The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

Device Description

The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and superior surfaces to prevent back out and migration. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights accommodate variability among patients and is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the DISCOVERY cervical intervertebral body fusion device, focusing on its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Testing	Compliance with ASTM F2077 and ASTM F2267 standards	"The device functioned as intended and the performance results show that the DISCOVERY is substantially equivalent to the predicate device."
Material Composition	Manufactured from PEEK Optima® LT1 per ASTM F2026	Explicitly stated as manufactured from PEEK Optima® LT1 per ASTM F2026
Tantalum Markers	Inclusion of tantalum markers per ASTM F560	Explicitly stated as including tantalum markers per ASTM F560
Clinical Performance (Implicit)	Substantially equivalent to predicate device in safety, effectiveness, and intended use for anterior cervical interbody fusion.	"The safety and effectiveness is adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification."

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical mechanical testing per ASTM F2077 and F2267. These standards typically involve a specific number of test articles for each type of test (e.g., static compression, dynamic compression, torsion, subsidence, expulsion). However, the exact sample sizes (number of devices tested) for these mechanical tests are not explicitly stated in the provided summary.

Data Provenance: The data is generated from laboratory testing performed by the manufacturer, Intuitive Spine, LLC, to evaluate the physical and mechanical properties of the device. This is a prospective generation of data for the purpose of the 510(k) submission. There is no mention of country of origin for the data other than it being generated by the submitting company.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable: For mechanical testing against ASTM standards, the "ground truth" is defined by the performance requirements and test methodologies outlined in those ratified engineering standards. There is no mention or requirement for human experts (e.g., radiologists) to establish ground truth for this type of non-clinical, mechanical performance testing. The "experts" in this context would be the engineers and technicians performing and interpreting the tests according to the ASTM protocols.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods like "2+1" or "3+1" are relevant for tests involving human interpretation or subjective assessments, often in clinical studies or image-reading tasks. For objective mechanical testing against engineering standards, there is no human adjudication process described or typically needed beyond ensuring adherence to test protocols and data analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on mechanical testing and material compatibility, not clinical performance studies involving human readers or cases. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable: This device is a physical medical implant (a cervical interbody fusion device), not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The ground truth used for the mechanical testing is defined by engineering standards (ASTM F2077, F2267, F2026, F560). These standards specify the test methodologies, acceptance criteria (e.g., load-bearing capacity, fatigue life, material properties), and benchmarks that the device must meet or demonstrate equivalence to.

8. The Sample Size for the Training Set

Not Applicable: As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI algorithm development. The device itself is manufactured to specifications, and its performance is tested, not "trained."

9. How the Ground Truth for the Training Set Was Established

Not Applicable: Given the absence of a training set, this question is not relevant.

Summary of the Study Proving Acceptance Criteria:

The study that proves the DISCOVERY device meets its acceptance criteria is a series of non-clinical mechanical tests performed in accordance with established ASTM (American Society for Testing and Materials) standards. Specifically, the following tests were conducted:

ASTM F2077: Standard 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

These tests included:

Static Compression
Dynamic Compression
Static Torsion
Dynamic Torsion
Subsidence
Expulsion

Additionally, the material composition (PEEK Optima® LT1 per ASTM F2026) and the tantalum markers (per ASTM F560) were specified and presumably verified to meet those respective standards, forming part of the device's technical specifications and implicitly, its acceptance criteria.

The conclusion drawn from these tests was that "The device functioned as intended and the performance results show that the DISCOVERY is substantially equivalent to the predicate device." This statement indicates that the device met the mechanical and material performance benchmarks required for substantially equivalent claims to the LDR Spine Cervical Interbody Fusion System (K091088).

Summary

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KIII 484

page 1 of 2

510(k) Summary

SEP 1 2 2011

Summary of 510(k) Safety and Effectiveness

Submitted By:	Intuitive Spine, LLC16450-3 S. Tamiami Trail #112Fort Myers, Florida 33908
Date:	July 27, 2011
Contact Person:	Jennifer PalinchikDevelopment and Regulatory Consultant
Contact Telephone:	(440) 933-8850
Device Trade Name:	DISCOVERY
Device Classification Name:	Intervertebral Body Fusion Device with Bone Graft,
Cervical Device Classification:	Class II
Reviewing Panel:	Orthopedic
Regulation Number:	888.3080
Product Code:	ODP
Predicate Device:	LDR Spine Cervical Interbody Fusion System (K091088)

Device Description:

Indications for Use:

Substantial Equivalence Information:

The design features, material, and indications for use of the DISCOVERY device are substantially equivalent to the predicate device listed above. The safety and effectiveness is

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adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.

Summary of Non-Clinical Test:

The following mechanical testing was performed per ASTM F2077 and F2267 to demonstrate substantial equivalence of the subject device to the predicate device: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the DISCOVER Y is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

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

Intuitive Spine, LLC % Thogus Products Company / RP+M Ms. Jennifer Palinchik 33490 Pin Oak Parkway Avon Lake, Ohio 44012

SEP 1 2 2011

Re: K111484

Trade/Device Name: DISCOVERY Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 27, 2011 Received: September 27, 2011

Dear Ms. Palinchik:

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 ffor 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

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Page 2 - Ms. Jennifer Palinchik

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 evenis) (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 go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.

Erie O. Keith

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

Enclosure

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Indications for Use

K111484 510(k) Number (if known):

Device Name: DISCOVERY

Indications for Use:

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)

(Division Sign-Off) Difision of Surgical, Orthopedic, and Restorative Devices

510(k) Number_KIII 1484

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.