(94 days)
The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain 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 Coral™ Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, cross-connectors, and connecting components. Coral™ Spinal System components can be rigidly locked creating a rigid construct for promoting fusion. Coral™ Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67, ASTM F136, ISO 5832-3, and ISO 5832-2. Alternatively, the entire system may be made out of medical grade stainless steel described by such standards as ASTM F138, ISO 5832-1, and ISO 5832-9. Caution use of dissimilar metals, i.e. stainless steel and titanium must not be used in combination, but must be used independently.
The provided document is a 510(k) summary for the Coral™ Spinal System. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on mechanical testing. This document does not contain information typically found in a study proving a device meets acceptance criteria related to diagnostic accuracy or clinical performance.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving performance in the context of diagnostic or AI/ML device evaluation. The information provided is for a traditional medical device (spinal implant) where substantial equivalence is primarily demonstrated through mechanical testing and comparison to existing devices.
However, I can extract the information provided about the device's substantial equivalence and general description:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be applicable to a diagnostic device or AI/ML system. Instead, it references substantial equivalence to predicate devices. For a spinal implant, this typically means demonstrating comparable mechanical properties and safety.
| Acceptance Criteria (Implied for Spinal Implant) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Devices | "Mechanical testing data under ASTM F-1717 was provided or referenced to demonstrate substantial 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 applicable and not provided in the document as it refers to mechanical testing data, not a clinical or diagnostic performance test set.
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 and not provided. Ground truth in the context of diagnostic accuracy, clinical outcomes, or AI labeling is not relevant for the type of substantial equivalence demonstrated here (mechanical testing of a spinal implant).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 and not provided. This is for an orthopedic implant, not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The closest concept to "ground truth" here would be the established standards for mechanical testing (e.g., ASTM F-1717) and the characteristics of the predicate devices. The "ground truth" for the device's safety and effectiveness is inferred through its mechanical equivalence to devices already on the market.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
Summary of why most fields are N/A:
The provided document is a 510(k) summary for a spinal surgical implant (Coral™ Spinal System). The primary method for demonstrating substantial equivalence for such devices is through mechanical testing against established standards (like ASTM F-1717) and comparison to legally marketed predicate devices. The request's questions are designed for evaluating diagnostic devices, particularly those that might use AI/ML, which involve clinical performance studies, ground truth establishment, expert review, and statistical measures like sensitivity and specificity. These concepts are not relevant to the information presented in this 510(k) filing for a spinal fixation system.
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K041592 Page 1 of 1
510(k) Summary
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| Submitter: | Theken Surgical283 E. Waterloo Rd.Akron, Ohio 44319 | SEP 16 2004 |
|---|---|---|
| Contact Person: | Randy ThekenManager, Theken Surgical | |
| Trade Name: | Coral™ Spinal System | |
| Common Name: | Screw/Rod spinal instrumentation | |
| Classification: | KWP 888.3050 - Spinal Interlaminal Fixation OrthosisMNI 888.3070 - Pedicle Screw Spinal SystemMNH 888.3070 - Spondylolisthesis Spinal Fixation SystemKWQ 888.3060 - Spinal Intervertebral Body Fixation OrthosisNKB 888.3060 - Spondylolisthesis Spinal Fixation System | |
| Predicate Device: | Sofamor Danek Colorado II Spinal System, K991031 (et al)DePuy-Motech Moss Miami Spinal System, K955348 (et al) | |
| Device Description: | The Coral™ Spinal System consists of a variety of shapes and sizes ofscrews, rods, hooks, cross-connectors, and connecting components.Coral™ Spinal System components can be rigidly locked creating arigid construct for promoting fusion. Coral™ Spinal System implantcomponents are fabricated from medical grade titanium alloy describedby such standards as ASTM F67, ASTM F136, ISO 5832-3, and ISO5832-2. Alternatively, the entire system may be made out of medicalgrade stainless steel described by such standards as ASTM F138, ISO5832-1, and ISO 5832-9. Caution use of dissimilar metals, i.e.stainless steel and titanium must not be used in combination, butmust be used independently. | |
| Intended Use: | The Coral(tm) Spinal System is a non-cervical spinal fixation deviceintended for use as a posterior pedicle screw fixation system, aposterior non-pedicle screw fixation system, or as an anterolateralfixation system. Pedicle screw fixation is limited to skeletally maturepatients. The device is indicated for all of the following indicationsregardless of the intended use: degenerative disc disease (defined asdiscogenic back pain with degeneration of the disc confirmed byhistory 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 failedprevious fusion. | |
| Substantial Equivalence: | The Theken Surgical Coral™ Spinal System is substantially equivalentto other legally marketed devises. Mechanical testing data underASTM F-1717 was provided or referenced to demonstrate substantial equivalence. |
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Image /page/1/Picture/1 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 an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and head.
SEP 16 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Randy R. Theken President Theken Surgical 283 East Waterloo Road Akron, Ohio 44319
Re: K041592
Trade/Device Name: Coral™ Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; spinal intervertebral body fixation orthosis; pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWQ, KWP, MNH, MNI Dated: June 7, 2004 Received: June 14, 2004
Dear Mr. Theken:
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 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 such 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 r hat 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. Randy Theken
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Actil; in were Sections product radiation control provisions (Dections 991 - 12 view as described in your Section 510(k)
This letter will allow you to begin marketing your device to leggion of secti I his letter will anow you to begin manxeanty of substantial equivalence of your device to a legally prematication. The PDA muling of backland of 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 ac 110 % 4649. Also, please note the regulation entitled, contact the Office of Compliance at (301) 377-17-17 Part 807.97). You may obtain Misoralianing by Icrerchee to premainters in the Act from the Division of Small other general intormation on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer institutions www.fda.gov/cdrh/dsmarmain.html
Sincerely yours,
Miriam C. Provost
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
Enclosure
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Indications for Use
510(k) Number (if known):____K041592
Coral™ Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a The Coral™ Spinal System is a not-cervical spinal nation edicle screw fixation system,
posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally
or as an anterolateral fixation system. Pedicle screw fixations regardless of or as an anterolateral lixation system. "I cullowing indications regardless of
mature patients. The device is indicated for all of the following including in mature patients. The device is included for and of the last pain with degeneration of the disc confirmed by history and radiographic studies),
degeneration of the disc confirmed by history aninol stoposis deformities or spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or spondylolisthesis, traditia (f.e., fracture of disistance), of the sources and failed previous fusion.
X_____________________________________________________________________________________________________________________________________________________________________________ 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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.