NovaBone Putty - Bioactive Synthetic Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremitics, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone Putty is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NoyaBone Putty must not be used to gain screw purchase or to stabilize screw placement.

Device Description

NovaBonc Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the NovaBone Putty - Bioactive Synthetic Graft:

The provided 510(k) summary is for a medical device (NovaBone Putty) seeking substantial equivalence to a legally marketed predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a predicate, rather than establishing entirely new performance criteria through extensive clinical trials. Therefore, the information provided focuses on equivalence rather than detailed acceptance criteria and studies demonstrating absolute performance against novel benchmarks.

Crucially, this document does not contain the kind of detailed acceptance criteria, study data, ground truth establishment, or multi-reader multi-case studies typically associated with AI/CADe devices or new clinical effectiveness studies.

Instead, it describes the device, its intended use, and argues for substantial equivalence based on technological characteristics and animal in vivo performance data.

Analysis of Provided Information:

Based on the provided text, the following information can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for substantial equivalence based on technological similarity and in vivo performance (animal studies), there isn't a table of explicit acceptance criteria and corresponding reported performance that you might find for a diagnostic device or a new therapeutic.

However, the key "acceptance criteria" for a 510(k) submission on the part of the FDA are that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness.

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (from submission)
Substantial Equivalence:	Claimed to be substantially equivalent to NovaBone Putty (K060728) and NovaBone (K021336, K052494) predicate devices.
- Technological Characteristics:	Identical primary component (45S5 Bioglass particulate) to NovaBone predicate. Includes synthetic binder.
- Intended Use:	Same intended use as predicates: bony voids/gaps not intrinsic to stability, gently packed into skeletal system (extremities, spine, pelvis). Non-load-bearing. Not for vertebroplasty/kyphoplasty.
- Biocompatibility:	Bioactive glass (45S5 Bioglass) is biocompatible. Binder is biocompatible.
- Osteoconductivity:	Bioactive glass (45S5 Bioglass) is osteoconductive.
- Resorption & Bone Replacement:	Particles are slowly absorbed and replaced by new bone tissue during healing.
- Rate of Absorption (Animal Data):	Majority absorbed within 6 months, >98% absorbed by 12 months (in animals).

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (In vivo performance data): The document mentions "In vivo performance data were presented in support of the requested expansion of device claims." However, it does not specify the sample size, species, or country of origin for these in vivo studies. It only states that "Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months." This suggests animal data, retrospective or prospective is not specified, but typically animal studies would be prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. This type of information is usually relevant for diagnostic devices where expert consensus or pathological review establishes a "ground truth" for disease presence or absence. For a bone graft material, the in vivo performance is observed through histology, imaging, and gross examination in animal models, not typically via expert medical reviewer consensus on images to establish "ground truth" in the diagnostic sense. The "experts" would likely be veterinarians, pathologists specializing in bone, or orthopedic researchers involved in the animal studies. Their qualifications are not stated in this document.

4. Adjudication Method for the Test Set:

Not Applicable. As per point 3, there isn't an "adjudication" of expert opinions in the context of device performance in animal models described here. The animal study results would be evaluated based on scientific methodologies and statistical analysis of objective measurements (e.g., bone formation, material resorption).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is not mentioned as this device is a bone void filler material, not a diagnostic aid that assists human readers in interpreting images. Therefore, there is no effect size reported for human readers with or without AI assistance.

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

No. This device is a physical bone graft material, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used:

For the in vivo performance data (animal testing), the ground truth would be based on histological analysis, imaging (e.g., X-ray, micro-CT), and gross observation of bone formation and material resorption in the animal models. These are objective measures taken from the tissue samples or imaging over time.

8. The Sample Size for the Training Set:

Not Applicable. This document describes a physical medical device, not an AI or machine learning model that would have a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As per point 8.

Summary Limitations:

It is important to reiterate that this 510(k) summary is designed to demonstrate "substantial equivalence" to existing, legally marketed devices. It focuses on comparing the new device's characteristics and intended use to those predicates, and supporting claims with basic biological performance data (primarily animal studies for absorption). It is not a clinical trial report or a performance study for a diagnostic AI device, which would typically contain the specific criteria and study details requested in your prompt.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS". The logo is in a bold, sans-serif font. The word "NOVABONE" is in all caps and is the largest text in the image. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in a smaller font.

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510(k) Summary NovaBone Putty - Bioactive Synthetic Graft

12/31/07

1. Submitter Information:

Name:	NovaBone Products, LLC	MAY - 6 2008
Address:	13709 Progress Boulevard, #33Alachua, FL 32615
Telephone:	(386) 462-7660
Facsimile:	(386) 418-1636
Contact:	David M. Gaisser

2. Name of Device:

Trade Name:	NovaBone Putty - Bioactive Synthetic Graft
Common Name:	Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material
Regulation Number:	21 CFR 888.3045
Regulation Name:	Bone Void Filler

3. Legally Marketed Predicate Device:

Predicate #1:	NovaBone Putty - Bioactive Synthetic Graft -[K060728]
Predicate #2:	NovaBone - Resorbable Bone Graft Substitute -[K021336, K052494]

4. Device Description

5. Intended Use

NovaBone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spinc and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

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In cases of fracture fixation or where load support is required, procedures. standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.

Technological Characteristics 6.

The technological characteristics of the NovaBone Putty device are identical to the NovaBone Putty device cleared per K060728, which are in turn similar to those of the NovaBone predicate. The device and predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. The device indications are the same as for the predicates. The device is intended to be used alone, or in combination with autogenous bone.

The primary component of NovaBone Putty is identical to the bioactive glass (4585 Bioglass) particulate found in the NovaBone predicate. This synthetic material is both biocompatible and osteoconductive. The NovaBone Putty includes a synthetic binder as an inert carrier for ease of handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue. Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the matcrial being absorbed by 12 months. The timeframe for full absorption in humans has not been determined, but is expected to be at least 12 months.

7. Warnings and Precautions

NovaBone Putty is not indicated for usc in load-bearing applications. It should not be used for vertebroplasty or kyphoplasty procedures. NovaBone Putty is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.

NovaBone Putty is intended for manual application and is not intended for injection. Injection of NovaBone Putty should not be conducted as it could result in device over-pressurization, which may lead to device extrusion beyond the intended application site or to embolization of fat or the device into the bloodstream.

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510(k) Premarket Notification NovaBone Products, LLC NovaBone Putty – Bioactive Synthetic Graft

8. Complications

Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, decp wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arisc from anesthesia and / or surgery.

9. Conclusion

NovaBone Putty is claimed to be substantially equivalent to the NovaBone Putty and NovaBone (particulate) predicate devices as a non-structural osteoconductive bone void filler for osseous defects. In vivo performance data were presented in support of the requested expansion of device claims.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2008

NovaBone Products, LLC % Mr. David M. Gaisser 13709 Progress Boulevard, #33 Alachua, FL 32615

Re: K080009

Trade/Device Name: NovaBone Putty-Bioactive Synthetic Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 31, 2007 Received: February 27, 2008

Dear Mr. Gaisser:

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. David M. Gaisser

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 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 N. Mullean

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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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: NovaBone Putty - Bioactive Synthetic Graft

Indications For Use:

Prescription Use _ XX

OR (Per 21 CFR 801.109) Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Kl. Olsen

Division of General, Restorative, and Neurological Devices

510(k) Number K040009

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.