(260 days)
The Advanced Vertebral Solutions IBF device, when used with autologous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Advanced Vertebral Solutions IBF device is to be implanted via a transforaminal approach. The device is to be used singly in the lumbosacral spine with supplemental posterior fixation.
Advanced Vertebral Solutions Express IBFD AVS Express is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces. Advanced Vertebral Solutions Express IBFD AVS Express is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Advanced Vertebral Solutions designed the Advanced Vertebral Solutions Express IBFD AVS Express to be placed through a transforaminal approach and to address vertebrae in the lumbosacral region of the spine.
The provided 510(k) summary describes a medical device, the Advanced Vertebral Solutions EXPRESS IBFD, which is an intervertebral fusion device, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. As such, the information provided is not for an AI/ML powered device, and therefore several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, how ground truth for training set was established) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for each test are implied to be "meeting the standards of the predicate devices" or "within acceptable limits as defined by the ASTM standards for intervertebral body fusion devices." The document states that the new device met these criteria.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static and Dynamic Compression Test (per ASTM F2077) | Performance comparable to predicate devices and within limits defined by ASTM F2077 for intervertebral body fusion devices. | Met the acceptance criteria. |
| Static and Dynamic Compression Shear Test (per ASTM F2077) | Performance comparable to predicate devices and within limits defined by ASTM F2077 for intervertebral body fusion devices. | Met the acceptance criteria. |
| Subsidence Test (per ASTM F2267) | Performance comparable to predicate devices and within limits defined by ASTM F2267. | Met the acceptance criteria. |
| Wear Debris Test (per ASTM F2077 and ASTM F1877) | Performance comparable to predicate devices and within limits defined by ASTM F2077 and F1877. | Met the acceptance criteria. |
| Static Expulsion Test | Performance comparable to predicate devices and demonstrating adequate resistance to expulsion. | Met the acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document describes non-clinical (mechanical) testing of a medical implant, not performance testing of an algorithm on a data set. The sample sizes would refer to the number of devices tested in each mechanical test, which is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical or image data. The "data" here refers to the physical and mechanical properties of the device, likely generated in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in this context refers to the physical properties measured in mechanical tests, not expert interpretation of clinical data. The "experts" would be the engineers and technicians performing the ASTM standard tests.
4. Adjudication method for the test set
- Not applicable. Since there's no expert interpretation or uncertainty addressed, no adjudication method would be used. The results are quantitative measurements against established standards.
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 not an AI/ML powered device. No clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for this device's performance is based on established engineering standards and quantitative measurements from non-clinical mechanical tests (e.g., meeting specific load-bearing requirements, wear rates, and expulsion resistance detailed in ASTM standards F2077, F2267, and F1877). It's about validating physical integrity and performance, not diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML powered device.
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510(k) Summary
1< 160037 SEP 2 3 2010
(
Advanced Vertebral Solutions, EXPRESS IBFD
.
| Submitter: | ADVANCED VERTEBRAL SOLUTIONS, LLC |
|---|---|
| 124 S. Maple Street | |
| Ambler, PA 19002 | |
| Contact Person | Mike Dugery |
| President | |
| Phone: 215 534 2481 | |
| Email: mdugery@vasculabtech.com | |
| Date Prepared | September 21, 2010 |
| Device Class | Class II |
| Trade Name | Advanced Vertebral Solutions, EXPRESS IBFD |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| and Number | 21 CFR 888.3080 |
| Classification Panel: | Orthopedics |
| Product Code | MAX |
| Predicate Devices | ParamountTM Intervertebral Body Fusion Device (K072120) |
| and Patriot TM Intervertebral Body Fusion Device (K072970) | |
| Device Description | Advanced Vertebral Solutions Express IBFD AVS Express is a |
| device for interbody fusion of the anterior column of the spine. | |
| These cages are hollow so that bone can grow through the | |
| device, fusing the adjacent bony surfaces. | |
| Advanced Vertebral Solutions Express IBFD AVS Express is a | |
| hollow device with texture on two opposing convex sides, and | |
| is offered in various lengths, widths, heights and shapes. | |
| Advanced Vertebral Solutions designed the Advanced Vertebral | |
| Solutions | |
| Express IBFD AVS Express to be placed through a | |
| transforaminal approach and to address vertebrae in the | |
| lumbosacral region of the spine. | |
| Intended Use | The Advanced Vertebral Solutions IBF device, when used withautologous bone graft, is indicated for use in patients withDegenerative Disc Disease (DDD) at one or two contiguouslevels from L2 to S1. These DDD patients may also have up toGrade 1 spondylolisthesis or retrolisthesis at the involvedlevel(s). DDD is defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographicstudies. These patients should be skeletally mature and havehad six months of non-operative treatment.The Advanced Vertebral Solutions IBF device is to beimplanted via a transforaminal approach. The device is to beused singly in the lumbosacral spine with supplementalposterior fixation. |
| Materials: | The implant is manufactured from ASTM2026 implant gradePolyetheretherketone (PEEK) and ASTM F136 implant gradeTitanium Alloy 6Al4V. |
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| Statement ofTechnologicalComparison | The purpose of this submission is to obtain market clearance for theproposed the Advanced Vertebral Solutions EXPRESS IBFD. TheAdvanced Vertebral Solutions EXPRESS IBFD and its predicatedevices have the same indications for use, have a similar design, andare made of the similar materials and chemical composition. |
|---|---|
| --------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Summary of Technological Comparison | |||
|---|---|---|---|
| Characteristic | AdvancedVertebralSolutions | GlobusPatriot | ISTParamount |
| Material | PEEK ZA 500 or Ti alloy | PEEK-OPTIMA® | PEEK-OPTIMA® |
| RadiopaqueMarkers | Tantalum or Ti alloy | Tantalum | Tantalum |
| Shape | Five Banana shapes | Banana | Banana |
| Surgical Approach | TLIF | Direct Posterior orTLIF | Direct Posterior orTLIF |
| Adjunctive Fixation | Required | Required | Optional |
| Bone to ImplantSurface | Ridged | Ridged | Ridged |
| How Supplied | Non-Sterile | Non-Sterile | Non-Sterile |
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| Nonclinical TestSummary | The following tests were performed to demonstrate that theAdvanced Vertebral Solutions EXPRESS IBFD is substantiallyequivalent to other predicate devices.Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Subsidence Test per ASTM F2267 Wear Debris ASTM F2077 and ASTM F1877 Static Expulsion Test The results of these studies showed that the subject AdvancedVertebral Solutions EXPRESS IBFD met the acceptancecriteria. |
|---|---|
| Clinical Test Summary | No clinical tests were performed. |
| Conclusion | The Advanced Vertebral Solutions EXPRESS IBFD issubstantially equivalent to its predicate devices. Thisconclusion is based upon the fact that this device is substantiallyequivalent in terms of indications for use, technologicalcharacteristics, materials, design and principles of operation. |
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advanced Vertebral Solutions. LLC % Mr. Mike Dugery President 124 South Maple Street Ambler, Pennsylvania 19002
SEP 2 3 2010
Re: K100037
Trade/Device Name: Advanced Vertebral Solutions EXPRESS IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 02, 2010 Received: September 03, 2010
Dear Mr. Dugery:
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
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Page 2 - Mr. Mike Dugery
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 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,
[signature]
Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10003
2 3 2010
Indications for Use
K100037 510(k) Number:
Device Name:
Advanced Vertebral Solutions EXPRESS IBFD
Indications:
The Advanced Vertebral Solutions EXPRESS IBFD, when used with autologous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from 1.2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Advanced Vertebral Solutions EXPRESS IBFD is to be implanted via a transforaminal approach. The device is to be used singly in the lumbosacral spine with supplemental posterior fixation.
Prescription Use X
AND/OR
Over-the-counter
(Part 21 CFR 801 Subpart D) (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 Surgical, Orthopedic, and Restorative Devices
K100037 510(k) Number_
N/A