(15 days)
The TOSCA® Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities on curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The TOSCA® Anterior Cervical Plate System consists of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine though the anterior approach. The plates and screws are made from Titanium alloy Ti64A14V, are in conformance with ASTM F136-98, and are supplied non-sterile.
The provided document describes the TOSCA® Anterior Cervical Plate System, a medical device used for spinal fixation. It details the device's description, intended use, and the type of testing performed to support its safety and effectiveness.
However, the document is a 510(k) Summary for a predicate device clearance, which primarily focuses on demonstrating substantial equivalence to existing legally marketed devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the way envisioned by the posed questions (e.g., performance metrics like sensitivity/specificity, sample sizes, expert-based ground truth typical for AI/diagnostic device studies).
Therefore, many of the requested fields cannot be directly answered from the provided text because the nature of this document (a 510(k) for a mechanical spinal implant) does not typically involve the types of studies and criteria mentioned in the prompt (e.g., AI performance, reader studies, ground truth establishment with experts for diagnostic data).
Here's an attempt to extract the available information and explain why other fields cannot be filled:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Withstands clinical loading |
| - Withstand clinical loading | Maintains mechanical integrity |
| - Maintain mechanical integrity | Performs according to specification |
| - Perform according to specification | Suited for its intended purpose |
| Material Conformance: | Conforms to ASTM F136-98 |
| - Conformance to ASTM F136-98 |
Explanation: The document explicitly states: "Mechanical testing was conducted, and data collected, in accordance with ASTM 1717 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose." It also mentions the materials "are in conformance with ASTM F136-98." These serve as the implied acceptance criteria and the device's reported performance against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. Mechanical testing typically involves a number of samples or specimens rather than patient data.
- Data provenance: Not specified. The testing was "conducted," but the location or whether it mimicked real-world clinical scenarios with data of origin is not detailed. Given it's mechanical testing, it's likely laboratory-based.
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 device is a mechanical implant, not a diagnostic AI or imaging device that requires expert-established ground truth for its performance evaluation against diagnostic data. Its "performance" relates to mechanical integrity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As the performance relates to mechanical testing, there is no "adjudication method" in the sense of reconciling expert opinions on diagnostic interpretations. Mechanical testing results are typically objectively measured against defined 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 is a mechanical implant; it does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical implant; it is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Test Standards and Specifications: The "ground truth" or reference for this device's performance would be the specifications derived from standards like ASTM 1717 for mechanical properties and ASTM F136-98 for material composition. The device's ability to 'withstand clinical loading' and 'maintain mechanical integrity' is measured against these engineering specifications.
8. The sample size for the training set
- Not applicable. This device is a mechanical implant; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
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NOV 2 3 2004
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | SIGNUS Medizintechnik GMBHBrentanostr 9, Alzenau, Germany D-63755Phone: 49-6023 9166-0 |
|---|---|
| Contact Person: | Tracy L. Gray RN, BS, RAC |
| Date Prepared: | November 5, 2004 |
| Trade Name: | The TOSCA® Anterior Cervical Plate System |
| Classification, Nameand Number: | Class II21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Product Code: | KWQ |
| Predicate Device(s): | The subject device is equivalent to the following devices:The SCI Anterior Cervical Plate System (K990005), manufacturedby Spinal Concepts, Inc.; and The EBI Anterior Plate System (K943694 - K002980)Manufactured by EBI, L.P. |
| Device Description: | The TOSCA® Anterior Cervical Plate System consists of various sizes ofbone plates and screws that are either fixed angle or variable angle. Thescrews are used to secure the plates to the vertebral bodies of the cervicalspine though the anterior approach. The plates and screws are made fromTitanium alloy Ti64A14V, are in conformance with ASTM F136-98, andare supplied non-sterile. |
| Intended Use: | The TOSCA® Anterior Cervical Plate System is intended for anteriorcervical fixation for the following indications: degenerative disc disease(as defined by neck pain of discogenic origin with degeneration of the discconfirmed by patient history and radiographic studies), spondylolisthesis,trauma (i.e. fracture or dislocation), spinal stenosis, deformities oncurvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor,pseudoarthrosis, and failed previous fusion. |
| Functional andSafety Testing: | Mechanical testing was conducted, and data collected, in accordance withASTM 1717 to ensure the device performs according to specification, toverify that the device is able to withstand clinical loading and maintainmechanical integrity, and is suited for its intended purpose. |
| Conclusion: | SIGNUS Medizintechnik GMBH considers the TOSCA® AnteriorCervical Plate System to be equivalent to the predicate devices listedabove. This conclusion is based upon the devices' similarities infunctional design, materials, and indications for use. |
Confidential
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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 features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
Ms. Tracy L. Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Hwy, Suite 350 Minneapolis, Minnesota 55422
Re: K043082
Trade/Device Name: The TOSCA® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 5, 2004 Received: November 8, 2004
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimered prior to rialy 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, mereleve, mains 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 n your de rise is exactional controls. Existing major regulations affecting your device can may or can been 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 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.
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Page 2 – Ms. Tracy L. Gray
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally precred 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. 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 Mace gacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark 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
Enclosure
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Indications for Use
510(k) Number (if known): K
Device Name: The TOSCA® Anterior Cervical Plate System
Indications For Use: The TOSCA® Anterior Cervical Plate System is intended for Indications i of OSC. The TOGON - Allenter Conomic degenerative disc disease (as arnehol cervical likation for the rollowing mith degeneration of the disc confirmed by detined by neck pain of alooogenis shift min designing and trauma (i.e. fracture or patient filstory and fadiographie stadios), open in the scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.
Prescription Use __ X_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ffice of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices 1043087 510(k) Number.
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§ 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.