(45 days)
The Manta Ray™ ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture/dislocation), Tumor, Spinal stenosis, Deformity (i.e. scoliosis, kyphosis and/or lordosis), Pseudoarthrosis, Failed previous fusion
The Manta Ray™ ACP System is an anterior cervical plate fixation system. The system consists of a number of plates and screws. The plates feature a normal lordotic curvature as well as a transverse plane curvature for anatomic fit and are available in a variety of lengths for one to four level configurations. Screws are available in fixed and variable angle styles to create rigid or semi-rigid constructs as well as multiple lengths to fit individual patient pathologies. All implants are machined from implant grade titanium alloy, Ti-6Al-4V (ELI) per ASTM F-136.
Here's an analysis of the provided text regarding the Manta Ray Anterior Cervical Plate (ACP) System's acceptance criteria and studies:
Based on the provided 510(k) summary, the device is a medical implant, and the approval process for such devices typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study with acceptance criteria for a diagnostic AI. The "Performance Data" section specifically mentions mechanical testing to characterize the device.
Therefore, many of the requested points related to AI performance, ground truth, expert adjudication, and observer studies are not applicable to this type of medical device submission.
Here's the breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Testing: To characterize stiffness and strength. (Implied acceptance: Must meet or exceed properties of predicate devices and/or established biomechanical standards for spinal implants.) | Static testing was performed to characterize the stiffness and strength of the Manta Ray™ ACP System. (Specific numerical results are not provided in this summary.) |
| Fatigue Testing: To characterize fatigue life. (Implied acceptance: Must demonstrate durability matching or exceeding predicate devices and/or biomechanical standards for spinal implants over its intended lifespan.) | Fatigue testing was performed to characterize the fatigue life of the Manta Ray™ ACP System. (Specific numerical results are not provided in this summary.) |
Note: The 510(k) summary does not provide specific numerical acceptance criteria (e.g., minimum stiffness in Nm/deg, or minimum cycles to failure at a given load). These would typically be detailed in the full test reports submitted to the FDA, but are not present in this public summary. The "acceptance criteria" here are inferred from the type of testing performed for spinal fixation devices. The reported device performance is that these tests were performed.
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 in the summary. For mechanical testing, samples refer to the number of physical devices tested.
- Data Provenance: Not applicable in the context of mechanical testing. The data would originate from the testing facility where the mechanical tests were conducted.
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 physical implant, not a diagnostic AI system requiring expert-established ground truth on patient data. Ground truth for mechanical testing is based on engineering principles and material science.
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
- No. This is not an AI or diagnostic device. This is a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI or algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards / Biomechanical Principles: For mechanical testing, the "ground truth" would be established by industry standards (e.g., ASTM standards for spinal implants) and valid biomechanical testing methodologies that define expected performance characteristics for stiffness, strength, and fatigue life. Failure criteria are defined by these standards.
8. The sample size for the training set
- Not applicable. This is not an AI model requiring a training set. If referring to the design and manufacturing process, there is no "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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APR 2 5 2008
510(k) Summary (21 CFR Part 807.92)
A. Submitter Information
| Submitter's Name: | Theken Spine, LLC |
|---|---|
| Address: | 1800 Triplett Blvd.Akron, Ohio 44306 |
| Telephone Number: | 330-475-8600 |
| Fax Number: | 330-773-7697 |
| Contact Person: | Dale Davison |
| Date Prepared: | 03 March 2008 |
| Trade Name: | Manta Ray™ Anterior Cervical Plate (ACP) System |
| Common Name: | Anterior Spinal Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (per 21 CFR 888.3060) |
| Device Classification: | Class II (per 21 CFR 888.3060)Panel: Orthopedic, Product Code: KWQ, Panel Code: 87 |
| Material Composition: | Implant grade Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 |
| Device Description: | The Manta Ray™ ACP System is an anterior cervical plate fixation system. The system consists of a number of plates and screws. The plates feature a normal lordotic curvature as well as a transverse plane curvature for anatomic fit and are available in a variety of lengths for one to four level configurations. Screws are available in fixed and variable angle styles to create rigid or semi-rigid constructs as well as multiple lengths to fit individual patient pathologies. All implants are machined from implant grade titanium alloy, Ti-6Al-4V (ELI) per ASTM F-136. |
| Intended Use: | The Manta Ray™ ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture/dislocation), Tumor, Spinal stenosis, Deformity (i.e. scoliosis, kyphosis and/or lordosis), Pseudoarthrosis, Failed previous fusion |
| Performance Data: | Static and fatigue testing was performed to characterize the stiffness, strength and fatigue life of Manta Ray™ ACP System |
| Predicate Device: | X-Spine Systems - Spider Cervical Plating System (K052292 - October 21, 2005)Theken Surgical, LLC - Tether™ ACFS (K010466 - May 16, 2001) |
C. Substantial Equivalence
Theken Spine, LLC believes that the Manta Ray™ ACP System is substantially equivalent to Theren Spine, ELO believes that the Mana Ray - Stablishment of equivalence is based on the same
other legally marketed predicate devices. Establishment of equivalence is be other legally marketed predicate devices. Establishment dies in design concept, the use of Infications and contrainuleations for use as woll as emilantical testing and engineering analysis.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2008
Theken Spine % Mr. Dale Davison Vice President of Engineering 1800 Triplett Blvd Akron, OH 44306
K080690 Re: Trade/Device Name: Manta Ray™ Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 3, 2008 Received: March 11, 2007
Dear Mr. Davison:
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. Dale Davison
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,
Mark M. Millman
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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Indications for Use
510(k) Number (if known): K080690
Device Name: Manta Ray ACP System
Indications For Use:
The Manta Ray™ ACP System is an anterior cervical plate that is intended for t ne manta + (a) = + (a) = + (a) = + (a) = = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
- Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fracture/dislocation)
- Tumor
- Spinal stenosis
- Deformity (i.e. scoliosis, kyphosis and/or lordosis)
- Pseudoarthrosis
- Failed previous fusion
AND/OR × Prescription Use (Part 21 CFR 801 Subpart D)
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)
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(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K080610
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