Ellys and Aurys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.c. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Device Description

The Ellys components are kidney shaped and are used in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the space for home graft. The implant is always implanted in the vertical position. These components are available in various heights (8mm-150mm) to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The Aurys components are trapezoidal in cross sccion and are used singly. The interior of these components have three hollow compartments that run the vertically and are provided for the placement of bone grafi. I like the Aurys components are also available in various hcights (9mm-1.50mm) and have angled ends to match the angle of the vertebral endplates. The ends have ridges similar to the Ellys to interface with the vertebral endplates. There are also holes evenly spaced on the medial/lateral surfaces to complete bone graft impaction after insertion.

Both the l'llys and Aurys components are fabricated from pure poly(ether cther ketone) (PEIFA). This material closcly matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shickling clicci. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.

AI/ML Overview

The provided text describes a medical device, the Ellys and Aurys Vertebral Body Replacements, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria for performance, a study proving the device meets those criteria, or any specifics regarding device performance metrics, sample sizes, expert involvement, or ground truth establishment.

The document is a 510(k) premarket notification summary and the FDA's clearance letter. It focuses on:

Device Description: Physical characteristics, materials, and available sizes of the Ellys and Aurys components.
Intended Use/Indications for Use: The specific medical conditions and anatomical locations for which the device is intended.
Equivalent Device: Listing of similar previously cleared devices.
Nonclinical Tests: A brief mention that "Testing was performed per ASTM F1717." This indicates a standard was followed for mechanical testing, but no results or acceptance criteria are provided in this document.

Therefore, I cannot populate most of the requested table and answer the questions about the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

Here's an attempt to answer based on the limited information given, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biomechanical Testing	Adherence to ASTM F1717	Not specified in document
Material Properties	PEK material properties	Not specified in document
Radiological Confirmation	Visibility of metal wires	"Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively." (No quantitative criteria or performance data given)
Stability (in vivo)	Not specified in document	"These are not stand-alone devices, ISOBAR (6.2 Hemispherical Screws with Offset Clamps and 05.5 Rods must be utilized to enhance the stability of the reconstruction..." (Indicates dependency on other devices for stability, but no performance data)
Migration/Rotation	Resistance to rotation and migration	"The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration." (No quantitative criteria or performance data)

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified. The document only mentions "Testing was performed per ASTM F1717" without any details on sample size or specific test results.
Data Provenance: Not specified. Given the nature of a 510(k) summary for a physical device, testing would typically be in vitro (bench testing) or potentially ex vivo (using cadaveric spines), often conducted by the manufacturer or a contracted testing lab. There is no indication of clinical data or patient data in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document describes pre-market notification for a physical medical device, not an AI/software device that would require expert-established ground truth for performance evaluation in the context of image interpretation or similar tasks. Biomechanical testing per ASTM F1717 does not typically involve expert consensus for ground truth.

4. Adjudication method for the test set

Not applicable. This concept is relevant for studies involving human interpretation (e.g., medical imaging reviews) where discrepancies need resolution. For biomechanical testing, results are typically objective measurements.

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 is not an AI/software device. No MRMC study was performed or mentioned.

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

Not applicable. This is not an AI/software device. No algorithm standalone performance was done or mentioned.

7. The type of ground truth used

For the nonclinical (biomechanical) testing, the "ground truth" would be the objective measurements obtained according to the ASTM F1717 standard's protocols, compared against performance specifications derived from the standard or predicate devices. This is not the "expert consensus, pathology, or outcomes data" typically associated with AI/diagnostic device ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/software device. There is no mention of a training set.

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

Not applicable. This is not an AI/software device. There is no mention of a training set or its ground truth establishment.

Summary

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Date February 16, 2004

033109
Page 1 of 1

MAR 2 3 2004

Submitter

Scient x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name

Vertebral Body Replacement Device

Classification name

Vertebral Body Replacement Device per 21 CFR section 888.3060

Equivalent Device

The Ellys and Aurys VBR are similar in design, material fixation and indication and indications as the PENK Tertris® (Signus Medical, K031757), and Verte-Stack™ (Medtronic, K021791).

Device Description

The Aurys components are trapezoidal in cross sccion and are used singly. The interior of these components have three hollow compartments that run the vertically and are provided for the placement of bone grafi. I ike the Aurys components are also available in various hcights (9mm-1.50mm) and have angled ends to match the angle of the vertebral endplates. The ends have ridges similar to the Ellys to interface with the vertebral endplates. There are also holes evenly spaced on the medial/lateral surfaces to complete bone graft impaction after insertion.

Intended Use

Ellys and Aurys Vertebral Hody Replacements are vertebral body replacements for use in the lumbar and thorace spine (T1-I 5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR (16.2 Hemispherical Screws with Offset Clamps and 05.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Summary Nonclinical Tests

Testing was performed per ASTM F1717.

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Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight. The seal is black and white.

Public Health Service

MAR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scient'x, Inc. C/o Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K033109

Trade Name: Ellys and Aurys Vertebral Body Replacements Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: February 16, 2004 Received: February 23, 2004

Dear Mr. Webb:

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 elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. J.D. Webb

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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours,

Sincerely yours,

Mark N Milliman

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

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510(k) number (if known): K033109

Page 1 of 1

Device Name: Ellys and Aurys Vertebral Body Replacements

Indications for Use:

Ellys and Aurys_Vertebral Body Replacements Indications for Use Amended

(PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use

(Optional format 1-2-96) ________

ﻟﺴ

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

Division of General, Restorative, and Neurological Devices

510(k) Number K033109

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.