Search Results
Found 3 results
510(k) Data Aggregation
(135 days)
Akesis Galaxy RTi
The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures for adults.
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
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.
Ask a specific question about this device
(25 days)
Akesis Galaxy RTx
The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.
The Akesis Galaxy RTx, 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.
The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient's head is immobilized in a headframe which has been fitted prior to the commencement of treatment. The entire system consists of a) the y-ray treatment unit, and b) the stereotactic localization system.
The provided text describes the 510(k) premarket notification for the Akesis Galaxy RTx, a radionuclide radiation therapy system. It details the device's technical characteristics, its comparison to a predicate device, and various performance data submitted in support of its substantial equivalence.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance for diagnostic or assistive functions related to image analysis or data processing. The device described is a physical radiation therapy system, and the performance data pertains to its safety, electrical compatibility, hardware/software verification, and its ability to meet specifications for radiation delivery.
Therefore, I cannot provide the requested information for an AI/ML device, as the provided text relates to a different type of medical device for radiation therapy.
If you have information about an AI/ML device and its associated acceptance criteria and study data, please provide that text.
Ask a specific question about this device
(156 days)
Akesis Galaxy
The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures
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.
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."
Ask a specific question about this device
Page 1 of 1