(36 days)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. The ROC™ Lumbar Plating when intended to arovide 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 lumbosacral spine: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 – S1.
The ROC™ Lumbar Plating System is a spinal fixation system intended to improve stability of the lumbosacral spine. There are a variety of implants that can be used for this procedure including; lumbar plates, botts, offset links and locking nuts. All components are made from titanium alloy, Ti 6Al 4V meeting specifications of ASTM F136.
This 510(k) summary is for a spinal implant system, not an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment) is not applicable.
However, I can extract the relevant information about the non-clinical performance testing that was performed for this device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Biocompatibility (material specification) | Made from titanium alloy, Ti 6Al 4V, meeting specifications of ASTM F136. |
| Mechanical Performance | Static Testing (e.g., axial compression, bending, torsion) | Performed and submitted in the application. (Specific numerical criteria and results are not detailed in this summary document but were part of the full submission.) |
| Mechanical Performance | Dynamic Testing (fatigue) | Performed and submitted in the application. (Specific numerical criteria and results are not detailed in this summary document but were part of the full submission.) |
| Substantial Equivalence | To existing predicate devices | The device was found substantially equivalent to the TiMX plating system (Depuy Spine) and the Simmons plating system (Smith & Nephew). |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in the 510(k) summary for mechanical testing. Standard testing typically involves multiple samples to achieve statistical significance.
- Data provenance: The performance data was generated through physical testing of the device components/system. This is laboratory-based testing, not human or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for mechanical performance is established by engineering standards (e.g., ASTM F136 for material, and other mechanical testing standards for static and dynamic performance) and the results obtained from the tests themselves. It does not involve expert clinicians establishing a "ground truth" in the way it would for AI diagnostic algorithms.
4. Adjudication method for the test set
- Not applicable. This refers to consensus reaching among experts for AI/ML ground truth, which is not relevant for physical device testing against engineering standards.
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 physical implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an AI/ML algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance is established by:
- Engineering Standards: Adherence to material specifications (ASTM F136).
- Mechanical Testing Results: The quantitative and qualitative outcomes of static and dynamic load testing.
- Predicate Device Performance: The established safety and effectiveness profile of existing, legally marketed predicate devices to which this device demonstrated substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device; there is no training set.
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ROC™ Lumbar Plating System 510(k) SUMMARY January 2005
FEB 1 8 2005
- Company: Alphatec Manufacturing Inc. l. 6110 Corte Del Cedro Carlsbad, CA 92009, USA (760) 431-9286
- Ellen Yarnall, Director of Regulatory Affairs ll Contact Person:
- ROC™ Lumbar Plating System 111 Trade/Proprietary Name:
IV Product Description:
The ROC™ Lumbar Plating System is a spinal fixation system intended to improve stability of the lumbosacral spine. There are a variety of implants that can be used for this procedure including; lumbar plates, botts, offset links and locking nuts. All components are made from titanium alloy, Ti 6Al 4V meeting specifications of ASTM F136.
V. Classification
MNI (21 CFR 888.3070) Orthosis, Spinal Pedicle Fixation Orthosis. Spondyloisthesis Spinal Fixation MNH (21 CFR 888.3070)
VI Indications for Use
The ROC™ Lumbar Plating when intended to provide immobilization 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 lumbosacral spine: severe spondylolisthesis (arades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 - S1.
VII Substantial Equivalence:
The ROC™ Lumbar Plating System is substantially equivalent to other commercially available system such as the TiMX plating system offered by Depuy Spine and the Simmons plating system offered by Smith & Nephew.
VIII Performance Data:
Static and dynamic testing of the ROC™ Lumbar Plating System was performed and submitted in this application.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ellen Yarnall Director of Regulatory Affairs Alphatec/Nexmed 6110 Corte Del Cedro Carlsbad, California 92009
Re: K050078
Trade/Device Name: ROCTM Lumbar Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw System Regulatory Class: II Product Code: MNH, MNI Dated: January 10, 2005 Received: January 13, 2005
Dear Ms. Yarnall:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becaren be device is substantially equivalent (for the indications felerenced above und nave actions and marketed predicate devices marketed in interstate for use stated in the encreative to togally to togal (1) the Medical Device Amendments, or to conninered prof to May 20, 1978, in ecordance with the provisions of the Federal Food. Drug, devices that have been roomstreat require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 va may) mercleve, mains of the Act include requirements for annual registration. Iisting of general controls profitering 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 If your device is exassimon (ontrols. Existing major regulations affecting your device can may be subject to such additions, 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 that 1197 Has made a count regulations administered by other Federal agencies. You must or any I ederal states and Pegirements, 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 (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. Ellen Yarnall
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your antial equivalence of your device to a legally premarket notincation: "The PDF miding of basification 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 if you desire specific advice for your do no 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 comact the Office of Complanes an (21 t notification" (21CFR Part 807.97). You may obtain Misoraliung Uy telefonoe to promanteensibilities under the Act from the Division of Small other general information on your response 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,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ROC™ Lumbar Plating System
Indications for Use:
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. The ROC™ Lumbar Plating when intended to arovide 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 lumbosacral spine: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 – S1.
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)
Mark A. Melkerson
storative,
510(k) Number
§ 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.