OsteoSelect® PLUS DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® PLUS DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® PLUS DBM Putty can be used as follows:

Extremities ●
. Pelvis
Posterolateral spine ●

Device Description

OsteoSelect® PLUS DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® PLUS DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.

AI/ML Overview

This document is a 510(k) premarket notification for the OsteoSelect® PLUS Demineralized Bone Matrix Putty. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and studies for an AI/ML medical device. This is a traditional medical device (bone void filler) and not an AI/ML device, therefore, many of your questions related to AI/ML specific evaluations (e.g., human-in-the-loop performance, effect size of AI assistance, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria (based on the documented performance testing) and the studies that support it.

Here's the breakdown of what can be inferred from the provided text:

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

Acceptance Criteria Category	Reported Device Performance (as inferred from the text)
Biocompatibility	Deemed biocompatible based on prior comprehensive biocompatibility testing performed in accordance with ISO 10993.
Viral Inactivation/Clearance	Process validated to inactivate and/or clear a panel of model human enveloped and non-enveloped viruses, demonstrating suitable viral inactivation potential. Successful inactivation potential of the modified particle size formulation also shown.
Mechanical/Handling	- Extrusion: Tested from a syringe. - Handling Characteristics: Maintained consistent characteristics for the duration of shelf life. - Performance Under Irrigation: Tested. - Cohesiveness: Showed cohesiveness while packing into void spaces. - Adhesion: Handled without sticking to surgical gloves.
Osteoinductive Potential	Each lot tested in a rodent model after gamma sterilization as part of release criteria. The document implies it meets the criteria for osteoinductivity.
Shelf Life	Tested to maintain consistent handling characteristics.
Chemical/Physical Testing	Comprehensive battery of non-clinical chemical and physical testing referenced and relied upon.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for any of the performance tests. The text indicates "each lot of OsteoSelect® PLUS DBM Putty is also tested for osteoinductive potential in a rodent model." This implies ongoing lot-release testing, but the specific number of samples or animals per test is not detailed.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is not an AI/ML device and does not involve human interpretation of outputs that would require establishing a "ground truth" by human experts in the context of diagnostic accuracy.
The "ground truth" for the osteoinductive potential is established through the rodent model, which is a biological assay. The interpretation of these assays is typically done by qualified laboratory personnel, but the number or specific qualifications are not detailed in this submission.

4. Adjudication method for the test set

Not applicable as this is not an AI/ML diagnostic or prognostic device requiring expert adjudication of outputs.

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-assisted diagnostic or prognostic device.

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

Not applicable. This is a physical medical device (bone void filler), not an algorithm.

7. The type of ground truth used

Osteoinductive Potential: The ground truth is established through a rodent model (animal study/biological assay).
Biocompatibility: Established through compliance with ISO 10993 standards, which may involve various in vitro and in vivo tests.
Viral Inactivation: Established through validation studies using model viruses.
Mechanical/Handling: Established through in-house testing against predefined specifications (though the specific specifications are not detailed, only the categories of assessment).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that undergoes "training."

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

Not applicable.

Summary of Studies that Prove the Device Meets Acceptance Criteria:

The document mentions that the device's performance against the acceptance criteria is demonstrated through:

Prior Comprehensive Biocompatibility Testing: Conducted on the predicate device in accordance with ISO 10993. This testing supports the biocompatibility of OsteoSelect® PLUS DBM Putty.
Viral Inactivation/Clearance Validation: Studies that validated the process used to make Demineralized Bone Matrix for its ability to inactivate and/or clear a panel of model human viruses. This included specific validation for the modified particle size formulation of the PLUS version.
Performance Testing (for DBM particle size change): Due to a change in DBM particle size distribution, specific tests were conducted on OsteoSelect® PLUS DBM Putty to evaluate:
- Extrusion from a syringe.
- Maintenance of consistent handling characteristics over shelf life.
- Performance under irrigation.
- Cohesiveness when packing into void spaces.
- Handling without sticking to surgical gloves.
Lot Release Osteoinductive Potential Testing: Each lot of OsteoSelect® PLUS DBM Putty is tested in a rodent model after gamma sterilization to confirm osteoinductive potential.
Referenced Non-Clinical Testing (Chemical, Physical, Animal): The submission references and relies upon a "comprehensive battery" of such tests previously conducted for the OsteoSelect® DBM Putty (predicate device).

In essence, the acceptance criteria are met through a combination of biocompatibility and viral inactivation studies inherited from the predicate device, specific performance testing for the new formulation (especially handling characteristics), and ongoing lot-release testing for osteoinductivity.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized image of three faces in profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the image.

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

August 18, 2015

Bacterin International Incorporated Mr. Howard L. Schraver 600 Cruiser Lane Belgrade, Montana 59714

Re: K150621

Trade/Device Name: OsteoSelect® PLUS Demineralized Bone Matrix Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device. Regulatory Class: Class II Product Code: MQV, MBP Dated: June 17, 2015 Received: June 18, 2015

Dear Mr. Schrayer:

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 Part 807); labeling (21 CFR [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 8091); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)

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Page 2 - Mr. Howard L. Schrayer

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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 vours.

Mark N. Melkerson -S

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) く150621

Device Name

OsteoSelect® PLUS Demineralized Bone Matrix Putty

Indications for Use (Describe)

OsteoSelect® (DBM) Putty is indicated for use as a bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® (DBM) Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

OsteoSelect® (DBM) Putty can be used as follows:

· Extremities
· Posterolateral spine
· Pelvis

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 Bacterin International, Inc OsteoSelect® PLUS Demineralized Bone Matrix Putty

1.0 Manufacturer Name

Bacterin International, Inc. 600 Cruiser Lane Belgrade, MT 59714

2.0 Contact

Howard Schrayer Regulatory Consultant Phone: 609-924-9510 E-mail: hs.ss@verizon.net

3.0 Date Prepared: August 14, 2015

4.0 Device Name and Classification

Proprietary Name:	OsteoSelect® PLUS Demineralized Bone Matrix Putty
Common/Usual Name:	Bone void filler
Classification:	Osteoinductive Bone Void Filler W/O Human Growth Factor
Regulation Number:	21 CFR 888.3045
Device Class:	II
Product Code:	MBP and MQV

5.0 Indications for Use

Extremities ●
. Pelvis
Posterolateral spine ●

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6.0 Device Description

7.0 Predicate Devices

Primary Predicate	OsteoSelect® Demineralized Bone Matrix PuttyBacterin International, Inc.K091321 (use in extremities and pelvis)K130498 (use in posterolateral spine)
References	DBX® MIX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation K063676Progenix Plus Bone Void Filler DeviceMedtronic Sofamor Danek K082002

8.0 Comparison to Predicate Devices

The device characteristics and indications for use of the OsteoSelect® PLUS DBM Putty are similar or the same as the predicate device.

9.0 Biocompatibility and Performance Testing

The 510(k) Notice contains summaries of manufacturing procedures, physical test results, shelf life testing, functionality (efficacy testing) results and biocompatibility testing previously conducted on the OsteoSelect® DBM Putty predicate. OsteoSelect® PLUS DBM Putty was deemed biocompatible based on this prior comprehensive biocompatibility testing performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.

The process used to make Demineralized Bone Matrix for OsteoSelect® DBM Putty was validated for its ability to inactivate and/or clear a panel of model human enveloped and non-enveloped viruses representing DNA- and RNAcontaining viruses and various viral shapes and sizes. This testing demonstrated the process provides suitable viral inactivation potential for a wide spectrum of potential human viruses. Other testing and justification was provided in support of an adequate viral inactivation process with successful inactivation potential of the modified particle size formulation. This inactivation potential provides

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additional viral contamination risk reduction beyond that provided through donor screening and sterilization.

Based on the change to the DBM particle size distribution, OsteoSelect® PLUS DBM Putty was tested to evaluate extrusion from a syringe, maintenance of consistent handling characteristics for the duration of shelf life, performance under irrigation, cohesiveness while packing behavior into void spaces, and handling without sticking to surgical gloves. The results of these evaluations provide evidence supporting the suitability of the device for its intended use.

Each lot of OsteoSelect® PLUS DBM Putty is also tested for osteoinductive potential in a rodent model after gamma sterilization as part of the release criteria.

A comprehensive battery of OsteoSelect DBM Putty non-clinical testing, including chemical, physical, and animal, is additionally referenced and replied upon for the evaluation of the OsteoSelect® PLUS DBM Putty.

Testing has provided a reasonable assurance of safety and efficacy for the intended use of the device, and supports a determination of substantial equivalence.

9.0 Conclusion

Bacterin International, Inc. believes that the information provided establishes that the OsteoSelect® PLUS DBM Putty device is similar with respect to indications for use, design, function, and fundamental scientific technology to legally marketed devices and that there are no new concerns of safety or efficacy. Therefore, it is concluded that the subject device is substantially equivalent to the predicate.

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.