The Fidji Small Cement Restrictor is intended for use in conjunction with standard PMMA cement and is designed to occlude the medullary canal during the introduction of the cement during surgeries such as arthroplasty. It is also designed to prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

Device Description

The Fidji Small Cement Restrictor is a hollow, trapezoidal block that is machined from cxtruded Polyetherctherketone (PEEK), which complies with ASTM F202. It contains a titanium alloy, removable anchor that is designed to aid in maintaining its position within the medullary space of the femur or humerus. It also contains tantalum inserts that serve as location and orientation markers for radiographs.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Spine Next Fidji Small Cement Restrictor), which compares it to a predicate device to demonstrate substantial equivalence. These submissions typically do not contain detailed information about acceptance criteria, clinical trials, or performance metrics in the way that PMA (Pre-Market Approval) applications or studies for AI/software devices do.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.

Here's a breakdown of what can be extracted and what is explicitly not present:

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

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for a 510(k) is typically "substantial equivalence" to a predicate device in terms of design, materials, indications for use, and performance characteristics.
Reported Device Performance:
- Functional Design: "virtually identical in their function and principle of operation" to the predicate.
- Material: Made from Polyetheretherketone (PEEK) matching ASTM F202, identical to the predicate device's material.
- Mechanical Compression Characteristics: "similar mechanical compression characteristics since their material of construction is identical."
- Safety: Stated as "similar" to the predicate device.
- Indications for Use: Identical to the predicate, with a specific warning against spinal use.

Acceptance Criteria Category	Reported Device Performance (vs. Predicate)
Functional Design	Virtually identical function and principle of operation
Material of Construction	Identical (PEEK, ASTM F202)
Mechanical Compression	Similar (due to identical material)
Safety	Similar
Indications for Use	Identical (occlude medullary canal, prevent cement flow, facilitate pressurization, not for spinal 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 information is not provided in the document. 510(k) submissions for devices like this typically rely on engineering comparisons, material testing, and similarity to an existing device rather than large-scale clinical test sets or data provenance studies.

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)

This information is not provided. As explained above, this type of expert review is not typically part of a 510(k) for this kind of device.

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

This information is not provided.

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

This information is not provided. This device is a physical implant, not an AI or software device. Therefore, MRMC studies are not applicable.

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

This information is not provided. This device is a physical implant, not an algorithm. Therefore, standalone algorithm performance is not applicable.

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

For physical devices in a 510(k), the "ground truth" is typically established through:
- Material specifications: Conformance to ASTM standards (e.g., ASTM F202 for PEEK).
- Engineering design comparisons: Demonstrating similarity in shape, dimensions, and mechanism.
- Mechanical testing: To confirm similar characteristics (like compression) to the predicate.
- Existing clinical history of the predicate device: Assuming the predicate device's safety and effectiveness for its intended use is well-established.

8. The sample size for the training set

This information is not provided. Training sets are relevant for AI/machine learning models, not for physical medical implants of this nature.

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

This information is not provided. Not applicable to this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a 510(k) premarket notification which aims to demonstrate substantial equivalence to a legally marketed predicate device (Medtronic Sofamor Danek Cement Restrictor (K013663)). The proof relies on a comparative analysis rather than a traditional clinical trial or performance study with acceptance criteria in the typical sense.

The core of the "proof" is based on:

Comparison of Indications for Use: Both devices are for occluding the medullary canal, preventing cement flow, and facilitating cement pressurization during arthroplasty, and neither is for spinal indications.
Comparison of Functional Design and Principle of Operation: Stated as "virtually identical."
Comparison of Materials of Construction: Both use PEEK and comply with ASTM F202.
Comparison of Mechanical Characteristics: Stated as "similar mechanical compression characteristics" due to identical materials.
Claim of Similar Safety and Effectiveness: Based on the above similarities and the predicate's established history.

Crucially, the FDA's acceptance of the 510(k) filing (via the letter of substantial equivalence) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance, which is substantial equivalence to the predicate. The letter affirms this based on the information provided in the submission, with the added condition of including a specific warning about spinal use.

Summary

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

DEC 2 2 2003

510(k) SUMMARY

SUBMITTED BY

Diane Johnson Spine Next America 4720 Salisbury Road Suite 135 Jacksonville, FL 32256

March 7, 2003 Date Submitted:

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:	Prosthesis, Hip, Cement Restrictor
Common/Usual Name:	Cement Restrictor
Product Classification:	Class II
Proprietary Name:	Fidji Small Cement Restrictor

PREDICATE DEVICE

Cement Restrictor (CR) manufactured by Medtronic Sofamor Danek USA, Inc. [reference 510(k) K013663 cleared December 5, 2001]

This summary of 510(k) safcty 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

This device is intended for use in conjunction with standard PMMA cement. The Fidji Small Cement Restrictor is designed to occlude the medullary canal before the introduction of PMMA cement during surgeries such as arthroplasty. It is also designed to prevent cement from flowing down the diaphysis thereby facilitating cement pressurization.

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

THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

COMPARISON TO THE PREDICATE DEVICE

In general, both the Spine Next Fidji Small Cement Restrictor and its predicate device, the Medtronic Sofamor Danek Ccment Restrictor, are devices that are used as for occlusion of the medullary canal before the introduction of PMMA cement during surgeries such as total hip arthroplasty, as well as for the prevention of cement from flowing down the diaphysis thereby facilitating cement pressurization. Neither of theses devices is intended for use in spinal indications. Technologically they are virtually identical in their function and principle of operation.

Both devices are similar in that they are not intended for use under load conditions. They both serve as a cement restrictor in the medullary canal with similar surgical techniques for implantation. Both devices have similar mechanical compression characteristics since their material of construction is identical.

The Spine Next Fidji Small Cement Restrictor Device is substantially Conclusion: equivalent to the Medtronic Sofamor Danek Cement Restrictor (K013663) based upon the devices' similarities in functional design, performance, safety, and indications-for use.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2003

Ms. Diane Johnson Director, Regulatory Affairs Spine Next America Corporation 104 Greenwood Creek Road Queenstown, Maryland 21658

Re: CK03076 Dand K030871

FIDJI Small Cement Restrictor and FIDJI Large Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: November 3, 2003 Received: November 4, 2003

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 provisious of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm.

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

Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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.

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

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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

Page 3 - Ms. Diane Johnson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosures (2)

{5}------------------------------------------------

510(k) Number (if known):

Device Name: Spine Next® Fidji® Small Cement Restrictor

Indications for Use:

THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Miller

vision Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030767

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use

Optional Format 1-2-96

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.