(70 days)
The NuVasive HELIX Revolution ACP System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX Revolution ACP System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The NuVasive HELIX Revolution ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.
This document is a 510(k) summary for the NuVasive HELIX Revolution ACP System, a cervical plate and screw system. It is a premarket notification for a medical device seeking substantial equivalence to a predicate device already on the market.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device adherence:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the way you've described for an AI/software device. This is a 510(k) submission for a physical medical device (a cervical plate and screw system), which follows different regulatory pathways and testing requirements than software or AI-driven diagnostic tools.
For this type of device, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device. The performance is assessed through mechanical testing against relevant standards or comparisons to the predicate, not typically through metrics like sensitivity, specificity, or AUC as seen in AI studies.
The closest information provided is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The subject HELIX Revolution ACP System is substantially equivalent to the Helix ACP System currently distributed commercially in the U.S. by NuVasive." (Section C) |
| Principles of Operation | "The subject device ... employs the same principles of operation." (Section F) |
| Intended Use | "The subject device has indications for use identical to those of its predicate" (Section F) |
| Mechanical Performance | "Mechanical testing was presented." (Section G) - Specific results are not detailed in this summary. |
2. Sample size used for the test set and the data provenance
There is no test set sample size described in this document in the context of an AI/software evaluation. The "data provenance" is also not applicable in the way you've defined, as this is a physical medical device. The "testing" referred to (mechanical testing) would involve physical samples of the device components, not a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. There is no mention of experts establishing a "ground truth" through consensus for a test set, as this is typically relevant for diagnostic AI applications, not a mechanical implant.
4. Adjudication method for the test set
This information is not applicable to this 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data, often for establishing ground truth in diagnostic accuracy studies.
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
There is no MRMC comparative effectiveness study mentioned. This type of study is specific to evaluating the impact of AI on human reader performance, which is not relevant for a cervical plate and screw system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no standalone performance evaluation mentioned. Again, this is relevant for AI algorithms, not for physical implants.
7. The type of ground truth used
This information is not applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) as used in AI/diagnostic studies does not apply to the mechanical testing or substantial equivalence claims for a physical implant. The "truth" for this device lies in its mechanical properties meeting relevant standards and its functional equivalence to a legally marketed predicate.
8. The sample size for the training set
There is no training set sample size mentioned. Training sets are used for machine learning models, which are not relevant to this device.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth establishment process described.
In summary:
The provided document is a 510(k) premarket notification for a physical medical device (cervical plate and screw system). The regulatory pathway for such a device is based on demonstrating "substantial equivalence" to a predicate device, primarily through mechanical testing and comparison of intended use and principles of operation.
The questions you've posed (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training sets) are highly specific to the evaluation of AI/software as a medical device (SaMD) or AI-assisted diagnostic tools. These concepts are not addressed or typically relevant in a 510(k) summary for a mechanical implant like the NuVasive HELIX Revolution ACP System.
The closest relevant information is that "Mechanical testing was presented" (Section G), suggesting that tests were conducted to ensure the device's physical properties are suitable and comparable to the predicate, but specific criteria and results are not detailed in this summary. The "acceptance criterion" for the overall submission is the FDA's determination of "substantial equivalence."
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Image /page/0/Picture/1 description: The image shows the logo for Nuvasive Creative Spine Technology. The logo features a stylized leaf-like design to the left of the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the text "Creative Spine Technology" in a smaller, italicized font.
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided:
A. Submitted by:
FEB 1 9 2010
Sheila Bruschi Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615
B. Device Name
Trade or Proprietary Name: NuVasive HELIX Revolution ACP System Common or Usual Name: Cervical Plate and Screw System Classification Name: Spinal Intervertebral Body Fixation Orthosis Device Class: Class II Classification: $888.3060 Product Code: KWQ
C. Predicate Devices
The subject HELIX Revolution ACP System is substantially equivalent to the Helix ACP System currently distributed commercially in the U.S. by Nu Vasive.
D. Device Description
The NuVasive HELIX Revolution ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.
E. Intended Use
The NuVasive HELIX Revolution ACP System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX Revolution ACP System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE" in all caps. Below the company name is the text "Creative Spine Technology" in a smaller font size. The logo is simple and modern.
F. Comparison to Predicate Devices
The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.
G. Summary of Non-Clinical Tests
Mechanical testing was presented.
Summary of Clinical Tests H.
(Not Applicable).
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 9 2010
Nu Vasive, Inc % Ms. Sheila Bruschi Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K093804
Trade/Device Name: NuVasive Helix Revolution ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 21, 2010 Received: January 22, 2010
Dear Ms. Bruschi:
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 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. Sheila Bruschi
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/ReportalProblem/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 your
Saukautmehm
Mark N. Melkerson 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
K093804 510(k) Number (if known):___
Device Name: HELIX Revolution Anterior Cervical Plating System
Indications For Use:
The NuVasive HELIX Revolution Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX Revolution Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use × (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)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K093804
§ 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.