(21 days)
The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable verteral body resected or excised during partial and total vertebrectory procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The Supplemental fixation systems that may be used with the Stryker Spine AVS™ PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
The AVSTM PL Peek Spacer is a rectangular shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMA LT1. The spacer incorporates two (2) Tantalum marker pins to aid in radiographic visualization. The AVSTM PL Peek Spacer System is comprised of six (6) different sized footprints with a variety of heights and lordotic angles.
The provided document is a Special 510(k) Premarket Notification for a line extension to the AVS™ PL PEEK Spacer System. This type of submission is typically for modifications to an already cleared device and relies on substantial equivalence to a predicate device, rather than requiring extensive new clinical studies to prove performance against specific acceptance criteria for a novel AI/software component.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically associated with the evaluation of AI/ML or diagnostic devices.
Here's why the requested information is absent and what the document does provide:
1. Acceptance Criteria and Reported Device Performance:
- This document focuses on demonstrating substantial equivalence to a predicate device (Stryker Spine AVSTM PL PEEK Spacer, K050624) for additional sizes of an existing spinal implant.
- The "performance" criteria for such a device are primarily related to its mechanical properties, biocompatibility, and intended use matching the predicate device. These are assessed through non-clinical testing (e.g., mechanical tests, material characterization) and comparison to the predicate, not typically reported in a table of "device performance" in the same way an AI/ML device would report accuracy, sensitivity, or specificity.
- The document states: "Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ PL PEEK Spacer to be substantially equivalent to their predicate device in terms of its material, design, and indications for use." This is the core "acceptance" criteria for a 510(k) line extension.
2. Sample Size Used for the Test Set and Data Provenance:
- No "test set" in the context of an AI/ML device (e.g., patient images, patient records) is mentioned because this is a physical medical device. The "testing" would involve benchtop mechanical testing, not a dataset of patient cases.
- Therefore, there is no data provenance (country of origin, retrospective/prospective) for a "test set."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This concept is not applicable here as there is no "ground truth" to establish for an AI/ML model's output. The "truth" for a spinal implant relates to its material properties, dimensions, and mechanical performance, which are evaluated through engineering principles and standardized tests, not expert consensus on medical images or diagnoses.
4. Adjudication Method:
- Not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. MRMC studies are used to evaluate the impact of AI/ML systems on human reader performance, which is not relevant for a physical spinal implant.
6. Standalone (Algorithm Only) Performance:
- Not applicable as there is no algorithm or software being evaluated.
7. Type of Ground Truth Used:
- Not applicable. The "ground truth" for ensuring the safety and effectiveness of this PEEK spacer would involve engineering specifications, material standards, and biomechanical testing results, not medical expert consensus, pathology, or outcomes data in the context of an AI system.
8. Sample Size for the Training Set:
- Not applicable as there is no AI/ML model to train.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no AI/ML model or training set.
In summary, the provided document is a regulatory submission for a physical medical device (vertebral body replacement) focusing on a line extension (new sizes). It relies on the concept of substantial equivalence to a predicate device, which is proven through non-clinical performance data and comparison, rather than clinical studies or data science metrics typically associated with AI/ML device evaluations.
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Line Extension to the AVS™ PL PEEK Spacer System
Special 510(k) Premarket Notificatio
Special 510(k) Summary of Safety and Effectiveness: Special STo(R) Summary of PEEK Spacer System
| Proprietary Name: | AVSTM PL PEEK Spacer SystemAUG 1 6 2006 |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II |
| Spinal Vertebral Body Replacement Device, | |
| 21 CFR 888.3060 | |
| Device Product Code: | MQP |
| For Information contact: | Simona Voic |
| Regulatory Affairs Project Manager | |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Telephone: (201) 760-8145 | |
| Fax: (201) 760-8345 | |
| Email: Simona. Voic@stryker.com | |
| Date Summary Prepared: | July 25, 2006 |
| Predicate Device | Stryker Spine AVSTM PL PEEK Spacer (K050624) |
| Predicate Device Information | The AVSTM PL Peek Spacer is a rectangular shaped, |
| hollow frame implant with lateral fenestrations, | |
| machined from medical grade PEEK OPTIMA LT1. | |
| The spacer incorporates two (2) Tantalum marker pins | |
| to aid in radiographic visualization. The AVSTM PL | |
| Peek Spacer System is comprised of six (6) different | |
| Description of Device Modification | sized footprints with a variety of heights and lordoticangles. The AVSTM PL Peek System was determinedsubstantial equivalent via K040731 and K050624. |
| Intended Use | This Special 510(k) premarket notification is intendedto introduce additional sizes of the AVSTM PL PeekSpacer. |
| The Stryker Spine AVSTM PL PEEK Spacer is avertebral body replacement indicated for use in thethoraco-lumbar spine (T1-L5) to replace a collapsed,damaged, or unstable vertebral body resected orexcised during partial and total vertebrectomyprocedures due to tumor or trauma, to achieve anteriordecompression of the spinal cord and neural tissues,and to restore the height of a collapsed vertebral body.It is recommended to pack bone graft material insidethe implant.The Stryker Spine AVSTM PL PEEK Spacer is intendedfor use with supplemental fixation. The supplementalfixation systems that may be used with the StrykerSpine AVSTM PL PEEK Spacer include, but are notlimited to, Stryker Spine plate or rod systems (XIA,Spiral Radius 90D, and Trio). |
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Summary of the Technological Characteristics
Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ PL PEEK Spacer to be substantially equivalent to their predicate device in terms of its material, design, and indications for use. Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was also demonstrated for the subject spacers.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine, and its presence in the logo signifies the department's role in promoting and protecting the health of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2006
Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K062132
Trade/Device Name: AVS™ PL PEEK Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 25, 2006 Received: July 26, 2006
Dear Ms. Voic:
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. This
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Page 2 - Ms. Simona Voic
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 this, 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ontain 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.
Sincerely yours.
Per Sera D. Primo no
DEO V.S.C.R.R
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Line Extension to the AVS™ PL PEEK Spacer System
Special 510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name: AVS™ PL PEEK Spacer System
Indications for Use:
The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable verteral body resected or excised during partial and total vertebrectory procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The Supplemental fixation systems that may be used with the Stryker Spine AVS™ PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.O. hma
(Division Sign-Of Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K062132
§ 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.