(79 days)
The Dental Tray holds an impression of the upper teeth, and is part of the GTC Relocatable Head Holder in stereotactic collimated beam, computer planned, LINAC (linear accelerator) based treatment. The Dental Tray holds the dental impression. The dental impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments.
The Dental Tray holds an impression of the upper teeth as part of the predicate system. This impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments. The material of the GTC Dental Tray has been modified from that described in (K934523). The GTC Dental Tray addressed in this 510(k) PMN has the same intended use, design, and technological characteristics as the Dental Tray included in the commercially available GTC Relocatable Head Holder System (K934523).
The provided text describes a "Dental Tray for use with the Gill-Thomas-Cosman Relocatable Head Holder," a Class II device. However, the text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a "Summary of Safety and Effectiveness" which focuses on general information, intended use, and the basis for substantial equivalence to a predicate device.
Specifically, the text:
- Identifies the device as a Gill-Thomas-Cosman (GTC) Dental Tray.
- States its intended use as holding an impression of upper teeth for repeat positioning of a stereotactic frame in LINAC-based stereotactic radiotherapy.
- Mentions a predicate device (K934523) and claims substantial equivalence based on the same intended use, design, and technological characteristics, despite a material modification.
There is no information in the provided excerpts related to:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi Reader Multi Case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore,Based on the provided text, I cannot answer your request as the information regarding acceptance criteria, study details, and performance metrics is not present. The document focuses on the general description, intended use, and substantial equivalence claim for a dental tray component rather than detailed performance study results.
§ 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.