Orthocon MONTAGE-OS Settable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm². MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

Device Description

MONTAGE-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE-QS device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of the MONTAGE-QS device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE-QS components must be mixed immediately prior to use.

AI/ML Overview

The provided text describes a medical device, MONTAGE-QS Settable, Resorbable Bone Putty, and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria and a study proving the device meets those criteria in the context of typical AI/software device evaluation.

Based on the provided information, here's an attempt to answer your request, focusing on the information that is present and noting where information is absent for an AI device.

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

The document does not explicitly state "acceptance criteria" in the way one would for an AI model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the performance evaluation is based on demonstrating equivalence to a predicate device through various tests. The "performance" for MONTAGE-QS is a qualitative assessment of its material properties and biological response compared to the predicate.

Test Category	Specific Test	Acceptance Criteria (Implied/Compared)	Reported Device Performance (MONTAGE-QS)
Efficacy	Cranioplasty in rabbit critical-sized defect	Equivalence to HydroSet in filling bone defects (histology-based)	MONTAGE-QS performance for cranioplasty was judged to be equivalent to HydroSet.
Bench Testing	Visual Inspection (Putty component color)	Met specification	Putty color met specification.
	Putty Stiffness	Met specification	Putty stiffness met specification.
	Putty Vitamin E Acetate Concentration	Met specification	Putty vitamin E acetate concentration met specification.
	Hand Mixing Time	Met specification (related to mixing time, stickiness, mixability)	Mixing time, stickiness, and mixability met specification.
	Hand Mixing Stickiness	Met specification (related to mixing time, stickiness, mixability)	Mixing time, stickiness, and mixability met specification.
	Mixability	Met specification (related to mixing time, stickiness, mixability)	Mixing time, stickiness, and mixability met specification.
	Package Leak Test	All test articles passed	All test articles passed.
	Temperature Sensitivity	Acceptable maximum temperature increase following hand-mixing	Acceptable maximum temperature increase following hand-mixing.
	Water Uptake, Swelling, and Dissolution	Acceptable water uptake, swelling and dissolution	Acceptable water uptake, swelling and dissolution.
In-Vivo Testing	Histopathologic evaluation (critical sized cranial bone defect)	Substantial equivalence to predicate device (HydroSet) through histopathologic evaluation	Substantial equivalence was assessed from histopathologic evaluation (compared to predicate).
Biocompatibility	ISO 10993 (Cytotoxicity, irritation, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, neurotoxicity)	Compliance with ISO 10993 recommendations	Conducted in accordance with ISO 10993 recommendations and GLP requirements.

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

Test Set Sample Size:
- Efficacy Evaluation (Cranioplasty): The study was conducted in a "rabbit cranial critical-sized defect model." The specific number of rabbits or defects studied is not provided.
- Bench Testing: The sample sizes for each bench test are not specified.
- In-Vivo Testing: Similar to the efficacy evaluation, it refers to an "animal model" without giving specific numbers.
Data Provenance: The document states "rabbit cranial critical-sized defect model" and "in-vivo animal testing," indicating the data is from preclinical animal studies. The country of origin and whether it was retrospective or prospective data are not specified.

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)

The "ground truth" for this device's evaluation (e.g., whether bone defects were filled, or histopathological assessments) would have been established by experts in veterinary pathology or relevant scientific fields. However, the document does not state the number of experts or their qualifications. The assessments are described as "histology-based assessments" and "histopathologic evaluation."

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

The document does not describe any adjudication method for establishing ground truth or evaluating the test results.

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

This is a submission for a bone putty, not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This is a submission for a bone putty, not an AI or software device. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For the efficacy and in-vivo testing, the ground truth was based on histopathologic evaluation in an animal model. For bench testing, it was based on measurable physical and chemical properties against predetermined specifications.

8. The sample size for the training set

This is a submission for a physical medical device (bone putty), not an AI or software device. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The device's performance is demonstrated through testing against specifications and comparison to a predicate, not by training an algorithm.

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

As a training set is not applicable for this type of device, the method for establishing its "ground truth" is not applicable.

Summary

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October 12, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

Re: K231475

Trade/Device Name: MONTAGE-QS Settable, Resorbable Bone Putty Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: September 12, 2023 Received: September 12, 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Adam D. Digitally signed by Adam D. Pierce -S Digitally signed by Date: 2023.10.12 Pierce -S 14:48:11 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality

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Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231475

Device Name Montage-OS Settable, Resorbable Bone Putty

Indications for Use (Describe)

Orthocon MONTAGE-OS Settable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm2. MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
X 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:	(855) 475 - 9175
Date Prepared	October 9, 2023
General Device Information
Product Name:	MONTAGE-QS™ Settable Resorbable Bone Putty
Common Name:	Calcium Phosphate Cement
Classification:	Class II
Product codes:	GXP
Regulation:	21 CFR 882.5300
Predicate Devices:Primary Predicate:Stryker	Stryker Injectable Cement[510(k) Number K060763]
Reference Devices:Orthocon, Inc.	MONTAGE-QS Settable, Resorbable Bone Putty[510(k) Number K191140]
Orthocon, Inc.	MONTAGE Settable, Resorbable Bone Putty[510(k) Number K221933]

Device Description

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Indications for Use

Orthocon MONTAGE-QS Settable, Resorbable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm². MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

The following table shows comparisons of characteristics of MONTAGE-QS Settable, Resorbable Bone Putty and the predicate device.

SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. MONTAGE-QS Settable, Resorbable Bone Putty 510(k) — K231475

Stryker Injectable Cement HydroSet

510(k) - K060763

Comparisons of Technological Characteristics

Device is intended for use in the repair ofneurosurgical burr holes, contiguouscraniotomy cuts and other cranial defectswith a surface area no larger than 25cm².	Stryker® Injectable Cement is intended for usein the repair of neurosurgical burr holes,contiguous craniotomy cuts and other cranialdefects.
At the time of application, device is in theform of a putty-like material	At the time of application, device is in the formof a paste-like material
Device is designed to be manually applied tothe cranial defect	Device is designed to be manually applied tothe cranial defect
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	Stryker Injectable cement is formulated as atwo-part powder/liquid device that forms a"settable" (hardening) material when manuallymixed at the time of surgery
Sterile mixture of two separate componentsof putty-like consistency comprised ofgranular calcium phosphate,(hydroxyapatite and β-tricalciumphosphate), calcium stearate, vitamin Eacetate, triacetin, polyalcohols and amixture of a lactide-diester and polyester-based (lactide and caprolactone)absorbable polymers. MONTAGE-QS is tobe mixed immediately prior to use.Resulting settable material from the twoputties is primarily comprised of calciumphosphate.	Sterile mixture of two separate components, apowder comprised of dicalcium phosphatedihydrate, tetracalcium phosphate and tri-sodium citrate; and a liquid comprised ofsodium phosphate, polyvinylpyrrolidone andwater. Stryker Injectable Cement is to bemanually mixed immediately prior to use.Resulting settable material from the twocomponents is primarily comprised of calciumphosphate.
Implanted device is resorbable in greaterthan 30 days primarily due to presence ofcalcium phosphate.	Implanted device is resorbable in greater than30 days primarily due to presence of calciumphosphate.

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Single-patient-use device is provided sterile by gamma irradiation	Single-patient-use device is provided sterile by gamma irradiation and ethylene oxide
The bone putty is available in individual and/or multi-pack patient use sizes of up to 5cc (approximately 10 grams).	The device is available in individual; and/or multi-pack patient use sizes of 3, 5, 10 and 15cc.
Each putty is placed into a separate inner foil “blister” which are contained within a single outer foil pouch. The outer foil pouch contains a desiccant. The inner blister and outer pouch are heat sealed and sterilized.	Each kit contains one liquid-filled glass syringe and one plastic bowl of powder packaged within a double pre-formed tray with a Tyvek lid.
Mixing for homogeneity takes 30 sec.	Mixing for homogeneity takes 45 sec.
Material is settable within 5 minutes of application	Material is settable within 10 minutes of application
Material provides a working time of 1 minutes.	Material provides a working time of 2 minutes.
Device cures with no appreciable exothermic reaction.	Device cures with no appreciable exothermic reaction

Testing Completed

Efficacy Evaluation

The cranioplasty efficacy performance of MONTAGE-QS was compared to HydroSet in a rabbit cranial critical-sized defect model. Test results confirmed that each device filled bone defects. From the histology-based assessments, MONTAGE-QS performance for cranioplasty was judged to be equivalent to HydroSet in this critical-sized defect model.

Performance Data

Performance testing included a series of laboratory evaluations and in vivo testing. These evaluations are summarized below.

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Bench Testing

Test	Description	Conclusions
Visual Inspection	Evaluated putty component colorusing a reference scale	Putty colormet specification
Putty Stiffness	Evaluated putty stiffnessusing a reference scale	Putty stiffness metspecification
Putty Vitamin EAcetateConcentration	Solvent extraction and chemicalanalysis	Putty vitamin E acetateconcentration met specification
Hand Mixing Time	Evaluated hand-mixing time usinga reference scale	Mixing time, stickiness, andmixability met specification
Hand MixingStickiness	Evaluated stickinessusing a reference scale
Mixability	Evaluated mixability using a referencescale
Package Leak Test	Bubble emission leak test	All test articles passed
TemperatureSensitivity	Determined maximum temperatureincrease observedduring mixing	Acceptable maximum temperatureincreasefollowing hand-mixing
Water Uptake,Swellingand Dissolution	Measured volume and masschanges over time	Acceptable water uptake,swelling and dissolution

In-Vivo Testing

In-vivo animal testing was used to demonstrate substantial equivalence of MONTAGE-QS Settable, Resorbable Bone Putty in the repair of a critical sized cranial bone defect in an animal model compared to the predicate device. Substantial equivalence was assessed from histopathologic evaluation.

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, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity and neurotoxicity.

Clinical Testing

No clinical studies have been conducted in support of this 510(k).

Conclusions

This submission demonstrates that Orthocon MONTAGE-QS Settable, Resorbable Bone Putty is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).