(87 days)
The TBI Stand is used to safely support and reposition a patient for radiation therapy treatment in the vertical (standing) position when a physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physician utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.
The TBI Stand is used to safely support and reposition a patient for radiation therapy treatment in the vertical (standing) position when physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physicians utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.
The provided document describes a 510(k) premarket notification for a medical device called the "TBI Stand." This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel clinical performance through acceptance criteria and a detailed study.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC study, standalone performance, ground truth, training set), and effect size cannot be extracted from this document, as these concepts are not applicable to a 510(k) substantial equivalence submission for the TBI Stand.
The document focuses on comparing the TBI Stand's technological characteristics to a legally marketed predicate device (MED-TEC Radio Therapy Treatment Chair K951947) to demonstrate that it is substantially equivalent and thus safe and effective for its intended use.
Here's a breakdown of what can be extracted related to the device and its comparison:
1. A table of acceptance criteria and the reported device performance:
Instead of "acceptance criteria," the document provides a "Predicate Comparison Table" which lists technological characteristics of both the predicate device and the TBI Stand. The "reported device performance" in this context is how the TBI Stand meets or exceeds these characteristics compared to the predicate.
| Specifications | MED-TEC Treatment Chair K951947 (Predicate) | Mick Radio-Nuclear Total Body Irradiation Stand (TBI) (Reported Device Performance) |
|---|---|---|
| Vertical Patient Positioning | Yes, upper torso | Yes, whole body |
| Head Positioning | Yes | Yes |
| Shoulder Positioning | No | Yes |
| Arm Support | Yes | Yes |
| Hand Grips | Yes | Yes |
| Seat-Padded | Yes | Yes |
| AP/PA Treatment Positions | Yes | Yes |
| Transparent Back Support | Yes | Yes |
| Film Cassette Holder | No | Yes |
| Reproducible Settings | Yes | Yes |
| Lung Shield Supports | No | Yes |
| Radiation Spoiler (Scatter Screen) | No | Yes |
| Construction: | Wood, Plastic and Carbon Fiber | Stainless Steel, Delrin, Acrylic, Wood, Formica |
| Weight: | 22 lbs | 100 lbs |
| Use Location | On treatment table | Rolls on floor |
Summary of why the other points cannot be answered:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a comparison of design and features, not a performance study involving a test set of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in this context.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication occurred.
- 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 stand, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a 510(k) of this nature is the established performance and safety of the predicate device, against which the new device's characteristics are compared.
- 8. The sample size for the training set: Not applicable. No training set is involved for this type of device submission.
- 9. How the ground truth for the training set was established: Not applicable, as there is no training set.
§ 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.