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

Device Description

The CAPSTONE® Spinal System consists 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 devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.

AI/ML Overview

This document is a 510(k) summary for the CAPSTONE® Spinal System, seeking to expand its indications for use. It's important to note that this is a medical device submission, not a submission for an AI/ML powered device, therefore, many of the requested categories (e.g., ground truth, experts, training sets, MRMC studies) are not applicable in this context. The acceptance criteria for this type of submission are primarily focused on demonstrating substantial equivalence to previously cleared devices and safety/effectiveness for the expanded indication through clinical and non-clinical data.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit from Submission Aims)	Reported Device Performance (Summary)
Demonstrate substantial equivalence to predicate devices (K121760, K120368, K103731, K082732) for the existing components.	"The CAPSTONE® Spinal System implants contained in this application are identical to those previously cleared in earlier 510(k) applications." "The fundamental scientific technology of the CAPSTONE® Spinal System has not been altered for this submission."
Demonstrate safety and effectiveness for the expanded indication (supplement to pedicle screw fixation in degenerative scoliosis).	"Published retrospective clinical data for the CAPSTONE® Spinal System as well as devices similar to the subject spinal system were provided in support of this application. This clinical data demonstrated that the use of interbody cages to treat deformity conditions posed no new risks to patients."
No new risks introduced by the expanded indication or existing device.	"No changes were made to the existing devices, nor were any new components added to the system." "This clinical data demonstrated that the use of interbody cages to treat deformity conditions posed no new risks to patients."
No additional testing required due to the nature of the change.	"Therefore, no additional testing was required or performed."
Conclusion of Substantial Equivalence for the expanded indication.	"The design features, materials used, manufacturing and sterilization methods are equivalent to the previously cleared CAPSTONE® Spinal System components with the exception of broadening a portion of the indications to include the aforementioned deformity conditions."

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

Sample Size for Test Set: Not explicitly stated as a distinct "test set" in the context of device performance testing. The "clinical data" mentioned refers to retrospective studies.
Data Provenance: "Published retrospective clinical data" - the country of origin is not specified, but the submission is to the US FDA. The data is retrospective.

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

Not Applicable. This submission is for a physical medical device, not an AI/ML powered device where expert-established ground truth for a test set is typically required. The "truth" here is established from clinical outcomes observed in the retrospective studies.

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

Not Applicable. As above, this concept does not apply to this type of device submission. Clinical outcomes from the retrospective data would typically be reviewed and adjudicated by treating physicians in the original studies, but this level of detail is not provided here.

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. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

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

Not Applicable. This is a physical spinal implant, not an algorithm.

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

The "ground truth" for the expanded indication is based on outcomes data from the "published retrospective clinical data" on the CAPSTONE® Spinal System and similar interbody cages. The key finding from this data was that using these cages for deformity conditions posed "no new risks to patients."

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML model that requires a "training set."

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

Not Applicable. As above, a training set is not relevant for this type of device.

Summary

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Page 1 of 2

CAPSTONE® Spinal System 510(k) Summary - K123027

July 2013

JUL 2 5 2013

Company:	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact:	Lee Grant

Proposed Proprietary Trade Name: CAPSTONE® Spinal System

Classification Name(s): Intervertebral Body Fusion Device (per 21CFR Section 888.3080); Product Code: MAX

Distinguished Regulatory Affairs Advisor

Description: The CAPSTONE® Spinal System consists 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 purpose of this 510(k) submission is to expand the indications of the CAPSTONE® Spinal System to allow the device to be used a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

Indications for Use: The CAPSTONE® 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® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

Summary of the Technological Characteristics: The CAPSTONE® Spinal System implants contained in this application are identical to those previously cleared in earlier 510(k) applications. The devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies. The

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fundamental scientific technology of the CAPSTONE® Spinal System has not been altered for this submission.

Identification of Legally Marketed Devices: The components contained in this CAPSTONE® Spinal System application are identical to those cleared in K121760 (SE 08/29/12), K120368 (SE 04/09/12), K103731 (SE 07/18/11) and K082732 (SE 10/16/08).

Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Published retrospective clinical data for the CAPSTONE® Spinal System as well as devices similar to the subject spinal system were provided in support of this application. This clinical data demonstrated that the use of interbody cages to treat deformity conditions posed no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.

Conclusion: The design features, materials used, manufacturing and sterilization methods are equivalent to the previously cleared CAPSTONE® Spinal System components with the exception of broadening a portion of the indications to include the aforementioned deformity conditions.

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

July 25, 2013

Medtronic Sofamor Danek, Incorporated % Mr. Lee Grant Senior Principal, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

Re: K123027

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: May 14, 2013 Received: May 15, 2013

Dear Mr. Grant:

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

Image /page/2/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and health.

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Page 2 - Mr. Lee Grant

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 vours.

Erin詞《eith

For

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

Enclosure

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K123027 510(k) Number (if known):

Device Name: CAPSTONE® Spinal System

Indications for Use:

The CAPSTONE® 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 SI. 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 nonoperative treatment.

Additionally, the CAPSTONE® 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.

Prescription Use × (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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.