The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.

CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

Device Description

The CAPSTONE PTCTM and CLYDESDALE PTC™ Spinal Systems consist of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE PTC™ and CLYDESDALE PTC™ Spinal Systems will be available in all the same sizes as the predicate systems. The CAPSTONE PTC™ and CLYDESDALE PTC™ System implants (subject devices) and the CAPSTONE® and CLYDESDALE® Spinal System implants (predicate devices), are both made from PEEK material with tantalum markers. The only difference in the subject and predicate devices is the subject devices also have a commercially pure titanium coating. In addition, the predicate and subject devices are both convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MEDTRONIC Sofamor Danek CAPSTONE PTCTM and CLYDESDALE PTC™ Spinal Systems:

This document is a 510(k) Summary for a medical device seeking substantial equivalence to previously cleared devices. It describes non-clinical testing performed to demonstrate that the new devices (which incorporate a titanium coating) are as safe and effective as their uncoated predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Standard	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Coating Microstructure	ASTM F1854	Conform to standards for porous coatings on medical implants (e.g., porosity, pore size).	Testing performed; implies conformity.
Shear Fatigue Testing	ASTM F1160	Withstand specified shear and bending fatigue loads for calcium phosphate and metallic coatings.	Testing performed; implies performance within acceptable limits.
Static Shear Testing	ASTM F1044	Exhibit sufficient static shear strength for calcium phosphate and metallic coatings.	Testing performed; implies performance within acceptable limits.
Tensile Testing	ASTM F1147	Demonstrate adequate tensile strength for calcium phosphate and metallic coatings.	Testing performed; implies performance within acceptable limits.
Abrasion Testing	ASTM F1978	Exhibit appropriate abrasion resistance for metallic thermal spray coatings.	Testing performed; implies performance within acceptable limits.
Static Compression	ASTM F2077	Withstand specified static compression loads for intervertebral body fusion devices.	Testing performed; implies performance within acceptable limits.
Dynamic Compression	ASTM F2077	Withstand specified dynamic compression loads for intervertebral body fusion devices.	Testing performed; implies performance within acceptable limits.
Static Compression Shear	ASTM F2077	Withstand specified static compression shear loads for intervertebral body fusion devices.	Testing performed; implies performance within acceptable limits.
Dynamic Compression Shear Fatigue	ASTM F2077	Withstand specified dynamic compression shear fatigue loads for intervertebral body fusion devices.	Testing performed; implies performance within acceptable limits.
Subsidence Testing	ASTM F2267	Demonstrate acceptable load-induced subsidence under static axial compression.	Testing performed; implies performance within acceptable limits.
Static Push-out (Expulsion) Testing	ASTM Draft Standard F04.25.02.02	Resist expulsion under specified static push-out forces.	Testing performed; implies performance within acceptable limits.
Wear Particulate Testing	ASTM F1877	Exhibit acceptable wear particulate characteristics (size, morphology, quantity).	Testing performed; implies acceptable wear characteristics.
Biocompatibility	(Animal testing using canines and CP Ti coated coupons)	No adverse biological reactions; demonstrate tissue compatibility with CP Ti coating.	Animal testing supports biocompatibility, implying no adverse reactions.

Important Note: This document primarily focuses on demonstrating substantial equivalence through non-clinical performance to existing predicate devices. It does not explicitly state numerical acceptance criteria or specific performance values for the new devices, but rather relies on compliance with established ASTM standards and implicitly, that the new devices perform comparably to or better than the predicate devices tested under the same standards. The conclusion explicitly states the belief that the devices are "substantially equivalent to the predicates," which is the ultimate acceptance criterion for a 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Non-Clinical): The document details various non-clinical mechanical and material tests. For each ASTM standard, there would be a defined sample size (e.g., number of test specimens). However, the document does not explicitly state the specific sample sizes used for each mechanical or material test.
Data Provenance: The data provenance is laboratory testing (mechanical, material, and in-vivo animal testing). It is not human clinical data, so country of origin and retrospective/prospective distinctions are not applicable in the typical sense. The testing was conducted to U.S. (ASTM) standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. For non-clinical, mechanical, and material testing, "ground truth" is established by adherence to universally accepted standards (ASTM standards in this case) and scientific principles, not by expert consensus on subjective interpretations. The expertise lies in the engineers and technicians performing the tests and interpreting the results in accordance with the specified standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies where expert consensus is needed to establish ground truth for a subjective assessment. This document describes objective, non-clinical engineering and material science tests.

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 submission is for an intervertebral body fusion device (an implant), not a diagnostic device or AI software. Therefore, an MRMC study related to human readers improving with AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical implant, not an algorithm or software device.

7. The Type of Ground Truth Used

Engineering and Material Standards Compliance, and Animal Study Outcomes.
- For the mechanical and material tests (ASTM F1854, F1160, F1044, F1147, F1978, F2077, F2267, F04.25.02.02, F1877), the ground truth is the specified performance criteria within the respective ASTM standards. The device's performance is compared against these objective, quantitative criteria.
- For biocompatibility, the ground truth is established through animal testing outcomes (canines) demonstrating tissue compatibility and the absence of adverse biological reactions to the CP Ti coating.

8. The Sample Size for the Training Set

Not Applicable. This submission describes mechanical and biocompatibility testing for an implant, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI/algorithm, this question is not relevant.

Summary

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MAR 1 3 2014

510(k) Summary

MEDTRONIC Sofamor Danek CAPSTONE PTCTM and CLYDESDALE PTC™ Spinal Systems March 2014

I.	Company:	Medtronic Sofamor Danek, USA Inc.
		1800 Pyramid Place
		Memphis, Tennessee 38132
		(901) 396-3133
II.	Contact:	Julie Bassett
		Regulatory Affairs Program Manager
		Telephone: (901) 399-3248
		Fax: (901) 346-9738
III.	Proposed Proprietary Trade Name:	CAPSTONE PTCT™ Spinal System and CLYDESDALE PTCT™ Spinal System
IV.	Classification Names:	Intervertebral Body Fusion Device (21 CFR 888.3080)
	Class:	II
	Product Code:	MAX

V. Description :

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The CAPSTONE PTC™ and CLYDESDALE PTC™ Spinal Systems will be available in all the same sizes as the predicate systems.

VI. Indications for Use:

CAPSTONE PTCTM Spinal System:

Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.

CLYDESDALE PTC™ Spinal System:

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S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

Summary of the Technological Characteristics: VII.

The CAPSTONE PTC™ and CLYDESDALE PTC™ Spinal Systems have the same fundamental technology as the predicate CAPSTONE® and CLYDESDALE® Spinal Systems. The CAPSTONE PTC™ and CLYDESDALE PTC™ System implants (subject devices) and the CAPSTONE® and CLYDESDALE® Spinal System implants (predicate devices), are both made from PEEK material with tantalum markers. The only difference in the subject and predicate devices is the subject devices also have a commercially pure titanium coating. In addition, the predicate and subject devices are both convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.

VIII. Identification of Legally Marketed Devices:

The CAPSTONE PTC™ Spinal System has the same indications for use and fundamental scientific technology as the predicate, CAPSTONE® Spinal System (K073291, SE 4/24/2008 and K123027, SE 07/25/2013). The CLYDESDALE PTCTM Spinal System has the same indications for use and fundamental scientific technology as the predicate, CLYDESDALE® Spinal System (K1130528, SE 12/20/2011 and K122037, SE 3/22/2013). An additional predicate, Spinal Element's Lucent Ti-Bond Spinal System (K110632, SE 5/23/2012), is also being used to demonstrate that the commercially pure titanium coating is not new and currently exists on other legally marketed devices.

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IX. Discussion of Non-Clinical Testing:

Testing of the plasma-sprayed coating was performed according to FDA's Guidance for FDA Reviewers/Staff, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements," issued February 2, 2000. The testing was performed according to the applicable ASTM standards listed below:

Coating Microstructure:

. ASTM F1854, Standard test method for stereological evaluation of porous coatings on medical implants

Shear Fatigue Testing:

ASTM F1160, Standard Test Method for Shear and Bending Fatigue . Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/ Metallic Coatings

Static Shear Testing:

ASTM F1044, Standard test method for shear testing of calcium . phosphate coatings and metallic coatings

Tensile Testing:

ASTM F1147, Standard test method for tension testing of calcium . phosphate & metallic coatings

Abrasion Testing:

ASTM F1978. Standard Test Method for Measuring Abrasion Resistance . of Metallic Thermal Spray Coatings by Using the Taber Abraser
In order to demonstrate substantial equivalence to the predicate devices, mechanical testing was conducted. Static compression, dynamic compression, static compression shear, and dynamic compression shear fatigue testing were performed in accordance with ASTM F2077: Test Methods for Intervertebral

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Body Fusion Devices. Subsidence testing was performed in accordance with ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression. Static push-out (expulsion) testing was also performed in accordance with ASTM Draft Standard F04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices. In addition, wear particulate testing was performed in accordance with ASTM F1877, Standard Practice for Characterization of Particles.

Animal testing was also performed using canines and CP Ti coated coupons.

Conclusion: XI.

Based on the risk analysis, test results, and additional supporting documentation provided in this pre-market notification, Medtronic believes the subject CAPSTONE PTC™ and CLYDESDALE PTC™ Spinal Systems are substantially equivalent to the predicates, the CAPSTONE® and CLYDESDALE® Spinal Systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2014

Medtronic Sofamor Danek USA, Incorporated Ms. Julie Bassett Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K133205

Trade/Device Name: CAPSTONE PTC™ Spinal System and CLYDESDALE PTC™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 17, 2014 Received: February 18, 2014

Dear Ms. Bassett:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Julie Bassett

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiqqins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133205

Device Name

CAPSTONE PTC™ Spinal System

Indications for Use (Describe)

Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scollosis.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

. . . . FOR FDA USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : 评论: .. Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

David Hwang Rh Division of Orthopedie Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{8}------------------------------------------------

Expiration Date: January 31, 2017 See PRA Statement below.

Form Approved: OMB No. 0910-0120

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133205

Device Name

CLYDESDALE PTC™ Spinal System

Indications for Use (Describe)

CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CL YDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY ・・・。 ...

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

David Hwang Ph.D.

Division of Orthopedie Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.