(28 days)
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
- Degenerative disc disease (DDD) - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
- Trauma (including fractures);
- Tumor;
- Spondylolisthesis;
- Spinal stenosis;
- Deformity (i.e., scoliosis, kyphosis, lordosis);
- Pseudarthrosis; and
- Failed previous fusions.
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System consists of bone plates, screws, and instrumentation intended for anterior fixation to the cervical spine. The plate system incorporates a mechanism that allows for uni-axial motion in compression to ensure postoperative load sharing between the plate and the graft.
The provided document is a 510(k) premarket notification for a spinal fixation system, not a study describing the acceptance criteria and performance of a device, particularly an AI/ML-enabled device. This document describes a traditional medical device (spinal plate system) and primarily relies on demonstrating substantial equivalence to a predicate device rather than clinical performance studies with acceptance criteria, ground truth, or human reader involvement.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred/noted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device. The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing comparable materials, design, intended use, and performance based on non-clinical (laboratory/bench) testing.
- Reported Device Performance:
- Non-Clinical Performance: "Laboratory and bench testing results demonstrate that the proposed Ant-Cer device is substantially equivalent to the predicate device."
- Clinical Performance: "Clinical data and conclusions were not needed for this device."
As such, a table of acceptance criteria and reported device performance, as typically understood for an AI/ML device (e.g., sensitivity, specificity, AUC values), is not available in this document. The "performance" assessment here is focused on substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is provided. Non-clinical bench testing was performed, but sample sizes for these tests are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable. No clinical test set is described.
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 not an AI/ML device, and no MRMC study was conducted or is relevant to this traditional medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: For the non-clinical testing, the "ground truth" would be established by engineering and mechanical testing standards and specifications, comparing the device's physical properties and performance (e.g., strength, durability, dynamic motion) against those of the predicate device and relevant ASTM/ISO standards. No clinical ground truth (e.g., pathology, outcomes data) was used or required for this submission.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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AUG 2 9 2005
ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | Abbott Spine (formerly Spinal Concepts, Inc.) |
|---|---|
| ESTABLISHMENT REGISTRATION NUMBER: | 1649384 |
| CONTACT PERSON: | Noah BartschSpecialist, Regulatory AffairsTelephone: 512.533.1840Fax: 512.918.2784 |
| DATE: | July 29, 2005 |
| TRADE NAME: | SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System |
| COMMON NAME: | Spinal Fixation System |
| CLASSIFICATION NAME: | KWQ: Spinal Intervertebral Body Fixation Orthosis |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3050 |
| PREDICATE DEVICE: | Spinal Concepts, Inc. (now Abbott Spine, Inc.) Ant-Cer Dynamic Anterior Cervical Plate System, K024326, cleared January 23, 2003. |
DEVICE DESCRIPTION:
Divice Discurix Ant-Cer Dynamic Anterior Cervical Plate System consists of bone plates, The SC-Acul IX The Cor Dynamed for anterior fixation to the cervical spine. The plate system serews, and motioninentign that allows for uni-axial motion in compression to ensure postoperative load sharing between the plate and the graft.
INDICATIONS:
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the The SC-Acul ix All Cor Dyname Panepine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
Degenerative disc disease (DDD) - as defined by neck pain of discogenic origin with ﻨﺴﺒ degeneration of the disc confirmed by patient history and radiographic studies;
- Trauma (including fractures); 2.
- Tumor; 3.
- Spondylolisthesis; 4.
- Spinal stenosis; న్.
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K os 5 207 a
p 2 of 2
- Deformity (i.e., scoliosis, kyphosis, lordosis); 6.
- Pseudarthrosis; and 7.
- Failed previous fusions. 8.
The subject device is the result of design COMPARISON TO PREDICATE DEVICE: I he subject to the predicate device, has the same intended use, and is substantially equivalent to the predicate device. NON-CLINICAL PERFORMANCE AND CONCLUSIONS: PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL): Laboratory and bench testing results demonstrate that the proposed Ant-Cer device is substantially equivalent to the predicate device.
CLINICAL PERFORMANCE AND CONCLUSIONS:
Clinical data and conclusions were not needed for this device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and two wavy lines below, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
AUG 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
Re: K052072
K032072
Trade Name: SC-AcuFix™ Ant-Cer™ Dynamic Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: July 29, 2005 Received: August 1, 2005
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we have reviewed your Section 9 ro(x) premained 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 encrosule) to regally mancties provice Americal Device American son to commerce prior to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval approval application (PMA). and Costnetic Act (Act) that do not require approvince approvisions of the Act. The Act. The You may, merciole, market the actives, bases of the more of registration, listing of
general controls provisions of the Act include requirements for annual registereding and general controls provisions of the rist 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 If your device is classified (sec above) into exist on a considerating your device can
may be subject to such additional controls. Existing major regal consected and them ED may be subject to such additional controls. Existing may of to 898. In addition, FDA may be found in the Code of Feach 1988.
publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Noah Bartsch
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with of act that FDA has made a delerinmation that your as roo be roo be recension would be in or any Federal statules and regulations deminds. but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not areastice asset comply with an the Act s requirements, more 801); good manufacturing practice requirements as setting as set CFR Part 807), labeling (21 CFRT art 807), good and if applicable, the electronic forth in the quality systems (QD) regaliation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 product radiation control provisions (Declons of 1 evice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your d I his letter will anow you to oegin maneting your antial equivalence of your deventity ware development premarket notification. THC PDA miding of baction 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 desire specific advice for your ac-1.0. Also, please note the regulation entitled, and colliact the Office of Comphalled at (210) = 15 = 18 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = 1 " Misbranding by relefence to premanter noalities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson Acting 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
K052072 510(k) Number (if known):
Device Name:
The SC-AcuFix™ Ant-Cer™ Dynamic Cervical Plate System
Indications for Use:
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the The SC-Acult ix Allt Oct Dyname i alspine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
-
- Degenerative disc disease (DDD) as defined by neck pain of discogenic origin with Degenerative disc discusse (DDD) - ) - (DD) - ) - ) - ( - ) - ) - ( - ) - ) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
-
- Trauma (including fractures);
-
- Tumor;
-
- Spondylolisthesis;
- Spinal stenosis; 5.
-
- Deformity (i.e., scoliosis, kyphosis, lordosis);
-
- Pseudarthrosis; and
-
- Failed previous fusions.
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
KOS 2072 * (k) Number
Page 1 of 1
§ 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.