FortrOss Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

FortrOss Bone Void Filler is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. FortrOss Bone Void Filler is radiopaque, provided sterile and is intended for single use only.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (FortrOss Bone Void Filler) and an FDA clearance letter. It describes a modification to an existing device, not a new device requiring extensive clinical trials for performance validation. Therefore, many of the typical acceptance criteria and study components you'd expect for medical imaging AI or diagnostic devices are not present.

The "performance testing" section explicitly states: "Non-clinical evaluation consisting of material specifications and engineering design review and validation relevant to the line extensions described above were performed." This indicates that the validation focused on comparing the modified device's characteristics (new size, packaging, accessory) to the predicate device, rather than on proving clinical performance or diagnostic accuracy.

Given this context, here's how the requested information maps to the provided text:

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

Based on the document, there are no specific quantitative acceptance criteria or reported device performance metrics in the typical sense for a diagnostic or AI device. The acceptance criterion for this 510(k) Special Modification is Substantial Equivalence to the predicate device.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device (K091031)	"Based on information presented in this submission, we conclude that the FortrOss Bone Void Filler is substantially equivalent to predicate device." (Conclusion statement)
Material Specifications and Engineering Design Validation for Modifications (20cc size, mixing chamber, placement accessory)	"Non-clinical evaluation consisting of material specifications and engineering design review and validation relevant to the line extensions described above were performed." (Performance Testing section)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable (N/A) as this was a non-clinical evaluation of a device modification, focusing on material and design validation, not clinical performance with a test set of data.

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 applicable (N/A). No ground truth was established by experts for a test set in this 510(k) submission, as it did not involve clinical performance evaluation.

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

This information is not applicable (N/A). No adjudication method was used, as there was no test set requiring ground truth establishment or expert review.

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 applicable (N/A). This device is a bone void filler, not an AI or diagnostic tool. No MRMC study was conducted.

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

This information is not applicable (N/A). This device is a physical medical implant, not an algorithm or AI.

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

This information is not applicable (N/A). There was no "ground truth" in the diagnostic sense. The "ground truth" for the non-clinical evaluation would have been the established material specifications, engineering design principles, and physical performance testing results confirming the modified device's characteristics met pre-defined requirements, demonstrating equivalence to the predicate.

8. The sample size for the training set

This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable (N/A). As there is no training set for an AI/ML algorithm, no ground truth was established for it.

Summary

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KII0561

Special 510(k): Device Modification

FortrOss Bone Void Filler

APR 2 9 2011

510(k) Summary

Pioneer Surgical Technology Special 510(k): Device Modification

FortrOss Bone Void Filler

ADMINISTRATIVE INFORMATION

Manufacturer Name:

375 River Park Circle Marquette, MI 49855 +1 (906) 226-4812 Telephone: Fax: +1 (906) 226-4459

Pioneer Surgical Technology

Official Contact:

Representative/Consultant:

Jonathan Gilbert

David J. Collette, MD or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: dcollette@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

FortrOss Bone Void Filler Bone Void Filler Filler, Bone Void, Calcium Compound 21 CFR 888.3045, Class II MQV Orthopaedic and Rehabilitation Devices Restorative Devices Branch

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Special 510(k); Device Modification

FortrOss Bone Void Filler

INTENDED USE

DEVICE DESCRIPTION

PREDICATE DEVICE

K091031 - Pioneer FortrOss Bone Void Filler

COMPARISON TO MARKETED DEVICE

The intended use and composition of this device are identical to those of the predicate. This submission introduces a larger (20 cc) product size, a packaging modification consisting of a mixing chamber intended to facilitate reconstitution of the device at the time of implantation, and an accessory to facilitate placement of the device along the posterolateral spine.

PERFORMANCE TESTING

Non-clinical evaluation consisting of material specifications and engineering design review and validation relevant to the line extensions described above were performed.

CONCLUSION

Based on information presented in this submission, we conclude that the FortrOss Bone Void Filler is substantially equivalent to predicate device.

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

APR 2 9 2011

Pioneer Surgical Technology % PaxMed international, LLC David J. Collette, M.D. 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K110561

Trade/Device Name: FortrOss Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: March 31, 2011 Received: April 1, 2011

Dear Dr. Collette:

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.

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Page 2 - David J. Collette, M.D.

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

Sincerely yours,

B. R

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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FortrOss Bone Void Filler

Indications for Use

510(k) Number: K110261

Device Name: FortrOss Bone Void Filler

Indications for Use

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)

Division Sigr (Division Sign-On), Orthopedia
Division of Surgical, Orthopedia
Devision of Surgical, Devices DIVIsion of Surges

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Page 1 of

510(k) Number .

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.