The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Device Description

The Mixing and Delivery System is used to mix graft material such that it can be delivered to the patient. The system is comprised of the mixing/delivery syringe and auxiliary components including a threaded spindle with nut, open bore luer cap, pusher and cannulae which provide alternative methods of delivery for the mixed material.

AI/ML Overview

This document describes the 510(k) premarket notification for the "Mixing and Delivery System" by Bone Solutions, Inc. The document is a review of the device for substantial equivalence to legally marketed predicate devices. It does not provide detailed information about clinical studies or specific acceptance criteria for AI/ML device performance.

Based on the provided text, here is an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" in the context of device performance as one might expect for an AI/ML algorithm. Instead, it lists non-clinical performance testing conducted to demonstrate that the device performs as intended and met all specified criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Device should not leak liquids or air	The Mixing and Delivery System met all specified criteria
Device components should not separate under axial load	The Mixing and Delivery System met all specified criteria
Device components should not disconnect under torsional forces	The Mixing and Delivery System met all specified criteria
Device should maintain sterility	The Mixing and Delivery System met all specified criteria
Device packaging should maintain integrity	The Mixing and Delivery System met all specified criteria

Note: The phrase "met all specified criteria" indicates that the device performed acceptably against these tests, implying these were the "acceptance criteria" for these particular tests. The document does not provide specific quantitative thresholds for these criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document pertains to a medical device (a mixing and delivery system for bone graft material), not an AI/ML diagnostic or prognostic algorithm. Therefore, the concepts of "test set," "sample size," and "data provenance" in the context of image data or patient data are not applicable here. The testing mentioned is engineering/performance testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device involving expert adjudication for a test set.

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 is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The ground truth for the performance tests (Liquid and Air Leak Testing, Separation from Axial Load Testing, Disconnection Torsional Testing, Sterility Validation Testing and Packaging Validation Testing) would be based on established engineering standards and specifications, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm that requires a training set or ground truth for training.

Summary

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February 18, 2020

Bone Solutions, Inc. % Karen E. Warden, Ph.D. President BackRoads Consulting Incorporation Po Box 566 12520 Heath Road Chesterland, Ohio 44026

Re: K192674

Trade/Device Name: Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 21, 2020 Received: January 23, 2020

Dear Dr. Warden:

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.

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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); 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 mediation-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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192674

Device Name Mixing and Delivery System

Indications for Use (Describe)

The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical 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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510(k) Summary

Date:	11 February 2020
Sponsor:	Bone Solutions, Inc.5712 Colleyville Blvd, STE 210Colleyville, TX 76034
Sponsor Contact:	Drew Diaz, CEOOffice: 817.809.8850customerservice@bonesolutions.net
510(k) Contact:	Karen E. Warden, PhDPresident, BackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457info@followbackroads.com
Proposed Trade Name:	Mixing and Delivery System
Common Name:	Piston syringe
Device Classification:	Class II
Regulation Name,Regulation Number,Product Code:	Piston syringe, 880.5860, FMF
Submission Purpose:	To add auxiliary components to the cleared Bone Solutions Mixing andDelivery System components.
Device Description:	The Mixing and Delivery System is used to mix graft material such that itcan be delivered to the patient. The system is comprised of themixing/delivery syringe and auxiliary components including a threadedspindle with nut, open bore luer cap, pusher and cannulae which providealternative methods of delivery for the mixed material.
Indications for Use:	The Mixing and Delivery System is intended to be used for the delivery ofhydrated allograft, autograft, or synthetic bone graft material to anorthopedic surgical site.
Primary Predicate:	Bone Solutions Mixing and Delivery System (Bone Solutions, Inc. -K161568)
Reference Devices:	InFill™ Graft Delivery System (Pinnacle Spine Group - K143488), ETEXMixing and Delivery System (ETEX Corporation - K141245)
Performance Data:	The following non-clinical performance testing was performed todemonstrate the device performs as intended:Liquid and Air Leak TestingSeparation from Axial Load TestingDisconnection Torsional TestingSterility Validation Testing and Packaging Validation TestingThe Mixing and Delivery System met all specified criteria and did not raisenew safety or performance questions.
SubstantialEquivalenceComparison:	The subject Mixing and Delivery System components possess the sameindications for use and technological characteristics as the predicatedevices and/or reference devices as shown below.

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System →Features↓	Subject device: BoneSolutions Mixing andDelivery SystemK192674	Primary predicate: BoneSolutions Mixing andDelivery SystemK161568	Reference device: InFill™Graft Delivery SystemK143488
Indicationsfor Use:	The Mixing and DeliverySystem is intended to beused for the delivery ofhydrated allograft,autograft, or synthetic bonegraft material to anorthopedic surgical site.	The Bone Solutions Mixingand Delivery System isintended to be used for thedelivery of hydratedallograft, autograft, orsynthetic bone graftmaterial to an orthopedicsurgical site.	The InFill™ Graft DeliverySystem is intended to beused for the delivery ofhydrated allograft, autograftor synthetic bone graftmaterial to an orthopedicsurgical site
Basicdesign	Piston syringe with auxiliarycomponents	Piston syringe with auxiliarycomponents	Piston syringe with auxiliarycomponents
Material	Medical grade polymers	Medical grade polymers	Medical grade polymers
Principle ofoperation	Mix and deliver graftmaterial	Mix and deliver graftmaterial	Mix and deliver graftmaterial
Howsupplied	Sterile, single use only	Sterile, single use only	Sterile, single use only
Syringe	Piston	Piston	Piston
Plunger	Axial push or helical screw	Axial push	Helical screw
Tip	Luer	Luer	Luer
Volume	14cc	14cc	14cc
Cannula	Luer & open bore threaded	Luer & open bore threaded	Luer & open bore threaded
Length	100 & 150mm	-- NA --	150, 275 & 300mm
Diameter	4.3 & 8.0mm	4.3 & 8.0mm	3.5, 4.8 & 8.0mm
Accessories	Mixing plunger, funnel	Mixing plunger, funnel	Mixing plunger, funnel

Substantial Equivalence Conclusion:

Bone Solutions has demonstrated that the Mixing and Delivery System possesses the same intended use and technological characteristics as the predicate devices. Therefore the Mixing and Delivery System is substantially equivalent for its intended use.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).