(319 days)
The Anatomica Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:
- . degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- . spondylolisthesis;
- . trauma (i.e., fracture or dislocation);
- . spinal stenosis; curvatures (i.e.,scoliosis, kyphosis, and/or lordosis);
- . tumor:
- . pseudoarthrosis; and
- . failed previous fusion.
Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (T1, T3) when treating thoracic conditions only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop.
The Anatomica Cervical System is a titanium spinal fixation system for occipito-cervico-thoracic (OCT) fixation that contains screws, hooks, and wires that are assembled to rods using one of several types of connectors (expansion loop, compression loop, ME connector, lateral connector, cable lock connector). The occiput screws are for use in the occiput. The wires are for use in the cervical spine. The screws are for use in the thoracic spine (T1-T3). The hooks are for use in the cervical spine.
The provided text describes a spinal fixation system, not an AI/ML powered device, therefore the typical acceptance criteria and study designs relevant to AI/ML powered devices (such as clinical performance metrics, ground truth establishment, reader studies, etc.) are not applicable.
Instead, the document focuses on the mechanical and material performance of the physical implant device.
Here's an analysis based on the information provided, reinterpreting your requested categories for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Study) |
|---|---|
| Mechanical Performance | |
| Static Bend | Tested in accordance with ASTM F1717-01 |
| Fatigue Bend - Fatigue Life | Tested in accordance with ASTM F1717-01 |
| Fatigue Bend - Incremental Load Block | Tested in accordance with ASTM F1717-01 |
| Torsion | Tested in accordance with ASTM F1717-01 |
Note: The document states that the performance testing was "in accordance with ASTM F1717-01, Standard test methods for spinal implant constructs in a vertebrectomy model." While it doesn't explicitly list numerical acceptance criteria values (e.g., "must withstand X N-m for static bend"), complying with a recognized ASTM standard implies that the device met the performance requirements/benchmarks specified within that standard for the tested parameters. The "Reported Device Performance" is the act of having performed these tests and presumably achieving results comparable to the predicate device and within the ASTM standard's expectations for safety and effectiveness. The document also states "mechanical testing to have similar performance characteristics" to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "Articles provided from regular production lots." It does not specify a numerical sample size (e.g., number of screws, rods, or construct assemblies tested). For mechanical testing of medical devices, sample sizes are typically determined by statistical methods to ensure sufficient confidence in the results, but the specific numbers are not disclosed here.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). This refers to physical samples from "regular production lots" of the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context would implicitly be the physical properties and mechanical behavior of the materials and device constructs as measured by standardized testing equipment, against a benchmark defined by the ASTM standard. There isn't a human expert consensus involved in establishing this "ground truth."
4. Adjudication Method for the Test Set
Not applicable. This concept pertains to resolving discrepancies in human expert interpretations, which is not relevant for mechanical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is for evaluating human interpretation with and without assistance from an AI. The device described is a physical spinal implant system undergoing mechanical performance testing, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance Standards: The "ground truth" for the device's performance is established by the specified ASTM F1717-01 standard. This standard dictates the methods for testing and implicitly sets performance expectations for spinal implant constructs in a vertebrectomy model. The performance of the subject device is then compared against these established standards and its predicate devices.
- Predicate Device Performance: The basis for substantial equivalence also relies on the subject device showing "similar performance characteristics" to its legally marketed predicate devices, the Altius OCT System. Therefore, the established performance profile of the predicate device acts as another form of "ground truth" or benchmark.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the machine learning sense. The "training" for a physical device is its design, engineering, and manufacturing process, optimized through experience and engineering principles, but not through data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8.
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Section 5: 510(k) Summary
MAY 2 5 2007
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Anatomica Cervical System is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices
| Sponsor/Manufacturer: | Anatomica AB | |
|---|---|---|
| Stora Åvägen 25 | ||
| 436 34 AskimSwedenTel: +46 (0)31-748 89 00 | ||
| Fax: +46 (0)31-28 72 76 | ||
| Official Correspondent: | Marcos Velez-Duran | |
| M Squared Associates, Inc. | ||
| 719 A Street, NE | ||
| Washington, DC 20002 | ||
| Telephone: 202-546-1262 Ext 206 | ||
| Facsimile: 202-546-3848 | ||
| Email: MVelez-Duran@MSquaredAssociates.com | ||
| Date: | July 7, 2006 | |
| Proprietary Name: | Anatomica Posterior Cervical Fixation System | |
| Common Name: | Spinal fixation system | |
| CFR Section Number: | 888.3050 Spinal interlaminal fixation orthosis, and | |
| 888.3070 Pedicle screw spinal system | ||
| Proposed Regulatory Class: | II | |
| Device Product Code: | KWP - Spinal interlaminal fixation orthosis, and | |
| MNI - Orthosis, spinal pedicle fixation | ||
| Reason for 510(k): | The subject device is a new device intended for commercial | |
| distribution in the U.S.A. |
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Predicate Devices: Altius OCT System by Interpore Cross, 510(k) K033961 and K043229.
Device Description : The Anatomica Cervical System is a titanium spinal fixation system for occipito-cervico-thoracic (OCT) fixation that contains screws, hooks, and wires that are assembled to rods using one of several types of connectors (expansion loop, compression loop, ME connector, lateral connector, cable lock connector). The occiput screws are for use in the occiput. The wires are for use in the cervical spine. The screws are for use in the thoracic spine (T1-T3). The hooks are for use in the cervical spine.
Intended Use: Both the subject device and the predicate device are intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput to T3).
Performance Testing: Articles provided from regular production lots were tested for Static Bend, Fatigue Bend- fatigue life, Fatigue Bend-incremental load block, and Torsion in accordance with ASTM F1717-01, Standard test methods for spinal implant constructs in a vertebrectomy model.
Basis for Substantial Equivalence: The subject Anatomica Posterior Cervical Fixation System is substantially equivalent to the legally marketed Altius OCT System (Interpore Cross, 510(k) #K033961 and #K043229). Both the predicate and subject device systems are manufactured from Titanium and address the same indications for use. Both systems share similar design features and have been shown through mechanical testing to have similar performance characteristics.
page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2007
Anatomica AB % M Squared Associates, Inc. Mr. Marcos Velez-Duran Consultant for Anatomica AB 719 A Street. NE Washington, DC 20002
Re: K061943
Trade/Device Name: Anatomica Posterior Cervical Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI Dated: March, 30, 2007 Received: April 2, 2007
Dear Mr. Velez-Duran:
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
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Page 2 - Mr. Marcos Velez-Duran
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliken
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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Section 4: Indications for Use Statement
510(k) Number: To be assigned
Device Name: Anatomica Posterior Cervical Fixation System
Indication for Use: The Anatomica Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:
- . degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- . spondylolisthesis;
- . trauma (i.e., fracture or dislocation);
- . spinal stenosis; curvatures (i.e.,scoliosis, kyphosis, and/or lordosis);
- . tumor:
- . pseudoarthrosis; and
- . failed previous fusion.
Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (T1, T3) when treating thoracic conditions only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop.
| 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K061943
Page 1 of 1
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§ 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.