(62 days)
The X-MESH™ Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 X-MESH™ Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The X-MESH™ Expandable Cage 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 X-MESH™ Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™ M-2 ANTERIOR PLATE™ . ISOLA® . VSP®, MOSS®MIAMI, TiMX™, MONARCH™ EXPEDIUM™, VIPER™, and PROFILE™).
The X-MESH™ Expandable Cage System comes in three approach-specific shapes for the anterior lateral, direct anterior and posterior approaches. Each cage comes fully assembled with rough, convex endplates containing spikes that help anchor the device in the vertebral endplates, and provide resistance to migration and rotation. This mesh cage contains diamond pattern, side slots and large graft windows for graft material. The cage can be expanded axially and has a setscrew for locking it in position.
The provided [K080568](https://510k.innolitics.com/search/K080568) document describes a medical device, the X-MESH™ Expandable Cage System, and its clearance through the 510(k) pathway. This pathway is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial for a novel AI/software medical device would.
Instead, the "acceptance criteria" here refer to the performance data submitted to characterize the device to demonstrate substantial equivalence to predicate devices for its intended use.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biomechanical integrity (strength, stability, resistance to migration/rotation) under intended loads | "Performance data were submitted to characterize the subject X-MESH™ Expandable Cage System." |
| Material properties (biocompatibility, mechanical strength) | "Manufactured from ASTM F 136 implant grade titanium alloy." |
| Functionality (axial expansion, setscrew locking) | "The cage can be expanded axially and has a setscrew for locking it in position." |
| Compatibility with supplemental internal fixation systems | Device is "intended for use with supplemental internal fixation" and lists compatible systems. |
Explanation: The document does not quantify specific acceptance criteria values (e.g., "withstanding X N of force") nor does it provide detailed raw performance data. The phrase "Performance data were submitted to characterize the subject X-MESH™ Expandable Cage System" is a general statement indicating that this information was provided to the FDA as part of the 510(k) submission to demonstrate that the device performs as intended and is substantially equivalent to predicate devices. The materials specification (ASTM F 136 titanium alloy) and the description of the device's design (spikes, expansion mechanism) are implicitly part of this performance characterization.
Regarding the other requested information, the document does not contain the specified details as it pertains to a traditional hardware medical device clearance, not an AI/software medical device with a diagnostic or predictive function.
Here's why and what's missing:
- 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is described. The performance data would likely involve mechanical testing, not a "test set" of patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth associated with a test set (e.g., for diagnoses) is mentioned.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is 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 is a hardware implant, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware implant, 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 device. The "ground truth" for this device would be its mechanical properties, material composition, and biological response, which are assessed through engineering tests, material certifications, and potentially animal/cadaver studies (though not detailed here).
- 8. The sample size for the training set: Not applicable. There is no AI model or training set described.
- 9. How the ground truth for the training set was established: Not applicable. There is no AI model or training set described.
In summary, the provided document relates to a 510(k) premarket notification for a physical medical implant (an expandable cage system). The "performance data" mentioned refers to engineering and material characterization data to demonstrate substantial equivalence to existing predicate devices, not clinical studies or AI/software validation as implied by the detailed questions.
{0}------------------------------------------------
510(K) SUMMARY 6.
MAY - 1 2008
| Submitter: | DePuy Spine, Inc. |
|---|---|
| 325 Paramount Drive | |
| Raynham, MA 02767 |
| Contact Person: | Hande TufanSenior Regulatory Affairs Associate |
|---|---|
| Voice: | 508-828-3065 |
| Fax: | (508) 828-3797 |
| E-Mail: | ftufanya@dpyus.jnj.com |
February 28, 2008 Date Prepared:
Device Class: Class П
Classification Name: Spinal Vertebral Body Replacement Device
Classification Panel: Orthopedics
FDA Panel Number: 87
| Product Code(s): | MQP |
|---|---|
| Proprietary Name: | X-MESHTM Expandable Cage System |
| Predicate Devices: | Surgical Titanium Mesh (K030249)Stackable Cage System (K013382) |
Device Description: The X-MESH™ Expandable Cage System comes in three approach-specific shapes for the anterior lateral, direct anterior and posterior approaches. Each cage comes fully assembled with rough, convex endplates containing spikes that help anchor the device in the vertebral endplates, and provide resistance to migration and rotation. This mesh cage contains diamond pattern, side slots and large graft windows for graft material. The cage can be expanded axially and has a setscrew for locking it in position.
- The X-MESH™ Expandable Cage System is indicated for Intended Use: use in the thoracolumbar spine (i.e., T1 to 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.
Doep
Page 6-1
{1}------------------------------------------------
080568
The X-MESHT™ Expandable Cage System is also indicated
for treating fractures of the thoracic and lumbar spine.
The X-MESHT™ Expandable Cage 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 X-MESHT™ Expandable Cage System is intended for
use with supplemental internal fixation. The supplemental
internal fixation systems that may be used include titanium
plate or rod systems (i.e., KANEDATM SR, UNIVERSITY
PLATETM, M-2 ANTERIOR PLATET™, ISOLA®, VSP®,
MOSS®MIAMI, TIMXTM, MONARCHTM, EXPEDIUMTM,
VIPERTM, PROFILETM).
Materials: Manufactured from ASTM F 136 implant grade titanium
alloy.
Performance Data: Performance data were submitted to characterize the
subject X-MESHT™ Expandable Cage System.
DePuy Spine, Inc., a Johnson & Johnson Company
2 82
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2008
DePuy Spine, Inc. % Mr. Hande Tufan Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, MA 02767
Re: K080568 Trade/Device Name: X-MESH™ Expandable Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 2, 2008 Received: April 3, 2008
Dear Mr. Tufan:
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 - Mr. Hande Tufan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
KOXOS68
న. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: X-MESHTM Expandable Cage System
Indications For Use:
The X-MESH™ Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 X-MESH™ Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The X-MESH™ Expandable Cage 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 X-MESH™ Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™ M-2 ANTERIOR PLATE™ . ISOLA® . VSP®, MOSS®MIAMI, TiMX™, MONARCH™ EXPEDIUM™, VIPER™, and PROFILE™).
Prescription Use X (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| DePuy Spine, Inc., a Johnson & Johnson Company | |
| 510(k) Number | K080568 |
page 1 of 1
Page 5-1
§ 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.