(272 days)
The Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.
The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.
The Valeo® Spacer System -AL, -TL, -PL, -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.
The Valeo Spacer System consists of cervical and lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Valeo Spacer System is manufactured from MC2, a ceramic material, and is provided sterile.
I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way you've outlined. The document is a 510(k) summary for a medical device (Valeo® Spacer System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against detailed acceptance criteria through a specific study with statistical methods.
Here's a breakdown of why I cannot fulfill your request as precisely as you've asked, followed by what information is available in the text:
- No detailed acceptance criteria and reported device performance table: The text states, "Testing performed on this device indicates that the Valeo Spacer System is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met." This is a high-level statement and does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific mechanical thresholds) or the granular performance metrics from a dedicated study.
- No information on sample size, data provenance, number of experts, adjudication, MRMC studies, or standalone algorithm performance: These concepts are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not the nature of this 510(k) submission for an intervertebral body fusion device. The testing mentioned refers to mechanical and biocompatibility testing against standards like ASTM F2077.
- No details on ground truth used or training set information: Again, these are relevant for machine learning or diagnostic device studies, which are not described in this document.
What information is available from the provided text regarding performance and testing:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria/Standard: Adherence to ASTM F2077 performance standards.
- Reported Device Performance: "all applicable requirements were met," and the device was "substantially equivalent to predicate devices."
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Sample size used for the test set and the data provenance: Not applicable/Not provided. The document refers to testing against a standard (ASTM F2077), which would involve a specific number of test articles for mechanical and material testing, but this is not detailed in the summary. Data provenance (e.g., country of origin, retrospective/prospective) is not relevant for this type of device submission as described.
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Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable/Not provided. Ground truth establishment by experts is not a component of proving substantial equivalence for this type of mechanical device.
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Adjudication method for the test set: Not applicable/Not provided.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/Not provided. This type of study is for evaluating medical imaging or diagnostic device performance, often involving human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is relevant for AI/algorithm-based devices.
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The type of ground truth used: Not applicable/Not provided in the context of diagnostic performance. For an intervertebral body fusion device, "ground truth" might refer to known material properties or biomechanical benchmarks, but this is not specified as "ground truth" in the diagnostic sense.
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The sample size for the training set: Not applicable/Not provided. This is for AI/machine learning.
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How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided text is a 510(k) premarket notification for an intervertebral body fusion device. Its focus is on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through adherence to established performance standards (ASTM F2077) for mechanical and material properties. It does not describe a clinical study in the way one would for a diagnostic device, nor does it provide the detailed performance metrics, ground truth establishment, or expert involvement that your questions imply for a diagnostic or AI-based product.
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510(k) Summary
| Contact: | Robert M. Wolfarth, CQAAmedica Corporation801-839-3500 | |
|---|---|---|
| Device Trade Name: | Valeo® Spacer System | JAN 2 8 2010 |
| Manufacturer: | Amedica Corporation1885 West 2100 SouthSalt Lake City, UT 84119 | |
| Common Name: | Intervertebral body fusion device | |
| Classification: | 29 CFR §888.3080 | |
| Class: | II | |
| Product Code: | MAX, ODP |
Indications For Use:
The Valeo Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.
The Valeo Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.
The Valeo Spacer System -AL. -TL. -PL. -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.
Device Description:
The Valeo Spacer System consists of cervical and lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Valeo Spacer System is manufactured from MC2, a ceramic material, and is provided sterile.
Predicate Device(s):
The Valeo Spacer System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used.
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Performance Standards:
Testing performed on this device indicates that the Valeo Spacer System is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met.
. .
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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 stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 2 8 2010
Amedica Corporation % Mr. Robert M. Wolfarth, CQA Director, Regulatory Affairs and Quality Assurance 1885 West 2100 South Salt Lake City, Utah 84119
Re: K091278
Trade/Device Name: Valeo® Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: January 21, 2010 Received: January 25, 2010
Dear Mr. Wolfarth:
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
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Page 2 - Mr. Robert M. Wolfarth, COA
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/ucm111800 htm fars 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Barbeze Prichup
Mark N. Mallek
Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091278
Device Name: Valeo® Spacer System
The Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.
The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 to Tl, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.
The Valeo® Spacer System -AL, -TL, -PL, -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.
Prescription Use V (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 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)
Al
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K091278 510(k) Number_
§ 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.