(58 days)
The X-Spine ACP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- 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., fractures or dislocations), ●
- Tumors, ●
- Deformity (defined as kyphosis, lordosis, or scoliosis) .
- Pseudoarthrosis, and/or .
- Failed previous fusions. .
The X-Spine Anterior Compact Plate (ACP) System includes titanium alloy anterior cervical plates and bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The implant components are provided clear and non-sterile.
The provided text is a 510(k) premarket notification summary for the X-Spine Anterior Compact Plate (ACP) System. This document focuses on the regulatory clearance process for a medical device (an orthopedic implant), not a diagnostic algorithm or a device that generates performance data in the typical sense of accuracy, sensitivity, or specificity. Therefore, many of the requested fields related to acceptance criteria, statistical studies, and ground truth for AI algorithms are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it's a structural implant. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device using performance data that characterizes the device's properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Synthes CSLP System). | Performance data submitted characterized the X-Spine ACP System. (Specific results not detailed in this summary) |
| Device meets the intended use and safety requirements. | FDA determined the device is substantially equivalent for its stated indications for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is for a mechanical orthopedic implant, not a diagnostic or AI device that typically uses test sets of data. Performance data would likely involve mechanical testing, material characterization, and potentially animal or cadaveric studies, not human clinical test sets in the context of diagnostic performance. The document only states "Performance data were submitted to characterize the X-Spine ACP System." without further detail on the nature or origin of this data.
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. Ground truth as typically defined for AI algorithms (e.g., expert consensus on images, pathology results) is not relevant for the regulatory clearance of a mechanical orthopedic implant. The "ground truth" for such a device would be its mechanical properties, biocompatibility, and functional performance, evaluated through engineering and materials science methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is for clinical data interpretation or AI output evaluation, not for the submission of performance data for a mechanical implant.
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 imaging and AI interpretation, not a mechanical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical, mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a mechanical implant would be its physical and mechanical properties and performance, validated through engineering principles and testing (e.g., fatigue testing, pull-out strength, materials characterization), not expert consensus on images or pathology.
8. The sample size for the training set
Not applicable. This device is an orthopedic implant, not an AI algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.
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| JUL 3 0 2004 | PREMARKET NOTIFICATION 510(K) SUMMARY |
|---|---|
| Company: | X-Spine Systems7026 Corporate Way, #212Centerville, OH 45459-4288Telephone: 800/903-0640Fax: 866/481-0740 |
| Company Contact: | David Kirschman, MD |
| Date: | May 28, 2004 |
| Proposed ProprietaryTrade Name: | Anterior Compact Plate (ACP) System |
| Classification Name: | Orthopedics, 888.3060, Class II |
| FDA Product CodeClassification: | KWQ |
| Device Description: | The X-Spine Anterior Compact Plate (ACP) System includestitanium alloy anterior cervical plates and bone screws. The plateattaches to the anterior portion of the vertebral body of the cervicalspine, levels C2 to C7. The implant components are provided clearand non-sterile. |
| Intended Use: | The X-Spine ACP System is intended for anterior screw fixation to the cervicalspine. The system is indicated for use in the temporary stabilization of theanterior spine during the development of cervical spinal fusion in patients withdegenerative disc disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies),spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, deformity(defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failedprevious fusions. |
| Predicate Device: | Synthes CSLP System |
| Performance Data: | Performance data were submitted to characterize the X-Spine ACP System. |
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Image /page/1/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2004
X-Spine Systems, Inc. C/o Ms. Janet M. Webb MEDVantage, Inc. 121 W. Chestnut Street, #3506 Chicago, Illinois 60610
Re: K041469
Trade/Device Name: X-Spine Systems Anterior Compact Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 28, 2004 Received: June 2, 2004
Dear Ms. 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 I ca may , more 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 - Ms. Janet M. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in your a counting of substantial equivalence of your device to a legally premated predicated 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 If you dome of Compliance at (301) 594-4659. 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 other general miornitudes 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 N 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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Indication for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: X-Spine Systems Anterior Compact Plate System
Indications for Use:
The X-Spine ACP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- 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., fractures or dislocations), ●
- Tumors, ●
- Deformity (defined as kyphosis, lordosis, or scoliosis) .
- Pseudoarthrosis, and/or .
- Failed previous fusions. .
Prescription Use × Over-The-Counter Use __ or (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millerson
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.