Orthocon MONTAGE Settable, Resorbable 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 Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

Device Description

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

AI/ML Overview

The provided document does not describe the acceptance criteria and a study proving a digital health device meets acceptance criteria. Instead, it is a 510(k) premarket notification for a medical device called "MONTAGE Settable, Resorbable Bone Putty."

Therefore, I cannot provide the information requested in points 1-9 as they pertain to the evaluation of a digital health device, specifically looking for metrics like human reader improvement with AI assistance, standalone algorithm performance, and details about training/test sets for AI models.

Instead, the document details the substantial equivalence of the MONTAGE Settable, Resorbable Bone Putty to a predicate device (Stryker Injectable Cement) based on technological characteristics and performance data.

Here's a summary of what the document does provide regarding the MONTAGE device's performance evaluation:

Acceptance Criteria and Reported Device Performance (Bench Testing):
The document lists several bench tests with their conclusions, implying that the "met specification" or "acceptable" status indicates the device met its acceptance criteria for these specific properties.

Test	Acceptance Criteria (implied by "met specification" or "acceptable")	Reported Device Performance
Visual Inspection	Putty color and handling met specification	Putty color and handling met specification
Putty Handling	Putty stickiness met specification	Putty stickiness met specification
Putty Stiffness	Putty stiffness met specification	Putty stiffness met specification
Putty Vitamin E Acetate Concentration	Putty vitamin E acetate concentration met specification	Putty vitamin E acetate concentration met specification
Hand Mixing Time	Mixing time met specification	Mixing time met specification
Hand Mixing Stickiness	Stickiness met specification	Stickiness met specification
Mixability	Mixability met specification	Mixability met specification
Device Stiffness	Device stiffness met specification	Device stiffness met specification
Package Gross Leak	All test articles passed leak test	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

Sample size used for the test set and the data provenance: Not applicable for a medical device without AI components. However, biocompatibility testing was conducted on the "final, finished, gamma-irradiation sterilized device," and in-vivo animal testing was performed using "New Zealand White rabbits."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical medical device.
The type of ground truth used:
- Biocompatibility: In accordance with ISO 10993 recommendations and GLP requirements.
- Bench Testing: Internal specifications derived from engineering and material science principles.
- In-Vivo Testing: Histopathologic evaluation and histomorphometric measurements of implant absorption over time from animal study, compared to the predicate device.
The sample size for the training set: Not applicable for this type of medical device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

January 13, 2023

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

Re: K221933

Trade/Device Name: MONTAGE Settable, Resorbable Bone Putty Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: December 14, 2022 Received: December 14, 2022

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 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.

Image /page/1/Picture/5 description: The image shows the text "Adam D." on the first line and "Pierce -S" on the second line. The text is black and the background is a light blue and white grid pattern. The text is large and easy to read.

Digitally signed by Adam D. Pierce -S Date: 2023.01.13 13:22:26 -05'00'

Adam 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 Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221933

Device Name

MONTAGE Settable, Resorbable Bone Putty

Indications for Use (Describe)

Orthocon MONTAGE Settable, Resorbable 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 Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

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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General Company Information

Name:	Orthocon, Inc.
Address:	700 Fairfield Avenue, Suite 1Stamford, CT 06902
Telephone:	(855) 475 - 9175
Contact:	Howard Schrayer
Date Prepared	January 12, 2023

General Device Information

Product Name:	MONTAGE Settable, Resorbable Bone Putty
Common Name:	Calcium Phosphate Cement
Classification:	Class II
Product codes:	GXP
Regulation:	21 CFR 882.5300

Predicate Device

Stryker	Stryker Injectable Cement
	[510(k) Number K060763]

Device Description

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Indications for Use

Orthocon MONTAGE 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 Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

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

SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. MONTAGE Settable. Resorbable Bone Putty 510(k) - 221933

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 use inthe repair of neurosurgical burr holes,contiguous craniotomy cuts and other cranial defects.
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 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, 1,4-butanediol and amixture of a lactide-diester and polyester-based (lactide and caprolactone)absorbable polymers. MONTAGE is to bemixed immediately prior to use. Resultingsettable material from the two putties isprimarily comprised of calcium phosphate	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.

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Implanted device is resorbable ingreater than 30 days primarily due topresence of calcium phosphate.	Implanted device is resorbable in greaterthan 30 days primarily due to presence ofcalcium phosphate.
Single-patient-use device is providedsterile by 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 ofup to 5cc (approximately 10 grams).	The device is available in individual; and/ormulti-pack patient use sizes of 3, 5, 10 and15cc.
Each putty is placed into a separateinner foil "blister" which are containedwithin a single outer foil pouch. Theouter foil pouch contains a desiccant.The inner blister and outer pouch areheat 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 45 sec.	Mixing for homogeneity takes 45 sec.
Material is settable within 10 minutes ofapplication	Material is settable within 10 minutes ofapplication
Material provides a working time of 2minutes.	Material provides a working time of 2minutes.
Device cures with no appreciableexothermic reaction	Device cures with no appreciableexothermic reaction

Performance Data

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

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Bench Testing

Test	Description	Conclusions
Visual Inspection	Evaluated putty component colorusing a 3-point scale	Putty color and handling metspecification
Putty Handling	Evaluated putty stickiness togloves using a 3-point scale
Putty Stiffness	Measured putty stiffness using aPenetrometer	Putty stiffness metspecification
Putty Vitamin E AcetateConcentration	Solvent extraction and chemicalanalysis	Putty vitamin E acetateconcentration metspecification
Hand Mixing Time	Evaluated hand-mixing time usinga 2-point scale	Mixing time, stickiness, andmixability met specification
Hand Mixing Stickiness	Evaluated stickiness to glovesusing a 3-point scale
Mixability	Evaluated mixability using a 2-point scale
Device Stiffness	Measured device stiffness using aPenetrometer	Device stiffness metspecification
Package Gross Leak	Bubble emission leak test	All test articles passed
Temperature Sensitivity	Determined maximumtemperature increase observedduring mixing	Acceptable maximumtemperature increasefollowing hand-mixing
Water Uptake, Swellingand Dissolution	Measured volume and masschanges during 72 hours inphosphate buffered saline, pH7.4, at 37°C	Acceptable water uptake,swelling and dissolution

In-Vivo Testing

In-vivo animal testing was used to demonstrate substantial equivalence of MONTAGE Settable, Resorbable Bone Putty in the repair of a critical sized cranial bone defect of New Zealand White rabbits compared to the predicate device. Substantial equivalence was assessed from histopathologic evaluation and histomorphometric measurements of implant absorption over time.

Clinical Testing

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

Conclusions

This submission supports the position that Orthocon MONTAGE Settable. Resorbable Bone Putty is substantially equivalent to the predicate device.

The information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon MONTAGE Settable, Resorbable Bone Putty and that Substantial Equivalence to the predicate device has been established. Each of the tests conducted passed the requirements as stated in the protocols and in recognized standards. The data presented demonstrate that the device is suitable for its indicated use. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

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).