(88 days)
The NOMOS TALON Positioning and Immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during:
- a) diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and
- b) during treatment procedures in the radiation therapy suite.
The NOMOS TALON Positioning and Immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and during treatment procedures in the radiation therapy suite. Major components include the TALON Skull Mount, NOMOGrip, Target Box, CT Reference Pointer, Radiotherapy Table Adapter, and CT Head Support.
The provided text describes the NOMOS TALON Positioning and Immobilization System and its claim of substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details about sample sizes, ground truth establishment, or expert involvement for performance evaluation.
Therefore, I cannot populate the requested table and answer many of the questions based on the provided text.
Here's an assessment based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document primarily focuses on claiming substantial equivalence to predicate devices based on indications, design, materials, manufacturing, and specifications. It mentions "specifications for repeat fixation are similar to those of the NOMOS gNomos Stereotactic System (K901670B)" but does not quantify these specifications or report specific performance metrics for the TALON system. | Not specified in the document. No specific performance metrics (e.g., accuracy, precision, repeatability) are provided for the NOMOS TALON system that could be compared against acceptance criteria. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned in the document.
- Data Provenance: Not mentioned in the document. The document refers to predicate devices and their existing marketing status but gives no details about new testing data for the TALON system.
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 mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned in the document.
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
- Not applicable. This device is a physical positioning and immobilization system, not an AI or imaging interpretation tool. There is no mention of such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not mentioned in the document. The document relies on similarity comparisons to predicate devices rather than direct performance testing against a defined ground truth for the TALON system itself.
8. The sample size for the training set
- Not applicable. This device is a physical system, not a machine learning model that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.