The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. 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. When used for these indications, the Capstone Control™ Spinal System, is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the Capstone Control™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

These patients should be skeletally mature and have had 6 months of nonoperative treatment. The Capstone Control™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.

Device Description

The Capstone Control™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone. The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The Capstone Control™ Interbody Fusion Devices are provided in various widths, heights, and lordosis, which can be inserted between two vertebral bodies to give support and correction during interbody fusion surgeries. The hollow geometry of the implants also allows the implants to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (Capstone Control™ Spinal System), primarily focusing on its substantial equivalence to previously cleared predicate devices. It does not contain information about an AI/ML-based device or any study proving that a device meets acceptance criteria related to AI/ML performance (e.g., diagnostic accuracy, sensitivity, specificity).

The "Performance Data" section details mechanical testing, biocompatibility, bacterial endotoxin testing, and MRI compatibility of the physical implant device. These are standard performance tests for implantable medical devices, not for AI/ML algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as the document does not pertain to an AI/ML device.

If the request was based on a misunderstanding and the 'device' in question is the Capstone Control™ Spinal System itself, then the relevant information regarding its acceptance criteria and proof of meeting them can be extracted from the 'Performance Data' section.

Assuming you were asking about the physical device and its performance for the clearance, here's the information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Static compression (ASTM F2077)	Not explicitly stated in the document (implied: meet or exceed predicate performance)	"The acceptance criteria was met for all tests."
Static compression-shear (ASTM F2077)	Not explicitly stated in the document (implied: meet or exceed predicate performance)	"The acceptance criteria was met for all tests."
Compression fatigue (ASTM F2077)	Not explicitly stated in the document (implied: meet or exceed predicate performance)	"The acceptance criteria was met for all tests."
Compression-shear fatigue (ASTM F2077)	Not explicitly stated in the document (implied: meet or exceed predicate performance)	"The acceptance criteria was met for all tests."
Subsidence (ASTM F2267)	Not explicitly stated in the document (implied: meet or exceed predicate performance)	"The acceptance criteria was met for all tests."
Bacterial Endotoxin	20 endotoxin units (EU)/device pyrogen limit specification (as per ANSI/AAMI ST72 and USP <161>)	"Testing was successfully performed, and it was confirmed that the subject devices meet the 20 EU/device testing limit."
Biocompatibility	Materials considered biocompatible (due to long history of clinical use)	PEEK and Tantalum markers, stainless steel for trials. Considered biocompatible.
MRI Compatibility	Remains MR-Conditional	Determined not to present a new worst case to existing MR-Conditional predicate. Remains MR-Conditional.

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

Sample Size: Not explicitly stated for mechanical testing. Typically, mechanical tests involve a small, statistically valid number of samples (e.g., n=5 or n=10 per test) of the "worst-case" device configuration. For Bacterial Endotoxin Testing, "worst case subject interbody fusion devices" were used, implying a limited number.
Data Provenance: Not specified regarding "country of origin" of data, but the testing was conducted to support a US FDA submission. The studies detailed are prospective bench tests performed on the manufactured device.

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

This question is not applicable as the document describes mechanical, material, and chemical property testing of a physical device, not a diagnostic AI/ML device requiring expert ground truth for interpretation of medical images/data. The "ground truth" for these tests is based on established engineering standards (ASTM) and chemical/biological safety standards (ANSI/AAMI, USP).

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

This question is not applicable. Adjudication methods are relevant for human interpretation or AI output evaluation where subjective or complex assessments are involved, typically in diagnostic or clinical studies. For bench testing, the results are objectively measured against defined criteria.

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:

This question is not applicable. No MRMC study was performed as this is a physical medical implant, not an AI/ML diagnostic tool.

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

This question is not applicable. This document does not describe an algorithm.

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

For mechanical tests: Engineering standards (ASTM F2077, ASTM F2267) and comparison to predicate device performance.
For bacterial endotoxin: Chemical/biological safety standards (ANSI/AAMI ST72, USP <161>).
For biocompatibility: Historical clinical use of materials.
For MRI compatibility: FDA guidance for MR environment (Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment) and comparison to predicate device.

8. The sample size for the training set:

This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

This question is not applicable. There is no "training set" as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 6, 2019

Medtronic Sofamor Danek USA, INC. Mr. Justin O'Connor Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K190165

Trade/Device Name: Capstone Control™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 31, 2019 Received: January 31, 2019

Dear Mr. O'Connor:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190165

Device Name Capstone ControlTM Spinal System

Indications for Use (Describe)

Additionally, the Capstone Control™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K190165 - 510(k) Summary

MEDTRONIC Capstone Control™ Spinal System

April 2019

I. Submitter	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738
Contact Person	Justin O'ConnorSr. Regulatory Affairs SpecialistDirect Telephone: (901)399-2480
Date Prepared	April 2019
II. Name of Device	Capstone Control™ Spinal System
Common Name	Intervertebral Body Fusion Device
Classification Name	Intervertebral Fusion Device with Bone Graft, Lumbar
Classification	Implants: Class IIInstrument Trials: Class II
Product Codes	MAX (21 CFR 888.3080)
III. Predicate Devices	Predicate 1 (Primary Predicate): Capstone Control™ SpinalSystem - K171107 (S.E. 09/26/2017)Predicate 2 (Additional Predicate): Capstone Control™ SpinalSystem - K120368 (S.E. 04/09/2012)Predicate 3 (Additional Predicate): Perimeter® InterbodyFusion Device – K090353 (S.E. 08/29/2009)Predicate 4 (Additional Predicate): Capstone® Spinal System -K073291 (S.E. 04/24/2008)
IV. Description	The Capstone Control™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone. The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The Capstone Control™ Interbody Fusion Devices are provided in various widths, heights, and lordosis, which can be inserted between two vertebral bodies to give support and correction during interbody fusion surgeries. The hollow geometry of the implants also allows the implants to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
V. Indications for Use	The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. 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. When used for these indications, the Capstone Control™ Spinal System, is intended for use with supplemental fixation systems cleared for use in the lumbar spine.Additionally, the Capstone Control™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.These patients should be skeletally mature and have had 6 months of nonoperative treatment. The Capstone Control™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.
VI. Comparison ofTechnological	The subject CAPSTONE CONTROL™ Spinal System has the same intended use, indications, materials, technological characteristics, spinal location, surgical approach, and sterilization
Characteristics withthe Predicate Devices	method as its predicates. Both the subject and predicate CapstoneControl™ devices are based on the same technologicalcharacteristics of providing fusion support for patients diagnosedwith Degenerative Disc Disease (DDD) at one to two contiguouslevels from L2 to S1, as well as used to provide anterior columnsupport in patients diagnosed with degenerative scoliosis as anadjunct to pedicle screw fixation. The only difference between thesubject and predicate Capstone Control™ devices is the subjectdevices have a length, which falls outside the cleared range of theCapstone Control™ Spinal System but does not raise any issues ofsafety and effectiveness. Please see the Substantial Equivalencesection of this submission for more detail.
VII. Performance Data	Mechanical TestingIn order to demonstrate substantial equivalence, Medtronic used tofollowing FDA guidance document: Class II Special Controls Guidance Document:Intervertebral Body Fusion Device issued June 12, 2007 Design verification testing for the worst-case subject interbodyfusion device was completed in accordance with the following: ASTM F2077: Test Methods for Intervertebral FusionDevices ASTM F2267: Standard Test Method for Measuring LoadInduced Subsidence of Intervertebral Body Fusion Deviceunder Static Axial Compression The verification tests completed were the following: Static compression (ASTM F2077) Static compression-shear (ASTM F2077) Compression fatigue (ASTM F2077) Compression-shear fatigue (ASTM F2077) Subsidence (ASTM F2267) The acceptance criteria was met for all tests. Please see theBench Performance Testing section of this submission formore detail.
	BiocompatibilityIdentical to the predicate devices, the sterile interbody fusiondevices in the subject devices are made of Polyetheretherketone(PEEK) and contain Unalloy Tantalum markers, which allow forradiographic visualization during the surgical procedure. The non-sterile trials in the subject devices are manufactured from stainlesssteel, which is identical to the material used to manufacture theinstruments cleared in the predicate devices. The materialsmentioned above are considered biocompatible due to their longhistory of clinical use in medical devices.
	Bacterial Endotoxin TestingThe bacterial endotoxin test, also known as Limulus amebocytelysate (LAL) test, was performed utilizing worst case subjectinterbody fusion devices to verify that the subject devices meet the20 endotoxin units (EU)/device pyrogen limit specification.Testing was successfully performed, and it was confirmed that thesubject devices meet the 20 EU/device testing limit for generalmedical devices that are implanted as outlined in ANSI/AAMIST72, Bacterial endotoxins – Test methods, routine monitoring,and alternatives to batch testing and USP <161>, Medical Devices- Bacterial Endotoxin and Pyrogen Tests.
	Magnetic Resonance Imaging (MRI)The subject interbody fusion devices are part of the CapstoneControl™ Spinal System that was cleared as MR-Conditional inPrimary Predicate 1 (K171107, S.E. 09/26/2017). In accordancewith the Guidance for Industry and FDA Staff - EstablishingSafety and Compatibility of Passive Implants in the MagneticResonance (MR) Environment, Medtronic re-evaluated the MRIcompatibilty of the subject implants and determined that they donot present a new worst case to the existing Capstone Control™Spinal System. Therefore, the Capstone Control™ Spinal Systemwith the addition of the subject interbody fusion devices, remainsclassified as MR-Conditional.
VIII. Conclusion	Based on the supporting evidence provided, Medtronic believes thesubject devices are substantially equivalent to the below predicates,as well as, the 5th percentile of PLIF devices that have been clearedby the FDA for market release.

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Predicate 1 (Primary Predicate): Capstone Control™●Spinal System - K171107 (S.E. 09/26/2017)
Predicate 2 (Additional Predicate): Capstone Control™●Spinal System - K120368 (S.E. 04/09/2012)
Predicate 3 (Additional Predicate): Perimeter®●Interbody Fusion Device - K090353 (S.E. 08/29/2009)
Predicate 4 (Additional Predicate): Capstone® Spinal●System - K073291 (S.E. 04/24/2008)

K190165 510k Summary Page 5 of 5

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.