NovaBone Porous - Bone Graft Scaffold is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Porous is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities 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.

Device Description

NovaBone Porous is an osteoconductive bioactive device. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. On implantation, NovaBone Porous undergoes a timedependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Porous is progressively resorbed and replaced by new bone tissue during the healing process.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "NovaBone Porous - Bone Graft Scaffold." It includes information about the device's characteristics, intended use, and a conclusion based on an in vivo study. However, it does not explicitly detail specific quantitative acceptance criteria or the full results of a study that directly prove the device meets such criteria in a comparative manner.

Let's extract the available information and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance metric that is compared against a pre-defined threshold. The "conclusion" states the findings of an in vivo study, which serves as the reported device performance.

Acceptance Criteria (Not explicitly stated as quantitative)	Reported Device Performance (from in vivo study)
Evidence of osteoconductive nature	Demonstrated new bone formation at early post-implantation periods
No local or systemic adverse effects related to the device	No evidence of local or systemic adverse effects observed
Biocompatibility	Supported by additional in vitro data (details not provided)

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

The document mentions an "in vivo study data" and "additional supporting in vitro data."

Sample Size for Test Set: Not specified for the in vivo study.
Data Provenance: The in vivo study is implied to be pre-clinical (likely animal studies, given the nature of the device and the typical regulatory pathway for such products), but the specific country of origin or whether it was retrospective or prospective is not stated.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned. The document only states that "in vivo study data were presented supporting the osteoconductive nature." This suggests a scientific evaluation, but specific adjudication processes are not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: No. This type of study is typically performed for diagnostic or screening devices where human readers interpret results, often with and without AI assistance. This device is a bone graft scaffold, not a diagnostic tool requiring human interpretation of images or other data in this context.
Effect Size of Human Readers (with vs. without AI assistance): Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone Performance Done?: Not applicable. This device is a physical bone graft, not an algorithm. The "performance" refers to its biological interaction with the body in vivo.

7. Type of Ground Truth Used

Ground Truth: The in vivo study data likely used histopathological examination and clinical observation/imaging as the ground truth to assess "new bone formation" and "local or systemic adverse effects." The document does not explicitly state "pathology" but it is strongly implied by the nature of in vivo studies for bone regeneration.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a physical product, not a machine learning algorithm that requires a "training set" in the computational sense. The product development process involves iterative testing and refinement, but not a formal "training set" for an algorithm.

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

Establishing Ground Truth for Training Set: Not applicable. As above, there is no "training set" in the context of an AI algorithm described for this device.

Summary of Missing Information:

The document provides a high-level summary of an in vivo study used to support the device's efficacy and safety for a 510(k) submission. However, it lacks the detailed methodology, quantitative acceptance criteria, and specific metrics typically found in a comprehensive study report, especially those relevant to evaluating AI-powered devices (which this is not). The request's questions are heavily geared towards AI/software performance evaluations, which do not directly apply to this physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS". The word "NOVABONE" is written in large, bold, black letters. There is a starburst design in the middle of the word. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" written in smaller, black letters.

K060432

510(k) Summary NovaBone Porous - Bone Graft Scaffold

02/17/06

Submitter Information: 1.

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

Name of Device: 2.

Trade Name:	NovaBone Porous – Bone Graft Scaffold
Common Name:	Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material
Classification Name:	Unknown

Legally Marketed Predicate Device: 3.

Predicate #1:	NovaBone - Resorbable Bone Graft Substitute[K021336]
Predicate #2:	ProOsteon 500R - Resorbable Bone Graft[K990131]

4. Device Description

ડ. Intended Use

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

{1}------------------------------------------------

510(k) Premarket Notification NovaBone Products, LLC NovaBone Porous - Bone Graft Scaffold

Technological Characteristics 6.

The technological characteristics of the NovaBone Porous device are similar to those of the predicates, although not identical. Chemically, the device is comprised of the same material as the NovaBone predicate. Some changes in material crystalline structure have been made during the porous device formation process, but the osteoconductive nature of the device in unchanged. Physically, the device is designed as a bulk, porous osteoconductive space-filling device, similar to the Pro Osteon 500R predicate. It is designed to be gently packed into defect sites and used as a non-structural scaffold for the body's natural healing and bone regeneration process. The device acts as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow.

The NovaBone Porous device is a single-phase bioactive glass (45S5 Bioglass) device. The device indications are the same as those for the predicate devices.

7. Warnings and Precautions

NovaBone Porous does not possess sufficient mechanical strength to support loadbearing defects prior to hard tissue ingrowth. 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 Porous is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. NovaBone Porous must not be used to gain screw purchase or to stabilize screw placement.

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, deep 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 arise from anesthesia and / or surgery.

9. Conclusion

NovaBone Porous functions as a bone void filler for non-structural osseous defects. In vivo study data were presented supporting the osteoconductive nature of the device demonstrating new bone formation at early post-implantation periods, with no evidence of local or systemic adverse effects related to the device observed. Additional supporting in vitro data were supplied.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its wings. Below the eagle are two wavy lines, possibly representing water.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 4 2006

2006

Nova Bone Products, LLC C/o Mr. David M. Gaisser VP, Operations/RA/QA 13709 Progress Boulevard, #33 Alachua, Florida 32615

Re: K060432

Trade/Device Name: NovaBone Porous -- Bone Graft Scaffold Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt bone void filler device Regulatory Class: II Product Code: MOV Dated: February 17, 2006 Received: February 22, 2006

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.

{3}------------------------------------------------

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Lehman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

NovaBone Porous - Bone Graft Scaffold Device Name: Device

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)
--------------------------------------------------------

Division of General, Restorative, and Neurological Devices

510(k) Number K060432

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.