BUTTERFLY PLATE FIXATION SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.

The BUTTERFLYT™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Pseudoarthrosis.
Spondylolysis.
Spondylolisthesis.
Fracture.
Neoplastic disease.
Unsuccessful previous fusion surgery.
Lordotic deformities of the spine.
Idiopathic thoracolumbar or lumbar scoliosis.
Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

Device Description

The BUTTERFLY PLATE Fixation System construct consists of a plate fitted to match the antero-lateral vertebral bodies of the thoracic and lumbar spine. The plate is fastened to the bodies by either rigid bolts or variable-angle screws. The BUTTERFLY PLATE consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. The BUTTERFLY PLATE anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The purpose of this submission is to add a cover plate to the system and to add a 6.5mm screw. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832- 3. Stainless steel and titanium implant components must not be used together in a construct.

AI/ML Overview

The provided text describes a medical device, the Medtronic Sofamor Danek BUTTERFLY PLATE Fixation System, and its regulatory clearance (510(k) K014267). It does not contain information about acceptance criteria or a study that proves the device meets those criteria, particularly in the context of AI, machine learning, or diagnostic performance metrics.

The document is a 510(k) summary for a physical medical device (spinal fixation system) and focuses on describing the device, its intended use, and establishing substantial equivalence to previously cleared predicate devices.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria, device performance, study methodology, or AI-related metrics because the provided text does not contain this type of information.

However, I can provide the following based on the document's content, explaining why specific parts of your request cannot be met:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document is a 510(k) summary for a physical implant (spinal fixation system). It establishes substantial equivalence based on device design, materials, and intended use to predicate devices, rather than clinical performance metrics or acceptance criteria typically seen for diagnostic devices or AI algorithms. The "Functionality & Safety Testing" section mentions "A Risk Analysis was performed," but does not detail acceptance criteria or performance results as you would expect for AI or diagnostic studies.

Acceptance Criteria	Reported Device Performance
Not applicable (N/A)	Not applicable (N/A)
(The document does not specify quantitative acceptance criteria or clinical performance metrics for this physical implant in a manner that would fit this table. Instead, it relies on substantial equivalence to predicate devices for safety and effectiveness.)	(The document states the device is "substantially equivalent" to predicate devices, implying comparable safety and effectiveness. However, no specific performance data or studies are presented to meet predefined acceptance criteria.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe any test set or clinical study involving data collection on human subjects or samples in the context of device performance evaluation. It is a regulatory submission for a physical implant based on substantial equivalence.

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)

Cannot be provided. This information is relevant to diagnostic or AI studies. The provided text is for a physical medical implant and does not involve establishing ground truth through expert review for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. This information is relevant to diagnostic or AI studies. The provided text is for a physical medical implant and does not involve adjudication of a test set.

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. An MRMC study was not done, as this regulatory submission is for a physical spinal implant, not an AI or diagnostic tool. Therefore, there are no effect sizes related to human readers improving with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. A standalone algorithm performance study was not done, as this device is a physical spinal implant and does not incorporate an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. This information is relevant to diagnostic or AI studies. The provided text is for a physical medical implant and does not describe establishing ground truth for performance evaluation in this context. The "ground truth" for a physical implant pertains to its mechanical integrity, biocompatibility, and clinical outcomes, which are implicitly addressed through material standards and substantial equivalence, not data labeling or expert consensus.

8. The sample size for the training set

Cannot be provided. This information is relevant to AI/ML development. The provided text describes a physical medical implant and does not refer to any training set.

9. How the ground truth for the training set was established

Cannot be provided. This information is relevant to AI/ML development. The provided text describes a physical medical implant and does not refer to any training set or its ground truth establishment.

In summary: The provided 510(k) summary (K014267) is for a physical medical device (spinal fixation system) and focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the type of AI/ML or diagnostic study information (acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert reviews, MRMC studies) requested in your prompt.

Summary

{0}------------------------------------------------

Medtronic Sofamor Danek BUTTERFLY PLATE Fixation System 510(k) Summary December 2001

K014267
Page 1 of 2

Submitter:	Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, TN 38132	JAN 2 5 2002
Contact Person:	Richard Treharne
Trade Name:	BUTTERFLY PLATE Fixation System
Classification Name:	Spinal Intervertebral Body Fixation Orthosis, Class II
Predicate Device(s):	The BUTTERFLY PLATE Fixation System is substantially equivalent to itself, the BUTTERFLY PLATE Fixation System, which was cleared in K010632 on May 31, 2001 and the Sofamor Danek Z-Plate Anterior Fixation System, which was cleared on May 19, 1993.
Device Description:	The BUTTERFLY PLATE Fixation System construct consists of a plate fitted to match the antero-lateral vertebral bodies of the thoracic and lumbar spine. The plate is fastened to the bodies by either rigid bolts or variable-angle screws. The BUTTERFLY PLATE consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. The BUTTERFLY PLATE anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The purpose of this submission is to add a cover plate to the system and to add a 6.5mm screw. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832- 3. Stainless steel and titanium implant components must not be used together in a construct.
Intended Use:	The BUTTERFLYT™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
	When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
1.	Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2.	Pseudoarthrosis.
3.	Spondylolysis.
4.	Spondylolisthesis.
5.	Fracture.
6.	Neoplastic disease.
7.	Unsuccessful previous fusion surgery.
8.	Lordotic deformities of the spine.
9.	Idiopathic thoracolumbar or lumbar scoliosis.

{1}------------------------------------------------

1. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated 11. with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

Functionality & Safety Testing: A Risk Analysis was performed on the BUTTERFLY PLATE and was included in this submission. Conclusion: The subject components contained in this submission are substantially equivalent to the original BUTTERFLY PLATE Fixation System (K010632) and to the Sofamor Danek Z-Plate Anterior Fixation System (K922543).

page dof2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K014267

Trade Name: Butterfly Plate Fixation System Regulation Number: 888.3050 and 888.3070 Regulatory Name: Spinal interlaminal fixation orthosis and Pedicle Screw System Regulatory Class: II Product Code: KWP and MNH Dated: December 21, 2001 Received: December 27, 2001

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

{3}------------------------------------------------

Page 2 - Richard W. Treharne, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This and includes on the promotion and advertising of your device, (201) 594-4639. Radinonary, con use at (301) 594-4639. Also, please note the regulation prease condor the Orifice or Somphanes et notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnees and its tollars. Inc. 100 million in (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, Pam,

Mark McMullen

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

{4}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BUTTERFLY PLATE FIXATION SYSTEM

The BUTTERFLY™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

1. Pseudoarthrosis.
1. Spondylolysis.
1. Spondylolisthesis.
1. Fracture.
1. Neoplastic disease.
1. Unsuccessful previous fusion surgery.
1. Lordotic deformities of the spine.
1. Idiopathic thoracolumbar or lumbar scoliosis.

Deformity (i.e., scoliosis, lordosis) and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity. Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic or lumbar spine.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Evaluation (ODE)

× Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use

Mark N. Milken

Restorat

510(k) Number

Regulation Number and Section

§ 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.