NanOss BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Description

Pioneer Surgical Technology NanOss BVF-E is a porous calcium phosphate material mixed with a gelatin based carrier. The product is an osteoconductive scaffold mixed with a gelatin carrier for use in repairing bony defects in spinal and general orthopedic indications.

The product is supplied sterile for single use in various configurations, as pre-mixed granules, or in separate containers to be combined by the user or as pre-molded strips and forms. A commercially available dispensing syringe and a mixing spatula are included in the package.

NanOss BVF is a macroporous ceramic granule composed of greater than 95% nanocrystalline hydroxyapatite. The calcium phosphate granules are presented as ground particles. The macroporous structure of the NanOss provides a resorbable osteoconductive scaffold.

The gelatin based carrier is presented as ground freeze-dried particles. The combined product forms a cohesive and adhesive material upon rehydration with surgical fluids, e.g. saline or blood.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "Pioneer Surgical NanOss BVF-E," a resorbable calcium salt bone void filler. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than conducting a de novo study with acceptance criteria and performance metrics in the way a new drug or high-risk medical device might.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically described for a new diagnostic or AI-driven device (e.g., sensitivity, specificity, AUC) are not directly applicable in this context.

Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating:

Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, intended use, and performance testing.
Compliance with Special Controls (if applicable): For Class II devices, compliance with any relevant special controls guidance documents published by the FDA.

Here's how the provided information relates to your request, adapting the terminology to fit the 510(k) framework:

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

Since this is a 510(k) for a bone void filler, the "acceptance criteria" are not quantitative performance metrics like sensitivity or specificity. Instead, they are met by demonstrating the device is substantially equivalent to existing devices and complies with regulatory requirements. The "reported device performance" is the evidence gathered to support this substantial equivalence.

Acceptance Criterion (for 510(k) Substantial Equivalence)	Reported Device Performance/Evidence
Intended Use: Device's intended use is the same as, or similar to, predicate device(s).	"NanOss BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process." (Identical or very similar to predicate devices, as implied by substantial equivalence claim).
Technological Characteristics: Device has the same technological characteristics as the predicate, or has different characteristics that do not raise new questions of safety and effectiveness.	"NanOss BVF is a macroporous ceramic granule composed of greater than 95% nanocrystalline hydroxyapatite. The calcium phosphate granules are presented as ground particles. The gelatin based carrier is presented as ground freeze-dried particles. The combined product forms a cohesive and adhesive material upon rehydration with surgical fluids, e.g. saline or blood." "Predicate devices are similar in characteristics, which may include indications, ceramic materials, porcine gelatin carrier, porous structure, and presentation."
Performance Testing: Non-clinical testing demonstrates safety and effectiveness comparable to predicate devices and supports the technological characteristics.	"E-Matrix NanOss BVF and/or components have undergone non-clinical testing, including chemical, physical, component biocompatibility, and handling characteristics." "Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate devices."
Compliance with Special Controls (for Class II devices): Meets all requirements of applicable special controls guidance documents.	"Additionally, it meets all of the requirements of the FDA special controls guidance (Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA)."

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 provided in the document. 510(k) submissions for devices like bone void fillers typically rely on non-clinical (benchtop, material characterization, biocompatibility) testing, and sometimes animal studies, rather than human clinical trials that would involve "test sets" or "data provenance" in the way an AI/diagnostic device would. The document mentions "Performance Testing" which is described as "chemical, physical, component biocompatibility, and handling characteristics," all of which are laboratory-based and not clinical trials with human 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 is not applicable and not provided. "Ground truth" established by experts is relevant for diagnostic or AI imaging devices, where human expert interpretation is the standard against which device performance is measured. For a bone void filler, the "ground truth" relates to its material properties, biocompatibility, and intended biological function, which are evaluated through lab tests and comparisons to known predicate devices, not expert consensus on interpretations.

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

This is not applicable and not provided. Adjudication methods are used in clinical studies involving human interpretation or complex outcomes, which are not detailed in this 510(k) submission for this type of device.

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 is not applicable and not provided. An MRMC study is specific to imaging diagnostics, particularly those involving AI assistance, and is not relevant to a bone void filler material.

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

This is not applicable and not provided. This concept is related to AI algorithms; the NanOss BVF-E is a material implant, not an algorithm.

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

As explained in point 3, the "ground truth" for this device relates to its material properties, biocompatibility, and functional characteristics (e.g., resorbability, osteoconductivity, handling properties). This "ground truth" is established through:

Chemical characterization: Confirming the composition (e.g., >95% nanocrystalline hydroxyapatite).
Physical testing: Evaluating porosity, particle size, strength, etc.
Biocompatibility testing: In vitro and in vivo (animal) studies to ensure the material is not toxic or does not cause adverse biological reactions.
Comparison to predicate devices: Leveraging the established safety and effectiveness of similar, already marketed devices.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train an AI algorithm. This device is a bone void filler, not an AI system.

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

This is not applicable and not provided for the same reasons as point 8.

Summary

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KC031558 (B 1 of 2)

AUG 2 5 2008 510(k) Summary Pursuant to 21 CFR 807.92

Submitted By: Pioneer Surgical Technology 1. 375 River Park Circle Marquette, MI 49855
1. Jon Gilbert Contact: Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855 (906) 226-4812
Pioneer Surgical NanOss BVF-E 3. Product: CFR Section 880.3045 Resorbable Calcium Salt Bone Void Filler Device Class II (special controls) Product Code: MQV
1. Common/Trade Name:

Filler, Bone Void, Calcium Compound Pioneer NanOss BVF-E

Description:

Intended Use/Indication:

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Technological Characteristics:

The gelatin based carrier is presented as ground freeze-dried particles. The combined product forms a cohesive and adhesive material upon rehydration with surgical fluids, e.g. saline or blood.

Performance Testing:

E-Matrix NanOss BVF and/or components have undergone non-clinical testing, including chemical, physical, component biocompatibility, and handling characteristics. Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate devices.

Substantial Equivalence:

Pioneer Surgical NanOss BVF-E is comparable to several Bone Void Filler devices already on the market. One of the predicate devices (NanOss Bone Void Filler) is a major component of the new product. Predicate devices are similar in characteristics, which may include indications, ceramic materials, porcine gelatin carrier, porous structure, and presentation.

Devices to Which Substantial Equivalence is Claimed:

K032288- Vitoss Scaffold Foam Bone Graft Material K050025 - Angstrom Medica, Inc. NanOss Bone Void Filler K043421 – RTI Opteform K060728 - NovaBone Putty - Bioactive Synthetic Graft

Conclusions:

The comparisons and testing conducted on Pioneer Surgical NanOss BVF-E demonstrate that the device is substantially equivalent to other bone void fillers currently in commercial distribution. Additionally, it meets all of the requirements of the FDA special controls guidance (Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2008

Pioneer Surgical Technology % Mr. Jonathan Gilbert VP, Regulatory and Clinical Affairs 375 River Park Circle Marquette, Michigan 49855

Re: K081558

Trade/Device Name: Pioneer Surgical NanOss BVF-E Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: May 30, 2008 Received: June 30, 2008

Dear Mr. Gilbert:

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 above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Mr. Jonathan Gilbert

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

Mark N. Melkerson 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 Statement

510(k) Number:	K081558
Device Name:	Pioneer Surgical NanOss BVF-E
Indications for Use:	NanOss BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defect created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

510(k) Number:

K081558

Device Name:

Pioneer Surgical NanOss BVF-E

Indications for Use:

NanOss BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defect created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Prescription Use X Over-the-counter use _________________________________________________________________________________________________________________________________________________________ or (per CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yailaw Buelus
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K081558

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.