(410 days)
Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. The Chabner XRT™ Garments are not intended for pediatric use.
The device is a non-sterile garment worn by patients as an aid in the support and positioning of patients during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. There are three versions of the garment: 1) brassiere; 2) athletic style shorts; and 3} girdle. All versions of the device are devoid of metal and can be worn for use with all treatment or diagnostic machines without causing a bolus (i.e., the materials do not mimic the properties of tissue during a radiological procedure) or attenuation effect. All materials used in the device's construction are
The provided document, K121284, is a 510(k) summary for the Chabner XRT™ Garments, a patient support and positioning device. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested details about acceptance criteria, efficacy studies, and ground truth establishment are not explicitly present in this type of regulatory submission, which is for demonstrating substantial equivalence rather than novel efficacy.
Here's an attempt to extract and describe the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria or detailed performance results from a study directly comparing the Chabner XRT™ Garments against such criteria. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices based on shared fundamental characteristics.
| Acceptance Criterion (Implied by Predicate Equivalence) | Reported Device Performance (Chabner XRT™ Garments) |
|---|---|
| Intended Use: Aid in patient support and positioning during various radiological procedures. | Reported: "Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures." (Matches predicate) |
| Radiotranslucency: Allows radiation to pass through without affecting therapy or diagnosis. | Reported: "All versions of the device are devoid of metal and can be worn for use with all treatment or diagnostic machines without causing a bolus...All materials used in the device's construction are |
§ 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.