Search Results

The Integrated Conical Collimator Verification and Interlock system (ICVI) is an accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or tumors.

Integrated Conical Collimator Verification and Interlock system (ICVI) is a secondary collimation system. It also has a security feature that verifies the correct selection of a conical collimator and prevents the radiation treatment device from commencing irradiation when the selected conical collimator is out of conformance with the treatment plan.

Integrated Conical Collimator Verification and Interlock system (ICVI) consists of a collimator mount that attaches to the accessory plate (Slot 2) of the linear accelerator, conical collimators that insert into the mount and are capable of being read electronically by the mount, and a locking ring that locks the conical collimator to the mount.

The provided document is a 510(k) summary for the Integrated Conical Collimator Verification and Interlock system (ICVI). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain a detailed study that proves the device meets specific acceptance criteria in the manner one would expect for an AI/CADe device.

Instead, the summary focuses on demonstrating substantial equivalence to a predicate device and outlines general performance testing. The "acceptance criteria" presented are primarily a comparison of characteristics between the subject device and the predicate device for demonstrating substantial equivalence, rather than quantitative performance metrics from a formal study.

Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, training set details) are not available in this document because the described "testing" is not a clinical study to quantify performance against specific efficacy or diagnostic accuracy metrics. It's a verification and validation process against engineering specifications and regulatory requirements for a physical accessory device.

Here's an attempt to answer the questions based on the provided text, highlighting what is available and what is missing:

Acceptance Criteria and Device Performance

A table of "acceptance criteria" in the traditional sense of performance metrics (e.g., sensitivity, specificity, AUC) is not provided. Instead, the document presents a comparison of characteristics between the subject device (ICVI) and the predicate device (SNT Linac Accessories, K971893) to establish substantial equivalence. The "Acceptance Criteria" column below will represent these comparative characteristics, and "Reported Device Performance" will indicate how the ICVI meets or exceeds the predicate.

The document states: "Results of verification and validation testing showed conformance to applicable requirement specifications and assured hazard safeguards functioned properly." This is a general statement of compliance, not a detailed report of quantitative performance against specific acceptance criteria.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable/Not Provided. The document describes "verification and validation testing" but does not refer to a clinical "test set" in the context of diagnostic or efficacy studies. The testing would have involved physical devices and perhaps simulated use cases for mechanical and electronic functionality, but no patient data is mentioned.

2. 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. This is a hardware accessory device with safety interlocks. The "ground truth" would be engineering specifications and functional correctness, verified through engineering tests rather than expert consensus on medical images or diagnoses.

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

   • Not Applicable/Not Provided. Not relevant for this type of device and testing.

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:

   • Not Applicable/Not Provided. This device is a physical accessory for a linear accelerator with an interlock system. It is not an AI/CADe device, and no MRMC study would be relevant or expected for its regulatory submission.

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

   • Not Applicable/Not Provided. This is a physical device, not an algorithm. The "standalone" performance would be its functional verification (e.g., does the interlock activate when it should, does it accurately read the collimator). The document states: "Testing was performed to demonstrate - That the device functions correctly with the specified Linear Accelerators. - That the device meets mechanical specifications. - Usability was assessed to the requirements of IEC 62366:2007." These are standalone functional tests.

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

   • Engineering Specifications and Functional Requirements. The ground truth for this device's "acceptance" is its adherence to mechanical specifications, proper electronic verification of collimator selection, and reliable activation of safety interlocks as designed. This is not derived from patient outcomes or expert medical interpretation but from engineering design and validation.

7. The sample size for the training set:

   • Not Applicable/Not Provided. This is not an AI/ML device, so there is no "training set."

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

   • Not Applicable/Not Provided. As it's not an AI/ML device, no training set or its associated ground truth establishment method is relevant.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the ICVI system to a predicate device, as required for a Class II medical device. The "study" described is verification and validation testing to ensure the device meets its engineering specifications, functions correctly, and provides the intended safety features (electronic verification and interlock). It is not a clinical study to assess diagnostic accuracy or treatment efficacy, and therefore, the detailed metrics and methodologies typical for AI/CADe clinical studies are not present. The primary "acceptance criteria" are the functional equivalence or superiority to the predicate device in terms of features, intended use, and safety mechanisms.

Ask a specific question about this device