(221 days)
The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation.
The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX and Profile).
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The provided text describes a medical device, the "Surgical Titanium Mesh™ System," and its intended use, materials, and performance data, as submitted in a 510(k) summary to the FDA. However, the document does not contain the level of detail required to answer all the questions about acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI/algorithm-based device as implied by the questions asking for "standalone" performance, MRMC studies, or training/test set details.
This document describes a physical medical implant, not an AI or software device. Therefore, many of the questions are not applicable to the information provided.
Here's an analysis based on the provided text, addressing what can be answered and clearly stating what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics of the device itself. It mentions "Biomechanical testing, including static axial compression and dynamic axial compression," were conducted, and that "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."
However, no specific numerical acceptance thresholds or the results against those thresholds are provided. The FDA's 510(k) clearance process determined "substantial equivalence" to predicate devices, which implies the device's performance was deemed acceptable relative to established standards for similar devices already on the market.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. It only states that "Clinical data were provided."
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)
This information is not provided. The term "ground truth" is typically associated with AI/ML model validation, which is not applicable to a physical implant in this context. The clinical data would have been evaluated by medical professionals as part of standard clinical practice and regulatory review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are usually relevant for expert reviews in image analysis or similar diagnostic tasks, not physical device performance in biomechanical or clinical studies as described here.
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
No, an MRMC study was not done, as this is a physical implant, not an AI or diagnostic imaging device that requires human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done, as this is a physical implant, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biomechanical testing, the "ground truth" would be the measured physical properties and fatigue life under specified loads, measured against engineering standards. For clinical data, the "ground truth" would be patient outcomes, such as successful spinal stabilization, fusion (if applicable), pain reduction, neurological improvement, and absence of device-related complications, as documented in medical records. The document only generally states "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
Summary of what is provided in the document related to "acceptance criteria" and "study":
The document states that the performance data included:
- Biomechanical testing: "static axial compression and dynamic axial compression." This testing likely involved established engineering standards for spinal implants to assess their strength and durability. The acceptance criteria would be defined by these standards (e.g., ability to withstand a certain number of load cycles at a specified force without failure, or a minimum static strength). The reported performance would be the results of these tests, demonstrating compliance. However, the specific numerical criteria and results are not detailed in this summary.
- Clinical data: "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors." This data would show the safety and effectiveness of the device in a real-world setting. The acceptance criteria for clinical data would typically involve demonstrating favorable patient outcomes (e.g., spinal stabilization, successful tumor resection with hardware in place, acceptable complication rates) comparable to predicate devices or established treatment methods. Again, specific details of this clinical data or its full methodology are not included in this 510(k) summary.
In conclusion, based solely on the provided text, it is impossible to complete a detailed table of acceptance criteria and reported device performance with specific quantitative figures, nor can most of the questions relating to AI/algorithm development and validation be answered, as the document describes a physical medical implant.
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| IX. 510(k) Summary | MAY - 8 2001 | K003043 |
|---|---|---|
| SUBMITTER: | DePuy AcroMed ™, Inc.325 Paramount DriveRaynham, MA 02767-0350 USA | |
| CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | April 13, 2001 | |
| PROPRIETARY NAME: | Surgical Titanium Mesh™ System | |
| CLASSIFICATION NAME: | Implant, fixation deviceSpinal intervertebral body fixation orthosis device | |
| PREDICATE DEVICE: | Stackable Cage System (K990148)Rezaian Spinal Fixator (K841189) | |
| INTENDED USE: | The Surgical Titanium Mesh System is indicated for use inthe thoracolumbar spine (T1-L5) to replace a diseasedvertebral body resected or excised for the treatment oftumors, to achieve anterior decompression of the spinalcord and neural tissues, and to restore the height of acollapsed vertebral body.The Surgical Titanium Mesh System is also indicated fortreating fractures of the thoracic and lumbar spine.The Surgical Titanium Mesh System is designed to restorethe biomechanical integrity of the anterior, middle, andposterior spinal column even in the absence of fusion for aprolonged period. Bone graft material is recommended tobe packed inside of the mesh cage prior to implantation.The Surgical Titanium Mesh System is intended for usewith supplemental internal fixation. The supplementalinternal fixation systems that may be used with theSurgical Titanium Mesh System include DePuy AcroMedtitanium plate or rod systems (e.g. Kaneda SR, UniversityPlate, M-2, ISOLA, VSP. Moss Miami, TiMX and Profile). | |
| MATERIALS: | Commercially Pure (CP) TitaniumTitanium alloy (Ti-6Al-4V) | |
| PERFORMANCEDATA: | Biomechanical testing, including static axial compressionand dynamic axial compression, were conducted.Clinical data were provided to demonstrate theperformance of the device in patients with spine tumors. |
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus without the snake, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 8 2001
Ms. Karen F. Jurczak Regulatory Affairs Associate DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K003043
Trade/Device Name: Surgical Titanium Mesh System Regulation Number: Unclassified Product Code: MQP Dated: April 13, 2001 Received: April 16, 2001
Dear Ms. Jurczak:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon 910(x) health in the substantially equivalent (for the indications for use above and we nave determined the actrected predicate devices marketed in interstate commerce stated in the enclosure) to legally manufacted ptthe Medical Device Amendments, or to devices that provision 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 Cosment Act (Act). Tou may, atererors, and controls provisions of the Act include requirements for annual provisions of the Act. "The general countincturing 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 (1 remance rippioval), it they of our control in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mspections, the Food and Desult in regulatory action. In addition, FDA may publish Compy with ans 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.
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Page 2 - Ms. Karen F. Jurczak
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 notification. The I Dri imaling of succion 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 If you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for in Thio diagnestions on the promotion and advertising of your device, (201) 594-4637. Rudinonary, 18. quise at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained in 16507 watc Illionnation on your responsibilities and more (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
rominhellon propri
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
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IV. Indications for Use
510(k) Number (if known):
Surgical Titanium Mesh™ System Device Name:
Indications For Use:
The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation.
The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX and Profile).
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(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K002043
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use: | |
| OR Over-The-Counter | |
| Use: | |
| (Per 21 CFR 801.109) |
DePuy AcroMed Inc
Page B 2uy AcroMed, Inc. Indications For Use
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.