CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other bone Gallwathx Calcium Oulfato Drives of maxillary and mandibular osseous and periodontal defects such as:

Intrabony/infrabony defects .
Furcation defects .
Recession defects .
Dehiscence/fenestration defects (natural teeth and prosthetic root form implants) ●
Extraction socket (ridge preservation) defects .
Ridge augmentation defects .
Sinus lift defects .
Endodontic bony defects .

Device Description

Lifecore Biomedical Calcium Sulfate Bone Graft Binder (CalMatrix) is a calcium sulfate material that contains resorbable surgical grade plaster of paris with approximately 10% of a pharmaceutical grade sodium carboxymethylcellulose (CMC).

The Binder is a white, free-flowing powder. Calcium sulfate (CS) hemihydrate and PHARMACEUTICAL grade sodium carboxymethylcellulose are commercially available as raw materials for use in several orthopedic and dental devices. Calcium sulfate/CMC, when used in conjunction with demineralized bone matrix (DBM), controls the particles in the bony defect where bony walls may be insufficient to stabilize the graft. It increases the graft volume, and reduces particle migration during the early healing phase. CalMatrix remains pliable after mixing which allows the clinician an extended time period to complete the bone regeneration procedure.

AI/ML Overview

The CalMatrix™ Calcium Sulfate Bone Graft Binder 510(k) submission (K041324) does not present acceptance criteria or a study directly proving the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices. Instead, the submission focuses on establishing substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not define specific quantitative acceptance criteria or present a table of device performance against such criteria. The "performance data" section describes animal studies confirming biocompatibility and new bone growth, but these are not framed as meeting pre-defined acceptance criteria.

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

Test Set Sample Size: Not applicable. There isn't a "test set" in the context of evaluating a diagnostic or AI device's performance metrics. The "animal studies" involved "animal models," but the specific number of animals or defects is not provided.
Data Provenance: The animal studies were conducted using calcium sulfate/CMC with and without DBM. The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective to evaluate the biocompatibility and bone growth response of the material. "Clinical use of this product was evaluated in animal and human studies," but details on the human studies are not provided in this summary.

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

Not applicable. There is no "ground truth" establishment in the context of diagnostic assessment for this type of device submission. The animal studies would likely have involved veterinary pathologists or orthopedic surgeons assessing findings.

4. Adjudication Method for the Test Set

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

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

Not applicable. This type of study is relevant for evaluating human reader performance with and without AI, which is not the focus of this device submission.

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

Not applicable. This is not an AI/algorithm-driven device.

7. Type of Ground Truth Used

For the animal studies, the "ground truth" would implicitly be histopathology and radiographic assessment to confirm "new bone growth" and "no inflammatory or foreign body response."

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-driven device that requires a training set.

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

Not applicable.

Summary of the Device's "Proof" of Meeting "Acceptance Criteria" (Substantial Equivalence Approach):

The "acceptance criteria" for the CalMatrix™ Calcium Sulfate Bone Graft Binder are implicit in the substantial equivalence pathway for FDA 510(k) clearance. The manufacturer's proof that the device meets these (unwritten) criteria is based on:

Technological Characteristics Comparison: CalMatrix is composed of calcium sulfate hemihydrate with carboxymethylcellulose (CMC). It is compared to:
- CAPSET Calcium Sulfate Bone Graft Barrier (K955096): Also composed of calcium sulfate hemihydrate.
- ALLOMATRIX® Putty (K020895): Utilizes the same calcium sulfate (CS)/CMC blend.
  The primary difference is that ALLOMATRIX comes pre-mixed with DBM, while CalMatrix is mixed by the clinician. The submission argues they are substantially equivalent in "mechanical characteristics, product configuration, anatomical site, safety characteristics, and sterilization."
Intended Use Comparison: The indications for use for CalMatrix are explicitly stated as "the same as CAPSET" and are for treating multiple types of maxillary and mandibular osseous and periodontal defects.
Performance Data (Biocompatibility and Bone Growth):
- Animal Studies: These studies demonstrated that the materials (calcium sulfate/CMC, with and without DBM) were well tolerated, showing "no inflammatory or foreign body response," and "substantial new bone growth" in filled defects. While not providing specific quantitative acceptance thresholds, these findings support the material's safety and efficacy for its intended use, aligning with the expected performance of predicate devices.
- Historical Use: The submission heavily relies on the "well-documented" historical use and established biocompatibility of calcium sulfate (Plaster of Paris) and the widespread use and known biocompatibility of sodium carboxymethylcellulose (CMC) in medical devices. This serves as a significant part of the "proof" for safety and general expected performance.
Conclusion of Equivalence: The manufacturer concludes that the data supports substantial equivalence based on indications for use, product design and configuration, and materials used, directly comparing it to the specified predicate devices.

In essence, the "study" demonstrating that CalMatrix meets its "acceptance criteria" is the presentation of comparative analysis, biocompatibility data from animal studies, and reliance on the long-standing safety and efficacy profile of its constituent materials (calcium sulfate and CMC) in comparison to predicate devices, rather than a prospective study against novel, quantitatively defined performance metrics.

Summary

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LIFECORE BIOMEDICAL, INC. CalMatrix™ Calcium Sulfate Bone Graft Binder

Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K04132U". The characters are written in black ink on a white background. The characters are all uppercase, and they are all the same size.

Section 12: Premarket Notification 510(k) Summary

JUL 1 9 2004

Submitter's Name / Contact Person 1.

Kim E. Aves Regulatory Affairs Manager Lifecore Biomedical, Inc. 952-368-6324 Ph:

2. General Information

Trade Name	CalMatrix Calcium Sulfate Bone Graft Binder• 0.173g CalMatrix Binder - for use with 0.25cc of bone graftmaterial• 0.345g CalMatrix Binder - for use with 0.5cc of bone graftmaterial• 0.690g CalMatrix Binder - for use with 1.0cc of bone graftmaterial
Common / Usual Name	Surgical Grade Calcium Sulfate (Plaster of Paris)/CMC
Classification Name	None (unclassified)No formal classification of Calcium Sulfate or Plaster of Paris hasbeen determined. Reference FDA Publication 91-4246.
Identification ofEquivalent Devices	CAPSET Calcium Sulfate Bone Graft Barrier (K955096)ALLOMATRIX® Putty (K020895)

3. Device Description

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LIFECORE BIOMEDICAL, INC. CalMatrix™ Calcium Sulfate Bone Graft Binder

4. Intended Use

CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other Calivianx Gulolan Gallato Don't sed to treat multiple types of maxillary and mandibular osseous and periodontal defects such as:

Intrabony/infrabony defects .
Furcation defects .
Recession defects .
Dehiscence/fenestration defects (natural teeth and prosthetic root form . implants)
Extraction socket (ridge preservation) defects .
Ridge augmentation defects .
Sinus lift defects .
Endodontic bony defects .

After site preparation in the usual manner, select an appropriately sized package of CalMatrix Binder to go with the quantity of bone graft material of choice selected to treat the defect size. Combine the two dry ingredients, add the syringe liquid provided in the CalMatrix package and mix. Place the composite graft into the prepared defect site and suture the soft tissue flaps back in the usual manner or as indicated by clinical expertise. The graft material may be aovered by a barrier or membrane prior to suture placement if, in the judgment of the clinician, it is indicated.

5. Technological Characteristic Comparisons

Both CalMatrix and CAPSET are composed of calcium sulfate hemihydrate, with the CalMatrix grade exception that carboxymethylcellulose (CMC). CalMatrix and ALLOMATRIX utilize the same calcium sulfate (CS)/CMC blend, except that ALLOMATRIX is provided with human demineralized bone matrix (DBM) already mixed in. CalMatrix is to be mixed with DBM or other bone graft material by the clinician prior to application. CalMatrix is also substantially equivalent to the predicate devices in terms of mechanical characteristics, product configuration, anatomical site, safety characteristics, and sterilization.

6. Performance Data

Animal studies were conducted using calcium sulfate/ CMC and demineralized bone and as well as CS/cellulose with no DBM. All the test materials were well tolerated with no inflammatory or foreign body response in the animal models. Substantial new bone growth was shown in the filled defects at follow-up. Clinical use of this product was evaluated in animal and human studies.

7. Biocompatibility

The historical use of calcium sulfate as a bone substitute is well documented in the medical literature. Plaster of Paris (calcium sulfate hemihydrate) may be the oldest bone substitute material in continuous use. Its biocompatibility has been well established.

Sodium carboxymethylcellulose (CMC) is in widespread use in a variety of industries including foods, cosmetics, medical devices and pharmaceuticals. Recent studies have

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LIFECORE BIOMEDICAL, INC. CalMatrix™ Calcium Sulfate Bone Graft Binder

reported no inflammatory response or other adverse effects on bone healing associated with the use of CMC.

Both calcium sulfate and CMC have been shown to be biocompatible materials that are well tolerated in the oral environment for use in guided bone regeneration.

8. Conclusion (statement of equivalence)

The data submitted in this 510(k) supports substantial equivalence of Lifecore CalMatrix to the following commercially marketed devices:

Lifecore CAPSET Calcium Sulfate Bone Graft Barrier (K955096), Lifecore . Biomedical, Inc.
ALLOMATRIX® Putty (K020895), Wright Medical Technology, Inc. .

Substantial equivalence is based on the indications for use, product design and configuration, and materials used. The intended use of CalMatrix is the same as CAPSET, and the materials used are the same as those found in ALLOMATRIX (with the exception that the human demineralized bone matrix is added prior to application). The comparative analysis demonstrates the substantial equivalence of Lifecore CalMatrix to the predicate devices in commercial distribution.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2004

Ms. Kim E. Aves Regulatory Affairs Manager Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318-3051

Re: K041324

Trade/Device Name: CalMatrix™ Calcium Sulfate Bone Graft Binder Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LYC Dated: May 17, 2004 Received: May 18, 2004

Dear Ms. Aves:

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 de ices 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 (ГМА). 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.

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Page 2 -Ms. Aves

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.

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 (301) 594-4518. 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,

Clubs

Shin-Ling, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041324

CalMatrix™ Calcium Sulfate Bone Graft Matrix Device Name: Indications for Use:

Indications For Use:

CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other bone Gallwathx Calcium Oulfato Drives of maxillary and mandibular osseous and periodontal defects such as:

Intrabony/infrabony defects .
Furcation defects .
Recession defects .
Dehiscence/fenestration defects (natural teeth and prosthetic root form implants) ●
Extraction socket (ridge preservation) defects .
Ridge augmentation defects .
Sinus lift defects .
Endodontic bony defects .

After site preparation in the usual manner, select an appropriately sized package of Aller Site preparation in the quantity of bone graft material of choice selected to treat Califiative billion to go we the wo dry ingredients, add the syringe liquid provided in the the detect size. Oombine the most the composite graft into the prepared defect site and Galliating package and mix. Thate the usual manner or as dictated by clinical expertise. Suture the soft lised hape backed by a barrier or membrane prior to suture placement if, in the judgment of the clinician, it is indicated.

AND/OR Prescription Use / (Part 21 CFR 801 Subpart D)

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)

Robert S. Betz DDS for Dr. Susan Rummer

nesthesiology. General Hospital. Control. Dental Devices 510(k) Number:

Page 1 of

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.