Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and biocompatible and may be used in an infected site.

Device Description

Dimensional Bioceramics (DB) Calcium Sulfate Device (CSD) [DB-CSD] Bone Void Filler Kit is provided sterile for single patient use. The Kit contains medical grade calcium sulfate powder and mixing solution in pre-measured quantities. When mixed together in a sterile mixing bowl, the resultant paste may be injected, digitally implanted, or applied to a mold to produce pellets. DB-CSD resorbs and is replaced with bone during the healing process. DB-CSD is a moldable, biocompatible, biodegradable, and resorbable calcium sulfate material that is to be applied directly to the intended sites. It may be used within an infected site. The critical specifications are chemistry, crystallinity, physical form, porosity, and solubility.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Dimensional Bioceramics Calcium Sulfate Device (DB-CSD), which is a bone void filler. It details the device's characteristics, indications for use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device.

However, the provided text does not describe:

Acceptance criteria in the context of a statistical study with specific numerical thresholds for performance metrics (e.g., sensitivity, specificity, F1-score).
Performance metrics for an AI/algorithm-based device.
Details about a test set, including its sample size, data provenance, ground truth establishment by experts, or adjudication methods.
Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness studies involving human readers and AI assistance.
Standalone algorithm performance.
Training set details (sample size, ground truth establishment).

The "Summary of Testing" section primarily focuses on:

Laboratory Testing: Comparison of critical specifications (chemistry, crystallinity, physical form, porosity, solubility) of DB-CSD with a predicate device through various analytical techniques (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, ICP-AES). The acceptance criterion here is substantially equivalent to the predicate device.
Biocompatibility Testing: Demonstrated DB-CSD met the requirements of ISO 10993-1. The acceptance criterion is meeting these ISO standards.
Pyrogenicity Testing: ISO Materials Mediated Rabbit Pyrogen testing showed DB-CSD is non-pyrogenic. The acceptance criterion is non-pyrogenic.
Sterilization and Shelf-Life Testing: Validated radiation dose in accordance with ISO 11137-2006 to a Sterility Assurance Level (SAL) 10-6. The acceptance criterion is achieving SAL 10-6.
Animal Testing: An ovine model study analyzed biocompatibility, implant resorption, bone formation, and surgical handling. The results indicated biocompatibility, complete resorption, and normal bone healing. The acceptance criteria relate to these biological outcomes being comparable to the predicate device.
Clinical Testing: Explicitly states "N/A: This product type does not require clinical testing."

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance and clinical study design for an AI device because this document pertains to a resorbable calcium salt bone void filler device, which is a physical medical device, not an AI or imaging diagnostic device.

If you have a document describing an AI/algorithm-based medical device study, I would be happy to analyze it according to your criteria.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Dimensional Bioceramics™ LLC % Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue #509 Chevy Chase, Maryland 20815

September 25, 2017

Re: K171161

Trade/Device Name: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: August 14, 2017 Received: August 17, 2017

Dear Ms. Trisler:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Katherine D. Kavlock -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171161

Device Name Dimensional Bioceramics Calcium Sulfate Device (DB - CSD)

Indications for Use (Describe)

Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and may be used in an infected site.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K171161 510(k) SUMMARY DB-CSD

I. SUBMITTER
Submitter Name:	Dimensional Bioceramics™ LLC
Submitter Address:	163 McKenzie Creek RoadScotts Valley, CA 95066
Contact Person:Telephone #:	David Delaney, Director831.234.4892
Date Prepared:	August 14, 2017
II. DEVICE
Device Trade Name:	Dimensional Bioceramics Calcium Sulfate Device(DB-CSD)
Regulatory Name(s):	Resorbable Calcium Sulfate Bone Void Filler
Classification #:	21 CFR 888.3045
Product Code:	MQV
III. PREDICATE DEVICE(s)	K141830, Stimulan Rapid Cure, Biocomposites, Ltd.
IV. DEVICE DESCRIPTION
Device Identification,Characteristics,Mechanism of Action:	Dimensional Bioceramics (DB) Calcium Sulfate Device(CSD) [DB-CSD] Bone Void Filler Kit is provided sterilefor single patient use. The Kit contains medical gradecalcium sulfate powder and mixing solution in pre-measured quantities. When mixed together in a sterilemixing bowl, the resultant paste may be injected, digitallyimplanted, or applied to a mold to produce pellets.DB-CSD resorbs and is replaced with bone during thehealing process.DB-CSD is a moldable, biocompatible, biodegradable,and resorbable calcium sulfate material that is to beapplied directly to the intended sites. It may be usedwithin an infected site.The critical specifications are chemistry, crystallinity,physical form, porosity, and solubility.
V. INDICATIONS FOR USE	Dimensional Bioceramics™ (DB) Calcium Sulfate Device(CSD) is a bone graft substitute that is intended for useas a bone void filler for voids and gaps and pelvis thatare not intrinsic to the stability of the bony structure.These osseous defects may be surgically created orcreated from a traumatic injury to the bone. DB-CSD isintended to be gently packed into bony voids or gaps ofthe skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replacedwith bone during the healing process. DB-CSD isbiodegradable and biocompatible and may be used in aninfected site.
VI. SUMMARY OF TESTING[PERFORMANCE DATA]	Performance, Safety and Biocompatibility test data areprovided in the 510(k) application. They include thefollowing:
Laboratory Testing	Critical specifications (chemistry, crystallinity, physicalform, porosity, and solubility) of DB-CSD were comparedwith those of the predicate device. Chemistry wasdetermined by Fourier Transformed InfraredSpectroscopy (FTIR) and X-ray Diffraction (XRD)techniques. Crystallinity was determined by X-rayDiffraction. Physical form was determined by ScanningElectron Microscopy. Porosity was determined byMercury Intrusion Porosimetry. Solubility was measuredin vitro dissolution method measuring Ca2+ ionconcentration in solution using Inductively CoupledPlasma - Atomic Emission Spectroscopy.
Biocompatibility Testing:	Biocompatibility tests, according to ISO 10993-1 wereperformed and are provided in the 510(k)documentation. They demonstrated DB-CSD met therequirements of the ISO standards.
Pyrogenicity Testing:	ISO Materials Mediated Rabbit Pyrogen testing wasperformed and provided in the 510(k). The results of thetesting indicate the DB-CSD is non-pyrogenic.
Sterilization and Shelf-LifeTesting	DB-CSD will be provided as a single use, sterile medicaldevice. The radiation dose of 25k Gy-40 kGy has beenvalidated in accordance with ISO 11137-2006,Sterilization of Health Care Products - Radiation toSterility Assurance Level (SAL) 10-6.
Animal Testing:	An animal study was performed to analyze thebiocompatibility, implant resorption, bone formation, andsurgical handling properties following metaphysealimplantation in an ovine, critical size, cancellous bonedefect model. No abnormal acute hematologic andmajor organ toxicity was observed in both subject andpredicate devices. Histological and radiographic datademonstrated that both materials appeared to be
	biocompatible, and complete resorption of the implantedregions, followed by normal bone healing occurred forboth subject and predicate devices by 12 weeks.
Clinical Testing:	N/A: This product type does not require clinical testing.
VII. COMPARISON OFTECHNOLOGICALCHARACTERISTICS WITHTHE PREDICATE DEVICE	DB-CSD intended use and critical specifications aresubstantially equivalent to the predicate device, StimulanRapid Cure of Biocomposites Ltd (K141830).
	Both medical devices are composed of a hydratedcalcium sulfate salt that is implanted following mixingwith a solution component that yields 5, 10, or 20 cc.
	Performance test results demonstrated that DB-CSD hassubstantially equivalent critical specifications (chemistry,crystallinity, physical form, porosity, and solubility) as thepredicate device, Stimulan Bone Void Filler.
VIII. CONCLUSIONS	Based on the comparison provided and the datasubmitted in the 510(k), it can be concluded the DB-CSDis substantially equivalent to the predicate device,Stimulan - Rapid Cure Bone Void Filler (K141830).

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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.