(65 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the GALAXY™ 3.2 Spinal System is indicated for the following:
DDD (neck pain of discogenic origin with degencration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.
The GALAXY™ 3.2 Spinal System consists of a variety of shapes and sizes of screws, hooks, rods and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. This system is intended for posterior use only.
Titanium implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with the GALAXY™ 3.2 Spinal System. These systems include the TSRH®, CD HORIZON®, DYNALOK™ PLUS, DYNALOK CLASSIC™ spinal systems and VERTEX™ Reconstruction Systems. Additionally, titanium ATLAS cable may be used with this system at the surgeon's discretion.
The GALAXY™ 3.2 Spinal System is fabricated from medical grade titanium or titanium alloy.
The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
The provided text is a 510(k) summary for the GALAXY™ 3.2 Spinal System, which is a medical device for spinal fixation. This document is a regulatory submission for market clearance, not a study report proving a device meets acceptance criteria in the way a clinical trial or performance study would for an AI/software device.
A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. This means the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The information provided does not describe a clinical study in the typical sense of testing the device's "performance" against specific acceptance criteria with a particular sample size, ground truth, or expert review for diagnostic accuracy.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory document.
However, I can provide what information is available based on the request:
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" for performance in the context of a clinical study or a comparative performance metric, nor does it report specific device performance metrics like sensitivity, specificity, or accuracy. The "performance" described is its intended use and mechanical function as a spinal fixation system.
The core "acceptance criteria" for a 510(k) is the demonstration of substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for 510(k) Clearance) | Reported Device Performance (from the document) |
|---|---|
| Safety and Effectiveness (demonstrated via substantial equivalence) | The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The system is designed to be rigidly locked in various configurations using screws, hooks, rods, and connecting components. The intended clinical performance is to stabilize the spine for conditions such as DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and tumors in the cervical (C1-T3) and thoracic spine. Specific uses for hooks, rods, and screws are detailed, with screws specifically limited to T1-T3 for thoracic conditions and not for the cervical spine. Titanium ATLAS™ Cable can be used for cable attachment to the posterior cervical or thoracic spine. |
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 document is not a clinical study report that would involve a "test set" in the context of AI/software performance. It's a regulatory submission affirming substantial equivalence based on device design, materials, and intended use, often supported by mechanical testing data (which is not detailed here) and comparison to existing predicate devices.
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 establishment with experts is relevant for diagnostic devices or AI, not for a spinal implant system's 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method 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 device is a physical spinal implant, not an AI or diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" in this sense is established for the device itself. The "truth" in a 510(k) is that the device is substantially equivalent to a predicate, implying comparable safety and effectiveness based on established medical and engineering principles.
8. The sample size for the training set
Not applicable. No training set is involved for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth in this context.
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GALAXY™ 3.2 Spinal System Summary of Safety and Effectiveness October 2004
Medtronic Sofamor Danek, Inc. USA 1. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: GALAXY(M 3.2 Spinal System II.
III. Spinal Interlaminal Fixation Orthosis
IV. Product Description
The GALAXY™ 3.2 Spinal System consists of a variety of shapes and sizes of screws, hooks, rods and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. This system is intended for posterior use only.
Titanium implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with the GALAXY™ 3.2 Spinal System. These systems include the TSRH®, CD HORIZON®, DYNALOK™ PLUS, DYNALOK CLASSIC™ spinal systems and VERTEX™ Reconstruction Systems. Additionally, titanium ATLAS cable may be used with this system at the surgeon's discretion.
The GALAXY™ 3.2 Spinal System is fabricated from medical grade titanium or titanium alloy.
The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
V. Indications
When intended to promote fusion of the cervical spine and the thoracic spinc, (CI-T3), the GALAXYTM 3.2 Spinal System is indicated for the following:
DDD (neck pain of discogenic origin with degencration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Page 1 of 2
0000005
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Screws/Connectors
The use of screws is limited to placement in T1-T3 only. Screws are not labeled to be placed in the posterior cervical spine.
Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.
VI. Substantial Equivalence
VI. substantially equivalent to VERTEX™ Reconstruction System components previously cleared in K042402.
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2005
Mr. Richard Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132
Re: K043020
Trade/Device Name: Galaxy™ 3.2 Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: November 1, 2004 Received: November 3, 2004
Dear Dr. Treharne:
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 - Richard W. Treharne, Ph.D.
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 presticated 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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510(k) Number (if known): | 043020
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the GALAXY™ 3.2 Spinal System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.
AND/OR Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(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 K043020 0000003
§ 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.