The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant 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.

Device Description

The Expandable PEEK VBR Implant is an expandable device constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LTI) as described by ASTM F-2026. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The Expandable PEEK VBR Implant is inserted between vertebral bodies in the posterior thoracolumbar spine from T1 to LS. Following insertion into the surgical site, the implant may be left undistracted or may be expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

AI/ML Overview

This document is a 510(k) Summary for the Expandable PEEK VBR Implant, submitted to the FDA in 2004. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving that the device meets specific performance criteria through clinical data.

Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML medical devices, is not present in this type of submission for a traditional implantable medical device.

However, I can extract the information that is available and indicate where the requested details are not provided.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not provide a table of acceptance criteria with corresponding device performance metrics in the way you'd expect for an AI/ML device (e.g., sensitivity, specificity, accuracy thresholds). For implantable devices like the Expandable PEEK VBR, "acceptance criteria" are generally met through:

Substantial Equivalence to Predicate Devices: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by comparing:
- Indications for Use: Must be the same.
- Technological Characteristics: Must be the same or substantially similar. If different, the differences must not raise new questions of safety and effectiveness.
- Performance Data: Often includes bench testing (biomechanical), material testing, and sometimes animal studies, but rarely human clinical trials for a 510(k) orthopedic device unless significant new questions of safety/effectiveness arise.

The text states: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Expandable PEEK VBR Implant is considered substantially equivalent to the legally marketed predicate devices."

Therefore, the tacit acceptance criteria are that the device performs equivalently to its predicates in terms of:

Acceptance Criterion (Implicit)	Reported Device Performance
Material Composition (Safety/Biocompatibility)	Constructed of Polyetheretherketone (PEEK OPTIMA™ LTI) as described by ASTM F-2026. Tantalum markers used are made to ASTM F-560. (Implicitly, these materials are known to be safe and biocompatible, meeting predicate device standards).
Biomechanical Integrity/Performance (Effectiveness)	"Equivalent biomechanical performance" to predicate devices. (Specific quantitative results are not provided in this summary, but would have been presented in bench testing data within the full 510(k) submission). "Designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column."
Indications for Use (Scope of treatment)	Same indications for use as predicate devices: replacing diseased vertebral bodies for tumor treatment, restoring height, and treating thoracic/lumbar spine fractures.
Device Functionality (Expansion, maintenance of height)	"Expandable device... expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height." (Implicitly functions acceptably compared to predicate).
Radiolucency (Visualization) (Post-op assessment)	"The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth." (Implicitly, this is an acceptable or advantageous characteristic compared to predicate).

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

Sample Size for Test Set: Not applicable/not provided for a traditional biomechanical equivalence study. The "test set" would typically refer to the samples used in bench testing. The 510(k) summary only states "equivalent biomechanical performance," which implies testing was done, but does not provide details on sample sizes of implanted devices/materials, nor "data provenance" (country of origin, retrospective/prospective) as these are not clinical trial results.
Data Provenance: Not applicable/not provided. Biomechanical testing is usually performed in a lab setting, not using patient data in the sense of AI/ML device validation.

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

Number of Experts: Not applicable. For an implantable device's biomechanical testing, "ground truth" is established through engineering principles, material science, and established ASTM standards, not typically by expert consensus of clinical cases.
Qualifications of Experts: If any experts were involved in test design or review, they would typically be biomechanical engineers, material scientists, or orthopedic surgeons, but their number and specific qualifications are not detailed in this summary.

4. Adjudication method for the test set

Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in human expert labeling/diagnosis in AI/ML studies. For a medical implant, "adjudication" would refer to reviewing and interpreting test results against predetermined engineering specifications, not expert consensus on medical cases.

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

MRMC Comparative Effectiveness Study: No, this type of study was not done. MRMC studies are specific to evaluating diagnostic imaging devices or AI-assisted diagnostic tools and measuring their impact on human reader performance. The Expandable PEEK VBR Implant is an orthopedic implant, not a diagnostic or AI device.
Effect Size of AI Improvement: Not applicable, as no AI component is involved.

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

Standalone Performance Study: No, this refers to algorithm-only performance for AI/ML devices. The Expandable PEEK VBR is an implantable medical device and does not have an algorithm.

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

Type of Ground Truth: The "ground truth" for demonstrating substantial equivalence for this device primarily relies on:
- Material Standards: Adherence to ASTM F-2026 (for PEEK) and ASTM F-560 (for tantalum).
- Biomechanical Test Standards/Engineering Principles: Testing according to relevant standards (though not specified in the summary) to demonstrate "equivalent biomechanical performance" to predicate devices.
- Established Clinical Practice: The indications for use are established treatments for spinal conditions.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of medical device.

In summary, this 510(k) submission is for a traditional, non-digital, implantable medical device. Its "acceptance criteria" and "study" for marketing clearance are centered around demonstrating substantial equivalence to an existing predicate device through comparisons of indications for use, technological characteristics, material compliance, and biomechanical performance (typically verified through bench testing). The concepts of test sets, training sets, ground truth by experts, MRMC studies, and standalone algorithm performance are not relevant to this type of device and submission.

Summary

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K04-09128

AUG 2 7 2004

510(k) SUMMARY

SUBMITTED BY

Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:	Vertebral Body Replacement Device
Common/Usual Name:	Vertebral Body Replacement Device
Product Classification:	Class II
Proprietary Name:	Expandable PEEK VBR Implant

PREDICATE DEVICE

Predicate device information is included in this premarket notification.

INDICATIONS-FOR-USE

The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant 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.

DEVICE DESCRIPTION

COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Expandable PEEK VBR Implant is considered substantially equivalent to the legally marketed predicate devices.

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Image /page/1/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 an abstract symbol resembling an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 2004

Wendy Spielberger, RAC Lead, Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618

Re: K040928

Trade/Device Name: Expandable PEEK VBR Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 13, 2004 Received: August 16, 2004

Dear Ms. Spielberger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regard) the enactment date of the Medical Device Amendments, or to commence pror to may 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been routes and in assee approval of a premarket approval application (PMA). alle Costience Act (71ct) that to nov requent to the general controls provisions of the Act. The I ou may, merceive, manel the Act include requirements for annual registration, listing of general connologic provisions 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 If your device is classified (600 a00 10) als. Existing major regulations affecting your device can Inay be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I teast of advised that I DTT blisdains of our device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must of any I cuchares und regulations and winned to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, lacemig (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Wendy Spielberger, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premits touritication: The Prix manigstification 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 If you desire specific advice for your ac 1100 594-4692. Also, please note the regulation entitled, colliati the Office of Comphalled as (50 t notification" (21CFR Part 807.97). You may obtain Misblanding of Crefeired to premainters in the Act from the Division of Small other general information on your responsible in total free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the success in brokey Manufacturers, micrnational and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Indications for Use

K040928 510(k) Number (if known):

Expandable PEEK VBR Device Name:

Indications-For-Use:

The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 I TIC Expandable I EER VDR anspiral body resected or excised for the treatment of tumors in to LD replace a anseason version of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also inclicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK multiated for treating tractares of as a biomechanical integrity of the anterior, middle and v DIC implain is absence of the absence of fusion for a prolonged period.

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 Evaluation (ODE)

__ and__, signature, Mark N. Millman

(Division Sign- Iff Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(K) Number K040928

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.