(90 days)
Klarity thermoplastic is intended for use by licensed physicians and trained radiation therapy professionals for the external support and stabilization of patients undergoing radiation therapy treatment in a licensed clinical setting.
Klarity™ is a "low temperature" Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F. (68° C.). Heating is best done by immersion in hot water. Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": [
"Substantially equivalent to Aquaplast™ Thermoplastic ([K935067](https://510k.innolitics.com/search/K935067)) in chemical composition, method of manufacture, physical appearance, physical characteristics, and intended use.",
"Pliant and moldable by hand when heated to 155° F (68° C).",
"To be used for stabilization of patients undergoing external beam Radiation Therapy.",
"To be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions."
],
"Reported Device Performance": [
"Klarity™ is equivalent to the predicate device in its chemical composition, method of manufacture, physical appearance, physical characteristics and intended use, verified by knowledge of the chemistry of the predicate device and physical testing.",
"Klarity™ is a 'low temperature' Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F (68° C).",
"Klarity™ Thermoplastic is to be used by, or under the supervision of licensed physicians for the stabilization of patients undergoing external beam Radiation Therapy.",
"Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use."
]
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not applicable. The submission is for a material (thermoplastic) used for patient stabilization, not a diagnostic or AI device that relies on a test dataset of patient data. The 'testing' involved physical characteristics of the material itself and comparison to a predicate device.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. Ground truth for patient data is not relevant for this device. The 'ground truth' for substantial equivalence was established via comparison to the predicate device and physical characteristics validated by experts in manufacturing and materials science (implied by the nature of the tests).",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable.",
"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": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a thermoplastic for patient stabilization, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with or without AI assistance is not applicable.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Substantial equivalence was established by comparing the device's chemical composition, manufacturing method, physical appearance, physical characteristics (mass density, radiation transmission, bolus effect, moldability, shrinkage), and intended use to a legally marketed predicate device (Aquaplast™ Thermoplastic). The 'ground truth' is the known characteristics and successful use case history of the predicate device itself, along with the results of physical testing on the Klarity™ material.",
"8. The sample size for the training set": "Not applicable. This is not an AI/ML device that requires a training set of data.",
"9. How the ground truth for the training set was established": "Not applicable."
}
§ 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.