The Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The v-ray treatment unit, and b) the stereotactic localization system.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (Akesis Galaxy Rotating Gamma System). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria for diagnostic output. Therefore, many of the typical elements requested for AI/diagnostic device studies will either not be applicable or will have limited information.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, explicit "acceptance criteria" against diagnostic performance metrics (like sensitivity, specificity, accuracy) are not provided in the document. Instead, the focus is on engineering performance, safety, and equivalence to a predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility (No change to patient-contact materials)	Conforms to FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1."
Electrical Safety (Compliance with IEC 60601-1)	Complies with IEC 60601-1.
Electromagnetic Compatibility (EMC) (Compliance with IEC 60601-1-2)	Complies with IEC 60601-1-2.
General Engineering Standards (Compliance with IEC 61217, 62274, 62366)	Successful testing performed in accordance with IEC standards 61217, 62274, and 62366.
Hardware and Software Verification and Validation (Conformance to QSR, ISO 13485, ISO 14971, FDA software guidance)	Tested according to QSR, ISO 13485, ISO 14971. Test results showed conformance to requirements and hazard safeguards. Software V&V conducted as recommended by FDA guidance for "major" level of concern.
Patient Position Accuracy (Improvement over predicate)	Improved to 0.25mm (from 0.30mm in predicate).
Specifications Met	Demonstrated that the Akesis Galaxy has met its specifications.
Substantial Equivalence (to predicate K970647)	Has the same intended use, radioisotope, operating principle, technical characteristics, performance specifications, and meets the same set of regulations and standards. Does not raise new safety/effectiveness issues.

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

No specific "test set" for diagnostic performance is mentioned as this device is a therapeutic radiation delivery system, not a diagnostic imaging or AI algorithm. The performance data provided relates to engineering and safety testing.

Sample Size for Test Set: Not applicable in the context of diagnostic/AI performance testing. The "test sets" would be the units of the device itself undergoing various engineering and safety tests.
Data Provenance: Not specified, but likely laboratory and manufacturing testing environments for engineering and safety verification.

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

Not applicable. This device does not establish a "ground truth" in the diagnostic sense, nor does it rely on human expert interpretation for its function. The "ground truth" for engineering and safety testing would be established by validated test procedures, reference standards, and regulatory requirements rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There's no physician-based adjudication process for the engineering and safety performance of a radiation therapy system described here.

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

No. An MRMC study is typically for evaluating the diagnostic performance of an AI algorithm with and without human assistance. This device is a radiation therapy system, not a diagnostic AI tool, and thus such a study is not relevant or reported in this document.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI algorithm but a physical medical device. The "standalone performance" is implicitly covered by the engineering and safety tests described, demonstrating that the device functions according to its specifications.

7. Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" consists of:

Compliance with recognized international standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 61217, 62274, 62366).
Compliance with regulatory requirements (21 CFR §820).
Conformance to the device's own internal design specifications and requirements.

8. Sample Size for the Training Set

Not applicable. This device is a hardware system, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no "training set."

Summary

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September 4, 2019

Akesis Inc % Christopher Brown Director Quality Assurance and Regulatory Affairs 5129 Commercial Circle CONCORD CA 94520

Re: K190844

Trade/Device Name: Akesis Galaxy Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide Radiation Therapy System Regulatory Class: Class II Product Code: IWB Dated: July 17, 2019 Received: July 19, 2019

Dear Christopher Brown:

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

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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 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,

For

Thalia M. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K190844

Device Name Akesis Galaxy

Indications for Use (Describe)

The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures

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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Premarket Notification [510(k)] Summary Akesis Galaxy Rotating Gamma System

The following information is provided following the format of 21 CFR 807.92.

I. GENERAL INFORMATION

Submitter's Name:	Akesis Inc.5129 Commercial CircleConcord, CA 94520
Contact Name:	Christopher BrownPhone: +1 925 408 1381Fax: +1 925 326 2646

II. DEVICE INFORMATION

Date Prepared:

Proprietary Name:	Akesis Galaxy
Classification Name:	Radionuclide radiation therapy system
Device Classification:	21 CFR 892.5750
Device Class:	Class II
Product Code:	IWB
Common/Usual Name:	Radionuclide radiation therapy system
III. PREDICATE DEVICE	OUR Rotating Gamma System (K970647)
IV. DEVICE DESCRIPTION	The Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The v-ray treatment unit, and b) the stereotactic localization system.

March, 29, 2019

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V. INTENTDED USE	The Galaxy Rotating Gamma System is a teletherapy device intended forthe stereotactic irradiation of human head structures
VI. INDICATIONS FOR USE	The Galaxy Rotating Gamma System is a teletherapy device intended forthe stereotactic irradiation of human head structures

VII. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Akesis Galaxy has the same intended use, uses the same radioisotope, applies the same operating principle, has the same technical characteristics and meets the same performance specifications. Both the predicate and the Akesis Galaxy meet the same set of regulations and standards.

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

-The treatment planning software has been removed
The treatment bed / table now supports three dimensional automated motions. Previously only one- dimensional automated motions were possible.
-Patient position accuracy is improved in the new device from 0.30mm to 0.25mm

VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence:

Biocompatibility Testing

In conformance with FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'", there was no change biocompatibility compared to the predicate device due to the patient-contact materials used in this medical device.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. Successful testing was performed in accordance with IEC standards 60601-1, 60601-1-2, 61217, 62274 and 62366.

Hardware and Software Verification and Validation Testing

Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.

Animal and Clinical Studies

Animal and clinical testing was not required.

Summary

These tests have demonstrated that the Akesis Galaxy has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.

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IX. CONCLUSIONS

The Akesis Galaxy has the same intended use, fundamental scientific technology and principles of operation as the predicate device.

Use of the Akesis Galaxy does not raise any new or different issues of safety or effectiveness when compared with the predicate device.

Performance tests have demonstrated that the Akesis Galaxy has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.

Regulation Number and Section

§ 892.5750 Radionuclide radiation therapy system.

(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.