(90 days)
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.
The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.
The provided text describes a medical device, the "Selective-Axis Posterior Noncervical Plating System," and its clearance process. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document explicitly states: "Mechanical testing of the Selective-Axis Plating System was performed in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s, dated May 3, 2004."
This sentence indicates that mechanical testing was performed according to a guidance document, but it does not provide the results of that testing, nor does it specify any acceptance criteria used to evaluate those results. It focuses on the substantial equivalence of the device to predicate devices based on technological characteristics.
Therefore, I cannot fulfill your request for the detailed table and study information because the provided text does not contain that level of detail regarding performance data.
To answer your request, if this information were available in the text, it would be presented as follows:
1. Table of Acceptance Criteria and Reported Device Performance
(This table cannot be filled from the provided text as the information is missing.)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| [Specific criterion 1, e.g., "Yield Strength ≥ X MPa"] | [Observed device performance 1, e.g., "Y MPa"] |
| [Specific criterion 2, e.g., "Fatigue Life ≥ Z cycles"] | [Observed device performance 2, e.g., "W cycles"] |
| ... (and so on for all relevant mechanical properties) | ... |
2. Sample size used for the test set and the data provenance:
(This information is not provided in the text. Mechanical testing uses physical samples of the device components, not "test sets" of data in the way a diagnostic AI would.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
(Not applicable. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation for ground truth.)
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
(Not applicable for mechanical testing.)
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 device is a mechanical implant and does not involve AI or human readers for its primary function.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
(Not applicable for mechanical testing of an orthopedic implant.)
7. The type of ground truth used:
(For mechanical testing, the "ground truth" would be established mechanical engineering standards and measurements. For example, the ground truth for yield strength is the actual force at which the material deforms permanently, measured directly during testing.)
8. The sample size for the training set:
(Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.)
9. How the ground truth for the training set was established:
(Not applicable. This is a mechanical device.)
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SEP 2 1 2005
451697
510(k) SUMMARY
Medical Device Advisory Development Group's Selective-Axis Posterior Noncervical Plating System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Medical Device Advisory Development Group 560 Old Ranch Road Seal Beach, CA 90740
Phone: 562-598-1753 Facsimile: 562-594-6583
Contact Person: Robert S. Howland
Date Prepared: June 22, 2005
Name of Device and Name/Address of Sponsor
Selective-Axis Posterior Noncervical Plating System
Medical Device Advisory Development Group 560 Old Ranch Road Seal Beach, CA 90740
Common or Usual Name
Posterior Pedicle Screw System
Classification Name
Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation (21 C.F.R. § 888.3070); Product Code: MNI, MNH
Predicate Devices
EBI's SpineLink-II Spinal Fixation System Scient'x Aladyn Rigid Spine Plate
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\\PH - 22194/0001 - 19157 v1
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Intended Use / Indications for Use
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.
Technological Characteristics and Substantial Equivalence
The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.
The Selective-Axis Plating System is substantially equivalent* to the other currently marketed spinal systems which are referenced above. The Selective-Axis Plating System and its predicate devices all employ multiangular pedicle screws, longitudinal plates or bars that connect the pedicle screws, cross-linking connectors that connect the longitudinal plates or bars, and locking nuts with similar technological features to stabilize the spine as
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* Any statement made in conjunction with this submission regarding an FDA determination of substantial equivalence to any other product is intended only to relate to whether the product can be marketed lawfully under FDA's section 510(k) premarket notification process. The term "substantial equivalence" as used herein is not related to "substantial equivalence" as the term is used in the patent context. [See Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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an adjunct to fusion. Thus, the Selective-Axis Plating System raises no new issues of safety or effectiveness.
Performance Data
Mechanical testing of the Selective-Axis Plating System was performed in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s, dated May 3, 2004.
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Advisory Development Group C/o C. Stephen Lawrence Hogan & Hartson L.L.P. Century Centre 2603 Main Street. Suite 1170 Irvine, CA 92614
Re: K051697
Trade/Device Name: Selective-Axis Posterior Noncervical Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: June 22, 2005 Received: June 23, 2005
Dear Mr. Lawrence:
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.
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Page 2 – Mr. C. Stephen Lawrence
This 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 thus, 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 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. J. Molloy
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Selective-Axis Posterior Noncervical Plating System
Indications for Use:
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral) pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.
Prescription Use V (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number COS1697
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