(69 days)
The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
InFix 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 InFix is intended to be used with bone graft.
InFix® is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136, and is available in various sizes and dimensions. The device is comprised of two opposing endplates supported by vertical members or "struts" that can be varied in height such that the surgeon can fix the vertebrae in a proper anatomical alignment and lordosis.
Each of the struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) end cap may be placed inside the device prior to packing of bone graft to effectively block the posterior opening in the device and contain the material inside.
Holes in the titanium endplates provide space for bone in-growth while angled spikes (teeth) penetrate the vertebral endplates and provide resistance to rotation and migration.
The provided text describes a 510(k) summary for a medical device called the "Spinal Concepts Inc. InFix® System". It does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/readership performance perspective.
The document is a premarket notification for a traditional medical device (a spinal implant) and focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It does not involve any AI components, human reader performance evaluations, or diagnostic accuracy studies typically associated with the questions posed in the prompt.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training/testing data sets as these concepts are not relevant to the provided text.
The only "study" mentioned is mechanical testing to demonstrate substantial equivalence, which is a different type of evaluation.
Summary of available information related to performance criteria, even though it's not AI-related:
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Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implicit): The device (InFix® System) is designed to be "substantially equivalent" to predicate devices (Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD)) based on mechanical performance. This implies that its mechanical properties must be comparable or superior to the predicate devices.
- Reported Device Performance: "Mechanical testing demonstrates that InFix® is substantially equivalent to the Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD) predicate devices."
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Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical devices subjected to mechanical testing, not a dataset of images or clinical cases. The provenance of the data is that it was generated through mechanical testing, presumably in a lab setting by the device manufacturer, Spinal Concepts, Inc.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically established by engineering specifications and objective measurements, not clinical expert consensus.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable as the device is a physical implant, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
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The type of ground truth used: For the mechanical testing, the ground truth would be quantitative measurements of material strength, load-bearing capacity, fatigue resistance, etc., against established industry standards and/or the performance of the predicate devices.
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The sample size for the training set: Not applicable. "Training set" refers to data used to train an AI model.
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How the ground truth for the training set was established: Not applicable.
In conclusion, the provided document is a regulatory submission for a physical medical implant, and the questions posed are primarily relevant to AI/diagnostic software. Therefore, most of the requested information is not present or applicable.
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AUG - 7 2003
page 1 of 1
510(K) Summary
| Submitted By: | Lisa Peterson |
|---|---|
| Regulatory Affairs Specialist | |
| Spinal Concepts, Inc. | |
| 5301 Riata Park Court, Bldg. F | |
| Austin, TX 78727 | |
| 512-918-2700 | |
| Date: | May 29, 2003 |
| Trade Name: | Spinal Concepts Inc. InFix® System |
| Classification Name: | Vertebral Body Replacement |
| Product Code: | MQP |
Predicate Devices: InFix® is substantially equivalent to the Interpore Cross GEO™ Structure. which was cleared as an oval shaped configuration on August 3, 2001 (K010530) and as a rectangular shaped configuration on February 6, 2002 (K020048) and Interpore Cross International Anterior Fixation Device (AFD) cleared on January 23, 2003 (K022143).
Device Description: InFix® is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136, and is available in various sizes and dimensions. The device is comprised of two opposing endplates supported by vertical members or "struts" that can be varied in height such that the surgeon can fix the vertebrae in a proper anatomical alignment and lordosis.
Each of the struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) end cap may be placed inside the device prior to packing of bone graft to effectively block the posterior opening in the device and contain the material inside.
Holes in the titanium endplates provide space for bone in-growth while angled spikes (teeth) penetrate the vertebral endplates and provide resistance to rotation and migration.
The InFix System is a vertebral body replacement device intended for use in the Intended Use: thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). InFix 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 InFix is intended to be used with bone graft.
Substantial Equivalence: Mechanical testing demonstrates that InFix® is substantially equivalent to the Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD)predicate devices.
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white and appears to be of moderate resolution.
Public Health Service
AUG - 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
K031672 Trade Name: InFix® System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 29, 2003 Received: June 5, 2003
Dear Ms. Peterson:
Re:
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.
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Page 2 - Ms. Lisa Peterson
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 vour 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" (21CFR 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,
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K031672
Device Name:
Spinal Concepts, Inc. InFix® System
Indications for Use:
The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
InFix 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 InFix is intended to be used with bone graft.
Wlf
(Division Sign-Off) Division of Gerenal, Restorative and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE SHUANNING PAGE | | O2/ // 7 2 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
v Prescription Use: (Per 21 CFR 801.109)
OR
Over-The-Counter: (Optional Format 1-2-96)
§ 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.