(217 days)
The Stryker Spine AVS® Anchor-L Lumbar Cage System is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS® Anchor-L Lumbar Cage System is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Cage System may be used as an intervertebral device with integrated fixation or in conjunction with supplemental fixation. When used as an intervertebral device with integrated fixation, the AVS® Anchor-L Lumbar Cage must be used with the three internal screws and plate fixation provided by AVS® Anchor-L Fixation Screws and Clip Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. The accompanying Clip Plate must be used anytime the device is used with any number of screws.
The AVS® Anchor-L Lumbar Cage System is a hollow, rectangular-shaped PEEK Optima® cage with three tantalum markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima® cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. When without additional supplemental fixation, the Anchor-L Lumbar Cage designed to be used exclusively with the internal supplemental fixation provided (AVS® ANCHOR-L Fixation Screws and Clip Plate).
The provided text is a 510(k) summary for a medical device called the AVS® Anchor-L Lumbar Cage System, which is an intervertebral fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices through design features and mechanical testing.
It does not contain information related to a study that involves an AI/ML device, nor does it include details like acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance. This type of information is typically found in submissions for AI/ML-driven diagnostic or assistive devices, not for a traditional orthopedic implant like this lumbar cage.
Therefore, I cannot provide a response filling in the requested table and details because the provided document does not contain the relevant information.
Based on the provided document, here's what can be extracted, acknowledging that much of the requested information is not present for this type of device:
The document describes a mechanical device, specifically an intervertebral fusion cage. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biomechanical performance data, not clinical performance or diagnostic accuracy.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical/Biomechanical) | Reported Device Performance |
|---|---|
| Static Compression (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Compression (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Static Compression Shear (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Compression Shear (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Static Torsion (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Torsion (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Expulsion (per ASTM F04-25-02-02 Draft) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Subsidence (per ASTM F2267) | Performed, demonstrated substantially equivalent performance to predicate devices. |
2. Sample sized 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 summary for the mechanical tests. Sample sizes for mechanical testing are typically relatively small and governed by the specific ASTM standards.
- Data provenance (country of origin, retrospective/prospective) is not applicable to mechanical testing of an engineering device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for mechanical tests is the physical measurement of performance against established engineering standards (ASTM). No human experts are used to establish ground truth in this context; rather, engineers and technicians conduct the tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable for mechanical testing. Test results are objective measurements.
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 comparative effectiveness study was not done. This device is a physical intervertebral cage, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is defined by adherence to specific ASTM (American Society for Testing and Materials) standards for mechanical and biomechanical properties of intervertebral body fusion devices. These standards specify how the device should perform under various forces (compression, shear, torsion, expulsion, subsidence).
8. The sample size for the training set
- This is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable. There is no training set for a mechanical device.
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Traditional 510(k) Premarket Notification
OCT 2 5 2012
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P
| 510(k) Summary: AVS® Anchor-L Lumbar Cage System | ||
|---|---|---|
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 | |
| Contact Person | Tiffani RogersManager, Regulatory AffairsPhone: 201-760-8206Fax: 201-760-8406Email: tiffani.rogers@stryker.com | |
| Date Prepared | August 2, 2012 | |
| Trade Name | AVS® Anchor-L Lumbar Cage System | |
| Common Name | Intervertebral Fusion Device | |
| Proposed Class | Class II | |
| Classification Nameand Number | Intervertebral body fusion device, 21 CFR 888.3080 | |
| Product Code | OVD, MAX | |
| Predicate Devices | The AVS® Anchor-L System was shown to be substantiallyequivalent to the devices listed below:• Medtronic SOVEREIGN (K110063)• Surgicraft STALIF TT (K073109)• Stryker Spine AVS PL (K073470 & K082014) | |
| Device Description | The AVS® Anchor-L Lumbar Cage System is ahollow, rectangular-shaped PEEK Optima® cage with threetantalum markers. It is intended for use as an interbody fusiondevice and is offered in a variety of heights, footprints, andlordotic angles to adapt to varying patient anatomies. The PEEKOptima® cage portion consists of two closed pockets for graftcontainment and has serrations on the superior and inferiorsurfaces of the cage. When without additional supplementalfixation, the Anchor-L Lumbar Cage designed to be used | |
| 510(k) Summary: AVS® Anchor-L, Lumbar Cage System | ||
| exclusively with the internal supplemental fixation provided | ||
| (AVS® ANCHOR-L Fixation Screws and Clip Plate). | ||
| Intended Use and | The Stryker Spine AVS® Anchor-L is an intervertebral body | |
| Indications for Use | fusion device indicated for use with autogenous bone graft in | |
| patients with degenerative disc disease (DDD) at one level or | ||
| two contiguous levels from L2 to SI. | ||
| DDD is defined as back pain of discogenic origin with | ||
| degeneration of the disc confirmed by history and radiographic | ||
| studies. DDD patients may also have up to Grade I | ||
| spondylolisthesis at the involved level(s). These patients should | ||
| be skeletally mature and have six months of nonoperative | ||
| therapy. | ||
| The AVS® Anchor-L Lumbar Cage System is to be implanted | ||
| via an open, anterior approach. | ||
| The AVS® Anchor-L Lumbar Cage System may be used as an | ||
| intervertebral device with integrated fixation or in conjunction | ||
| with supplemental fixation. When used as an intervertebral | ||
| device with integrated fixation, the AVS® Anchor-L Lumbar | ||
| Cage must be used with the three internal screws and plate | ||
| fixation provided by AVS® Anchor-L Fixation Screws and Clip | ||
| Plate. If AVS® Anchor-L is used with less than three or none of | ||
| the provided screws, additional supplemental fixation that has | ||
| been cleared by the FDA for use in the lumbosacral spine must | ||
| be used to augment stability. The accompanying Clip Plate must | ||
| be used anytime the device is used with any number of screws. | ||
| 510(k) Summary: AVS® Anchor-L Lumbar Cage System | ||
| Summary of theTechnologicalCharacteristics | The subject AVS® Anchor-L implant system and the predicatesshare similar design features:Graft windows for packing autogenous bone Serrations on the superior and inferior surfaces Comparable heights, widths, depths, and lordotic angles Testing in compliance with FDA's June 12, 2007 "Class IISpecial Controls Guidance Document: Intervertebral BodyFusion Device" was performed for the AVS® Anchor-L LumbarCage System and demonstrated substantially equivalentperformance to the identified predicate device systems.The following mechanical tests were performed: Static Compression (per ASTM F2077) Dynamic Compression (per ASTM F2077) Static Compression Shear (per ASTM F2077) Dynamic Compression Shear (per ASTM F2077) Static Torsion (per ASTM F2077) Dynamic Torsion (per ASTM F2077) Expulsion (per ASTM F04-25-02-02 Draft) Subsidence (per ASTM F2267) |
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Traditional 510(k) Premarket Notification
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine % Ms. Tiffani Rogers Manager, Regulatory Affairs 2 Pearl Court Allendale, New Jersey 07401
OCT 2 5 2012
Re: K120869
Trade/Device Name: Stryker Spine AVS® Anchor-L Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: October 11, 2012 Received: October 12, 2012
Dear Ms. Rogers:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Tiffani Rogers
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
.Enclosure
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Stryker Spine AVS® Anchor-L Lumbar Cage System
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K 120669
Device Name: Stryker Spine AVS® Anchor-L Lumbar Cage System
Indications For Use:
The Stryker Spine AVS® Anchor-L Lumbar Cage System is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS® Anchor-L Lumbar Cage System is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Cage System may be used as an intervertebral device with integrated fixation or in conjunction with supplemental fixation. When used as an intervertebral device with integrated fixation, the AVS® Anchor-L Lumbar Cage must be used with the three internal screws and plate fixation provided by AVS® Anchor-L Fixation Screws and Clip Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. The accompanying Clip Plate must be used anytime the device is used with any number of screws.
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)
C.A. - P.J.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120869
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.