growth plate modulation and angular deformity correction, which is implicitly assumed to be similar to the predicate device.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary based on 510(k) Submission:
The provided document is a 510(k) Premarket Notification. For such submissions, the primary objective is to demonstrate substantial equivalence to a predicate device. This means showing that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are different technological characteristics, that these differences do not raise new questions of safety and efficacy.
The "study" that proves the device meets the acceptance criteria in this context is the comparison to the predicate device and the rationale provided by the manufacturer (Morphpgraphics LC) and reviewed by the FDA. The "acceptance criteria" are the regulatory requirements for substantial equivalence, which are implicitly met if the FDA clears the device. The "device performance" relies on the established performance and safety profile of the predicate device (Blount Zimmalloy staple) and the new device's design and material specifications. No clinical trials or performance studies with defined endpoints and statistical significance are detailed in this 510(k) summary.
{0}------------------------------------------------
NOV 2 0 2003
510(k) Summary Statement
11/17/03
Page 1 of 2
Guided Growth Plate Device:
Number: K031493
Classification name: orthopedic implant (pediatric)
Patent pending by : Morphpgraphics LC, (Salt Lake City, Utah)
Manufactured by : Precimed Inc. (Chester Springs, Pa)
Description of device: The two hole plate features a contoured waist and low profile for pediatric usage. There is a center hole for accurate application of the plate over a temporary guide pin. This is to facilitate precise and reproducible placement of the implant relative to the adjacent growth plate that is localized radiographically.. The plate is available in two sizes (small / large) to accommodate the variations of bone size and geometry. It is transfixed to the bone using two parallel cannulated titanium screws. The Guided Growth Plate is made out of titanium which is (by design) flexible and compatible with both radiographic imaging and MRI.
Application: The Guided Growth Plate is applied under fluoroscopic or radiographic guidance to the metaphysis /epiphysis of a given bone on the convex side of the deformity. It should be placed sub-muscular but extra-periosteal and is secured with parallel screws. The screws diverge as the deformity corrects with continued growth and the implant is eventually removed. Typically a single plate is applied per level of deformity; this procedure may be repeated as necessary for recurrent deformities.
Indications for use : The Guided Growth Plate is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children.
Specific conditions / diseases for which the device will be indicated include:
{1}------------------------------------------------
K031493
Page 2 of 2
*valgus, varus or flexion, extension deformities of the knee (femur and/or tibia) *valgus, varus or plantar flexion deformities of the ankle *algus or varus deformities of the elbow (humerus) *radial or ulnar deviation, flexion or extension deformities of the wrist (radius)
Contraindication : The device should not be used for adult deformities; skeletal maturity precludes further growth. Likewise, if a given growth plate has closed due to other causes such as trauma or infection, the guided growth plate will be ineffective and should not be implanted.
Substantial equivalence : The Blount Zimmalloy staple, which is manufactured by Zimmer, Inc (Warsaw, Indiana) has been on the market since 1950. It was designed to inhibit longitudinal growth of the physis (growth plate) and has been commonly employed to correct angular deformities of the extremities.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three lines that curve upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Peter M. Steven, M.D. Professor, Department of Orthopedics University of Utah School of Medicine P.O. Box #58246 Salt Lake City, Utah 84158
Re: K031493 Trade/Device Name: Guided Growth Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: October 15, 2003 Received: October 21, 2003
Dear Dr. Stevens:
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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Peter M. Steven, M.D.
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 your 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) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): _
Guided Growth Plate Device Name:
Indications For Use:
The Guided Growth Plate is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children.
Specific conditions/diseases for which the device will be indicated include: *valgus, varus or flexion extension deformities of the knee (femur and/or tibia) *valgus, varus or plantar flexion deformities of the ankle *valgus or varus deformities of the elbow (humerus) *radial or ulnar deviation, flexion or extension deformities of the wrist (radius)
ﺳﮯ ﺍﯾ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Muriam C. Provost
al, Restorati
510(k) Number K031493
§ 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.