(28 days)
The Raycast High Precision Lung Board Solution is a patient positioning device intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.
The Raycast High Precision Lung Board is used to position the patient supine on the treatment couch with the arms lifted above the head. This will keep the arms outside of the treatment field, which is the thorax in this case. The Raycast High Precision Lung Board is attached to the treatment couch with a 2-vin indexing bar in order to reproduce the same position each day. The Raycast High Precision Lung Board should be fully supported by the treatment couch. Then the patient is asked to lie down on the couch with his head in a head support that is attached to the Raycast High Precision Lung Board. Once the patient is lying down, he can lift up his arms until the elbows rest against the 'wings' of the board and the hands can reach the T-shaped handgrip.
The position of the T-shaped handgrip can be adjusted both in height and length according to the patient's anatomy. To adjust the height of the handgrip, pull the white knob on the side and move the grip pole up or down. To adjust the length of the handgrip, pull the white knob at the cranial side and slide the handgrip more caudally or cranially. Various head supports can be placed on the Raycast High Precision Lung Board depending on the physician's preference. The standard set-up will be with an Orfit Head Support, but it is also possible to use a Silverman or Timo Head Support which they might already have available in their department.
Once the patient is set-up correctly, the arms should not be treatment field anymore, which is the thorax area in this case. This allows the physician to irradiate the thorax from various angles, including laterally without passing through the arms of the patient. The Raycast High Precision Lung Board itself will not be in the treatment field and as such will not be irradiated through.
The provided text is a 510(k) summary for a medical device called the "Raycast High Precision Lung Board Solution". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be directly extracted from this document.
The document primarily relies on a comparative analysis with a previously cleared predicate device (K040773 Extended Butterfly Board, Bionix Development Corp.) to establish substantial equivalence.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define explicit acceptance criteria in the typical sense of a clinical study (e.g., target sensitivity/specificity). Instead, it demonstrates equivalence to a predicate device across various attributes. The "acceptance criteria" are implied by the features and performance of the predicate device.
| Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Raycast High Precision Lung Board Solution) |
|---|---|
| Indications for Use: Patient positioning/re-positioning for external beam radiation therapy for cancer and other diseases, by/under direction of a licensed physician. | Identical. |
| Intended Use: Patient positioning/re-positioning for radiation therapy. | Identical. |
| Prescription Status: Prescription Use (Rx). | Identical (Rx). |
| CFR Regulation: 892.5050. | Identical (892.5050). |
| Material Board Assembly: Acrylic. | Identical (Acrylic). |
| Material T Handle Base and Posts: POM + Nylon. | Identical (POM + Nylon). |
| Material Flat Screws: Nylon. | Identical (Nylon). |
| Material Socket Head Cap Screws and Knurled Thumbscrews: Nylon. | Not applicable (proposed device does not have these screws). This difference is deemed not to raise new questions of safety or effectiveness. |
| Material Hand Grip Assembly: Vinyl. | POM + Nylon. Difference noted, but deemed similar in grip characteristics and resistance to extreme temperatures not applicable. No new questions of safety or effectiveness raised. |
| Material Attachment Pins: POM. | Identical (POM). |
| Hand Grip Spring: None. | Polyamide. Predicate device does not have this spring; this difference is deemed not to raise new questions of safety or effectiveness. |
| Fabrication: Machined and Thermoformed. | Identical (Machined and Thermoformed). |
| Design: Elevated thermoformed "wings" for upper arm support and patient positioning. | Identical. |
| Positioning: Handgrip for patient positioning and re-positioning. | Identical. |
| Mounting Holes: Yes. | Identical (Yes). |
| Thickness: 0.31". | Identical (0.31"). |
| LxWxH: 22.4" x 21.3" x 6.7". | Identical (22.4" x 21.3" x 6.7"). |
| Cleaning/Disinfection in Labeling: Water-based antiseptic cleaner/foam, no alcohol. | Soapy water or isopropanol-based disinfectant with soft cloth. Minor difference in description, scope is the same, no difference in SE. |
| Weight: 6.24 lbs. | Identical (6.24 lbs). |
| MR Safety: (Implied to be acceptable for predicate). | MR Safe. |
| Attenuation/SBU: (Implied to be acceptable for predicate). | ~6MV (4.15%) attenuation, ~mmH2O/11mm Skin Build Up. Extrapolated based on performance testing and SE comparison of materials, fabrication, thickness, and density to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This is not a clinical study involving a "test set" of patients or data in the typical sense. The primary "test" is a comparative analysis of the device's characteristics against a predicate device.
- Data Provenance: Not applicable. The data is primarily derived from the technical specifications and performance testing of the proposed device and comparison to the predicate device's known characteristics. No mention of country of origin or retrospective/prospective data collection in a clinical context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. There is no "ground truth" establishment in a clinical setting as this is a device comparison for substantial equivalence. The "truth" is established by the specifications and performance of the proposed device and the predicate.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set requiring adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is not mentioned or implied because the device is a patient positioning board, not an imaging or diagnostic AI device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is not an algorithm or AI. It's a physical medical device. Performance testing for a physical device typically involves bench testing, which was done for dosimetry (attenuation, water thickness) and MR safety.
7. The Type of Ground Truth Used:
- The "ground truth" in this context is the technical specifications, material properties, and physical performance data of both the proposed device and the predicate device. For example, material composition (Acrylic, POM, Nylon), dimensions, weight, and results of physical bench tests such as dosimetry and MR safety. The "truth" is effectively the established characteristics of the predicate device against which the new device is compared.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set for this type of device.
Additional Study Information from the Text:
- Bench Testing: "Bench testing was performed and includes a dosimetry test report for the device including device attenuation and water thickness, which have been validated to demonstrate SE to the predicate in safety and effectiveness."
- MR Safety Studies: "Additional studies performed are the MR safety studies performed in order to demonstrate that the device tested as MR safe."
In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence for a physical patient positioning device. It directly compares the proposed device to a legally marketed predicate based on technical specifications and bench testing, rather than reporting on a clinical study with acceptance criteria and a test set against a clinical ground truth.
§ 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.