SABLE™ Expandable Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.

Device Description

The SABLE™ Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

SABLE™ Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "SABLE™ Expandable Spacer," which is an intervertebral body fusion device.

It's crucial to understand that this document describes the regulatory clearance process for a physical medical device (an implantable spacer), not an AI/software-based medical device.

Therefore, the information requested in your prompt (acceptance criteria for an AI/software device, sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, etc.) is not applicable to this document.

The document discusses mechanical testing and bacterial endotoxin testing to demonstrate substantial equivalence to predicate devices, which are standard procedures for physical implants. It does not involve any AI algorithms, image analysis, or diagnostic performance evaluation that would necessitate the metrics you've asked for.

Here's a breakdown of why your questions cannot be answered by this document:

No AI/Software Component: The SABLE™ Expandable Spacer is a physical implant. There's no AI or software involved in its function or regulatory clearance as described.
Performance Data for a Physical Device: The "Performance Data" section specifically mentions mechanical testing (static and dynamic compression, compression-shear, subsidence) per ASTM standards and bacterial endotoxin testing. These are physical product tests, not software performance evaluations.
Ground Truth: For a physical device, "ground truth" relates to material properties, strength, biocompatibility, etc., not to diagnostic accuracy against expert consensus or pathology, as would be the case for AI.
Sample Size for Test/Training Sets (AI): These concepts are irrelevant as there is no AI model to train or test.
Experts for Ground Truth/Adjudication (AI): No human experts are used to establish ground truth for a physical implant's performance in the way they would for medical image analysis AI.
MRMC Study/Standalone Performance (AI): These are methodologies for evaluating AI diagnostic performance and are not applicable to an implantable device.

In summary, the provided document describes a different type of medical device and regulatory process than what your questions anticipate.

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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

January 14, 2020

Globus Medical Inc. Kelly Baker, PhD Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K192115

Trade/Device Name: SABLE™ Expandable Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 13, 2019 Received: December 16, 2019

Dear Dr. Baker:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192115

Device Name SABLE™ Expandable Spacer

Indications for Use (Describe)

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: SABLE™ Expandable Spacer

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Kelly Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	August 5, 2019
Device Name:	SABLE™ Expandable Spacer
Common Name:	Intervertebral Body Fusion Device
Classification:	Per 21 CFR as follows:§888.3080 Intervertebral Body Fusion DeviceProduct Code(s): MAXRegulatory Class: II, Panel Code: 87
Primary Predicate:	RISE® Spacer (K113447)

Additional

Predicates:	ALTERA® Spacer (K140411)
	SUSTAIN® Spacers (K181357)
	NeoFuse Ti3D Interbody (K170318)

Purpose:

The purpose of this submission is to request clearance for the SABLE™ Expandable Spacer.

Device Description:

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Indications for Use:

SABLE™ Expandable Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.

Performance Data:

Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Technological Characteristics:

Subject implants have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes.

Basis of Substantial Equivalence:

Subject interbody spacers have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacers to the predicate 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.