The OMF ASP System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Device Description

The Oromaxillofacial Advanced Surgical Planning (OMF ASP) System utilizes Commercial Off-the-Shelf (COTS) software to manipulate 3D medical images (CT-based systems) with surgeon input, and to produce digital and physical patient specific outputs including surgical plans, anatomic models, templates, and surgical guides for planning and performing maxillofacial surgeries.

The system utilizes medical imaging, such as CT-based imaging data of the patient's anatomy to create surgical plans with input from the physician to inform surgical decisions and guide the surgical procedure. The system produces a variety of patient specific to the maxillofacial region including anatomic models (physical and digital), physical surgical templates and/or guides, and patient specific case reports. The system utilizes additive manufacturing to create patient specific guides, and anatomical models.

AI/ML Overview

The provided text describes the OMF ASP system and its substantial equivalence to a predicate device but does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving it.

Specifically, the document states:

"All acceptance criteria for design validation were met."
"All acceptance criteria for performance testing were met."
"All acceptance criteria for software verification testing were met."
"All acceptance criteria for the cleaning validation were met."
"All acceptance criteria for the steam sterilization validation were met."
"All acceptance criteria for biocompatibility were met and the testing adequality addresses biocompatibility for the output devices and their intended use."

However, it does not explicitly state what those specific acceptance criteria were (e.g., quantifiable metrics like accuracy, sensitivity, specificity, or specific error margins for measurements). It also does not provide the reported device performance in measurable terms against those criteria.

Therefore, I can only provide a partial answer based on the available information.

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

Based on the provided text, specific quantifiable acceptance criteria and reported device performance (e.g., specific accuracy percentages, dimensions, etc.) are not detailed. The document only broadly states that "All acceptance criteria... were met" for various validation tests.

Acceptance Criteria Category	Nature of Acceptance Criteria (as implied)	Reported Device Performance (as implied)
Design Validation	Device designs conform to user needs and intended use for maxillofacial surgeries, identical to predicate in indications, design envelope, worst-case configuration, and post-processing conditions.	All acceptance criteria were met.
Performance Testing	Manufacturing process assessment; operator repeatability within the digital workflow; digital and physical outputs verified against design specifications.	All acceptance criteria were met.
Software Verification	Compliance with FDA guidance for software in medical devices (Moderate Level of Concern).	All acceptance criteria were met.
Cleaning Validation	Bioburden, protein, and hemoglobin levels within acceptable limits post-cleaning (in accordance with AAMI TIR 30).	All acceptance criteria were met.
Sterilization Validation	Sterility assurance level (SAL) of 10^-6 achieved for dynamic-air-removal cycle (in accordance with ISO 17665-1).	All acceptance criteria were met.
Biocompatibility Testing	Compliance with ISO 10993-1, -5, -10, -11 requirements for biological safety.	All acceptance criteria were met.

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

The document mentions "Cases used for testing were representative of the reconstruction procedures within the subject device's intended use" for performance testing, but does not specify the sample size used for any test sets, nor the data provenance (country of origin, retrospective/prospective nature).

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 document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any test sets.

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

The document does not provide any information regarding an adjudication method for test sets.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported. The document states, "No clinical data were provided in order to demonstrate substantial equivalence." The device is described as a "software system and image segmentation system for the transfer of imaging information" and a "pre-operative software tool for simulating/evaluating surgical treatment options," indicating it's primarily a planning and manufacturing aid, not an AI diagnostic tool intended to assist human readers in interpretation that would typically necessitate an MRMC study.

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

The document describes the OMF ASP System as utilizing "Commercial Off-the-Shelf (COTS) software to manipulate 3D medical images (CT-based systems) with surgeon input," and notes that its primary function is to "produce digital and physical patient specific outputs including surgical plans, anatomic models, templates, and surgical guides." It also mentions "operator repeatability within the digital workflow" during performance testing. This suggests a human-in-the-loop process for surgical planning and model generation, rather than a standalone algorithm performance evaluation. However, the exact nature of the "performance testing" to verify digital and physical outputs might imply some level of standalone assessment against design specifications, but this is not explicitly detailed as an "algorithm only" performance study.

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

The document does not explicitly state the type of ground truth used for any of the validation processes. It refers to "design specifications" against which outputs were verified, but the origin of these specifications (e.g., derived from expert consensus, anatomical measurements, etc.) is not detailed.

8. The sample size for the training set

The document does not mention or provide any information about a training set or its sample size. This is consistent with the description of the system using "Commercial Off-the-Shelf (COTS) software" rather than a custom-developed AI algorithm that would typically require a specific training phase.

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

Since no training set is mentioned (see point 8), this information is not applicable and not provided.

Summary

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August 11, 2022

VHA DEAN % Laura Gilmour Principal Consultant LG Strategies, LLC 2001 Parker Lane #122 Austin, Texas 78741

Re: K220648

Trade/Device Name: OMF ASP System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: June 8, 2022 Received: July 11, 2022

Dear Laura Gilmour:

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

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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,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K220648

Device Name OMF ASP System

Indications for Use (Describe)

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)

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5. 510(k) Summary

5.1 Applicant/Submitter
Company Name	VHA DEAN
Company Street Address	810 Vermont Avenue, NW
City	Washington
State	DC
Country	United States
Zip Code	20420
5.2 Contact Person
Full Name	Beth Ripley, MD, PhD
Job Title	Deputy Chief
Email	beth.ripley@va.gov
5.3 Correspondent Information
Full Name	Laura Gilmour
Job Title	Principal Consultant, Advanced Manufacturingand Regulatory Strategy
Phone	901-258-3629
Email	laura.gilmour@va.org
5.4 Date of Preparation
Date of Preparation	August 10, 2022

5.5 Device Information

Table 5.1 Device Information

Trade Name	OMF ASP System
Common or Usual Name	Patient specific maxillofacial anatomical models, templates,guides, and surgical plans
Classification Name	Bone cutting Instruments and Accessories.System, Image Processing, Radiological
Classification Regulation	872.4120
Regulatory Class	Class II
Product Code	DZJ
Subsequent Product Code	LLZ

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5.6 Predicate Device(s)

Table 5.2 Predicate Device(s)

Predicate Type	510(k) Number	Device Name	Manufacturer
Primary Device	K192192	VSP 2.0 System	3D Systems

The predicate devices have not been subject to a design-related recall.

5.7 Device Description

The following table provides a list of OMF ASP System outputs by material and function:

Category	Material	Function
Marking Guide	Duraform ProX PA	Marking of maxillofacial bone Marking of graft bone
Positioning Guide	Duraform ProX PA	Positioning of maxillofacial bone
Template/Anatomical Model	Duraform ProX PA	Visualization and fit check of graft anatomy Visualization of anatomy at time of medical scan Visualization of patient specific anatomy modified by established surgical plan

5.8 Intended Use/Indications for Use

The OMF ASP System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP System is also intended as a pre-operative software tool for simulating surgical treatment options.

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5.9 Comparison of Technological Characteristics with Predicate

VHA DEAN believes that the OMF ASP System is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar inputs as the devices cleared in K192192. The subject device uses an identical material to a subset of the devices cleared in K192192. The subject device has the same intended use and similar technological characteristics to the devices cleared in K192192. These technological characteristics include image transfer and manipulation via COTS software that is later used for 3D printing of anatomical models and guides for surgical planning. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.

5.10 Summary of Non-Clinical Testing

The following tests were performed to demonstrate safety based on current industry standards:

5.10.1 Design Validation

Design validation was performed to ensure OMF ASP System guide designs conform to user needs and intended use of supporting maxillofacial surgeries. The OMF ASP System has identical indications for use, identical design envelope, and an identical worst-case configuration and post processing conditions to the predicate device. All acceptance criteria for design validation were met.

5.10.2 Performance Testing

Process performance testing was completed to assess the manufacturing process as well as operator repeatability within the digital workflow. Cases used for testing were representative of the reconstruction procedures within the subject device's intended use. Both digital and physical outputs from all manufacturing processes were verified against the design specifications. All acceptance criteria for performance testing were met.

5.10.3 Software Verification

No custom software has been created or included as part of the subject device. All software used in the OMF ASP System process is commercial off-the-shelf (COTS) software. The software verification complied with two FDA guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005 and Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff issued September 9th 2019. Software documentation and software verification were completed to comply with a Moderate Level of Concem for the subject device as described in the aforementioned guidance documents. All acceptance criteria for software verification testing were met.

5.10.4 Cleaning and Sterilization Validation

The OMF ASP System has identical indications for use, identical design envelope, and an identical worstcase configuration and post processing conditions to the predicate device.

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Cleaning validation was performed in accordance with AAMI TIR 30. Following soiling and cleaning of the subject devices, bioburden, protein levels, and hemoglobin levels were analyzed. All acceptance criteria for the cleaning validation were met.

Steam sterilization validations were performed for dynamic-air-removal cycle in accordance with ISO 17665-1 to a sterility assurance level (SAL) of 10% using the biological indicator (BD) overkill method. All acceptance criteria for the steam sterilization validation were met.

5.10.5 Biocompatibility Testing

The OMF ASP System has identical indications for use, identical design envelope, and an identical worstcase configuration and post processing conditions to the predicate device. All acceptance criteria for biocompatibility were met and the testing adequality addresses biocompatibility for the output devices and their intended use. Biocompatibility testing was in compliance to ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization, and ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

5.11 Clinical Testing

No clinical data were provided in order to demonstrate substantial equivalence.

5.12 Conclusion

Based on the testing performed, including, design validation analysis, performance testing, software verification, biocompatibility testing, cleaning validation, and sterilization it can be concluded that the subject device does not raise any new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed OMF ASP System are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.