(156 days)
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.
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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."
§ 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.