The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

Device Description

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Apollo Spine Eclipse Vertebral Spacer-Cervical, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical testing and does not involve a study related to AI or a device that uses algorithms/software for performance evaluation.

Therefore, many of the requested points regarding AI/algorithm performance and clinical study design are not applicable to this submission.

Here's an analysis of the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the Eclipse Vertebral Spacer-Cervical, as presented in this 510(k) submission, are based on demonstrating mechanical equivalence to legally marketed predicate devices by conforming to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices.

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

Test Performed	Acceptance Criteria (based on ASTM Standards)	Reported Device Performance
Axial Compression Static	Adherence to ASTM F 2077 (Standard Test Method for Intervertebral Body Fusion Devices)	"ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." (Specific quantitative performance data is not provided in this summary.)
Axial Compression Dynamic	Adherence to ASTM F 2077	"ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use."
Compression-Shear Static	Adherence to ASTM F 2077	"ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use."
Compression-Shear Dynamic	Adherence to ASTM F 2077	"ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use."
Torsion Static	Adherence to ASTM F 2077	"ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use."
Torsion Dynamic	Adherence to ASTM F 2077	"ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use."
Subsidence	Adherence to ASTM F 2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices)	"ASTM Standards...F2667...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use."
Expulsion	Adherence to ASTM Draft F04.25.02.02 (Draft Standard for Expulsion Testing)	"ASTM Standards...and Draft F04.25.02.02 (Expulsion Testing) were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use."

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

This document summarizes mechanical testing, not a clinical study involving human patients. Therefore, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not applicable in their traditional sense for clinical data. The "samples" would refer to the Eclipse Vertebral Spacer devices manufactured for testing. The summary does not specify the number of devices tested for each mechanical test. The testing was performed in the context of a premarket notification in the USA.

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. The "ground truth" for mechanical testing is established by the specified ASTM standards and the measurements obtained during testing in a laboratory setting by qualified engineers/technicians, not by medical experts forming a consensus.

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

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if there's a disagreement) are relevant for clinical studies involving reader interpretations, not for mechanical bench testing.

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 device is a passive implant (intervertebral spacer) and does not involve AI or software for interpretation, nor a human-in-the-loop scenario. The submission is for a physical medical device.

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

Not applicable. As noted above, this device does not incorporate an algorithm or AI component.

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

For the mechanical testing, the "ground truth" is defined by the objective performance requirements outlined in the referenced ASTM standards (e.g., maximum load, cycles to failure, displacement limits). The device's performance is measured against these engineering specifications, and against publicly available data for predicate devices.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set or AI model involved.

Summary

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Apollo Spine Premarket Notification 510(k) Eclipse Vertebral Spacer June 4, 2010

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JAN - 7 2011

Submitter Information

Submitter's Name:	Apollo Spine
Address:	3700 Campus Dr. Suite 105Newport Beach, CA 92660
Telephone:	949-645-1615
Fax:	949-757-0460
Contact Person:	Christine Santagate, STD Medical
Telephone :	781-828-4400
Fax :	781-344-5895
Date Prepared:	June 4, 2010
Device Trade Name:	Eclipse Vertebral Spacer-Cervical
Common/Usual Name:	Intervertebral body fusion device
Classification:	21 CFR §888.3080
Class:	II
Product Code(s):	ODP

Predicate Device(s):

Eate Device(s).
BAK/Cervical (BAK/C®), P980048, Zimmer Spine, Approved 4/20/01 ●
LDR Spine Cervical Interbody Fusion System, ROI-C, Approved 4/15/09 .
SpineCraft ORIO-C Intervertebral Body Fusion Cervical Cage, Approved . 10/30/09

Substantial Equivalence:

The Eclipse Vertebral Spacer-Cervical was shown to be substantially equivalent to The Lonpo Vertobial Space. Sen the same indications for use, design, function, and materials used.

. ・

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101588
Page 2 of 2

Apollo Spine . Premarket Notification 510(k) Eclipse Vertebral Spacer June 4, 2010

JAN - 7 2011

Device Description:

Indications:

When used as an Intervertebral Body Fusion System:

Mechanical Test Data:

The following testing was performed on this device:

Axial Compression Static & Dynamic per ASTM F 2077 .
Compression-Shear Static & Dynamic per ASTM F 2077 .
Torsion Static & Dynamic per ASTM F 2077 .
Subsidence per ASTM F 2267 ●
Expulsion per ASTM Draft F04.25.02.02 ●

Conclusion:

ASTM Standards F2077, F2667 and Draft F04.25.02.02 (Expulsion Testing) were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three heads, depicted in a flowing, abstract manner.

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

Apollo Spine % STD Medical, Inc. Ms. Christine Santagate 3700 Campus Drive, Suite 105 Newport Beach, CA 92660

SEP 12 2311

Re: K101588

Trade/Device Name: Eclipse Vertebral Spacer System-Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 20, 2010 Received: December 29, 2010

Dear Ms. Santagate:

This letter corrects our substantially equivalent letter of January 7, 2011.

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 (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.

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

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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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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,
Mark A Milheim

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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Apollo Spine Premarket Notification 510(k) Eclipse Vertebral Spacer - Cervical June 4, 2010

Page 1//

JAN - 7 2911

Indications for Use Statement

510(k) Number (if known):

101588

Device Name: Eclipse Vertebral Spacer System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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) Division of Surgical, Orthopedic, and Restorative Devices

KIO1588 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.