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The Akesis Galaxy RTi, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position. consists of a) The y-ray treatment unit, and b) interface to a stereotactic localization system, and c) kV x-ray positioning and verification system

AI/ML Overview

The provided text describes a medical device, the Akesis Galaxy RTi Rotating Gamma System, which is a radionuclide radiation therapy system intended for stereotactic irradiation of human head structures in adults. The submission is a 510(k) premarket notification, indicating the device is being compared to a legally marketed predicate device (Akesis Galaxy RTx Rotating Gamma System).

Based on the provided information, the study focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity) derived from a clinical study with a test set, ground truth, and expert readers.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device's clinical application. Instead, acceptance criteria are aligned with demonstrating substantial equivalence to a predicate device and complying with recognized standards.

Acceptance Criteria Category	Reported Device Performance
Intended Use	"The Akesis Galaxy RTi has the same intended use... as the predicate device."
Operating Principle	"uses the same radioisotope, applies the same operating principle... as the predicate device."
Technical Characteristics	"has the same technical characteristics... as the predicate device." (Acknowledged differences: Addition of a kV x-ray imaging system, interface to compatible immobilization devices).
Performance Specifications	"meets the same performance specifications as the predicate device." Performance tests demonstrated that the Akesis Galaxy RTi "has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use."
Regulations and Standards	"Both the predicate and the Akesis Galaxy meet the same set of regulations and standards." Specifically, "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 60601-1-3, 60601-1-6, 60601-2-68, 60601-2-11, 60601-1-2, 61217, 62274 and 62366."
Electrical Safety and 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 60601-1-3, 60601-1-6, 60601-2-68, 60601-2-11, 60601-1-2, 61217, 62274 and 62366."
Hardware/Software V&V	"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 in Medical Devices." The software for this device was considered as a "major" level of concern."
Biocompatibility	"Biocompatibility testing was not performed since this device does not have any direct tissue contacting components / parts. This is in accordance with the 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", September 2020."
Safety and Effectiveness Issues	"Use of the Akesis Galaxy RTi does not raise any new or different issues of safety or effectiveness when compared with the predicate device."

Regarding the Absence of Diagnostic Performance Studies for AI/Machine Learning Devices:

It is crucial to note that this 510(k) submission is for a radionuclide radiation therapy system, which is a physical device used for treatment. It is not an AI/machine learning diagnostic device where performance is typically measured in terms of sensitivity, specificity, or AUC against a ground truth established by experts. Therefore, many of the questions regarding sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of device and submission.

The "study that proves the device meets the acceptance criteria" in this context refers to engineering tests, verification and validation activities, and comparisons of technical characteristics to a predicate device, rather than a clinical trial assessing a diagnostic AI algorithm.

Here's a breakdown for the N/A questions:

2. Sample size used for the test set and the data provenance: N/A (Not an AI/diagnostic device clinical study). The performance data cited are related to engineering and safety standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth as understood in AI/diagnostic performance studies is not applicable here).

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

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: Not applicable, as this device does not involve human readers interpreting images with or without AI assistance for diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a therapeutic device, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" here is compliance with engineering standards and specifications, not clinical diagnostic accuracy.

8. The sample size for the training set: N/A. (Not an AI/machine learning algorithm).

9. How the ground truth for the training set was established: N/A.

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