(9 days)
The C-JAWS Cervical Compressive Mini Frame, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allograft or auto grafts. This device is not intended for load bearing applications.
The C-JAWS implant is a single component system of anterior cervical anchoring. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two notched arms, which engage the vertebral bodies and works by plastic deformation of the implant's body. The staples are available in multiple sizes the C-JAWS implant is manufactured from CP titanium and has a smooth anodized finish. The purpose of this submission is to add additional sizes to the C-JAWS implant range: height of 12.5, 17.5 and 22.5mm and arm lengths of 10, 12, 14 and 17mm. In addition, radii (R=0.2mm) have been added to the extremity of both legs to reduce the sharpness of the tips of the C-JAWS legs. The modification is effective on the new submitted C-JAWS implants and has been applied to the K062181 cleared implants. Additional instruments are also added.
The provided document is a 510(k) summary for a medical device (C-JAWS Cervical Compressive Mini Frame) and contains information about its intended use and a brief mention of performance data. However, it does not include detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt (e.g., sample sizes for test and training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).
Here's an analysis based on the available information and a breakdown of why many of your requested points cannot be answered from this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in this document. Often, for devices like this, acceptance criteria would be related to: - Pull-out strength - Fatigue life - Compatibility with traditional rigid fixation - Maintenance of relative position of allografts/autographs | Biomechanical testing, including pull-out fixation tests, were conducted. (No specific numerical results or success/failure rates are provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "Biomechanical testing, including pull out fixation tests were conducted."
- Data Provenance: Not specified. This type of testing is typically done in a lab rather than using patient data for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. For biomechanical testing of a spinal implant, "ground truth" is typically established by engineering standards and measurement equipment, not clinical expert consensus.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified. This refers to how disagreements among expert readers are resolved in image-based diagnostic studies. For biomechanical testing, the "adjudication" is based on comparing results to established engineering specifications.
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
- MRMC Study: No. This document describes a mechanical implant, not an AI-assisted diagnostic device. Therefore, MRMC studies with human readers and AI assistance are not relevant.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For the biomechanical testing mentioned, the ground truth would typically be defined by engineering specifications and measurements (e.g., maximum force before failure, displacement under load). It's not clinical ground truth like pathology or outcomes data in this context.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no mention of an algorithm or training set as this is a physical implant.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. There is no mention of an algorithm or training set.
Summary of Study Information Available in the Document:
The document states: "Biomechanical testing, including pull out fixation tests were conducted." This indicates that the device underwent physical laboratory testing to evaluate its mechanical properties relevant to its intended use (maintaining the relative position of weak bony tissue). The specific details of these tests (e.g., number of samples, test parameters, exact results, or acceptance criteria) are not provided in this 510(k) summary. These details would typically be found in a more comprehensive testing report.
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AUG 2 3 2007
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SPECIAL 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
GENERAL INFORMATION 1.
| Trade Name | C-JAWS Cervical Compressive Mini Frame |
|---|---|
| Common Name | Anterior Cervical Buttress Staple System |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ |
| CFR section | 888.3060 |
| Device panel | Orthopedic |
| Legally marketedpredicate devices | C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K062181) |
| Submitter | MEDICREA™ TECHNOLOGIES |
| ZI Chef de Baie | |
| 17000 La Rochelle | |
| France | |
| Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681Phone 512-388-0199email : ortho.medix@sbcglobal.net |
2. PREDICATE DEVICE DESCRIPTION
The C-JAWS implant is a single component system of anterior cervical anchoring. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two notched arms, which engage the vertebral bodies and works by plastic deformation of the implant's body. The staples are available in multiple sizes the C-JAWS implant is manufactured from CP titanium and has a smooth anodized finish.
3. DESCRIPTION OF DEVICE MODIFICATION
The purpose of this submission is to add additional sizes to the C-JAWS implant range: height of 12.5, 17.5 and 22.5mm and arm lengths of 10, 12, 14 and 17mm.
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In addition, radii (R=0.2mm) have been added to the extremity of both legs to reduce the sharpness of the tips of the C-JAWS legs. The modification is effective on the new submitted C-JAWS implants and has been applied to the K062181 cleared implants.
Additional instruments are also added.
INTENDED USE 4.
The C-JAWS implant, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
5. PERFORMANCE DATA
Biomechanical testing, including pull out fixation tests were conducted.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2007
Medicrea Technologies % The OrthoMedix Group Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, Texas 78681
Re: K072040
Trade/Device Name: C-JAWS Cervical Compression Mini Frame Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: July 16, 2007 Received: July 25, 2007
Dear Mr. Webb:
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 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 -- Mr. J.D. Webb
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.
Sincerely yours,
Barbave Buchud
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MEDICREA™
INDICATIONS FOR USE
510(k) Number (if known): K072040
Device Name: C-JAWS Cervical compressive mini frame
Indications for Use
The C-JAWS Cervical Compressive Mini Frame, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allograft or auto grafts. This device is not intended for load bearing applications.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchner for mem
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number K072040
N/A