CALTRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or created from traumatic injury to the bone. The pellets resorbs and is replaced with new bone during the healing process. When used in the spine, the device is limited to posterolateral fusion procedures only.

Device Description

The CALTRIX Resorbable Bone Void Filler are made of high purity pharmaceutical grade calcium sulfate. It is bio-degradable, biocompatible and radiopaque pellets. CALTRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CALTRIX Resorbable Bone Void Filler, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific numerical acceptance criteria for performance beyond conforming to standards. It states the device "conforms to applicable standards." The "reported device performance" is primarily presented as meeting these standards and having similar performance characteristics to the predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (from text)	Reported Device Performance (from text)
Biocompatibility	Conforms to ISO 10993 series: Biological evaluation of medical devices	Device is "bio-degradable, biocompatible." Conforms to ISO 10993 series.
Material Purity	Conforms to ASTM F2224-03: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants	Made of "high purity pharmaceutical grade calcium sulfate." Conforms to ASTM F2224-03.
Sterilization	Conforms to ANSI/AAMI/ISO 11137 Sterilization of Health Care Products - Radiation Sterilization	Supplied sterile. Conforms to ANSI/AAMI/ISO 11137.
Resorption & Bone Growth	(Implied: Resorbs and is replaced by new bone within a clinically acceptable timeframe, and acts as an osteoconductive scaffold.)	"It is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process."
Safety & Effectiveness	(Implied: No new questions of safety or effectiveness compared to the predicate device.)	"Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." "Substantially equivalent to the predicate devices."
Intended Use	(Implied: Device meets the requirements for its indicated uses.)	Meets the stated intended use: "to fill bony void or gaps of the skeletal system... that are not intrinsic to the stability of the bone structure," with specific limitations for spinal use.

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

The document mentions "bench testing contained in this submission." However, it does not specify any sample sizes for this testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). The study primarily relies on demonstrating conformity to existing standards and comparison to a predicate device.

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

There is no information provided in the text regarding the number or qualifications of experts used to establish a ground truth for any test set. The submission focuses on compliance with established material and sterilization standards, and substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As there is no mention of a clinical test set or human-derived data analysis requiring adjudication, there is no information on any adjudication method.

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

This section is not applicable. The device described is a medical implant (bone void filler), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

This section is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's effectiveness and safety is primarily based on:

Adherence to recognized industry standards: ISO 10993, ASTM F2224-03, ANSI/AAMI/ISO 11137.
Demonstrated material properties: "high purity pharmaceutical grade calcium sulfate," "bio-degradable, biocompatible, and radiopaque pellets," "osteoconductive," "resorbed in approximately 14 weeks and be replaced by new bone."
Substantial equivalence to a legally marketed predicate device: "Osteo-Link Bone Void Filler Pellets (K060809)." The performance and safety profile of the predicate device serves as an established baseline.

8. The Sample Size for the Training Set

There is no mention of a training set. This device is a physical product, not an AI model, and therefore the concept of a training set does not apply in this context.

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

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

Summary

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510(K) SUMMARY

Image /page/0/Picture/1 description: The image shows a black silhouette at the top and a series of handwritten numbers and letters at the bottom. The handwritten characters appear to be "10x32729". The silhouette at the top is an irregular shape, and it is unclear what it represents.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

JAN 2 8 2009

1. Submitter's Name: AG DIGITAL Technology Corp.

Address:	11F, No. 15, Chi-nan Rd., Sec.1, Taipei (10051), TAIWAN
Phone:	+886-2-23575864
Fax:	+886-2-23575845
Contact:	Frank Chou / manager

1. Device Name :
  Trade Name: CALTRIX Resorbable Bone Void Filler Bone Void Filler Common Name: Classification name filler, bone void, calcium compound
1. DEVICE CLASS

CALTRIX Resorbable Bone Void Filler have been classified વટ

Regulatory Class: II Product Code: MQV Panel : Orthopedic Regulation Number: 21CFR 888.3045

4. Predicate Device:

The predicate device is the

· Osteo-Link Bone Void Filler Pellets (K060809) marketed by PROMED ADVANCE TECHNOLOGY CO., LTD.

1. Device Description:
  The CALTRIX Resorbable Bone Void Filler are made of high purity pharmaceutical grade calcium sulfate. It is bio-degradable, biocompatible and radiopaque pellets. CALTRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.

Product: Page 1 of 2

CALTRIX Resorbable Bone Void Filler Section 4 - 510(k) Summary REV. [A]

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6. Intended Use:

CALTRIX Resorbable Bone Void Filler is indicated bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or created from traumatic injury to the bone. The pellets resorbs and is replaced with new bone during the healing process. When used in the spine, the device is limited to posterolateral fusion procedures only.

7. Performance Summary:

The device conforms to applicable standards includes ISO 10993 series : Biological evaluation of medical devices , ASTM F2224-03 : Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants & ANSVAAMI/ISO 11137 Sterilization of Health Care Products -Radiation Sterilization ----etc.

8. Conclusions:

The CALTRIX Resorbable Bone Void Filler has the same intended use and technological characteristics as the Osteo-Link Bone Void Filler Pellets (K060809) marketed by PROMED ADVANCE TECHNOLOGY CO., LTD., Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the CALTRIX Resorbable Bone Void Filler is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AG Digital Technology Corp. % Harvest Consulting Corp (USA) Ms. Jennifer Reich 2904 N. Boldt Drive Flagstaff, Arizona 86001

JAN 2 8 2009

Re: K083279

Trade/Device Name: CALTRIX Resorbable Bone Void Filler AG DIGITAL Technology Corp Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: November 6, 2008

Received: November 7, 2008

Dear Ms. Reich:

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. Ryan Massey

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 the reporting 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. Milkeran

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

510(k) Number (if known):

Device Name: CALTRIX Resorbable Bone Void Filler AG DIGITAL Technology Corp.

Indications For Use:

V Prescription Use (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)

Page 1 of 1

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

510(k) Number L033215

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.