BF+ is indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BF+ is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Description

The BF+ is a synthetic, resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a bone void filler device named BF+. It focuses on establishing substantial equivalence to previously cleared devices rather than on performing a study to meet specific performance acceptance criteria for the device itself.

Therefore, many of the requested sections about acceptance criteria, study details, ground truth, and expert involvement are not applicable to the information given.

Here's an analysis based on the provided text:

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

Not applicable. The provided documentation is a 510(k) summary for a medical device (BF+ Bone Void Filler) seeking clearance based on substantial equivalence to predicate devices, not based on meeting specific performance acceptance criteria derived from a novel study on the device's functional performance metrics. The clearance is based on equivalence in indications for use, design, material, and function, rather than quantitative performance against predefined thresholds.

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

Not applicable. There is no mention of a "test set" in the context of device performance evaluation. The submission focuses on comparing the new device's characteristics to those of existing predicate devices.

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)

Not applicable. No test set or ground truth establishment by experts is described for this type of submission.

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

Not applicable. No test set or adjudication method is described.

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

Not applicable. This device is a bone void filler, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

Not applicable. This is a physical bone void filler, not an algorithm.

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

Not applicable. As the submission is for substantial equivalence, the "ground truth" is derived from the established characteristics and performance of the predicate devices. There is no new ground truth established for the BF+ device itself in this document.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary of what the document does provide:

The document describes the BF+ as a synthetic, resorbable calcium phosphate bone void filler. Its characteristics are:

Osteoconductive material
Provides a porous scaffold for bone formation
Interconnected porosity: 60-80%
Pore size range: 200-500um
Available in various shapes and sizes.

Its intended use/indications are:

Filling bone voids or defects of the skeletal system (extremities, spine, pelvis)
Defects are not intrinsic to the stability of the bony structure
Defects may be surgically created or from traumatic injury
Resorbs and is replaced with bone during healing.

The basis for FDA clearance is substantial equivalence to previously cleared predicate devices, based on equivalence in indications for use, design, material, and function. The FDA explicitly states, "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..."

Summary

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510(k) PREMARKET NOT BF+

VII. 510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

Brian Burkinshaw LDR SPINE USA 108 Wild Basin Rd. Austin, Texas 78746 Telephone: (512) 437-4311 Date Prepared: November 16, 2004

B. Device Name

Trade or Proprietary Name:	BF+
Common or Usual Name:	Bone Void Filler
Classification Name:	Unclassified

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

E. Intended Use

F. Substantial Equivalence

Data was provided which demonstrated the BF+ to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Mr. Brian Burkinshaw Dir. Technology Solutions LDR Spine USA 108 Wild Basin Road Austin, Texas 78746

Re: K043347

Trade/Device Name: BF+ Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: November 30, 2004 Received: December 6, 2004

Dear Mr. Burkinshaw:

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. Brian Burkinshaw

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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. Indications for Use

K043347 510(k) Number (if known):

Device Name: BF+

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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.