The CAPSTONE CONTROL™ System, including the CAPSTONE CONTROL PTC™ Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis 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 six 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.

Device Description

The subject CAPSTONE CONTROL™ Spinal System adds 24-degree lordotic PEEK cages with tantalum markers to the existing CAPSTONE CONTROLTM Spinal System. Both the predicate sizes, and including the subject 24-degree lordotic cages, will also be provided with a commercially pure titanium coating (CP Ti) on the opposing, endplate-contacting sides of the implant. The titanium coated interbody cages will be branded as the CAPSTONE CONTROL PTC™ Spinal System (PTC = Pure Titanium Coating) to differentiate the coated cages from the uncoated CAPSTONE CONTROLTM Spinal System cages. The titanium coating is identical to the coating on the predicate CAPSTONE PTC™ Spinal System implants (Predicate #4).

The subject instruments include 24-degree lordotic cam spreader trials that correspond to the subject 24-degree lordotic cages. The predicate and subject cam spreader trials, and other instruments used to facilitate the implantation of the uncoated CAPSTONE CONTROL™ Spinal System cages, will also be used with the CAPSTONE CONTROL PTC™ Spinal System.

The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems consist of interbody fusion 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal System cages are available in heights of 8mm to 18mm, lengths of 22mm, 27mm, and 32mm, and widths of 9mm or 10mm. The implants will be available with 0°, 6°, 12°, 18°, or 24° of lordosis. The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems also include cam spreader trials and a variety of instruments to help facilitate the implantation of the interbody fusion cages.

AI/ML Overview

This document describes the premarket notification (510(k) K171107) for the Medtronic Sofamor Danek CAPSTONE CONTROL™ Spinal System and CAPSTONE CONTROL PTC™ Spinal System. While the document outlines various tests conducted, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a study in the way a diagnostic AI/ML device would. The information provided is primarily related to mechanical and material performance testing for an intervertebral body fusion device.

Therefore, the requested information elements (especially those related to diagnostic performance like sensitivity, specificity, reader studies, ground truth establishment, training/test set sizes, and expert qualifications) are not applicable to this type of device and submission.

However, I can extract the relevant information from the provided text regarding the performance data and "acceptance criteria" as they are described within the context of a medical implant device submission.

Here's a breakdown based on the provided text, addressing elements that are applicable and noting where others are not:

1. A table of acceptance criteria and the reported device performance

The document states that "The pre-determined acceptance criteria, established using predicate test data, were met for all tests." and "The subject 24-degree lordotic CAPSTONE CONTROL PTC™ implants met the pre-determined acceptance criteria, established using predicate test data, for all tests." Specific numerical acceptance criteria and reported device performance values are not detailed in this summary document, only that the criteria were met. The tests performed are listed.

Test Category	Specific Tests Performed	Acceptance Criteria	Reported Device Performance
Commercially Pure Titanium Coating Evaluation	- ASTM F1854: Stereological evaluation of porous coatings	Predetermined, established using predicate test data	Met for all tests
	- ASTM F1160: Shear and bending fatigue testing	Predetermined, established using predicate test data	Met for all tests
	- ASTM F1044: Shear testing of calcium phosphate and metallic coatings	Predetermined, established using predicate test data	Met for all tests
	- ASTM F1147: Tension testing of calcium phosphate & metallic coatings	Predetermined, established using predicate test data	Met for all tests
	- EN ISO 3274: Geometrical Product Specification (GPS) Surface Texture: Profile Method (Nominal Characteristics of Contact)	Predetermined, established using predicate test data	Met for all tests
	- EN ISO 4287: Geometrical Product Specification (GPS) - Surface Texture: Profile Method (Terms, Definitions, and Surface Texture Parameters)	Predetermined, established using predicate test data	Met for all tests
	- EN ISO 4288: Geometrical Product Specification (GPS) Surface Texture: Profile Method (Rules and Procedures for the Assessment of Surface Texture)	Predetermined, established using predicate test data	Met for all tests
Mechanical Testing	- Static Compression	Predetermined, established using predicate test data	Met for all tests
	- Compression Fatigue	Predetermined, established using predicate test data	Met for all tests
	- Static Compression-Shear	Predetermined, established using predicate test data	Met for all tests
	- Compression-Shear Fatigue	Predetermined, established using predicate test data	Met for all tests
	- Subsidence (ASTM F2267)	Predetermined, established using predicate test data	Met for all tests
	- Expulsion (Push-out) (ASTM Draft Standard F.04.25.02.02) - for both coated and uncoated 24-degree lordotic implants	Predetermined, established using predicate test data	Met for all tests
	- Wear Debris (ASTM F1877)	Predetermined, established using predicate test data	Met for all tests
Design Validation	- Cadaver validation labs (insert and rotate 24-degree implant)	Functioned as intended; user needs met	Demonstrated success
MRI Safety Evaluation	- Comparison to a worst-case device for MR-safety, tested per: - ASTM F2052: Magnetically induced displacement force - ASTM F2213: Magnetically induced torque - ASTM F2119: MR image artifacts - ASTM F2182: RF induced heating	Inferred to behave in a similar (albeit reduced) manner for MRI issues compared to the worst-case system.	Passed by inference

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Mechanical and Material Testing: The document does not specify the exact sample size for each test (e.g., number of coating samples, number of implants for mechanical testing). It states "worst case subject 24-degree lordotic coated CAPSTONE CONTROL PTC™ implants" were tested and the "subject 24-degree lordotic uncoated CAPSTONE CONTROLTM implants were also tested" for expulsion.
Cadaver Labs: The number of cadavers or surgical procedures performed is not specified.
Data Provenance: Not specified. This type of engineering and bench testing is typically conducted in a laboratory setting. It is not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is not an AI/ML diagnostic device; therefore, no "ground truth" in the diagnostic sense was established by experts for a test set.
Cadaver Labs: "Independent surgeons" were involved in the design validation, but their number and specific qualifications are not detailed beyond being "surgeons."

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

Not Applicable. No diagnostic test set requiring adjudication was used.

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 is not an AI/ML diagnostic device requiring a MRMC study.

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

Not Applicable. This is not an AI/ML diagnostic device.

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

Not Applicable (in the diagnostic sense). For the mechanical and material tests, the "ground truth" or reference for acceptance criteria was established using "predicate test data" and compliance with recognized ASTM and ISO standards. For the cadaver labs, the "ground truth" was whether the implants and instruments "functioned as intended" and "user needs were met" by independent surgeons.

8. The sample size for the training set

Not Applicable. This is not an AI/ML diagnostic device. However, "predicate test data" was used to establish acceptance criteria, which could be seen as a form of "training data" for defining acceptable performance ranges based on previously cleared devices. The exact sample size of this predicate data is not specified.

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

Not Applicable (in the diagnostic sense). The "ground truth" for defining acceptance criteria was established through data and performance characteristics of legally marketed predicate devices and compliance with relevant industry standards (ASTM, ISO).

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 26, 2017

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.

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

Medtronic Sofamor Danek USA, Inc. Raphael McInnis Manager, Regulatory Affairs 1800 Pvramid Place Memphis. Tennessee 38132

Re: K171107

Trade/Device Name: CAPSTONE CONTROL™ Spinal System CAPSTONE CONTROL PTC™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 11, 2017 Received: September 13, 2017

Dear Mr. McInnis:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K171107

Device Name CAPSTONE CONTROL™ SPINAL SYSTEM CAPSTONE CONTROL PTC™ 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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510(k) Summary

MEDTRONIC Sofamor Danek CAPSTONE CONTROL™ SPINAL SYSTEM September 2017

Submitter: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738 Contact: Raphael McInnis Regulatory Affairs Sr. Manager Telephone: (901) 399-2057 (Direct)

Alternate Contact: Julie Bassett Regulatory Affairs Program Manager Telephone: (901) 399-3248 (Direct)

Date Prepared: September 25, 2017

II. Device:

Name of Device:	CAPSTONE CONTROL™ Spinal SystemCAPSTONE CONTROL PTC™ Spinal System
Common Name:	Interbody cage, interbody fusion device
Classification Name:	Intervertebral Body Fusion Device with bone graft(21 CFR 888.3080)
Class:	II
Product Code:	MAX

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III. Predicate Devices:

CAPSTONE® Spinal System Primary Predicate - K151128, SE 8/5/2015 CAPSTONE® Spinal System Predicate #2 - K073291, SE 4/24/2008 CAPSTONE CONTROL™ Spinal System Predicate #3 - K120368, SE 4/9/2012 CAPSTONE PTCTM Spinal System Predicate #4 - K133205, SE 3/13/2014 DIVERGENCE-LTM Spinal System Predicate #5 - K150135, SE 6/11/2015 SOVEREIGN® Spinal System Predicate #6 - K122037, SE 3/22/2013

The predicates have not been subject to a design related recall.

IV. Description of Devices

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V. Indications for Use:

The indications for use for the CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ are identical to the indications for use cleared for the primary predicate, CAPSTONE® Spinal System in K151128 (SE 8/5/2015). The indications for use are as follows:

The CAPSTONE CONTROL™ Spinal System, including the CAPSTONE CONTROL PTCTM Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two 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.

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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 six months of nonoperative treatment. The CAPSTONE CONTROLTM 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.

VI. Comparison of Technological Characteristics with the Predicate Devices:

The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems' interbody cages and cam spreader trials have the same intended use, materials, design features, and fundamental technology as their respective predicate devices:

CAPSTONE® Spinal System Primary Predicate - K151128, SE 8/5/2015 CAPSTONE® Spinal System Predicate #2 - K073291, SE 4/24/2008 CAPSTONE CONTROL™ Spinal System Predicate #3 - K120368, SE 4/9/2012 CAPSTONE PTCTM Spinal System Predicate #4 - K133205, SE 3/13/2014 DIVERGENCE-L™ Spinal System Predicate #5 - K150135, SE 6/11/2015 SOVEREIGN® Spinal System Predicate #6 - K122037, SE 3/22/2013

For instance, the subject CAPSTONE CONTROL PTC™ interbody cages have the same overall design as the predicate CAPSTONE CONTROL™ interbody cages. The primary difference is the titanium coating. The predicate and subject interbody cages are intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The cam spreader trials are used to assist the surgeon

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in selecting the appropriate size cage to use for the patient and are available in all the same lengths and lordotic options as the implants.

VII. Performance Data:

The following performance data were provided in support of substantial equivalence:

Commercially Pure Titanium Coating Evaluation

The commercially pure titanium coating used on the subject CAPSTONE CONTROL PTC™ Spinal System implants and CAPSTONE PTC™ Spinal System implants (Predicate #4) were evaluated in accordance with 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, and evaluated in accordance with the following standards:

. ASTM F1854: Standard test method for stereological evaluation of porous coatings on medical implants;
ASTM F1160: Standard Test Method for Shear and Bending Fatigue ● Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/ Metallic Coatings;
ASTM F1044: Standard test method for shear testing of calcium ● phosphate coatings and metallic coatings;
ASTM F1147: Standard test method for tension testing of calcium phosphate & metallic coatings;
EN ISO 3274: Geometrical Product Specification (GPS) Surface ● Texture: Profile Method - Nominal Characteristics of Contact (stylus instruments);
EN ISO 4287: Geometrical Product Specification (GPS) - Surface Texture: Profile Method -Terms, Definitions, and Surface Texture Parameters; and
EN ISO 4288: Geometrical Product Specification (GPS) Surface ● Texture: Profile Method – Rules and Procedures for the Assessment of Surface Texture.

The predetermined acceptance criteria, established using predicate test data,

were met for all tests.

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Mechanical Testing

Medtronic has evaluated the subject devices in accordance with FDA's Guidance Document, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, issued June 12, 2007 to demonstrate substantial equivalence to the predicate devices.

Design verification testing was completed on the worst case subject 24-degree lordotic coated CAPSTONE CONTROL PTC™ implants in accordance with:

ASTM F2077: Test Methods for Intervertebral Body Fusion Devices;
ASTM F2267: Standard Test Method for Measuring Load Induced ● Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression:
ASTM Draft Standard F.04.25.02.02: Static Push-out Test Method for ● Invertebral Body Fusion Devices; and
ASTM F1877: Standard Practice for Characterization of Particles. ●

Design verification testing consisted of the following tests:

Static Compression ●
Compression Fatigue ●
Static Compression-Shear ●
Compression-Shear Fatigue ●
Subsidence
Expulsion ●
Wear Debris ●

For expulsion (push-out) testing, the subject 24-degree lordotic uncoated CAPSTONE CONTROLTM implants were also tested. The subject 24-degree lordotic CAPSTONE CONTROL PTC™ implants met the pre-determined acceptance criteria, established using predicate test data, for all tests.

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Design Validation

Cadaver validation labs demonstrated that independent surgeons could insert and rotate the 24-degree implant without issue or failure of the implants or instruments. The cadaver validation labs demonstrated that the subject implants and instruments functioned as intended and user needs were met.

MRI Safety Evaluation

In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject 24degree lordotic CAPSTONE CONTROLTM interbody cages and the subject CAPSTONE CONTROL PTC™ interbody cages were evaluated using a comparison to a worst-case device for MR-safety that had been tested in accordance with the following standards:

ASTM F2052: Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment;
ASTM F2213: Standard test method for measurement of magnetically ● induced torque on medical devices in the magnetic resonance environment:
ASTM F2119: Standard test method for evaluation of MR image ● artifacts from passive implants: and
ASTM F2182: Standard test method for measurement of radio frequency ● induced heating on or near passive implant during magnetic resonance imaging.

For purposes of MR safety, the volume of metallic material, types of metallic material, and geometry of the implant were compared to a worst-case spinal system. Based on the performance and MR-Conditional classification of the worst case spinal system, it can be inferred that CAPSTONE CONTROL™ (24degree lordosis) and CAPSTONE CONTROL PTC™ implants will behave in a similar (albeit reduced) manner relative to MRI issues compared to the worstcase system.

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VIII. Conclusion:

Based on the risk analysis, test results, and additional supporting documentation provided in the pre-market notification, the subject CAPSTONE CONTROL™ Spinal System and CAPSTONE CONTROL PTC™ Spinal System are equivalent to the following predicates:

CAPSTONE® Spinal System Primary Predicate - K151128, SE 8/5/2015 CAPSTONE® Spinal System Predicate #2 - K073291, SE 4/24/2008 CAPSTONE CONTROL™ Spinal System Predicate #3 - K120368, SE 4/9/2012 CAPSTONE PTCTM Spinal System Predicate #4 - K133205, SE 3/13/2014 DIVERGENCE-L™ Spinal System Predicate #5 - K150135, SE 6/11/2015 SOVEREIGN® Spinal System Predicate #6 - K122037, SE 3/22/2013

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.