The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disease (DDD) at one or two contiguous 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 PEEK cages and titanium alloy 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,

AI/ML Overview

This document is a 510(k) summary for a medical device (CAPSTONE® Spinal System) and as such, it primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing detailed acceptance criteria and a comprehensive study report with quantitative performance metrics typical for novel AI/diagnostic device clearances.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided within this type of regulatory submission. The "study" here refers to the documentation of substantial equivalence through mechanical testing and comparison of features and intended use.

Here's an attempt to answer as much as possible based on the provided text, while acknowledging the limitations of this document type:

Acceptance Criteria and Device Performance

Note: The provided 510(k) summary does not specify explicit "acceptance criteria" in terms of performance metrics (e.g., accuracy thresholds, sensitivity, specificity) as one would expect for a diagnostic or AI device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it matches or is comparable to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Test Results comparable to predicate devices.	"Documentation, including mechanical test result, was provided which demonstrated that the subject CAPSTONE® Spinal System devices are substantially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08) as well as the VERTE-STACK® Spinal System (K043566 SE 01/07/05, K043561 SE 12/29/04)." (Implies that the mechanical performance meets the standards established by the predicate devices).
Similar Product Description, Design, and Materials.	The CAPSTONE® Spinal System consists of "PEEK cages and titanium alloy 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." This description is implicitly similar to the predicate devices.
Identical Intended Use/Indications for Use.	"The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels... 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." This precisely matches the indications of the predicate devices.
Compliance with regulatory requirements for classification.	Classified as an Intervertebral Body Fusion Device (21 CFR 888.3080), Class II. This implies it meets the general controls and any special controls for this product type.

Study Details for Substantial Equivalence

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms a number of "cases" or "patients" for a clinical study, as this is primarily a mechanical and design comparison for substantial equivalence. For mechanical testing, the "sample size" would refer to the number of devices tested, which is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data for a device demonstrating substantial equivalence based on mechanical testing and comparison to existing predicate devices. The "data" primarily refers to design specifications, material properties, and mechanical test results, not patient data in the typical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is an implant, and the "ground truth" for its performance is established through engineering and biomechanical testing, rather than expert evaluation of diagnostic output.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" of images or patient data requiring expert adjudication in this 510(k) summary.
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 is a spinal implant, not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a spinal implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device is established through:
  - Mechanical Testing Standards: Compliance with industry standards for spinal implants (e.g., fatigue, compression, expulsion testing).
  - Biocompatibility Standards: Ensuring materials are safe for implantation.
  - Design Specifications: Verification that the device meets its intended design parameters.
  - Predicate Device Performance: The primary "ground truth" is that the new device performs equivalently to previously cleared predicate devices, which have a history of safe and effective use.
The sample size for the training set:
- Not applicable. This is an implant, not a machine learning model requiring a "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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CAPSTONE® Spinal System 510(k) Summarv - K082342 September 2008

I.	Company:	Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, TN 38132(901) 396-3133	SEP 1 2 2008
	Contact:	Chris McKeeSr. Regulatory Affairs Specialist
II.	Proprietary Trade Name: CAPSTONE® Spinal System

III. Classification Name: Intervertebral Body Fusion Device (21 CFR 888,3080)

IV. Product Code: MAX

V. Product Description

VI. Indications

VII. Substantial Equivalence

Documentation, including mechanical test result, was provided which demonstrated that the subject CAPSTONE® Spinal System devices are substantially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08) as well as the VERTE-STACK® Spinal System (K043566 SE 01/07/05, K043561 SE 12/29/04).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Mr. Chris McKee Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K082342

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: August 13, 2008 Received: August 15, 2008

Dear Mr. McKee:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

SEP 1 2 2008

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 (OS) 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 - Mr. Chris McKee

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 marketed 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark W. Millerson

Mark N. Melkerson 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): K082342

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 disease (DDD) at one or two contiguous 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 implanted via an open or a minimally invasive posterior approach. Alternatively, these 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 x OR Over-The-Counter Use

Per 21 CFR 801.109

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Mark M. Milliken
K082342

( Division Sign-on) Restorative, and Neurological Dev

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.