(30 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.
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).
Not Found
The Surgical Titanium Mesh™ System is a medical device and thus does not include AI/ML components for which a test set would be used to establish device performance. The performance data section of the provided text indicates that:
- Biomechanical testing, including static axial compression and dynamic axial compression, were conducted.
Without additional information on acceptance criteria and the specific results of these biomechanical tests, it's not possible to populate the full table or answer all the detailed questions provided in the request. The 510(k) summary focuses on the device's intended use, materials, and substantial equivalence to predicate devices, rather than detailed performance metrics that would be associated with AI/ML diagnostic or predictive tools.
However, I can provide a general structure based on the available information and explicitly state what is missing:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Performance | Static Axial Compression: (Specific range/value for strength/stability, e.g., "Must withstand X N of force without permanent deformation > Y mm") | "Biomechanical testing, including static axial compression... were conducted." (No specific results provided in the document) |
| Dynamic Axial Compression: (Specific range/value for fatigue life/durability, e.g., "Maintain integrity for Z cycles at W load") | "Biomechanical testing... and dynamic axial compression, were conducted." (No specific results provided in the document) | |
| Material Properties | Biocompatibility: (e.g., "Materials must be biocompatible according to ISO 10993 standards") | Materials are "Commercially Pure (CP) Titanium" and "Titanium alloy (Ti-6Al-4V)". These are standard biocompatible materials for implants. (Implicitly met by material choice, but no specific test results on biocompatibility are presented). |
| Design Integrity | Structural Integrity: (e.g., "No fractures or irreversible deformation under anticipated physiological loads") | (Implicitly assessed through biomechanical testing, but no specific results are presented) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The "test set" in this context refers to physical prototypes or samples of the device undergoing biomechanical testing, not a dataset for an AI/ML model. The specific number of physical test samples used for static and dynamic axial compression is not stated in the provided text.
- Data Provenance: Not applicable in the traditional sense of clinical data. The tests were biomechanical in nature, likely performed in a lab setting rather than involving human subjects or clinical data in the context of an AI/ML model.
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 this is a medical device (implant) and not an AI/ML diagnostic tool, external human experts are not typically used to establish "ground truth" for biomechanical tests in the same way they would be for image interpretation or disease diagnosis. The "ground truth" for biomechanical performance is derived from physical measurements and engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data (e.g., for AI/ML performance evaluation) by resolving disagreements among human readers. Biomechanical testing relies on objective physical measurements and engineering analysis.
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 surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical implant, not an algorithm or software. Its performance is inherent in its physical and mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biomechanical testing, the "ground truth" is established by engineering standards and physical measurements. For example, the load at which a device fails or deforms beyond a specified limit is an objective physical measurement, not an expert consensus or pathology report.
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for a physical surgical implant.
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Surgical Titanium Mesh™ System
:
Comments of Children
ﭘ State of the country of the count
| IX. 510(k) Summary | |
|---|---|
| SUBMITTER: | DePuy AcroMed™, Inc.325 Paramount DriveRaynham, MA 02767-0350 USAMAR 21 2002 |
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | February 15, 2002 |
| PROPRIETARY NAME: | Surgical Titanium Mesh™ System |
| CLASSIFICATION NAME: | Implant, fixation deviceSpinal intervertebral body fixation orthosis device |
| PREDICATE DEVICE: | Surgical Titanium Mesh System (K003043)Surgical Dynamics Mesh Cage System (K003709) |
| 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.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) |
| PERFORMANCE DATA: | Biomechanical testing, including static axial compressionand dynamic axial compression, were conducted. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures or profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Regulatory Affairs Manager DePuy Acromed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re:
K020522 Trade Name: Surgical Titanium Mesh System Regulation Number: 888.3060 Regulation Name: Vertebral Body Replacement Device Class: II Product Code: MQP Dated: February 15, 2002 Received: February 19, 2002
Dear Mr. Maas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Society is substantially equivalent (for the indications for use stated in allo we have determined the device is substantially of the enaments on on the enactment alte the Medical Device Amendments, or to devices that have been reclassified in accordance with the or the Medical Dovice I michaments, or ad Cosmetic Act (Act). You may, therefore, market the provisions of the roderal rood, Dreg, and visions of the Act. The general controls provisions of the device, subject to the general ecistration, 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 If your device is olassified (500 above) aitional controls. Existing major regulations affecting your Approval), it thay be subject to back as a substions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirement, as set form in the Quant) "hough periodic (QS) inspections, the Food and Drug regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1 Dry Prify Pactives, FDA may publish further announcements concerning may result in the Federal Register. Please note: this response to your premarket notification your device in the Peachar 100 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. Frank Maas
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 noutication. THC PDA miding of substantial vour 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) additionally 007.10 for in This anaghoon the promotion and advertising of your device, please 574-4639. Traditionally, 10. quests (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information "Wisolanding of reference to premation in the Division of Small Manufacturers on your responsibilities ander the rice may of at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark A. Williams
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 100 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.
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).
Mark N. Milken
(Division Sig-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number _
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)
DePuy AcroMed, Inc. 510(K)
§ 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.