(140 days)
Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy. The apertures and range compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Proton Systems manufactures radiation therapy beam-shaping apertures and range compensators to customer patient-specific specifications.
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The snout is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at predetermined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or port, requires two custom-made, beam-modifying patient-specific devices: an aperture and a range compensator.
The aperture is inserted into the gantry's snout to shape and focus the proton beam as it exits the qantry en route to the targeted area. The aperture is made of brass 360 with a 2D pattern / hole cut out of it, which defines the area that is to be treated with the proton beam. The range compensator is made of acrylic or wax and controls the depth at which the proton beam energy is delivered. The custom shape and design for apertures and range compensators are generated out of the hospital's treatment planning software and are unique to each patient and each gantry angle (most patients will have two to three different gantry angles).
The provided text describes a 510(k) submission for a Radiation Therapy Beam-Shaping Aperture and Range Compensator (K121657). This submission is centered on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through novel studies.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a formal device performance study in the way one might expect for a new, unproven technology. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing legally marketed device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Same Intended Use as Predicate Device | Met: "Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy... and range compensator manufacturing service manufactures the solid Range Compensators for intensity modulation of external beam proton radiation therapy." (Matches predicate device indications for use.) |
| Same Technological Characteristics as Predicate Device | Met: Device material (Brass 360 for aperture, Machinable Wax or Acrylic for range compensator), device sizes (30 x 40 cm, 100 cm, 180 cm, 250 cm), type of radiation (Proton Beam), single use (No), supplied sterile (No), requires sterilization (No) are all identical to the predicate devices. |
| As Safe and Effective as Predicate Device | Claimed: "It has been shown in this 510(k) submission that the differences between the proton radiation therapy beam-shaping aperture and range compensator manufactured by Proton Systems and the predicate devices listed are insignificant and do not raise any questions regarding its safety and effectiveness. The subject device, as designed and manufactured, is as safe and effective as the predicate devices for their intended application..." |
| Does Not Raise Different Questions Regarding Safety and Effectiveness as Compared to Predicate Device | Claimed: "...and do not raise any questions regarding its safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of an equivalence claim based on comparison of specifications.
- Data Provenance: The submission relies on a comparison table of technological characteristics to already cleared devices (K071077 and K071078). It does not involve a "test set" of patient data in the sense of a clinical or performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. There was no "test set" requiring expert ground truth establishment for this type of submission.
4. Adjudication Method for the Test Set:
Not applicable. There was no "test set" requiring adjudication.
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 beam-shaping aperture and range compensator used in proton radiation therapy, not an AI-assisted diagnostic or treatment planning software requiring human reader evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The ground truth for this submission is the established safety and effectiveness of the predicate devices, which have already gone through their own clearance processes. The current submission demonstrates that the new device is fundamentally the same.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set was used.
Summary of the Study (Non-Clinical Testing):
The "study" described in the document is a non-clinical comparison to predicate devices (K071077 and K071078).
- Section 9. Non-Clinical Testing: States "Testing to support this submission can be found in Appendix 5 - Performance Testing." However, Appendix 5 is not provided in the excerpt. Based on the overall context of a 510(k) for a substantially equivalent device, this "Performance Testing" would likely involve engineering verification (e.g., dimensional accuracy, material properties, mechanical integrity) to ensure the manufactured devices meet the specifications required for their intended function, and that these specifications are equivalent to or better than the predicate devices. It would not involve clinical outcomes or expert reader studies.
- Section 10. Clinical Testing: Explicitly states, "There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device." This reinforces that the submission hinges on substantial equivalence based on technological characteristics and intended use.
In essence, this submission is a declaration that the new device is functionally identical to existing, cleared devices, and therefore, all existing safety and effectiveness data for those predicate devices apply to the new device.
§ 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.