BF+ (Ph) resorbable void filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis), caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BF+ (Ph) is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Description

The BF+ (Ph) system is manufactured using 100% tricalcium phosphate [Ca3(PO4)2]. BF+ (Ph) is a bone graft substitute that resorbs within 6-12 months and is replaced with bone during the healing process. The cube, granule, stick, and block forms are intended to allow for a full range of surgeon preference, and provide a multidirectional interconnected porosity structure similar to that of human cancellous bone. Density for cubes and granules range from 1.228 to 1.842 g/cm³, and from 1.535 to 1.842 g/cm³ for sticks and blocks.

AI/ML Overview

The provided text is a 510(k) summary for the BF+® (Ph) Bone Void Filler. This document describes a medical device and its equivalence to a predicate device, as required for FDA clearance. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way a diagnostic AI would be evaluated.

Here's why the requested information cannot be extracted from this document, and what the document does say:

Nature of the Device: The BF+® (Ph) is a bone void filler, a physical product intended to fill gaps in bones. It's a bone graft substitute. It is not an AI/ML diagnostic device, imaging system, or software that generates data or provides analysis based on input.
Regulatory Pathway: This is a 510(k) premarket notification. For devices cleared via this pathway, the primary demonstration is "substantial equivalence" to a predicate device already on the market. This often relies on comparing material properties, intended use, and existing safety/performance data of the predicate, rather than new, extensive clinical studies with specific performance criteria for the new device itself.
Content of the Document: The document explicitly states: "Mechanical testing of the LDR Spine USA BF+® (Ph) device was not performed, as the materials, processes and supplier are identical to that of the predicate BIOSORB® Resorbable Bone Void Filler manufactured by SBM France (Premarket Notification K021963)." This confirms that a stand-alone, new performance study for this specific device was not conducted to establish new performance metrics.

Therefore, since the device is a physical bone void filler and its clearance was based on substantial equivalence to a predicate without new mechanical testing for this device, the requested information (acceptance criteria, details of a performance study, sample sizes, expert ground truth, MRMC, standalone performance, etc.) is not present in this document.

To directly answer your request based on the lack of this information in the provided text:

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

Not applicable as this is a 510(k) for a physical bone void filler, not an AI/ML diagnostic device. No specific acceptance criteria or performance metrics (like sensitivity, specificity, AUC) are reported for this device's performance in a study. Its functional performance is considered substantially equivalent to the predicate.

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

No test set or clinical study data for device performance is mentioned as "Mechanical testing of the LDR Spine USA BF+® (Ph) device was not performed."

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, as no test set or ground truth establishment relevant to an AI/ML device is discussed.

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

Not applicable, as no test set or adjudication process is mentioned.

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 is a physical bone void filler, not an AI-assisted diagnostic tool for human readers.

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. The document states mechanical testing was not performed for this device, relying instead on the predicate.

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

Not applicable. No ground truth is established for this device as it is not an AI/ML or diagnostic device.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. No training set or ground truth establishment is mentioned.

In summary, the provided document describes a regulatory submission (510(k)) for a physical medical device (bone void filler) where clearance was based on substantial equivalence to a predicate device, rather than new, independent performance studies for the device itself. Therefore, the information you're asking for, which is typically relevant for AI/ML or diagnostic devices, is not present here.

Summary

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K06/462

Image /page/0/Picture/1 description: The image shows the logo for LDR Spine. The letters "LDR" are stacked on top of the word "spine." The font is bold and sans-serif. The logo is black and white.

A Passion for Innovation

510(k) Summary

DEC 1 6 2006

BF+® (Ph) Bone Void Filler

1. Owner's Name & Address

LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: (512) 344-3333 (512) 344-3350 Fax:

2. Contact Person

James Burrows Director of Clinical Marketing LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: (512) 344-3307 Fax: (512) 344-3350 Email: jamesburrows@ldrspine.com

3. Date 510(k) Summary Prepared: November 15, 2006

1. BF+® (Ph) Trade Name: Common Name: Bone Void Filler MQV: Filler, Bone Void, Calcium Compound - Class II Classification: per 21 CFR 888.3045

Legally Marketed Equivalent Predicate Devices: 5.

K021963 - Sciences et Bio Materiaux (SBM) France BIOSORB® Resorbable Bone Void Filler

6. Device Description

The identical (3 tricalcium phosphate (TCP) proposed for use has been used in other legally marked devices within the same classification for the same intended use.

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The cube, granule, stick, and block forms are intended to allow for a full range of surgeon preference, and provide a multidirectional interconnected porosity structure similar to that of human cancellous bone. Density for cubes and granules range from 1.228 to 1.842 g/cm³, and from 1.535 to 1.842 g/cm³ for sticks and blocks.

7. Intended Use of the Device

8. Non-Clinical Performance Data

Mechanical testing of the LDR Spine USA BF+® (Ph) device was not performed, as the materials, processes and supplier are identical to that of the predicate BIOSORB® Resorbable Bone Void Filler manufactured by SBM France (Premarket Notification K021963).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LDR Spine USA % Mr. James Burrows Director of Clinical Marketing 4030 West Braker Lane Austin, Texas 78759

Re: K061462

Trade/Device Name: BF+® (PH) Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Filler, Bone Void, Calcium Compound Regulatory Class: Class II Product Code: MQV Dated: November 15, 2006 Received: November 17, 2006

DEC 1 5 2006

Dear Mr. Burrows:

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. James Burrows

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Aenbeue Pruchud

Mark N. Melkerson Division 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

510(k) Number:

BF+® (Ph) Bone Void Filler Device Name(s):

Indications for Use:

BF+ (Ph) resorbable void filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis), caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

Prescription Use __ X

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Barbara Burchms

(Division Caroli) Division of General. Restorative, and Neardingican De 10:3

510(k) Number K061462

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.