(15 days)
The Render-Plan 3-D® is intended to be used for planning the dosimetry of treatments in radiation therapy. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
The Render-Plan 3-D® is an enhancement to the Render-Plan 3-D 1) (Formerly known as Renner-Plan) which has previously been cleared for (Formerly Known as Renner-Frish) winest (1999). This enhancement to Render-Plan 3-De does not raise additional types of safety of effectiveness considerations.
The provided document is limited to a summary of safety and effectiveness, and the FDA clearance letter for a device called "Render-Plan 3-D®". It appears to be a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies for effectiveness.
Based on the provided text, the following information can be extracted regarding the device and its assessment:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, accuracy, or any clinical outcomes. This submission focuses on demonstrating substantial equivalence and adherence to quality systems and regulations.
2. Sample size used for the test set and the data provenance
No information is provided about a specific "test set" with a defined sample size or data provenance. The submission states that the Render-Plan 3-D® is an "enhancement to the Render-Plan 3-D (Formerly known as Renner-Plan) which has previously been cleared for (1999)." This implies that the current device is being compared to its predicate, and effectiveness is asserted largely based on the predicate's prior clearance and the lack of new safety/effectiveness concerns.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
No information is provided about experts establishing ground truth for a test set. This type of detail is typically found in documentation for clinical trials or performance studies, which are not detailed here.
4. Adjudication method for the test set
No information is provided about an adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study is mentioned. The device is a "Render-Plan 3-D®" intended for "planning the dosimetry of treatments in radiation therapy," which processes inputs for dose setting. It is not described as an AI-assisted diagnostic or interpretative tool that would typically involve human reader performance comparisons.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone performance study for the algorithm is described. The device's function is described as processing inputs for dosimetry planning, implying it's a tool used by a healthcare professional rather than a standalone diagnostic.
7. The type of ground truth used
No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as being used for performance evaluation in this summary. The submission relies on affirming compliance with directives and the safety and effectiveness profile of its predicate device.
8. The sample size for the training set
No information is provided about a "training set" or its sample size. This suggests the device's development did not involve a machine learning approach that requires such a set.
9. How the ground truth for the training set was established
Since no training set is mentioned, there is no information on how its ground truth might have been established.
Summary of what is provided:
The document focuses on demonstrating that the Render-Plan 3-D® is an enhancement to a previously cleared predicate device, the Render-Plan 3-D (formerly Renner-Plan). The core argument for safety and effectiveness rests on:
- The new device being an enhancement to a predicate and not raising additional types of safety or effectiveness considerations.
- The device bears the CE mark and complies with relevant European Directives (e.g., Medical Device Directive 93/42/EEC Annex II).
- The manufacturer (PTI) operates under a Quality Management System compliant with ISO 9001.
- Risk analysis was conducted, concluding the device does not introduce new hazards and the level of concern is "Major" for software.
- The FDA determined the device is substantially equivalent to legally marketed predicate devices.
The submission is primarily a regulatory filing demonstrating equivalence and compliance with quality standards, rather than a detailed report of a performance study with specific acceptance criteria and outcome data for the device itself.
§ 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.