NB3D Bone Void Filler is intended 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 intended to be used in conjunction with bone marrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Description

NB3D is a resorbable porous, calcium phosphate bone void filler that provides a scaffold for the in-growth of new bone. NB3D is an osteoconductive implant with an interconnected porosity similar to human cancellous bone.

AI/ML Overview

The provided document is a 510(k) summary for the Pioneer Surgical Technology NB3D Bone Void Filler. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing device performance data against specific acceptance criteria from a clinical study. Therefore, the document does not contain the detailed information requested regarding clinical study design, acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.

Instead, it relies on comparative testing and established standards to show that the new device is as safe and effective as existing ones.

Here's a breakdown of what is available and what is not available based on your request:

1. Table of acceptance criteria and the reported device performance:

Not Available directly. The document does not specify quantitative acceptance criteria (e.g., success rates, sensitivity, specificity) for a clinical performance study. It states that characterization testing and animal testing were performed to demonstrate substantial equivalence to predicate devices.
Reported performance (Indirectly): The document affirms that NB3D has "the same intended use," "uses the same operating principle," "incorporates the same basic design," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes" as the predicate devices. The implication is that its performance is equivalent to these already-cleared devices.

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

Not Available for human clinical data. The document mentions "Animal testing performed to demonstrate substantial equivalence ... in a rabbit posterolateral spine fusion model." The sample size for this animal study is not specified, nor is the country of origin, or whether it was retrospective or prospective.

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

Not Available. This information pertains to human clinical studies or expert review processes, neither of which are detailed in this 510(k) summary.

4. Adjudication method for the test set:

Not Available. As above, this is relevant for human clinical studies and not present in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is a bone void filler, not an AI/software-based diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

Not Applicable. Again, this pertains to AI/software performance, not a bone void filler.

7. The type of ground truth used:

Animal Model Observations/Assessments: For the animal study, the document states "determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device." These assessments served as the "ground truth" for evaluating the performance in that specific animal model.

8. The sample size for the training set:

Not Applicable/Not Available. The concept of a "training set" is typically for machine learning algorithms. For a physical medical device like a bone void filler, there isn't a "training set" in this context.

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

Not Applicable/Not Available. As with point 8, this question is not relevant for this type of device submission.

Summary of available information regarding the "study that proves the device meets the acceptance criteria":

The "study" cited is animal testing and characterization testing.

Characterization testing: Included methods described in ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F1185. These are standards related to biocompatibility and material properties. The specific acceptance criteria within these standards are not detailed in the summary, but the implication is that the device met them.
Animal testing: Performed "to demonstrate substantial equivalence included determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device in a rabbit posterolateral spine fusion model."
- Test set sample size: Not specified.
- Data provenance: "rabbit posterolateral spine fusion model" (animal study).
- Ground truth: Radiographic, biomechanical, and histological observations.
- Goal: To show equivalence to a predicate device (Vitoss Bioactive) in an animal model.

In essence, the 510(k) process for this device relies on demonstrating that it is "substantially equivalent" to already-approved devices through comparison of design principles, materials, intended use, and pre-clinical testing, rather than presenting a full clinical trial with defined acceptance criteria and performance statistics for human subjects.

Summary

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510(k) Summary

Pioneer Surgical Technology NB3D Bone Void Filler

November 21, 2011

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Pioneer Surgical Technology
	375 River Park Circle
	Marquette, MI 49855
Telephone:	+1 (906) 226-4812
Fax:	+1 (906) 226-4459
Official Contact:	Jonathan Gilbert

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	NB3D Bone Void Filler
Common Name:	Bone Void Filler
Classification Regulations:	Filler, Bone Void, Calcium Compound
	21 CFR 888.3045
	Class II
Product Code:	MQV
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
Reviewing Branch:	Restorative Devices Branch

INTENDED USE

Pioneer Surgical Technology, Inc. K111944 - N83D

Page 1 of 2

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DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICES

Pioneer Surgical Technology submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, NB3D Bone Void Filler (NB3D) is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Pioneer Surgical Technology FortrOss Bone Void Filler cleared under K091031;

Orthovita, Inc. Vitoss Bioactive Foam Bone Graft Substitute-STRIP and PACK, cleared under K081439;

Synthes (USA) chronOSTM Composite, cleared under K071046; and

Medtronic Sofamor Danek MASTERGRAFT® Strip, cleared under K082166.

The subject device and the predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Characterization testing performed included methods described in ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F1185. Animal testing performed to demonstrate substantial equivalence included determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device in a rabbit posterolateral spine fusion model.

Overall, NB3D has the following similarities to the remaining predicate devices:

has the same intended use, .
. uses the same operating principle,
incorporates the same basic design, .
incorporates the same or very similar materials, and •
has similar packaging and is sterilized using the same materials and processes. .

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol in a circular fashion.

Public Health Service

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

NOV 222 2011

Pioneer Surgical Technology, Inc. % PaxMed International. LLC Mr. Floyd G. Larson 11234 El Camino Real. Suite 200 San Diego, California 92130

Re: K111944

Trade/Device Name: NB3D Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bond void filler device Regulatory Class: Class II Product Code: MOV Dated: November 10, 2011 Received: November 14, 2011

Dear Mr. Larson:

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

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Page 2 – Mr. Floyd G. Larson

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.

Sincerely yours,

Evil Keith

~ 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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Indications for Use

510(k) Number: . K111944

NB3D Bone Void Filler: Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

signature

(Division Division of Surgical, Orthopedic, sho Restorative Devices

510(k) Number K111944

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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.