(119 days)
The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The provided text describes the Paramount™ VBR System, a device for vertebral body replacement, and its 510(k) clearance. However, it does not contain information about a study based on acceptance criteria for device performance with a specific output metric, such as those typically found in AI/ML device submissions. The performance data mentioned refers to mechanical testing according to general ASTM standards and biocompatibility.
Therefore, many of the requested items related to a study proving the device meets acceptance criteria cannot be answered from the provided text.
Here's a breakdown of what can be extracted:
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Test Performance (ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02) | "demonstrate that the Paramount™ VBR device can be expected to perform in a manner substantially equivalent to the predicate devices." |
| Biocompatibility | "Biocompatibility of the device was demonstrated." |
Information Not Available in the Provided Text:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Explanation:
This document is a 510(k) summary for a traditional medical device (spinal implant), not an AI/ML-powered device. The "performance data" refers to standard engineering and biocompatibility tests to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics (like sensitivity, specificity, AUC) for an algorithm's output. Therefore, the details requested for AI/ML device studies (such as test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission and are not present in the provided text.
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JAN 1 2 2007
510(k) SUMMARY
DATE: November 17, 2006 SUBMITTER: Innovative Spinal Technologies, Inc. 111 Forbes Blvd. Mansfield, MA 02048 Telephone: 508/452-3520 Fax: 508/452-3600 CONTACT PERSON: Gina Yeh TRADE NAME: Paramount™ Vertebral Body Replacement System FDA CLASSIFICATION/ CODE: 888. 3060. MQP
DEVICE DESCRIPTION: The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.
INTENDED USE: The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
Spinal Concepts Inc. TRAXIS™ (K033517), Pioneer® PREDICATE DEVICES: Vertebral Spacer (K043206), and SpineVision Spacevision™ Cage (K042930).
PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Paramount™ VBR device can be expected to perform in a manner substantially equivalent to the predicate devices. In addition, biocompatibility of the device was demonstrated.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innovative Spinal Technologies, Inc. % Ms. Gina Yeh Program Manager, Regulatory Affairs 111 Forbes Boulevard Mansfield, Massachusetts 02048
JAN 1 2 2007
Re: K062759
Trade/Device Name: Paramount™ VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 22, 2006 Received: December 26, 2006
Dear Ms. Yeh:
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 misbrandijne 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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, U.A.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 - Ms. Gina Yeh
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) 276-0210 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sorban Buckun
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number:_ K062759
Device Name: Paramount™ VBR System
Indications:
The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
Prescription Use _ × or (21 CFR 801 Subpart D)
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)
Hubace Buchur
. Restorative. and Neurological Devices
510(k) Number Ko63759
§ 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.