Orthocon Montage-QS Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-QS is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.

When hardened in situ, Montage-QS may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.

Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during process.

Device Description

Montage-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The Montage-QS device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage-QS device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device called Montage-QS Settable, Resorbable Bone Putty. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain acceptance criteria or a detailed study of the device proving it meets specific acceptance criteria in the format requested.

The document primarily focuses on establishing substantial equivalence to previously cleared devices. It mentions some performance data from an animal study and in-vitro testing but not in the context of acceptance criteria. The requested information regarding sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies for a device approval study is not present. This type of detailed study design and results would typically be found in a separate, more comprehensive study report, not a 510(k) summary for a device like a bone void filler which primarily relies on substantial equivalence.

Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document describes a comparison study in rabbits that assessed new bone formation and implant material remaining, but this is presented as efficacy evaluation and not in the context of a formal acceptance criteria study typically seen for AI/software devices.

Here's what can be extracted and what is missing based on the provided text:

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

Cannot be provided. The document does not specify quantified acceptance criteria (e.g., "new bone formation must be > X%") for regulatory approval in the way an AI/software device might. It simply presents the results of an animal study comparing the new device to a predicate.

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

Sample Size: Not explicitly stated as a "test set" sample size. The animal study involved a "Montage-QS group," a "HydroSet predicate group," and an "empty defect negative control group." The number of animals in each group is not provided.
Data Provenance: An animal study (rabbit critical sized femoral defect model). Country of origin is not specified. It is a prospective study as it involved implanting devices and observing outcomes.

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 a hardware device (bone putty), not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is biological outcomes (new bone formation, material resorption) assessed via micro-CT and histopathology/histomorphometry. The qualifications of the personnel performing these assessments are not mentioned.

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

Not applicable. This concept pertains to human review of AI outputs, which is not relevant for this device.

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

No. This is not an AI device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for the animal study (efficacy evaluation) was based on micro-CT and histopathology/histomorphometry assessments to quantify device resorption and new bone formation.

8. The sample size for the training set

Not applicable / Not mentioned. This is not an AI device that would have a training set.

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

Not applicable. This is not an AI device.

Summary of available "performance" data (not acceptance criteria):

Measurement Aspect	Montage-QS Group (Device)	HydroSet Group (Predicate)	Empty Defect Control Group
New Bone Formation (12 weeks)	17.2%	12.4%	10%
Implant Material Remaining (12 weeks)	~75%	~75%	N/A

Other relevant performance data mentioned (without specific quantifiable results or acceptance criteria):

Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced.
An in-vitro study was conducted to demonstrate that once placed as indicated, the device provides temporary support to a complex repair until permanent hardware fixation is accomplished.
Biocompatibility testing was conducted in accordance with ISO 10993 recommendations (cytotoxicity, irritation, sensitization, systemic toxicity, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity). All conducted to GLP requirements.
Sterility: Gamma sterilization validated to provide SAL of 10^-9. Each lot tested for bacterial endotoxin for lot release.

Summary

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August 25, 2023

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Orthocon, Inc. Howard Schrayer Consultant 8 Lookout Hilton Head Island, South Carolina 29928

Re: K231903

Trade/Device Name: Montage-QS Settable, Resorbable Bone Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 28, 2023 Received: June 28, 2023

Dear Howard 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

Sara S. Thompson -S

For

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic 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) K231903

Device Name Montage-QS Settable, Resorbable Bone Putty

Indications for Use (Describe)

Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during process.

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 (Per 21 CFR 807.92)

General Company Information

Name:	Orthocon, Inc.
Contact:	Howard SchrayerRegulatory Affairs Consultant
Address:	700 Fairfield Avenue, Suite 1Stamford, CT 06902
Telephone:	(609) 273 - 7350
Date Prepared	August 24, 2023
General Device Information
Product Name:	Montage-QS Settable, Resorbable Bone Putty
Common Name:	Resorbable calcium salt bone void filler device
Classification:	Product code: MQV
Regulation:	21 CFR 888.3045
Predicate DevicesPrimary Predicate:Orthovita, Inc.	HydroSet XT™[510(k) Number K161447]
Reference Devices:
Orthocon, Inc.	Montage-QS Settable, Resorbable Hemostatic Bone Putty[510(k) Number K191140]
Orthocon, Inc.	Montage Settable, Resorbable Bone Putty[510(k) Number K222063]

Description

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cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process. The performance of Montage-QS was compared to HydroSet in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 17.2% in the Montage-QS group, 12.4% in the HydroSet proup, and 10% in the empty defect negative control group. Animal study data suggest that approximately 75% of implant material remained in both the Montage-QS group and the HydroSet group at 12 weeks following implantation.

Indications for Use

Orthocon Montage-QS Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surqically created, or osseous defects created as the result of traumatic injury to the bone. Montage-QS is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.

When hardened in situ. Montage-QS may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.

MONTAGE-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Purpose of Submission

Orthocon is proposing to modify the labeling (Instructions for Use) to provide for use of Montage-QS as a bone void filler that can be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surqical procedure.

Substantial Equivalence

This submission supports the position that Orthocon Montage-QS Settable, Resorbable Bone Putty is substantially equivalent to a number previously cleared devices, including the HydroSet referenced predicate and is exactly the same composition as the reference predicate Orthocon Montage-QS Settable, Resorbable Bone Putty [cleared under 510(k) K191140].

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SUBSTANTIAL EQUIVALENCE INFORMATION

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The differences described in the table above do not impact substantial equivalence.

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Testing Completed

Efficacy Evaluation

The performance of Montage-QS as a bone void filler was compared to HydroSet in a rabbit critical size femoral defect model. Micro-CT and histopathology / histomorphometry assessments were performed on defects treated with each material to quantify device resorption and new bone formation. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 17.2% in the Montage-QS group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data demonstrated that approximately 75% of implant material remained in both the Montage-QS group and the predicate group at 12 weeks following implantation.

Performance Data

Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced. In addition, an in vitro study was conducted to demonstrate that once placed as indicated, the device provides temporary support to a complex repair until permanent hardware fixation is accomplished.

Biocompatibility Testing

Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, systemic toxicity, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.

Sterility

The gamma sterilization process has been validated to provide a SAL of 10-9. Each lot of finished devices is tested for bacterial endotoxin for lot release.

Conclusions

The information provided establishes that the Orthocon Montage-QS Settable, Resorbable Bone Putty performs substantially equivalent to the predicate device for the same intended use. All results demonstrate that any differences in technology do not impact substantial equivalence.

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.

Orthocon, Inc.Montage-QS Settable,Resorbable Bone Putty	Orthocon, Inc.Montage-QS Settable, ResorbableHemostatic Bone Putty	Orthovita, Inc.HydroSet XTTMBone Void Filler
510(k) - TBD	510(k) – K191140	510(k) - K161447
	Comparisons
Device is indicated for use as a bone graftsubstitute to fill voids in damaged bone thatare not intrinsic to the stability of the bonystructure.	Device is indicated for use in the control ofbleeding from cut or damaged bone surfacesby acting as a tamponade	Device is indicated for use as a bone graftsubstitute to fill voids in damaged bone thatare not intrinsic to the stability of the bonystructure.
Hardened device can be drilled and tappedto provide temporary support for theplacement of provisional hardware during thesurgical procedure.	Not currently cleared for use in temporarysupport of provisional hardware, but exactlythe same formulation as the subject of this510(k).	Hardened device can provide temporarysupport for the placement of provisionalhardware during the surgical procedure.
At the time of application, device is in theform of a putty-like material	At the time of application, device is in theform of a putty-like material	At the time of application, device is in theform of a paste-like material
Device is designed to be manually appliedand spread onto voids in bone tissue	Device is designed to be manually appliedand spread onto bleeding bone tissue	Device is designed to be manually appliedor injected with a syringe and spread ontovoids in bone tissue
Montage-QS Settable, Resorbable BonePutty is formulated as a two-part putty/puttydevice that forms a "settable" (hardening)material when manually mixed at the time ofsurgery	Montage-QS Settable, Resorbable BonePutty is formulated as a two-part putty/puttydevice that forms a "settable" (hardening)hemostatic putty when manually mixed at thetime of surgery	HydroSet XT settable, resorbable bone voidfiller device is formulated as a two-partpowder/liquid device that forms a "settable"(hardening) material when manually mixedat the time of surgery
Sterile mixture of two separate componentsof putty-like consistency comprised of	Sterile mixture of two separate componentsof putty-like consistency comprised of	Sterile mixture of two separate components,a powder comprised of dicalcium phosphate
granular calcium phosphate, (hydroxyapatiteand β-tricalcium phosphate), calciumstearate, vitamin E acetate, a triglyceride,polyalcohols and a mixture of a lactide-diester and polyester-based (lactide andcaprolactone) absorbable polymers.Montage-QS is to be mixed immediatelyprior to use. Resulting settable material fromthe two putties is primarily comprised (~70%by weight) of calcium phosphate similar tothe mineral phase of native bone tissue	granular calcium phosphate, (hydroxyapatiteand β-tricalcium phosphate), calciumstearate, vitamin E acetate, a triglyceride,polyalcohols and a mixture of a lactide-diester and polyester-based (lactide andcaprolactone) absorbable polymers.Montage-QS is to be mixed immediately priorto use. Resulting settable material from thetwo putties is primarily comprised (~70% byweight) of calcium phosphate similar to themineral phase of native bone tissue	dihydrate, tetracalcium phosphate and tri-sodium citrate; and a liquid comprised ofsodium phosphate, polyvinylpyrrolidone andwater. HydroSet XT is to be manuallymixed immediately prior to use. Resultingsettable material from the two componentsis primarily comprised of calcium phosphatesimilar to the mineral phase of native bonetissue.
Implanted device is resorbable in greaterthan 30 days primarily due to presence ofcalcium phosphate.	Implanted device is resorbable in greaterthan 30 days primarily due to presence ofcalcium phosphate.	Implanted device is resorbable in greaterthan 30 days primarily due to presence ofcalcium phosphate.
The non-calcium salt and non-polymericcomponents degrade via dissolution; thepolymer degrades via hydrolysis and calciumsalts degrade via chemical dissolution and/orcellular removal.	The non-calcium salt and non-polymericcomponents degrade via dissolution; thepolymer degrades via hydrolysis and calciumsalts degrade via chemical dissolution and/orcellular removal.	The non-calcium salt components degradevia dissolution and calcium salts degradevia chemical dissolution and/or cellularremoval.
Single-patient-use device is provided sterileby gamma irradiation.	Single-patient-use device is provided sterileby gamma irradiation.	Single-patient-use device is provided sterileby gamma irradiation and ethylene oxide.
The bone putty is available in individualand/or multi-pack patient use sizes.	The bone putty is available in individualand/or multi-pack patient use sizes.	The device is available in individual; and/ormulti-pack patient use sizes.
Each putty is placed into a separate inner foil"blister" which are contained within a singleouter foil pouch. The outer foil pouchcontains a desiccant. The inner blister andouter pouch is heat sealed and sterilized.	Each putty is placed into a separate inner foil"blister" which are contained within a singleouter foil pouch. The outer foil pouchcontains a desiccant. The inner blister andouter pouch is heat sealed and sterilized.	Each kit contains one liquid-filled glasssyringe and one plastic bowl of powderpackaged within a double pre-formed traywith a Tyvek lid.
Mixing for homogeneity takes 30 sec.	Mixing for homogeneity takes 30 sec.	Mixing for homogeneity takes 45 sec.
Material is hardened within 5 minutes of application	Material is hardened within 5 minutes of application	Material is hardened within 10 minutes of application
Device hardens with no appreciable exothermic reaction.	Device hardens with no appreciable exothermic reaction.	Device hardens with no appreciable exothermic reaction