(99 days)
The VertiForm Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the Vertiform Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.
The VertiForm Posterior Fixation System consists of pedicle screw assemblies, set screw, rod and crosslink. The pedicle screw assemblies consist of Polyaxial Pedicle Screw, Fixed Pedicle Screw, and Uniplanar Pedicle Screw and are in a variety of geometries and sizes to accommodate patient anatomy. They will be provided non-sterile. The VertiForm Posterior Fixation System is manufactured from Titanium allov in accordance with ASTM F136, medical-grade commercially pure titanium per ASTM F67 and medical grade cobalt chrome per ASTM F-1537.
This document is a 510(k) summary for the VertiForm Posterior Fixation System, which is a pedicle screw spinal system. It describes the device, its intended use, and substantial equivalence to predicate devices. The document does not contain specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/ML medical device.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document provides the following information regarding performance testing:
| Test/Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Safety and Performance | Equivalent to predicate devices | "The results of this testing indicate that the VertiForm Posterior Fixation System is equivalent to the predicate devices." |
| Static Compression | Equivalent to predicate devices | Met |
| Dynamic Compression | Equivalent to predicate devices | Met |
| Static Torsion | Equivalent to predicate devices | Met |
Note: The acceptance criteria are implicitly stated as "equivalent to the predicate devices" rather than specific numerical thresholds. The reported performance is a general statement of equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document states "Performance testing has been conducted for the subject devices in accordance with the following guidance documents: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, ASTM F1717". This refers to non-clinical (mechanical) testing of the device hardware, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The study described is a non-clinical, mechanical performance test of a physical device, not an AI/ML algorithm requiring expert-established ground truth from medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the same reasons as point 3.
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
This information is not applicable/provided. No MRMC study or AI assistance is mentioned. The device is a physical spinal fixation system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The "ground truth" for the mechanical performance tests would be the measured physical properties (e.g., strength, stiffness, fatigue resistance) according to the ASTM standard, and comparison to predicate devices.
8. The sample size for the training set
This information is not applicable/provided. There is no training set for a physical implant device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no training set for a physical implant device.
In summary:
The provided document describes a traditional medical device (a spinal implant). The "study" mentioned is non-clinical performance testing of the device's mechanical properties, not a clinical trial or an evaluation of an AI/ML algorithm. Therefore, many of the requested details, especially those related to AI/ML device evaluation, are not present or applicable to this document. The key information provided is that mechanical tests (Static Compression, Dynamic Compression, Static Torsion) were performed according to ASTM F1717, and the device was found to be "equivalent to the predicate devices" in terms of mechanical safety and performance.
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Image /page/0/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 three human profiles facing right, with flowing lines that resemble hair or ribbons.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2014
Next Orthosurgical, Incorporated Mr. Huan Tran Manager, Quality and Regulatory Affairs 3270 Corporate View, Suite A Vista, California 92081
Re: K141291
Trade/Device Name: VertiForm Posterior Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. OSH. MNI. MNH Dated: July 23, 2014 Received: July 25, 2014
Dear Mr. Tran:
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. Isting 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 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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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,
Ronald刷Alean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: _
Device Name: VertiForm Posterior Fixation System
Indications For Use:
The VertiForm Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the Vertiform Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Next Orthosurgical. The logo features a golden sphere with a silver ring around it, resembling a planet. Below the sphere, the word "NEXT" is written in gold, with the word "ORTHOSURGICAL" written in a smaller font below it.
510(k) Summary for the VertiForm Posterior Fixation System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the VertiForm Posterior Fixation System
1. GENERAL INFORMATION
| Date Prepared: | May 19, 2014 |
|---|---|
| Trade Name: | VertiForm Posterior Fixation System |
| Common Name: | Pedicle Screw |
| ClassificationName: | Pedicle Screw Spinal System |
| Class: | III |
| Product Code: | |
| CFR section: | 21 CFR section 888.3070 |
| Device panel: | Orthopedic |
| Legally Marketed | Predicate Device: DePuy Moss Miami Spinal System Polyaxial Screws (K030383) |
| DePuy Expedium Spine System (K130877) | |
| Biomet Spine Array Spinal System (K062685) | |
| Medtronic CD Horizon Spinal System (K111457) | |
| Submitter: | Next OrthoSurgical3270 Corporate View, Suite AVista CA. 92081760-295-3600 Tele760-295-3610 Fax |
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Contact: Huan Tran 3270 Corporate View, Suite A Vista CA. 92081 760-295-3600 Tele 760-295-3610 Fax e-mail: htran@nextorthosurgical.com
2. DEVICE DESCRIPTION
The VertiForm Posterior Fixation System consists of pedicle screw assemblies, set screw, rod and crosslink. The pedicle screw assemblies consist of Polyaxial Pedicle Screw, Fixed Pedicle Screw, and Uniplanar Pedicle Screw and are in a variety of geometries and sizes to accommodate patient anatomy. They will be provided non-sterile. The VertiForm Posterior Fixation System is manufactured from Titanium allov in accordance with ASTM F136, medical-grade commercially pure titanium per ASTM F67 and medical grade cobalt chrome per ASTM F-1537.
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The VertiForm Posterior Fixation System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
4. INTENDED USE
The VertiForm Posterior Fixation System is intended for posterior. non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the Vertiform Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.
5. NON-CLINICAL TEST SUMMARY
Performance testing has been conducted for the subject devices in accordance with the following quidance documents:
- . Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, ASTM F1717
- . Construct tests included:
- Static Compression
- Dynamic Compression
- Static Torsion
The results of this testing indicate that the VertiForm Posterior Fixation System is equivalent to the predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed.
CONCLUSIONS NONCLINICAL AND CLINICAL 7.
Next Orthosurqical considers the VertiForm Posterior Fixation System to the predicate devices listed above. This conclusion is based on the device's similarities of operation, technology, materials and indications for use.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.