(92 days)
The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate.
The provided text describes the 510(k) summary for the Tempus™ Cervical Plate System. This is a medical device, and the evaluation is for substantial equivalence to predicate devices, not for an AI/ML diagnostic or prognostic system. Therefore, many of the requested categories in the prompt are not applicable to this type of medical device submission.
Here's an attempt to address the prompt based only on the provided text, noting where information is not relevant or available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing to ASTM F1717-11) | Reported Device Performance |
|---|---|
| Withstand anticipated forces of the cervical spine (implied by predicate equivalence) | Can withstand the anticipated forces of the cervical spine |
| Performance comparable to legally marketed predicate devices in: | Performance is comparable to legally marketed predicate devices in: |
| - Static Axial Compression Bending (in accordance with ASTM F1717–11) | - Static Axial Compression Bending tests |
| - Static Torsion (in accordance with ASTM F1717–11) | - Static Torsion tests |
| - Dynamic Axial Compression Bending (in accordance with ASTM F1717–11) | - Dynamic Axial Compression Bending tests |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the study described is a non-clinical, mechanical bench testing study (physical testing of the device), not a study involving patient data or a "test set" in the context of an AI/ML model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth for mechanical testing is established by physical measurements against engineering standards and specifications, not by expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable, as the evaluation is based on mechanical performance data against a standard, not on subjective interpretations requiring adjudication.
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 is not applicable. The device is a physical spinal implant, not an AI/ML system that would assist human readers in image interpretation or diagnosis.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) study was done
This is not applicable. The device is a physical product, not an algorithm. The "standalone" performance here refers to the device's mechanical integrity under various loads, which was indeed tested (as described under "PERFORMANCE DATA").
7. The Type of Ground Truth Used
The ground truth for this medical device study is based on:
- Engineering Standards: Adherence to ASTM F1717–11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
- Mechanical Properties: The device's ability to withstand specified forces and its static and dynamic mechanical performance as measured by standardized tests.
- Predicate Device Performance: Comparison to the known, accepted mechanical performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of mechanical bench testing for a spinal implant. The "training" in this context would refer to the design and refinement process, which isn't detailed here but doesn't involve a data training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There is no "training set ground truth" for this type of device. The design specifications and mechanical properties are engineering-driven.
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5.510(K) Summary
| Submitter's Name: | NeuroStructures, LLC |
|---|---|
| Submitter's Address: | 63 Bovet Road, Suite 135San Mateo, CA 94402 |
| Submitter's Telephone: | 800-352-6103 |
| Contact Name: | John Stephani |
| Date Summary was Prepared: | 02/16/2012 |
| Trade or Proprietary Name: | Tempus™ Cervical Plate System |
| Common or Usual Name: | Spinal intervertebral body fixation orthosis |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Synthes CSLP Cervical Plate (K030866)Centerpulse Spine-Tech Trinica Select™ Anterior Cervical PlateSystem (K012305) |
Description of the Device Subject to Premarket Notification:
The Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate.
Indications for Use
The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The indication for use for the Tempus™ Cervical Plate System is similar to that of the Centerpulse Spine-Tech Trinica Select™ Anterior Cervical Plate System (K012305) and similar to that of Synthes Spine Anterior CSLP System (K030866). The Synthes device does not include deformity in the indications for use but is similar in all other aspects. As the subject device has indications that are identical to one of
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the predicate devices and similar to the second predicate device device does not introduce differences that are critical to the surgical use of the device.
TECHNICAL CHARACTERISTICS
The plates and screws are manufactured from titanium alloy meeting requirements of ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401). Titanium alloy has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The Synthes CSLP plate is manufactured from commercially pure titanium, but the Trinica plate and Tempus™ plate are both manufactured from titanium alloy.
The Tempus™ Plates include locking pins that cover the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Both of the predicate devices have an interference to the screw head with the same intent. The Synthes CSLP plate has an automatic locking mechanism that collapses over the head of the screw. The Trinica™ Plate has a manual locking cover that is engaged over the screw head after the place, similar in technical characteristics to the locking pin that is utilized in the Tempus™ plate.
PERFORMANCE DATA
The Tempus™ Cervical Plate System has been tested in static axial compression bending, static torsion, and dynamic axial compression bending in accordance with ASTM F1717–11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The results of this non-clinical testing show that the Tempus™ Cervical Plate System can withstand the anticipated forces of the cervical spine and legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Tempus™ Cervical Plate System is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which features three diagonal lines that curve and merge into a single line at the bottom. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NeuroStructures, LLC % Meredith May, MS Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
MAY 2 3 2012
Re: K120515
Trade/Device Name: Tempus Cervical Plate System Regulation Number: 21 CFR 888.3060 · Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: February 16, 2012 Received: February 29, 2012
Dear Ms. May:
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 for too stated on the 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 . r ou may, aterest of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Trease nover, 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 may oc subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc advised that i Dri 3 ibsunted or a or device complies with other requirements of the Act that I Dr Has that to and regulations administered by other Federal agencies. You must of any I ederal statutes and regaranents, including, but not limited to: registration and listing (21
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Page 2 – Ms. Meredith May
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cr K F at 807), labeling (21 OFR 803); good manufacturing practice requirements as set device-related duverse ovents) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 800), please If you dcsire specific advice to: your do real conters offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Aso, please the Center 10. Doviete and readers of the sees of premarket notification" (21CFR Part note the regulations 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 rou may obtain of Scherers, 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 yours,
for Ront mair
LLC
Mark N. Melkerson ల్ల Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
Device Name: Tempus™ Cervical Plate System
The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-Off) Division of Surgical, Orthopedic, nd Restorative Devices
510(k) Number___K120515
Page 1 of 1
§ 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.