(89 days)
In Radiation Therapy and Diagnostic Radiology, an ongoing quality assurance program is essential for ensuring the overall quality of patient care. As part of the overall quality assurance program daily, monthly and annual tests to validate machine output, field size indicators, and general machine geometry are performed. In order to obtain reproducible results, these tests must be Since machine with the same conditions, with the same physical parameters. Since machine output and field size are directly related to the geometry of the test conditions it is important that the distance from the beam source to the test device is consistent. The Aktina Medical Physics Corporation Mechanical Frontpointer is designed to provide this ability. By utilizing the fixed geometry of the accessory mount system on a linear accelerator, a rigid based for measuring distance can be obtained. The Mechanical Frontpointer presented in this notification functions exactly as a standard mechanical tape measure however by being attached to a frame which slides into the accessory mount a reproducible setup is ensured.
The AKTINA Medical Physics Corporation Mechanical Frontpointer is intended for use in Medical Physics Quality Assurance. The intended use of this device is to provide a reproducible and accurate mechanism for the setup of test objects and equipment used in quality control and calibrations by medical physicists. The Mechanical Frontpointer is mounted in the accessory slot of the treatment machine and is not in contact with the patient at any time when in use.
The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating the device meets such criteria. The document is a 510(k) summary for the "Mechanical Frontpointer," which is a device for medical physics quality assurance, used to provide a reproducible and accurate mechanism for the setup of test objects and equipment.
The document focuses on:
- General Provisions: Trade name, common name, applicant information.
- Predicate Devices: Sears Tape Measure and Elekta Oncology Systems Mechanical Frontpointer K874558.
- Classification: Class I and Class II device classifications.
- Performance Standards: Notes that FDA has not established performance standards for Mechanical Frontpointers.
- Intended Use and Device Description: Explains its function in medical physics quality assurance for reproducible setup of test objects and equipment.
- Biocompatibility: States no studies were undertaken as the device does not contact the patient.
- Summary of Substantial Equivalence: Claims similarity in design, construction, materials, intended use, and performance to predicate devices without introducing new safety/effectiveness issues.
- FDA Clearance Letter: Official communication from FDA stating clearance based on substantial equivalence.
- Indications for Use: Details its role in radiation therapy and diagnostic radiology quality assurance for reproducible setup.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or MRMC studies, as these details are not present in the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.