K Number

Device Name

Akunah REFLECT

Manufacturer

Akunah PTY LTD

Date Cleared

2023-05-10

(224 days)

Product Code

LLZ QIH

Regulation Number

892.2050

Intended Use

Akunah Reflect Planning Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The software is used to assist in the positioning of shoulder components. Akunah Reflect Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. The software leads to the generation of a planning report. The software is to be used for adult patients only and should not be used for diagnostic purposes. Akunah Reflect should be used in conjunction with expert clinical judgement.

Device Description

Akunah REFLECT Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The user interface software is connected to an online management system (OMS), and is intended to be used by orthopaedic surgeons as a preoperative planning software for shoulder surgery. The software is intended to allow surgeons to: - Visualize, measure, reconstruct, and annotate anatomic data, - Select and position shoulder implant devices, - . Output pre-surgical planning reports The software is to be used for adult patients only and should not be used for diagnostic purpose.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K183105

Reference Devices

K203315, K193560

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on visualization, measurement, and manual positioning by the surgeon.

Therapeutic

No.
The Akunah Reflect Planning Software is a pre-surgical planning tool for shoulder procedures, assisting surgeons in visualization, measurement, and implant positioning. It does not directly treat or diagnose a disease but rather aids in the planning phase of a surgical procedure.

Diagnostic

No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the software "should not be used for diagnostic purposes."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Akunah REFLECT Software" and details its functions as a pre-surgical planner. The performance studies focus on software verification and validation, geometric accuracy of virtual models, measurement tools, and usability testing of the software on a desktop. There is no mention of any accompanying hardware component that is part of the regulated device itself. While it connects to an online management system, this is a software-based connection.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The primary intended use is explicitly stated as a "pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures." It is used to "assist in the positioning of shoulder components."
Exclusion of Diagnostic Use: The document explicitly states, "The software is to be used for adult patients only and should not be used for diagnostic purposes."
Nature of the Device: The device is a software tool for visualizing, measuring, reconstructing, and annotating anatomical data for surgical planning. This is a tool for surgical preparation, not for diagnosing a disease or condition based on in vitro analysis of biological samples.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This software does not perform such analysis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

QIH, LLZ

Device Description

Visualize, measure, reconstruct, and annotate anatomic data,
Select and position shoulder implant devices,
Output pre-surgical planning reports

The software is to be used for adult patients only and should not be used for diagnostic purpose.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder

Indicated Patient Age Range

adult patients only

Intended User / Care Setting

orthopaedic surgeons / pre-surgical planning

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation testing were performed, and documentation provided as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). Verification testing was performed to address all functional requirements, and usability testing was performed to demonstrate overall validation of the software against the user needs.

Akunah REFLECT met the acceptance criteria stated for all functional verification testing across all systems and modules.
Geometric accuracy of the virtual models created in the subject device were assessed. Both Akunah Auto-segmentation and Premorbid Reconstruction demonstrated equivalent accuracy as established by the predicate devices.
Measurement Tools were verified to achieve an acceptable accuracy
Usability testing demonstrated the validation of the software on the Desktop for surgical planning

In conclusion, all performance testing conducted demonstrated device performance and substantial equivalence to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K183105

Reference Device(s)

K203315, K193560

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

Image /page/0/Picture/0 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 ADMINISTRATION" in blue text.

Akunah PTY LTD Shanthan Pather Coo 131 Warriewood St QUEENSLAND, 4151 AUSTRALIA

Re: K222987

May 10, 2023

Trade/Device Name: Akunah REFLECT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: April 6, 2023 Received: April 6, 2023

Dear Shanthan Pather:

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 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.

Jessica Lamb

Jessica Lamb, Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K22987

Device Name Akunah REFLECT

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Akunah. The logo consists of a circular design made up of many small orange circles. To the right of the circular design is the word "akunah" in orange lowercase letters.

510(k) Summary

K222987

Traditional 510(k) – Akunah REFLECT

May 10th 2023

Device Name
Trade name:	Akunah REFLECT
Common Name:	Image processing system
Classification Name:	Medical image management and processing system
Regulation Number:	§892.2050
Submitter
Name:	Akunah Pty Ltd
Address:	Suite 307, Nicholson Street Specialist Centre
Level 9, 121 Newdegate St, Greenslopes 4120
Brisbane, Australia
Company Contact
Contact Name:	Akunah Pty Ltd
Contact Person:	Dr. Shanthan Pather
Title:	COO, Design & Regulatory Affairs Engineer
Address:	Suite 307, Nicholson Street Specialist Centre
Level 9, 121 Newdegate St, Greenslopes 4120
Brisbane, Australia
Tel:	+61 3445 1591
Fax:	+61 3445 1592
Email:	sha@akunah.com
Classification
Device	Class: Class II
Classification Panel:	Radiology
Product Code:	QIH, LLZ

21 CFR section 892.2050, Class II Radiology Devices – Panel: Radiology Office of Radiological Health (OHT8)

Equivalent / Predicate Device

Trade Name	510(k) number	Decision Date	Applicant
Mimics Medical (PRIMARY PREDICATE)	K183105	March 27, 2019	Materialise NV
BLUEPRINT™ Patient Specific
Instrumentation (REFERENCE)	K203315	April 15, 2021	Tornier SAS
Materialise Shoulder System,
Materialise Shoulder Guide and
Models, SurgiCase Shoulder Planner
(REFERENCE)	K193560	March 20, 2020	Materialise NV

Suite 307 Nicholson Street Specialist Centre Level 9, 121 Newdegate Street Greenslopes Private Hospital, QLD, 4127 AUSTRALIA

E: info@akunah.com P: +61 7 3445 1591 F: +61 7 3445 1592

akunah.com ABN 58 646 020 322

Image /page/4/Picture/0 description: The image shows the logo for Akunah. On the left side of the logo is a circular design made up of many small circles. The circles are arranged in a spiral pattern, with the circles getting smaller as they move towards the center. To the right of the circular design is the word "akunah" in lowercase letters. The word is written in a sans-serif font and is colored in a gradient of orange and yellow.

Device Description

Visualize, measure, reconstruct, and annotate anatomic data,
Select and position shoulder implant devices,
. Output pre-surgical planning reports

The software is to be used for adult patients only and should not be used for diagnostic purpose.

Intended Use

Akunah REFLECT Software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery.

Indication For Use

Comparison to Predicate Device

Akunah Reflect has been compared to legally marketed predicate device Materialise – Mimics Medical (K183105), and references devices:- Tornier - BLUEPRINT Patient Specific Instrumentation (K203315), and Materialise - Surgicase Shoulder Planner (K212569). The predicate device shares the same intended use for the software, specific to treatment planning for surgical procedures, allowing visualisation, reconstruction, measurements, annotations and editing of anatomic data. To achieve these features Akunah REFLECT employs similar fundamental technologies as the predicates.

The following technological differences exists between the subject device and the predicates:

Akunah REFLECT does not offer a hardware component – Patient Specific Guide (PSI) or Anatomic Models, as it is a software-only device
. Akunah REFLECT possess a unique user interface to optimise workflow and user experience.

The differences outlined above do not raise new questions of safety and effectiveness over the predicate device as demonstrated in verification and validation testing.

Image /page/5/Picture/1 description: The image shows the logo for Akunah. The logo consists of two parts: a circular pattern of orange dots on the left and the word "akunah" in orange on the right. The dots are arranged in concentric circles, creating a visually appealing design. The word "akunah" is written in a sans-serif font, with a gradient of orange color that transitions from a darker shade to a lighter shade.

Performance Data

Akunah REFLECT met the acceptance criteria stated for all functional verification testing across all systems and modules.
. Geometric accuracy of the virtual models created in the subject device were assessed. Both Akunah Auto-segmentation and Premorbid Reconstruction demonstrated equivalent accuracy as established by the predicate devices.
. Measurement Tools were verified to achieve an acceptable accuracy
. Usability testing demonstrated the validation of the software on the Desktop for surgical planning

In conclusion, all performance testing conducted demonstrated device performance and substantial equivalence to the predicate device.

Substantial Equivalence Conclusion

The results of the verification and validation testing raise no concerns regarding the safety and effectiveness of the product. Minor differences in the non-fundamental technological characteristics raise no question of safety and effectiveness of the software. Performance data support the demonstration of substantial equivalence and usability. Therefore, the intended use, fundamental technological characteristics, and principle of operation of the Akunah REFLECT software are substantially equivalent to the predicate device.