(84 days)
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 – T3). The intended indications are as follows:
• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Deformities or Curvature
• Tumors
• Pseudoarthrosis
• Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.
The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.
To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.
The provided text describes a medical device, the Atoll™ Cervico-Thoracic System, for which a 510(k) premarket notification was submitted. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets acceptance criteria through a traditional clinical study with specific performance metrics.
Therefore, the document does not contain information on acceptance criteria or a study designed to prove the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Here's a breakdown of why and what information is present in relation to your request:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) submission for the Atoll™ Cervico-Thoracic System does not define specific performance acceptance criteria (e.g., a certain accuracy, sensitivity, or specificity value) for the device's function as an aid in spine fusion.
- The demonstration of "performance" for this type of device (spinal fixation system) typically involves showing equivalence in terms of:
- Intended Use: The Atoll system shares similar indications for use (promoting fusion in cervico-thoracic regions for conditions like DDD, spondylolisthesis, etc.) with its predicate devices.
- Design: It consists of screws, hooks, rods, and connectors, similar to the predicate devices.
- Material Composition: It is made from medical implant grade titanium alloy (Ti-6Al-4V), a commonly accepted material for such implants and likely consistent with predicate devices.
- Physical Characteristics: While not explicitly detailed as a table, the submission asserts that its characteristics are "similar" to the predicate devices. This would typically be supported by mechanical testing (e.g., fatigue, static strength) to ensure it meets established standards for spinal implants, but specific results or pass/fail criteria are not included in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. Since this is a 510(k) for a spinal fixation system, there isn't a "test set" in the context of a diagnostic or AI device that would require data provenance or a sample size to calculate statistical performance. The "test" for this device involves comparing its design, materials, and intended use against already approved devices.
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):
- Not Applicable. This information is irrelevant for a 510(k) submission of a spinal fixation device, which does not involve establishing ground truth from expert evaluations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See 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:
- Not Applicable. This study type is specific to diagnostic aids or AI-powered devices involving human interpretation of medical images. The Atoll™ Cervico-Thoracic System is a physical implant, not a diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. See point 3. The "ground truth" for a spinal fixation device's safety and effectiveness is primarily established through its physical and mechanical properties, biocompatibility, and clinical history of similar predicate devices, rather than expert consensus on diagnostic images.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary:
The provided document details a 510(k) premarket notification for a spinal implant. The regulatory pathway for such devices focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting novel clinical performance data against specific acceptance criteria. This process typically involves comparing intended use, design, materials, and potentially non-clinical (e.g., mechanical) testing results against those of the predicates. The information requested (acceptance criteria, test/training sets, expert ground truth, MRMC studies) is characteristic of submissions for diagnostic or AI-enabled devices, not for a standalone physical implant like the Atoll™ Cervico-Thoracic System.
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Atoll Cervico-Thoracic System
3/5/2007
510(K) Summary
(21 CFR Part 807.92)
A. Submitter Information
| Submitter's Name: | Theken Spine, LLC | MAY 30 2007 |
|---|---|---|
| Address: | 283 E. WaterlooAkron, Ohio 44319 | |
| Telephone Number: | 330-773-7677 x221 | |
| Fax Number: | 330-773-7697 | |
| Contact Person: | Dale Davison | |
| Date Prepared: | 05 March 2007 | |
| B. Device Information | ||
| Trade Name: | Atoll™ Cervico-Thoracic System | |
| Common Name: | Posterior Cervical Instrumentation | |
| Classification: | Class II System with the corresponding product codes:KWP 888.3050 - Spinal Interlaminal Fixation OrthosisMNI 888.3070(b)(1) - Pedicle Screw Spinal System | |
| Predicate Device: | Synthes (USA) – Cervifix System (K990965)/Starlock SystemMedtronic Sofamor Danek USA, Inc. – VERTEX Reconstruction System (K003780)DePuy-AcroMed, Inc.-Summit Occipito-Crevico-Thoracic (OCT) Spinal System (K002733) | |
| Material Composition: | Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 | |
| Subject Device Description: | The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer. | |
| Intended Use: | The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 – T3). The intended indications are as follows:• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)• Spondylolisthesis |
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- . Spinal Stenosis
- Fracture/Dislocation ●
- Deformities or Curvature t
- Tumors
- Pseudoarthrosis t
- . Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Substantial Equivalence ပဲ
The characteristics of the Atoll Cervico-Thoracic System are similar to the following predicate devices:
-
- CerviFix System (K990965)/Starlock System manufactured by Synthes (USA) and cleared by the FDA on July 1, 1999.
- VERTEX™ Reconstruction System (K003780) manufactured by Medtronic 2. Sofamor Danek USA, Inc. and cleared by the FDA on September 28, 2001
-
- Summit OCT Spinal System (K002733) manufactured by DePuy AcroMed, Inc and cleared by the FDA on December 15, 2000.
Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices. Therefore, Theken Spine believes that there is sufficient evidence to conclude that the Atoll Cervico-Thoracic System is substantially equivalent to existing legally marketed devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
AUG 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Theken Spine % Mr. Dale Davison Vice President of Engineering 283 E. Waterloo Road Akron, Ohio 44319
K070638 Re: Trade/Device Name: Atoll™ Cervico-Thoracic System Regulation Number: 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP and MNI Dated: March 5, 2007 Received: March 7, 2007
Dear Mr. Davison:
This letter corrects our substantially equivalent letter of May 30, 2007.
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 (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 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
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Page 2 - Mr. Dale Davison
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.
This letter will allow you to continue 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 or view their Internet address http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Kaibare Buchen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K0706838
Device Name: Theken Atoll Cervico-Thoracic System
Indications For Use: The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-T3). The intended indications are as follows: degenerative disc disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; tumors; pseudoarthrosis; and revision of previous cervical and upper thoracic spine surgery.
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED | RH, Office of Device Evaluation (ODE) Division of
and Neurological Devices
510(k) Number K020638
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.