The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.

Device Description

The OLINDA/EXM® v2.0 is a modification of OLINDA/EXM® v1.1 (K033960) and includes new human models and nuclides. OLINDA/EXM® 2.0 employs a new set of decay data recommended by the International Commission on Radiological Protection (ICRP). OLINDA/EXM® 2.0 introduces a new series of anthropomorphic human body models (phantoms), so new values of Specific Absorbed Fractions (SAF), di (T←S) were generated. These phantoms were based on updated values of the mass of the target region (mr) recommended by the ICRP. The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).

AI/ML Overview

The provided document is a 510(k) summary for a medical device called OLINDA/EXM v2.0. This document primarily focuses on demonstrating substantial equivalence to a predicate device (OLINDA/EXM v1.1) rather than presenting a detailed clinical study with acceptance criteria and device performance in the way one might expect for a diagnostic or therapeutic AI device.

However, based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated in the document regarding acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes, as would be common for diagnostic algorithms. Instead, the "acceptance criteria" appear to be related to the verification and validation of the software itself and its consistency with the previous version. The performance is described in terms of "good compliance" with the predicate device.

Acceptance Criteria (Inferred from "Testing" description)	Reported Device Performance
All software specifications met	The testing results supports that all the software specifications have met the acceptance criteria.
Risk analysis completed and risk control implemented to mitigate identified hazards	(Implicitly met as per submission)
"Good compliance" in comparison to OLINDA/EXM v1.1 (K033960)	Comparisons were made between OLINDA/EXM® v2.0 and OLINDA/EXM® v1.1 (K033960). The results showed a good compliance.
Same technological characteristics as OLINDA EXM® v1.1	The proposed device OLINDA/EXM® v2.0 has the same technological characteristics as the original device OLINDA EXM® v1.1.
Same indication for use as OLINDA EXM® v1.1	The proposed device OLINDA/EXM® v2.0 and the predicate devices OLINDA/EXM® v1.1 (K033960) have the same indication for use.

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

This information is not explicitly provided in the document. The "tests for verification and validation" are mentioned, but the specific details of a "test set" (e.g., number of cases, type of data) are not described. Given that the device calculates radiation dose based on input data regarding biodistribution and relies on established models (ICRP decay data, anthropomorphic phantoms), the testing likely involved comparing output values for a range of inputs rather than a clinical dataset of patient images.

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

This information is not explicitly provided. Since the device calculates deterministic radiation doses based on models, the "ground truth" would likely be derived from established physical and biological models, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Adjudication methods like 2+1 or 3+1 are typically used when human experts are disagreeing on interpretations for a ground truth. This is not applicable to a dose calculation software validating against established models and data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This information is not explicitly provided, and it is unlikely such a study was performed or needed given the nature of the device. MRMC studies are typically for diagnostic AI systems where human readers interpret medical images. This device is a software tool for calculating radiation dose.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document implies that the "testing" described for verification and validation was a standalone evaluation of the algorithm's performance against its specifications and the predicate device. The comparison showing "good compliance" between OLINDA/EXM v2.0 and OLINDA/EXM v1.1 suggests an algorithm-only evaluation. However, the exact methodology is not detailed.

7. The Type of Ground Truth Used

The "ground truth" for this device likely refers to:

Established physical and biological models: The document mentions "new human models and nuclides," "new set of decay data recommended by the International Commission on Radiological Protection (ICRP)," and "updated values of the mass of the target region (mr) recommended by the ICRP." These are the underlying scientific references against which the calculations would be validated.
Outputs of the predicate device (OLINDA/EXM v1.1): The comparison showing "good compliance" with the predicate device implies that the predicate's outputs served as a reference for validating the new version.

8. The Sample Size for the Training Set

This information is not applicable/provided. OLINDA/EXM v2.0 is a deterministic calculation software based on established physical and biological models, not a machine learning or AI model that requires a "training set" in the conventional sense. It's a software tool that implements mathematical models and data.

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

This information is not applicable/provided for the same reasons as #8. The "ground truth" here is derived from scientific consensus and established data (e.g., ICRP recommendations) that are used as inputs or validation references for the software's calculations, not a "training set" for a learning algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 19, 2017

Hermes Medical Solutions AB % Joakim Arwidson Quality Manager Skeppsbron 44 11130 Stockholm SWEDEN

Re: K163687

Trade/Device Name: OLINDA/EXM v2.0 Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (Gamma) Camera Regulatory Class: Class I Product Code: IYX Dated: July 5, 2017 Received: July 7, 2017

Dear Joakim Arwidson:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163687

Device Name OLINDA/EXM v2.0

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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510 (k) SUMMARY

A. Submitted by:

Submitters name and address: Hermes Medical Solutions AB Skeppsbron 44 111 30 Stockholm Sweden

. Submitters telephone number

Phone:	+46 8 19 03 25
Cell:	+46 708 19 03 08
Fax:	+46 8 18 43 54
E-mail:	joakim.arwidson@hermesmedical.com

● Contact person

Joakim Arwidson Quality Manager Hermes Medical Solutions AB Skeppsbron 44 111 30 Stockholm Sweden

. Reqistration number 9710645

B. Preparation date:

2016-11-23

C. Proprietary/Trade name, Common name, Classification name:

Proprietary/Trade name . OLINDA/EXM® v2.0
. Common name Scintillation (gamma) camera.
. Classification name Scintillation (gamma) camera, Class I, 21CFR892.1100.

D. Legally marketed device (predicate device):

Following legally marketed device has been used for comparison.

OLINDA/EXM® v1.1 (K033960) ●

E. Description of the device that is subject of this premarket notification:

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The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).

F. Intended use:

G. Technological characteristics:

The proposed device OLINDA/EXM® v2.0 has the same technological characteristics as the original device OLINDA EXM® v1.1 and the same indication for use.

H. Testing:

The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.

I. Substantially Equivalent/Conclusions:

The proposed device OLINDA/EXM® v2.0 and the predicate devices OLINDA/EXM® v1.1 (K033960) have the same indication for use.

The proposed device will use similar technology and fundamental concepts and operation are also the same, as described in the 510(k) submission.

Comparisons were made between OLINDA/EXM® v2.0 and OLINDA/EXM® v1.1 (K033960). The results showed a good compliance.

In summary, the OLINDA/EXM® v2.0 described in this submission is in our opinion substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).