The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

Device Description

The StaXx® XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the implant. The device is offered in sizes ranging from 7mm to 30mm.

AI/ML Overview

This document describes the StaXx® XD System, a vertebral body replacement device. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert qualifications, and human-in-the-loop performance are not available in the provided document.

However, I can extract and infer some information based on the typical 510(k) pathway for devices like this.

Here’s a breakdown based on the provided text and general knowledge of 510(k) clearances:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in the provided document. For 510(k) devices, the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device. This is typically achieved through comparative evaluation of technological characteristics, materials, and mechanical testing results.
Reported Device Performance: The document states: "In addition, mechanical testing demonstrated that the StaXx® XD System is equivalent to its predicate device. The minor differences between the StaXx® XD System and the predicate device do not raise any new questions of safety or effectiveness." This statement serves as the reported performance relative to the predicate.

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (from document)
Mechanical Equivalence: StaXx® XD System demonstrates comparable mechanical properties and safety profiles to the predicate device, StaXx® XD System (K052670).	"mechanical testing demonstrated that the StaXx® XD System is equivalent to its predicate device."
Technological Equivalence: Minor differences do not raise new questions of safety or effectiveness.	"The minor differences... do not raise any new questions of safety or effectiveness."
Intended Use Equivalence: Same indications for use as the predicate device.	The intended use description is consistent with typical vertebral body replacement devices.
Material Equivalence: Materials are biocompatible and safe (implied by predicate equivalence).	Composed of PEEK-OPTIMA with 6% Barium Sulfate (material of the implant components is specified).

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

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no mention of a clinical "test set" in the sense of patient data used to evaluate AI performance. The equivalence was based on mechanical testing and comparison of device characteristics.
Data Provenance: Not applicable. The "data" referenced is mechanical testing data, not patient data from a specific country or collected retrospectively/prospectively.

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. As there was no clinical test set for AI performance, there were no experts establishing ground truth in this context.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable.

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 Study: No. This is a medical device (spinal implant), not an AI diagnostic/imaging device that would typically involve human readers.

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

Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: For the mechanical testing, the "ground truth" would be the established engineering standards, material properties, and performance benchmarks of the predicate device.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI model that requires a training set.

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

Ground Truth Establishment for Training Set: Not applicable.

Summary

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K090315
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SFP - 8 2009

510(k) Summary StaXx® XD System

Submitter Information

Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 203-712-1839 Telephone: 203-944-9493 Telefax:

Contact: Date Prepared: Roaida Rizkallah August 26, 2009

Device Information

Trade name: Common name: Classification: Product Code:

StaXx® XD System Vertebral Body Replacement Class II per 21 CFR 888.3070 Classification Name: Spinal Intervertebral Body Fixation Orthosis MQP

Device Description

Intended Use

Three Enterprise Drive • Suite 210 • Shelton, CT 06484 • Tcl: 203-944-9494 • Fax: 203-944-9493 • www.spinewave.com

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Substantial equivalence

The StaXx® XD System described in this submission is substantially equivalent to the following device:

Status Market Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company CompanyPredicate Device	of the Lammer a second a super-Manufacturer	510(k) No.
StaXx® XD System	Spine Wave, Inc.	K052670

In addition, mechanical testing demonstrated that the StaXx® XD System is equivalent to its predicate device. The minor differences between the StaXx® XD System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the StaXx® XD System is substantially equivalent to its predicate device.

ﻣﺴﻤﺴ ﻣ

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Spine Wave, Inc. % Ms. Roaida Rizkallah Senior Regulatory Affairs Specialist 2 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

SEP - 3 2009

Re: K090315

Trade/Device Name: StaXx® XD System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 26, 2009 Received: August 31, 2009

Dear Ms. Rizkallah:

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 aboye) 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 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 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.

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Page 2 - Ms. Roaida Rizkallah

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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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K090315 510(k) Number (if known): ___

StaXx® XD System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kareem S. Boney for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K090315

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.