Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, 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.

Device Description

Osteofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Filler.

AI/ML Overview

The provided text is for a medical device called "Osteofix™ Bone Void Filler." The documentation focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a specific study with performance metrics for the device, or details about ground truth, expert involvement, or sample sizes as one might find for a software or AI-based diagnostic device.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria. The overarching criteria seem to be related to safety, effectiveness, and substantial equivalence to predicate devices.	"Results demonstrated substantially similar rates of resorption [compared to Pro Osteon 500R]."
	"Results of bench testing demonstrate that Osteofix™ Bone Void Filler meets its specifications and does not raise new issues of safety or effectiveness."
	"In all instances, Osteofix™ Bone Void Filler functioned as intended."
	"The materials [in Osteofix™] were biocompatible."
	"Osteofix™ Bone Void Filler is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "a single comparison study" but does not give the number of samples or subjects.
Data Provenance: Not specified, but likely pre-clinical (bench testing) and possibly animal studies, given the nature of the device (bone void filler). The study compared Osteofix™ to Pro Osteon 500R.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This type of information is typically for diagnostic devices where expert interpretation is crucial for ground truth establishment. For a bone void filler, the "truth" would likely be based on objective measures like resorption rates, material composition, and mechanical properties.

4. Adjudication method for the test set

Not applicable/Not specified.

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 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.

7. The type of ground truth used

The "ground truth" (or basis for comparison/evaluation) appears to be:
- Predicate Device Performance: Comparison to "Pro Osteon 500R" regarding resorption rates.
- Product Specifications: Demonstrated by bench testing.
- Biocompatibility: Established through testing (though specific tests aren't detailed).
- Intended Function: "functioned as intended."

8. The sample size for the training set

Not applicable/Not specified. This concept applies more to machine learning models.

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

Not applicable/Not specified.

Summary

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510(k) SUMMARY

CALCITEC, INC. OSTEOFIX™ BONE VOID FILLER

APR 1 2 2007

Sponsor's Name, Address, Telephone Number, Contact Person and Date Prepared

Calcitec, Inc 7000 Bee Cave Road Suite 250 Austin, TX 78746 Phone: 512-306-9555 Facsimile: 512-306-9557

Contact Person: Brooke Campbell

Date Prepared: January 23, 2007

Name of Device

Osteofix™ Bone Void Filler

Common or Usual Name

Bone Void Filler, Bone Void Filler

Classification Name

Class II Classification: Classification Name: Filler, bone void, calcium compound

Predicate Devices

Interpore Cross International, Pro Osteon 500R (K990131) .
Berkelev Advanced Biomaterials, Inc., Cem-Ostetic (K040405) ●
Synthes, Norian SRS Bone Void Filler (K011897) ●

Intended Use / Indications for Use

પ્રધ્યમ

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aling process.

chaological Characteristics

eofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Fil ﺍﻟﻤﻌﻠﺎﺓ Calcina ) ﺃﻥ ﻣﺴﻠﺴﻞ ﺍﻟﻤﺸﺎﻫﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺪ

Performance Data

e performance of Osteofix™ has been compared to Pro Osteon 500R in a si nparison study. Results demonstrated substantially similar rates of resorpt aterial.

sults of bench testing demonstrate that Osteofix™ Bone Void Filler meets its specifications
I does not raise new issues of safety or effectiveness. In all instances, Osteofi ler functioned as intended.

compatibility Data

led for permanent blood contacting devices, and the materials w ocompatible. Additionally, the same materials are commonly used in similar medic

stantial Equivalence

<™ Bone Void Filler is substantially equivalent to the predicate devices. Osted iller has the same intended uses and similar indications, technological istics, and principles of operation as its predicate devices. The minor technol Terences between Osteofix™ Bone Void Filler and its predicate devices raise no new issues of
Tely or effectiveness. Performance data demonstrate that Osteofix™ Bone Void Fi

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Calcitec, Inc. % Ms. Brooke Campbell, Esq. Vice President. Clinical and Regulatory Affairs 7000 Bee Cave Road, Suite 250 Austin, Texas 78746

APR 1 2 2007

Re: K070220

Trade Name: Osteofix™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class: II Product Code: MQV Dated: April 5, 2007 Received: April 5, 2007

Dear Ms. Campbell:

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 – Ms. Brooke Campbell, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his lotter will anon you vo be on finding of substantial equivalence of your device to a legally promatted 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 other gollers, 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,
Barbara Buehno

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

K070220 510(k) Number (if known):

Device Name: Osteofix™ Bone Void Filler

Indications for Use:

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Darhare Buechnp

Page _ of _

Division of General, Restorative, and Neurological Devices

Ko 20220 510(k) Number

. 12

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.