The CAPSTONE® Spinal System is indicated for use 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. 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 FDA for use in the lumbar spine.

Device Description

The CAPSTONE® Spinal System consists of Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.

AI/ML Overview

The provided text is a 510(k) summary for the CAPSTONE® Spinal System, which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in terms of clinical performance or device accuracy in the way an AI/ML device would.

Therefore, many of the requested categories, such as "acceptance criteria," "device performance," "sample size for test set," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set," are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted from the provided text, aligning with the spirit of the request where possible, and explicitly stating when information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as such for clinical performance)	Reported Device Performance / Basis for Equivalence
Premarket Review Goal: Substantial Equivalence to a Predicate Device	Demonstrated substantial equivalence to the predicate CAPSTONE® Spinal System device.
Indications for Use: Identical to Predicate	The subject and predicate CAPSTONE® Spinal System devices are identical in terms of indications for use.
Intended Use: Identical to Predicate	The subject and predicate CAPSTONE® Spinal System devices are identical in terms of intended use.
Performance Specifications: Identical to Predicate	The subject and predicate CAPSTONE® Spinal System devices are identical in terms of performance specifications.
Technological Characteristics: Identical to Predicate (excluding new inserter)	The subject and predicate CAPSTONE® Spinal System devices are identical in terms of technological characteristics. A new threaded inserter instrument was added.
Cleaning and Sterilization: Appropriate for new instrument	Cleaning and sterilization validation activities have been conducted to provide appropriate instructions for the CAPSTONE® Spinal System, including the new instrument.

2. Sample size used for the test set and the data provenance

Not Applicable. This submission is not based on a clinical test set for performance evaluation but rather a comparison to an existing predicate device. The "test" here refers to non-clinical tests for cleaning and sterilization, not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Pertains to clinical performance studies, not substantial equivalence evaluations of this nature.

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

Not Applicable. Pertains to clinical performance studies, not substantial equivalence evaluations of this nature.

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 surgical implant, not an AI/ML diagnostic tool or an assistive technology for human readers.

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

Not Applicable. This device is a surgical implant, not a standalone algorithm.

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

Not Applicable. Pertains to clinical performance studies. The "ground truth" for this submission is the established performance and safety profile of the predicate device.

8. The sample size for the training set

Not Applicable. This device is a surgical implant, not an AI/ML model for which a training set would be used.

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

Not Applicable. This device is a surgical implant, not an AI/ML model.

Summary of the Study (or Basis for Clearance):

The "study" in this context is a premarket notification (510(k)) submission designed to demonstrate that the CAPSTONE® Spinal System is substantially equivalent to a legally marketed predicate device (also the CAPSTONE® Spinal System, implying an updated version or minor modification).

Objective: To demonstrate that the subject device is as safe and effective as the predicate device, thereby not requiring a Premarket Approval (PMA) application.
Methodology: The sponsor provided documentation (non-clinical tests and comparative analysis) to show that the subject device shares the same indications for use, intended use, performance specifications, and technological characteristics as the predicate device. The only noted change was the addition of a new threaded inserter instrument.
Testing Conducted: Cleaning and sterilization validation activities were performed for the CAPSTONE® Spinal System, specifically addressing the new instrument, to ensure appropriate instructions were provided in the labeling.
Conclusion: The FDA reviewed the submission and concurred that the device is substantially equivalent to the predicate device, allowing it to be marketed.

Summary

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K103731 page 1 of 2

CAPSTONE® Spinal System 510(k) Summary 6/24/2011

JUL 18 2011

Medtronic Sofamor Danek Company: I. 1800 Pvramid Place Memphis, TN 38132 (901) 396-3133
Thao Phan Contact: Regulatory Affairs Specialist
Proprietary Trade Name: CAPSTONE® Spinal System II.
Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) III.
IV. Product Code: MAX

V. Product Description

VI. Indications

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K103731 Page 2 of 2

VII. Substantial Equivalence

Documentation was provided which demonstrated that the subject CAPSTONE® Spinal System device is substantially equivalent to the predicate CAPSTONE® Spinal System device.

Brief Discussion of the Non-Clinical Tests Submitted VIII.

A new threaded inserter instrument was added to the CAPSTONE® Spinal System and cleaning and disassembly instructions for the new instrument were added to the labeling. The subject and predicate CAPSTONE® Spinal System devices are identical in terms of indications for use, intended use, performance specifications, and technological characteristics. Cleaning and sterilization validation activities have been conducted to provide the appropriate cleaning and sterilization instructions for the CAPSTONE® Spinal System.

Conclusions Drawn from the Non-Clinical Tests IX.

The information above demonstrates equivalence and supports a determination of substantial equivalence between the subject and predicate CAPSTONE® Spinal System devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Medtronic Sofamor Danek USA % Ms. Becky Ronner Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

JUL 1 8 2011

Re: K103731

Trade/Device Name: CAPSTONE® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 24, 2011 Received: June 27, 2011

Dear Ms. Ronner:

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

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Page 2 - Ms. Becky Ronner

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ernel Keith

J Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K103731

Device Name: CAPSTONE® Spinal System

Indications for Use:

The CAPSTONE® Spinal System is indicated for use 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 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 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 FDA for use in the lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIO3731 510(k) 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.