FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to turnor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.

Device Description

The Spine Next FIDJI Vetebral Body Replacement Type 5 devices are hollow blocks that are machined from extruded Polyetheretherketone (PEEK); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Spine Next FIDJI Vertebral Body Replacement Type 5. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with specific acceptance criteria as you might see for a PMA (Premarket Approval) application for a novel device.

Therefore, the information you're asking for regarding acceptance criteria, specific study details (sample sizes, experts, adjudication methods, MRMC studies, standalone performance), and ground truth establishment, is generally not applicable to a 510(k) submission like this one. 510(k)s focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing that shows the new device performs similarly within established standards, rather than generating new clinical data against specific performance targets.

However, I can extract the relevant information from the provided text that aligns with what is typically done for a 510(k) in terms of "comparison to predicate" which serves as the "proof" of meeting the implicit acceptance criteria of substantial equivalence.

Acceptance Criteria and Device Performance (Implicit through Predicate Comparison)

For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a legally marketed predicate device. This is primarily done by showing similar technical characteristics, indications for use, and performance. When comparing to a predicate, the "performance" often refers to engineering and bench testing rather than clinical study outcomes.

Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate)	Reported Device Performance (FIDJI vs. Predicate)
Similar Indications for Use	Met: Both Spine Next FIDJI and predicate devices are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed or unstable vertebral body due to tumor or trauma. The FIDJI's indications are consistent with the predicate.
Similar Materials of Construction	Met: Both the Spine Next FIDJI and the predicate devices (Vertebral Spacer and Vertestack) are fabricated from PEEK Optima LT.
Similar Principle of Operation and Function	Met: Both are vertebral body replacements, hollow blocks with tapered and angled surfaces. They are "virtually identical in their function and principle of operation."
Similar Load Bearing Capacity	Met: Both devices are load-bearing, intended for use under load conditions. The submission states, "All devices meet mechanical performance requirements." Specific mechanical test data would typically be in the full submission, but this summary indicates compliance.
Similar Biocompatibility	Met: Both are reported as biocompatible.
Availability in Various Sizes	Met: Both are provided in various sizes.
Sterile Presentation	Met: Both are sold sterile.
Similar Use/Handling	Met: While "subtle design differences will require minor adjustments to procedure by the implanting surgeon," the overall use and handling are considered similar.

Study Details Not Applicable to This 510(k) Submission

As this is a 510(k) submission, the device did not undergo a clinical study in the traditional sense that would generate new clinical performance data. Instead, it demonstrated equivalence to existing predicate devices based on design, materials, and mechanical performance testing (implied by "All devices meet mechanical performance requirements"). Therefore, the following information is not provided or required for this type of submission:

Sample size used for the test set and the data provenance: Not applicable for a 510(k) unless specific clinical data was used to demonstrate equivalence (which is not indicated here). The "test set" would primarily refer to engineering bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical ground truth establishment is not typically part of a 510(k) for this type of implant.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not indicated and generally not a requirement for an orthopedic implant 510(k).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for an orthopedic implant. Ground truth for performance would come from validated mechanical testing methodologies against industry standards or predicate device performance.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the "study" demonstrating the device meets "acceptance criteria" for a 510(k) is the comparison to predicate devices, primarily focusing on technical characteristics, materials, and functional equivalence, often backed by bench testing to ensure mechanical performance is comparable. The FDA's decision to clear the device (K042713) signifies their acceptance that this comparison adequately demonstrates substantial equivalence to legally marketed predicate devices.

Summary

{0}------------------------------------------------

DEC 2 9 2004

KO42713

510(k) SUMMARY

SUBMITTED BY

Tom Brewer Spine Next America 8381 Dix Ellis Trail Suite 110 Jacksonville, Fl. 32256

September 27, 2004 Date Submitted:

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:	Vertebral Body Replacement Device
Common/Usual Name:	Vertebral Body Replacement
Product Classification:	Class II
Proprietary Name:	Spine Next FIDJI Vertebral Body Replacement Type

PREDICATE DEVICE

Vertebral Spacer manufactured by Synthes [reference 510(k) K011037, cleared July 1, 20021

Vertestack manufactured by Medtronic Sofamor Danek [reference 510(k) K031780, cleared July 30, 2003]

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION

INDICATIONS FOR USE

The FIDJI vertebral body replacement type 5 device is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body

{1}------------------------------------------------

due to tumor or trauma (i.e., fracture). The vertebral body replacement can be used with Spine Next supplemental internal fixation systems, e.g., the SHIRAZ and SHIRAZ JAVA systems. The interior of the device can be packed with bone.

PRODUCT	FIDJI	Vertebral spacer/Vertestack
Materials of Construction	PEEK Optima LT	PEEK Optima LT
Load Bearing	Yes	Yes
Sold sterile	Yes	Yes
Biocompatible	Yes	Yes
Same Indications	Yes	Yes
Similar Use/Handling	Yes	Yes
Provided in various sizes	Yes	Yes

COMPARISON TO THE PREDICATE DEVICE

Comparison of Technical Characteristics with the Predicate Device

Both the Spine Next Vertebral Body Replacement type 5 and the predicate devices are used as Spinal vertebral body replacements.
Technologically they are virtually identical in their function and principle of operation, although subtle design differences will require minor adjustments to procedure by the implanting surgeon for proper product use. Both devices are similar in that they are intended for use under load conditions.
Both the Spine Next Vertebral Body Replacement type 5 and the predicated devices are fabricated from PEEK Optima LT
All devices meet mechanical performance requirements.
All devices have similar indications-for-use.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 symbol of three overlapping shapes that resemble birds in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2004

Ms. Lisa Peterson Regulatory Affairs Manager Spinal Concepts, Inc. 5301 Riata Park Court, Building. F Austin, Texas 78727

Re: K042713

Trade/Device Name: FIDJI Vertebral Body Replacement Type 5 Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 3, 2004 Received: December 6, 2004

Dear Ms. Peterson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.

{3}------------------------------------------------

Page 2 – Mr. Justin Eggleton

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K042713

Device Name:

Spinal Concepts, Inc. FIDJI Vertebral Body Replacement Type 5

Indications for Use:

Prescription Use X (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 Hyaluation (ODE)

(Division Sign-O0)
Division of General, Restorative,
and Neurological Devices

510(k) Number_ K042713

Page 1 of 1

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.