DB-Orthopedics Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Orthopedics is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Description

DB-Orthopedics Bone Void Filler is a moldable, injectable and biocompatible calcium phosphate bone void filler. The DB-Orthopedics kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Orthopedics Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called DB-Orthopedics. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance in a clinical or AI-assisted setting.

Therefore, many of the requested details, such as acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for AI models, are not applicable to this document. This submission is for a material (bone void filler) and relies on physical, chemical, and biocompatibility testing, along with comparison to a predicate device, to demonstrate safety and effectiveness.

However, I can extract information related to the device's technical specifications and the tests performed to support its substantial equivalence, which can be presented in a similar format to what you requested for acceptance criteria and performance data.

Here's the closest representation of the requested information based on the provided text:

Acceptance Criteria and Device Performance for DB-Orthopedics (based on provided 510(k) Summary)

This 510(k) submission for DB-Orthopedics focuses on demonstrating substantial equivalence to a predicate device (Callos™ Bone Void Filler, K051123) and expanding the indications for use of a previously cleared device (DB-Cranial Bone Void Filler, K182742). The "acceptance criteria" here refer to meeting established standards and demonstrating similar performance characteristics to the predicate, rather than an AI-driven performance metric.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance
Working Time (In Vitro)	Sufficient manipulation time for operative theater, meeting cement setting-times.	Ensures sufficient manipulation time is provided while also ensuring cement setting-times are met in the operative theater. (Performance aligns with criteria)
Setting Time	Bone void filler sets within simulated physiological conditions.	Measures the time for bone void filler to set in simulated physiologic conditions. (Performance measurement aligns with criteria)
Ca to P Ratio	Consistent and appropriate Calcium to Phosphorus ratio (e.g., similar to predicate/HA).	DB-Orthopedics has a ratio of 1.5. (Specific ratio reported)
Heavy Metal Analysis	Below trace limits as per ASTM F1185-03.	Samples analyzed for trace heavy metal content using ICP-MS, according to ASTM F1185-03. (Compliance with standard implied)
pH Profile	Minimal or acceptable effect on pH surrounding the implanted device.	Examines effects of the device on pH surrounding the implanted device. pH is measured in physiologic buffer solutions surrounding curing cements. (Test performed)
FTIR Analysis	Chemical composition similar to predicate device after curing.	Identifies the chemical composition of subject and predicate device following curing in simulated physiologic conditions. (Comparison performed)
Crystallographic Analysis (XRD)	Formation of expected crystalline structure (e.g., hydroxyapatite).	XRD analysis performed with samples set in simulated physiologic conditions, evaluated using powder x-ray diffraction and compared against known mineralogic standards. (Test performed, hydroxyapatite crystal formation confirmed under "Physical Form")
Temperature Profile	Acceptable temperature rise during curing.	Device samples tested in simulated physiologic solutions to measure temperature of curing cement. (Test performed)
Solubility and Dissolution	Acceptable solubility and dissolution rate to allow for bone replacement.	Test samples are cured and incubated at simulated physiological conditions for a specified time and measured for solubility and dissolution. (Test performed)
Tensile Testing	Acceptable mechanical strength, comparable to predicate.	Test samples mixed and cured for 24 hours at simulated temperature and pH. Tensile testing performed, load at breakage recorded and compared. (Test performed)
Dimensional Stability	Maintains shape and does not dissolve in an untimely manner.	Dimensional stability measured to establish that bone void fillers maintain shape and do not dissolve in an untimely manner. (Test performed)
Physical Form	Exhibits expected microstructure (e.g., hydroxyapatite crystal formation).	Test samples imaged by SEM to determine microstructure. Testing confirmed hydroxyapatite crystal formation. (Confirmed)
Biocompatibility	Biocompatible, no adverse biological reactions.	No biocompatibility studies needed as no changes from original submission were made and substantial equivalence demonstrated. (Relies on prior clearance)
Pyrogenicity	Non-pyrogenic.	Pyrogenicity (LAL) testing routinely performed on the product. (Routinely confirmed)
Sterilization and Shelf Life	Sterile (SAL of 10^-6) and stable for stated shelf life.	Sterilization method is gamma radiation (ISO 11137-2:2013 VDMax25). Labeled with a shelf life of 30 months. (Validation performed/stated)

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

Sample Size: Not explicitly stated for each test, but standard material testing involves multiple samples to ensure reproducibility and statistical significance.
Data Provenance: The tests are described as in vitro and ex vivo (simulated physiological conditions). The data would be derived from laboratory experiments conducted by Dimensional Bioceramics, LLC. No country of origin for the specific testing data is mentioned, but the company is based in Santa Cruz, CA, USA.
Retrospective/Prospective: The testing described appears to be prospective, performed specifically for this 510(k) submission to characterize the device.

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

Not applicable. This submission does not involve an AI diagnostic device requiring expert interpretation of medical images. Ground truth for material characteristics is established through established scientific methods and instrumentation (e.g., ICP-MS for elemental analysis, XRD for crystallography).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described as it's not a diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a bone void filler product, not a diagnostic imaging device, so MRMC studies are not relevant.

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

Not applicable. This device is a material, not an algorithm.

7. The Type of Ground Truth Used

For the physical and chemical tests, the "ground truth" is based on:
- Scientific Standards: Adherence to established ASTM or ISO standards (e.g., ASTM F1185-03, ISO 11137-2:2013).
- Instrumental Analysis: Data directly from scientific instruments (e.g., ICP-MS, FTIR, XRD, SEM).
- Comparison to Predicate: Performance alignment with the already cleared predicate device (Callos™ Bone Void Filler).
For biological aspects (biocompatibility, pyrogenicity), the "ground truth" relies on prior successful validation and routine testing, ensuring the material itself does not elicit harmful biological responses.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The "training" for this device comes from the established knowledge of the materials science for bone void fillers and the manufacturing processes validated through quality systems.

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

Not applicable. As above, no training set in the AI sense applies here. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements (e.g., Good Manufacturing Practices, ISO standards). The device is stated to be composed of "identical material" and manufactured by "identical processes" as a previously cleared reference device (DB-Cranial, K182742), indicating that prior validation and historical data serve as the "ground truth" for its production.

Summary

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Dimensional Bioceramics, LLC % Patsy Trisler Regulatory Consultant Trisler Consulting 7949 Beaumont Green East Dr Indianapolis, Indiana 46250

Re: K200752

Trade/Device Name: DB-Orthopedics Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: March 17, 2020 Received: March 23, 2020

Dear Patsy 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part

April 22, 2020

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200752

Device Name

DB-Orthopedics

Indications for Use (Describe)

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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510(k) Summary – K200752

I. SUBMITTER
Submitter Name:	Dimensional Bioceramics, LLC
SubmitterAddress:	2161 Delaware Ave., Suite ASanta Cruz, CA 95060
Contact Person:Phone Number:	Duran N. Yetkinler, M.D., Ph.D.408-757-6603
Date Prepared:	March 17, 2020
II. DEVICE
Trade Name:	DB-Orthopedics Bone Void Filler
Common Name	Bone Void Filler
ClassificationName NumberProduct CodeRegulatoryClass	Resorbable calcium salt bone void filler device21 CFR 888.3045MQVClass 2
III. PREDICATE DEVICE
PrimaryPredicateDevice:	K051123, Callos™ Bone Void Filler, Skeletal Kinetics
ReferenceDevice:	K182742, DB-Cranial Bone Void Filler, Dimensional Bioceramics, LLC
IV. INDICATIONS FOR USEThis submission expands the indications for use of the DB-Cranial 510(k) (ReferenceDevice K182742) clearance to orthopedics.
Indications forUse Statement	DB-Orthopedics Bone Void Filler is indicated to fill bony voids orgaps of the skeletal system (i.e. extremities, spine, pelvis). Thesedefects may be surgically created osseous defects or osseousdefects created from traumatic injury to the bone. DB-Orthopedicsis indicated only for bony voids or gaps that are not intrinsic to thestability of the bony structure. The product provides a bone voidfiller that resorbs and is replaced by bone during the healingprocess.
V. DEVICE DESCRIPTION
DeviceIdentification	DB-Orthopedics Bone Void Filler is a moldable, injectable andbiocompatible calcium phosphate bone void filler. The DB-Orthopedics kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities,which will be mixed together prior to implantation.
TechnologicalCharacteristics	The 3 cc, 5 cc, and 10 cc DB-Orthopedics Bone Void Filler kits areprovided sterile to SAL of 10-6 and are for single use only.
VI. PERFORMANCE TESTING
Test	Test Method Summary
Working TimeIn Vitro	Ensures sufficient manipulation time is provided while also ensuringcement setting-times are met in the operative theater.
Setting Time	This test measures the time for a bone void filler to set in simulatedphysiologic conditions.
Ca to P Ratio	This test determines CA/P ratios via ICP-MS. DB-Orthopedics has aratio of 1.5.
Heavy MetalAnalysis	Samples are analyzed for trace heavy metal content using ICP-MS,according to ASTM F1185-03
pH Profile	Examines effects of the device on pH surrounding the implanteddevice. pH is measured in physiologic buffer solutions surroundingcuring cements.
FTIR Analysis	This test identifies the chemical composition of subject and predicatedevice following curing in simulated physiologic conditions.
CrystallographicAnalysis	XRD analysis is performed with samples set in simulated physiologicconditions for specified times and evaluated using powder x-raydiffraction and compared against known mineralogic standards.
TemperatureProfile	Device samples are tested in simulated physiologic solutions tomeasure temperature of curing cement.
Solubility andDissolution	Test samples are cured and incubated at simulated physiologicalconditions for a specified time and measured for solubility anddissolution.
Tensile Testing	Test samples were mixed and cured for 24 hours at simulatedtemperature and pH. Tensile testing was performed using amechanical tester and load at sample breakage was recorded andcompared.
DimensionalStability	Dimensional stability is measured to establish that the bone voidfillers maintain shape and do not dissolve in an untimely manner.
Physical Form	Test samples were imaged by SEM to determine microstructure.Testing confirmed hydroxyapatite crystal formation.
Biocompatibility	No biocompatibility studies were needed to demonstrate substantialequivalence. No changes to the product were made from theoriginal submission.
Pyrogenicity	Pyrogenicity (LAL) testing is routinely performed on the product.
Sterilization andShelf Life	The sterilization method is gamma radiation. Sterilization validationis based on ISO 11137-2:2013 (VDMax25).DB-Orthopedics Bone Void Filler will be labeled with a shelf life of 30months.
Animal Testing	No animal studies were needed to demonstration substantial equivalence.
Clinical Testing	This product category does not require human clinical testing.

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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

DB-Orthopedics Bone Void Filler's intended use and critical specifications are identical to the predicate device, Skeletal Kinetics' Callos™ Bone Void Filler, K051123.

Further, this product is composed of the identical material, and is manufactured and packaged by the identical processes and in the identical facility, as the recently cleared Reference Device, K182742.

There are no notable differences in comparison to the predicate device, therefore, no questions related to safety and effectiveness were raised.

VIII. CONCLUSIONS

Based on the comparisons provided and the data submitted in this 510(k), it can be concluded the DB-Orthopedics is substantially equivalence to Callos™ predicate device.

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.