The Crosstrees® Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae® Bone Cement when delivered by the Crosstrees CDrive® Bone Filler Delivery System.

Device Description

The Crosstrees® PVA Pod device is designed to deliver bone cement to the fractured vertebral body in a controlled manner without the need for an additional permanent implant other than the bone cement. The device consists of a shaft assembly for delivery of PMMA cement to a fabric barrier. Following cement delivery, the fabric barrier is opened and withdrawn from the vertebral body. The Crosstrees® PVA Pod device is made from a variety of materials commonly used in orthopedic and radiological procedures including stainless steel and polymers. The device is available in either a 2.0 mL or 3.0 mL fill capacity. The device is provided with a number of class I tools that are used for surgical access and delivery of the Pod to the surgical site, as well as preparation and delivery of bone cement.

AI/ML Overview

The provided text describes a 510(k) summary for the Crosstrees® PVA Pod Device, which is a medical device and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device, as required for medical device clearance by the FDA. As such, the information you're looking for regarding acceptance criteria and study designs for AI/ML powered device performance (e.g., sample sizes for training/test sets, expert consensus for ground truth, MRMC studies, standalone performance) is not applicable to this type of medical device submission.

The "Performance Data" section explicitly states: "The Crosstrees® PVA Pod has the same sterilization process, same packaging, and is comprised of the same materials of construction as the predicate device. Device modifications have been assessed through Crosstrees design control process and the data generated demonstrates that the Crosstrees® PVA Pod device meets all performance characteristics and design specifications, thus supporting substantial equivalence to the predicate device. In all instances, the Crosstrees® PVA Pod device functioned as intended."

This indicates that the performance data for this device would relate to engineering specifications, material compatibility, sterilization validation, and functional testing to ensure it performs its intended physical function (delivering bone cement) safely and effectively, rather than validating an algorithm's diagnostic or predictive accuracy.

Therefore, I cannot provide the specific information requested in your numbered points as they pertain to AI/ML device validation, which is not relevant to this 510(k) submission.

However, I can provide a summary of the acceptance criteria and the study (or rather, "assessment" or "testing" in this context) that proves the device meets those criteria, based on the provided document:

Acceptance Criteria and Device Performance (for a Medical Device, not AI/ML)

The acceptance criteria for the Crosstrees® PVA Pod Device, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to its predicate device (Crosstrees® PVA Pod, K130089). This means proving that the minor modifications to the new device do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on Substantial Equivalence to Predicate)	Reported Device Performance (as stated in submission)
Intended Use Equivalence: Same intended use as predicate.	Met: "The Crosstrees® PVA Pod has the same intended use, indications for use..."
Indications for Use Equivalence: Same indications for use as predicate.	Met: "...and indications for use..."
Principles of Operation Equivalence: Same principles of operation as predicate.	Met: "...and principles of operation..."
Similar Technological Characteristics: Very similar technological characteristics to predicate.	Met: "...as well as very similar technological characteristics as its predicate device."
No New Safety/Effectiveness Issues: Minor technological differences (change in pod fabric dimensional specification, removal of yarn texturing process) raise no new issues.	Met: "The minor technological differences... raise no new issues of safety or effectiveness questions."
Meets Performance Characteristics & Design Specifications: Device functions as intended within design specifications after modifications.	Met: "Risk assessment of the modification and design verification testing, performed to support design control activities, demonstrates that the Crosstrees® PVA Pod performs as intended and is as safe and effective as the previously cleared device." "Testing conducted to support design control activities confirms that the product performs as intended." "In all instances, the Crosstrees® PVA Pod device functioned as intended."
Same Sterilization Process:	Met: "The Crosstrees® PVA Pod has the same sterilization process..."
Same Packaging:	Met: "...same packaging..."
Same Materials of Construction:	Met: "...and is comprised of the same materials of construction as the predicate device."

2. Sample Size for Test Set and Data Provenance:
This information is not applicable in the context of this medical device submission. The "testing" referred to is likely engineering verification and validation testing (e.g., mechanical strength, material compatibility, sterilization efficacy, dimensional checks) rather than a clinical "test set" involving patient data. The document does not specify sample sizes for such engineering tests or data provenance beyond stating that "design verification testing" was performed.

3. Number of Experts used for Ground Truth & Qualifications:
This information is not applicable. Ground truth in this context would refer to engineering specifications and performance metrics, not expert interpretations of medical images or clinical outcomes.

4. Adjudication Method for Test Set:
This information is not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. This is a medical device for delivering bone cement, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone Performance:
This information refers to the device's ability to perform its physical function as a standalone unit. The document states: "In all instances, the Crosstrees® PVA Pod device functioned as intended." This implies that the device performed its mechanical and functional role correctly in testing.

7. Type of Ground Truth Used:
The ground truth for this device submission would be the established engineering specifications, material properties, and functional performance benchmarks that the predicate device met. The new device's performance was measured against these predefined physical and functional requirements. It is a "device-focused" ground truth rather than a "patient outcome" or "expert consensus" ground truth.

8. Sample Size for Training Set:
This information is not applicable. There is no "training set" as this is not an AI/ML device.

9. How Ground Truth for Training Set was Established:
This information is not applicable.

Summary

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510(k) SUMMARY

Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

Crosstrees Medical, Inc.

Submitter's Name:

Date Prepared:

Address: 4735 Walnut Street, Suite E Boulder, CO 80301 720-880-5811 Telephone: Fax: 303-484-6099

Contact Person: Robert Scribner 720-880-5811 Telephone:

November 1, 2013

DEC 0 6 2013

Name of Device and Name/Address of Sponsor Crosstrees® PVA Pod Device

Common Name

Bone Cement Delivery Device

Classification Name

888.3027 - Cement, Bone, Vertebroplasty 888.1100 - Arthroscope

Predicate Devices

Crosstrees® PVA Pod Device (K130089)

Intended Use

Device Description

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Substantial Equivalence

The Crosstrees® PVA Pod has the same intended use, indications for use, and principles of operation, as well as very similar technological characteristics as its predicate device. The minor technological differences between the Crosstrees® PVA Pod and its predicate device, change in the pod fabric dimensional specification, and the removal of a yarn texturing process, raise no new issues of safety or effectiveness questions. Risk assessment of the modification and design verification testing, performed to support design control activities, demonstrates that the Crosstrees® PVA Pod performs as intended and is as safe and effective as the previously cleared device. Thus, the Crosstrees® PVA Pod is substantially equivalent.

Device	Crosstrees® PVA Pod	PredicateCrosstrees® PVA Pod(K130089)
Intended Use	The Crosstrees® Pod device isintended to provide surgeons with apercutaneous means to deliver bonecement to painful pathologiccompression fractures of the vertebralbody in levels T4-L5 of the thoracicand lumbar spine. Pathologicfractures of the vertebral body maybe caused by osteoporosis. It isintended to be used in combinationwith Crosstrees Fortibrae® BoneCement when delivered by theCrosstrees CDrive® Bone FillerDelivery System.	The Crosstrees® Pod device isintended to provide surgeons with apercutaneous means to deliver bonecement to painful pathologiccompression fractures of the vertebralbody in levels T4-L5 of the thoracicand lumbar spine. Pathologicfractures of the vertebral body maybe caused by osteoporosis. It isintended to be used in combinationwith Crosstrees Fortibrae® BoneCement when delivered by theCrosstrees CDrive® Bone FillerDelivery System.
Materials	Woven Polymer, Stainless Steel, UVCurable Adhesives, ThermoplasticInjection Molded Handles/Hubs	Woven Polymer, Stainless Steel, UVCurable Adhesives, ThermoplasticInjection Molded Handles/Hubs
MajorComponents	Expandable Member, Delivery Shaft
ExpandableMember Material	Woven Polymer Fabric Pod(Polyester)	Woven Polymer Fabric Pod(Polyester)
ExpandableMember Length	20mm	15, 20mm
ExpandableMember MaxVolume	2 mL	2 mL, 3mL
ExpandableMember Shape	Cylindrical/Elliptical	Cylindrical/Elliptical
How Supplied	Sterile Single Use (ANSI/AAMI/ISO11137-2006 Gamma Irradiation)	Sterile Single Use (ANSI/AAMI/ISO11137-2006 Gamma Irradiation)

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K133372 Page 3 of 3

Performance Data

The Crosstrees® PVA Pod has the same sterilization process, same packaging, and is comprised of the same materials of construction as the predicate device. Device modifications have been assessed through Crosstrees design control process and the data generated demonstrates that the Crosstrees® PVA Pod device meets all performance characteristics and design specifications, thus supporting substantial equivalence to the predicate device. In all instances, the Crosstrees® PVA Pod device functioned as intended.

Conclusion

The Crosstrees® PVA Pod has the same intended use, indications for use, and principles of operation, as well as very similar technological characteristics as its predicate device. Testing conducted to support design control activities confirms that the product performs as intended. Therefore, the Crosstrees® PVA Pod is substantially equivalent to its predicate.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The text is likely the name of a government agency.

Public Health Service

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

December 6, 2013

Crosstrees Medical, Incorporated % Ms. Janice Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K133372

Trade/Device Name: Crosstrees® PVA Pod Device Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, LOD Dated: November 12, 2013 Received: November 12, 2013

Dear Ms. Hogan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) 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 (reporting of medical

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Page 2 - Ms. Janice Hogan

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wigqins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Indications for Use Statement

K133372 510(k) Number (if known):

Device Name: Crosstrees® PVA Pod Device

Indications for Use:

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133372

Page __ of ___________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”