Search Results

AccuChanger is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for the collimation of megavoltage photon beams in conjunction with Stereotactic Radio Surgery (SRS) and Stereotactic Radio Therapy (SRT) treatments.

AccuChanger device is designed to be used for the Linac beam shaping during radiotherapy. It constitutes an add-on to a Linac used for automatic switching of circular collimators during treatments without entering the treatment room. AccuChanger uses a two-level circular-collimator set. It has two drums one mounted on top of the other. Each drum has nine drumb one mounted in a descending order of radius. Although it is possible for the collimation to combine any pair of collimators lo possible as a drum, only seventeen combinations are deemed valid. Each valid combination is forming a circular aperture valia. Back value of the circular collimators (upper/lower) is set as the beam shaping collimator, the other (lower/upper respectively) is set as a post/pre bounding "protecting" collimator to reduce radiation transmission. To start a treatment, a treatment file is needed specifying the aperture diameter at the isocenter for each of the treatment beams (defined input format). AccuChanger-CS calculates the fitting collimator size on one drum and chooses the best match on the other. Since the matching pairs are known in advance, a lookup table is used obviating the need of re-calculating the appropriate collimators pair.

The provided text is a 510(k) summary for the "AccuChanger" device. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the way a clinical study would for an AI/ML diagnostic tool.

Therefore, many of the requested details about acceptance criteria, full performance studies, sample sizes, ground truth establishment, and MRMC effectiveness studies are not available in this type of regulatory submission. The document primarily describes the intended use, device function, and comparison to predicate devices to demonstrate that it does not raise new safety or effectiveness concerns.

Here's a breakdown of the available information based on your request, along with explanations for what is not present:

Acceptance Criteria and Device Performance (Not in the context of a typical AI/ML study)

This 510(k) summary does not include a table of acceptance criteria and reported device performance in the manner of a clinical sensitivity/specificity study for an AI/ML product. The document asserts that the AccuChanger performs the same function as existing devices (shaping blocks, circular/cut blocks collimators) and complies with voluntary IEC safety standards.

Table of "Acceptance Criteria" and "Reported Device Performance":

Additional Information

1. Sample sizes used for the test set and the data provenance:

   • Not Applicable. This document is for a mechanical medical device (a linear accelerator accessory), not an AI/ML algorithm that relies on a "test set" of data for performance evaluation in the traditional sense. There is no mention of a test set, data provenance, or specific patient data used to evaluate its "performance."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. Ground truth, in the context of expert consensus on data, is not mentioned or relevant for this type of device. The device's function is mechanical manipulation of collimators, not diagnostic interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No test set or human adjudication method is described.

4. 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 is not an AI-assisted diagnostic device. No MRMC study was performed or is relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not Applicable. This device is an accessory to a linear accelerator, operated by a radiation oncologist or technician, and does not involve a standalone algorithm for performance evaluation in isolation from its mechanical function.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not Applicable. The "ground truth" for this device would be its ability to physically position the correct collimators and ensure accurate beam shaping, which is verified through engineering tests and quality control, not clinical "ground truth" derived from patient data. The document does not describe such studies.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set of data.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set for an AI/ML algorithm is used in this context.

Summary of what the document does provide:

• Intended Use: To assist radiation oncologists in delivering radiation to target volumes while sparing critical organs, specifically for Linac beam shaping during radiotherapy, including Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapy (SRT). It performs the function of shaping blocks/collimators.
• Device Description: An add-on to a Linac for automatic switching of circular collimators, using a two-level circular-collimator set with two drums. It contains a lookup table for pre-determined collimator pairs based on a specified aperture diameter.
• Predicate Devices: AccuLeaf K040553, Cranial Stereotactic Equipment K010065, XKnife K912630.
• Substantial Equivalence Claim: The device has "identical intended use and indications for use" as AccuLeaf, operates on "similar principles of operation and technological characteristics" to all predicates, and "does not present any new method of treatment." Minor differences do not raise new safety or effectiveness issues.
• Compliance: Adheres to voluntary IEC 60601-1 series standards.

This 510(k) is a regulatory filing for a mechanical accessory, and therefore, the detailed study information you're asking for, typical of AI/ML or diagnostic device submissions, is not present.

Ask a specific question about this device