(211 days)
Innocure Intensity Modulating Radiation Therapy Compensators are indicated to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).
An "Innocure IMRT Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan and field identification. The Compensator device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block tray.
An "Innocure IMRT Radiation Blocking Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The Blocking device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav.
An "Innocure Radiation Wound Protective Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav.
This document, K052383, is a 510(k) premarket notification for the "Innocure Intensity Modulating Radiation Therapy Compensators." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not explicitly available in this document. This is common for 510(k) submissions, which typically rely on comparison to a legally marketed predicate device rather than de novo clinical performance studies with detailed statistical analyses.
Here's a breakdown of what information can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided. This document is a 510(k) summary, which asserts substantial equivalence based on intended use and technological characteristics to a predicate device. It doesn't present specific performance metrics or acceptance criteria that a new, de novo study would typically establish.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This is not a clinical study on a test set of patients or medical images. The device is a physical compensator used in radiation therapy. The "test set" would implicitly be the technological characteristics and intended use compared against the predicate device.
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 applicable/Not provided. No "ground truth" establishment by experts in the context of a medical image or clinical outcome assessment is described, as this is a device for radiation beam shaping.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. There is no test set in the sense of a dataset 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
- No. This device is an Intensity Modulating Radiation Therapy Compensator, a physical device, not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device (Southeastern Radiation Products, Inc., K040804). The new device asserts that its technological characteristics and intended use are sufficiently similar not to introduce new safety or effectiveness concerns.
8. The sample size for the training set
- Not applicable/Not provided. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of available information relevant to "acceptance criteria" and "study":
The "study" presented is essentially the 510(k) submission process itself, which aims to demonstrate substantial equivalence to a predicate device rather than meeting specific performance criteria through a new clinical trial.
Predicate Device:
- Name: ".Decimal Tissue Compensator/Intensity Modulator"
- 510(k) Number: K040804
- Manufacturer: Southeastern Radiation Products, Inc.
Acceptance Criteria (Implicit via Substantial Equivalence):
The acceptance criteria, though not explicitly numerical targets, are implicitly the requirements for substantial equivalence as defined by the FDA. This means the device must:
- Have the same intended use as the predicate device.
- Have similar technological characteristics to the predicate device.
- Not raise different questions of safety and effectiveness than the predicate device.
Reported Device Performance (Implicit via Comparative Analysis):
The document states:
"The subject devices...have the same intended use and similar characteristics as the predicate device and does not introduce new issues of safety or effectiveness."
This statement is the "reported device performance" in the context of a 510(k) submission – it asserts that the new device performs equivalently to the predicate device concerning safety and effectiveness, based on a comparison of its design, materials, and intended use. No specific quantifiable "performance" metrics for the Innocure compensators are provided beyond this assertion of similarity.
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.