The ADAPT for Gamma3 System, when used with the Stryker Navigation System, assists the surgeon to determine the needed size and position of orthopedic implants during femur fracture surgery using the Gamma3 System.

When used in operation, the system should be operated only by trained personnel such as surgeons and clinic staff.

The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail indication may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

Device Description

The ADAPT for Gamma3 System consists of a software (ADAPT 2.0 for Gamma3 SW) and is compatible with hardware platforms, reference devices as well as Gamma3® implants and instruments. The software is designed to operate on the Stryker Navigation platforms (hardware platforms) and assists the surgeon to intraoperatively determine the size and position of Gamma3 implants during femur fracture surgery.

The Gamma3 Nail System is a family of intramedullary nails for basilar neck, intertrochanteric neck, peritrochanteric, subtrochanteric and femoral shaft fractures. The system consists of nails, lag screws, locking screws and screw sets.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "ADAPT for Gamma3" system, which is a software and hardware system designed to assist surgeons in determining the size and position of orthopedic implants during femur fracture surgery.

Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum accuracy percentages or specific error tolerances) for the ADAPT for Gamma3 system's performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device (ADAPT for Gamma3 System K173946).

The reported device performance section primarily focuses on non-clinical testing results and the conclusion of substantial equivalence.

Acceptance Criteria Category	Acceptance Criteria (as implied)	Reported Device Performance
Safety	Compliance with relevant electrical safety and electromagnetic compatibility standards.	Non-clinical testing demonstrated: - Electrical safety and system safety per IEC 60601-1 - Electromagnetic Compatibility per IEC 60601-1-2
Usability	Compliance with usability engineering standards.	Non-clinical testing included: - Formative and summative usability evaluation per IEC 62366-1 and IEC 60601-1-6
Reliability	Demonstrated reliability over its lifetime.	Non-clinical testing included: - Reliability over lifetime for the ADAPT mobile PC Unit and the ADAPT mobile Operating System
Performance (Equivalence)	The new ADAPT mobile platform must perform equivalently to the predicate ADAPT for Gamma3 System (K173946) regarding intended use, material, design, and operational principles.	Conclusion: "Testing demonstrated that ADAPT mobile is equivalent in performance to the predicate ADAPT for Gamma3 System (K173946)." The summary explicitly states: "A comparison of the systems demonstrated that the subject ADAPT for Gamma3 System and Gamma3 System are substantially equivalent to the predicate ADAPT for Gamma3 System (K173946) and Gamma3 System (K123401) regarding intended use, material, design, and operational principles."

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Clinical data is not required in support of this submission." This indicates that no clinical test set of patient data was used to prove the device meets acceptance criteria, at least in the traditional sense of evaluating diagnostic or treatment outcomes on patients. The evaluation was primarily based on non-clinical testing and comparison to a predicate device.

Therefore, information on data provenance (country of origin, retrospective/prospective) and sample size for a test set of clinical data is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical test set was used, no experts were explicitly mentioned as being used to establish ground truth for a clinical test set in this submission. The "ground truth" for the device's performance was established through engineering tests, usability evaluations, and comparison to the predicate device, rather than clinical outcomes or diagnoses.

4. Adjudication Method for the Test Set

Given that no clinical test set was used for performance evaluation, an adjudication method for a test set is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers improving with AI vs. without AI assistance. The ADAPT for Gamma3 system is described as a "computer controlled stereotaxic image guided surgery system" that "assists the surgeon," implying it's a tool used by the surgeon, rather than a standalone diagnostic AI or an AI that directly enhances human interpretation in a comparative reader study.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

The document does not describe a standalone performance study for the algorithm without human-in-the-loop performance. The device is referred to as assisting the surgeon and being used with the Stryker Navigation System. The "intended use" specifies "assists the surgeon to determine the needed size and position." This indicates it's designed as an assistive tool, not a standalone diagnostic or treatment algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance was:

Engineering specifications and regulatory standards: For electrical safety, EMC, usability, and reliability.
Performance of the predicate device (ADAPT for Gamma3 System K173946): The core of the 510(k) clearance is demonstrating substantial equivalence to this previously cleared device. The predicate device's performance, safety profile, and intended use effectively serve as the "ground truth" or benchmark for the new device.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth in this submission for the purpose of demonstrating substantial equivalence.

8. Sample Size for the Training Set

The document is a 510(k) clearance letter and does not provide information regarding a training set sample size. As it primarily describes a navigation system software update and hardware platform for an existing device, it's unlikely to involve a deep learning model that requires a large training set of annotated images in the typical sense. If internal algorithms were "trained," the details are not disclosed here.

9. How the Ground Truth for the Training Set Was Established

Since no information on a training set is provided, how its ground truth was established is not detailed in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Stryker GMBH Tina Mornak Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

October 12, 2018

Re: K181848

Trade/Device Name: ADAPT for Gamma3, Gamma3 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HSB Dated: September 14, 2018 Received: September 17, 2018

Dear Tina Mornak:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jesse Muir - S 2018.10.12 13:46:46 -04'00'

For:

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181848

Device Name ADAPT for Gamma3

Indications for Use (Describe)

When used in operation the system should be operated only by trained personnel such as surgeons and clinic staff.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Expiration Date: 06/30/2020

See PRA Statement below.

Form Approved: OMB No. 0910-0120

Indications for Use

510(k) Number (if known)

K181848

Device Name Gamma3

Indications for Use (Describe)

The Trochanteric Gamma3 Nail is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail indication may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Proprietary Name:	ADAPT for Gamma3Gamma3
Common Name:	Orthopedic Stereotaxic InstrumentRod, fixation, intramedullary and accessories
Regulation Description:	Stereotaxic instrumentIntramedullary Fixation Rod
Regulation Number:	21 CFR 882.4560: Stereotaxic instrument21 CFR 888.3020: Intramedullary Fixation Rod
Product Code:	OLO, HSB
Device Class:	II
Sponsor:	Stryker GMBHBohnackerweg 12545 Selzach / Switzerland
Contact Person:	Tina MornakSenior Regulatory Affairs Specialistt: 201-831-6365f: 201-831-6500tina.mornak@stryker.com
Date Prepared:	July 6, 2018
Primary Predicate:	ADAPT for Gamma3 System: K173946
Additional Predicate:	Gamma3 System: K123401Stryker PROFESS System: K141551

510(k) Summary

Description

The purpose of this submission is to introduce a new platform, ADAPT mobile, to the existing Stryker Navigation System. The ADAPT mobile platform will be used to run the previously cleared ADAPT 2.0 for Gamma3 SW (K173946) for use with the Gamma3 System (K123401).

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Intended Use

ADAPT for Gamma3

The ADAPT for Gamma3 System, when used with the Stryker Navigation System, is a computer controlled stereotaxic image guided surgery system intended to provide static location information derived from image processing of intraoperatively acquired X-ray images, by superposition of virtual implants and instruments onto those X-ray images.

Gamma3

The intended use of the Gamma3 Nail System includes the following:

Trochanteric Gamma3 Nail

The Trochanteric Gamma3 Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures.

Long Length Gamma3 Nail

The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric neck, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.

Indications for Use

ADAPT for Gamma3

When used in operation, the system should be operated only by trained personnel such as surgeons and clinic staff.

Gamma3

Summary of Technologies

A comparison of the systems demonstrated that the subject ADAPT for Gamma3 System and Gamma3 System are substantially equivalent to the predicate ADAPT for Gamma3 System (K173946) and Gamma3 System (K123401) regarding intended use, material, design, and operational principles.

Non-Clinical Testing

Non-clinical testing was performed, including:

Electrical safety and system safety per IEC 60601-1
. Electromagnetic Compatibility per IEC 60601-1-2
Formative and summative usability evaluation per IEC 62366-1 and IEC 60601-1-6 ●

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Reliability over lifetime for the ADAPT mobile PC Unit and the ADAPT mobile Operating . System
Testing demonstrated that ADAPT mobile is equivalent in performance to the predicate ADAPT for Gamma3 System (K173946).

Clinical Testing

Clinical data is not required in support of this submission.

Conclusion

The subject ADAPT for Gamma3 System and Gamma3 System are substantially equivalent to the predicate ADAPT for Gamma3 System (K173946) and Gamma3 System (K123401).

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).