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The Barcode Conical Collimator Verification device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.

The Barcode Conical Collimator Verification (BCCV) device provides verification of conical collimators for the Varian High Energy Clinac (K100890) and TrueBeam (K092871) devices. Conical collimators are used during stereotactic radiodurgery (SRS) treatments to deliver small diameter treatment beams. The BCCV will prevent treatment until the conical collimator, as required by the treatment plan, has been scanned.

The provided text describes a medical device, the Barcode Conical Collimator Verification (BCCV) system, and its FDA 510(k) clearance. However, it does not contain information about acceptance criteria, the study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance), or training set details.

The document is a 510(k) summary for premarket notification, which primarily focuses on establishing substantial equivalence to a predicate device rather than providing detailed clinical efficacy or performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present. The document only describes the device's function ("prevents treatment until the conical collimator, as required by the treatment plan, has been scanned"). It doesn't quantify performance metrics like accuracy, reliability percentages, or failure rates.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is an automated verification system, not an AI-assisted diagnostic tool for human readers.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's function implicitly describes a standalone automated verification process, but no specific study details are provided.
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

In summary, the provided document is a regulatory submission for device clearance and does not contain the detailed performance study information you've requested. Such information would typically be found in performance data sections of the full 510(k) submission, which is not publicly available in this excerpt, or in separate scientific publications or internal validation reports.

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PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatmont is indicated.

PT2 Varian Proton Therapy System is a proton radiation therapy system which delivers therapeutic radiation in accordance with a physician's prescription. The system consists of four major components, 1) Cyclotron required to generate the photon beam 2) Beam line - transports beam from the cyclotron to the required treatment room 3) Up to 4 radiation treatment rooms 4) Treatment Control room

The provided text is a 510(k) Premarket Notification summary for the PT2 Varian Proton Therapy System. This document, like many 510(k) submissions for medical devices, particularly for well-established technologies, does not typically contain the detailed performance study information you are requesting for an AI/ML device.

Here's why the requested information cannot be fully provided from this specific document:

• Type of Device: The PT2 Varian Proton Therapy System is a physical medical device (a proton radiation therapy system), not an AI/ML software device. For such devices, acceptance criteria and performance studies focus on mechanical accuracy, dose delivery precision, safety, and functional equivalence to a predicate device, rather than metrics like sensitivity, specificity, or reader studies common for AI/ML.
• Nature of 510(k) Submissions: 510(k)s aim to demonstrate substantial equivalence to a legally marketed predicate device. While they include summaries of verification and validation, they often do not delve into the granular details of all tests conducted, particularly not in a format relevant to AI/ML performance evaluation.
• Date of Submission: This document is from 2010, preceding the significant rise and regulatory guidance for AI/ML in medical devices.

Therefore, for your specific points:

1. A table of acceptance criteria and the reported device performance: This document states: "Results of verification and validation testing demonstrate that the PT2 Varian Proton Therapy System satisfies the intended use as described above." However, it does not provide a table with specific quantitative acceptance criteria (e.g., beam energy deviation tolerance, beam positioning accuracy tolerance) and their corresponding reported performance values. The "Technological Characteristics" table compares features with a predicate device, but these are not acceptance criteria in the sense of a performance study.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving patient data in the context of an AI/ML algorithm. Performance testing would have involved physical measurements and engineering validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical proton therapy system. Ground truth typically refers to clinical diagnosis or pathology in AI/ML image analysis. Here, ground truth would be established by physical measurement standards and engineering specifications.

4. Adjudication method for the test set: Not applicable for a physical proton therapy system.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a framework for evaluating AI/ML impact on human interpretation, which is not relevant for a proton therapy delivery system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. Performance testing for this device would be its ability to deliver a proton beam according to specifications, not an algorithm's diagnostic output.

7. The type of ground truth used: For a physical device like this, ground truth would be against established physics principles, engineering specifications, and validated measurement techniques (e.g., dosimetry, beam profiling). The document does not specify these in detail beyond stating "verification and validation testing."

8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm that is trained on data.

9. How the ground truth for the training set was established: Not applicable.

In summary, while the document confirms that verification and validation were performed and the device meets its intended use, it does not provide the detailed performance study information requested, as it is for a physical medical device and not an AI/ML product.

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The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The UNIQUE is a Single Energy Linear Accelerator and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. UNIQUE is supported by the following Varian accessories: RPM Respiratory Gating (063270), PortalVision (K091209), 4D Integrated Treatment Console (K091132), Millennium Multi-Leaf Collimator (K050442).

The provided text describes a 510(k) summary for the Varian UNIQUE linear accelerator. It focuses on demonstrating substantial equivalence to a predicate device, the Varian Trilogy, rather than presenting a study with specific acceptance criteria and reported device performance metrics in the way a diagnostic AI device would.

Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a diagnostic AI device is not applicable to this submission. This is a submission for a physical medical device (linear accelerator) used for radiation therapy, not a diagnostic algorithm.

However, I can interpret the available information to address the spirit of your request as best as possible within the context of a medical device 510(k) submission.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a table. Instead, the "acceptance criteria" are implied by demonstrating that the UNIQUE's performance and safety characteristics are "substantially equivalent" to the predicate device (Varian Trilogy K072916) and that its design meets internal requirements. The "reported device performance" is a general statement that "the results of verification and validation activities demonstrate that the acceptance criteria have been met."

Instead of performance metrics, the document focuses on comparing device characteristics:

2. Sample size used for the test set and the data provenance

Not Applicable (N/A). This K101757 submission is for a physical medical device (linear accelerator) used for radiation therapy. It does not involve a "test set" of medical images or data for an AI algorithm in the typical sense. The "testing" refers to verification and validation of the hardware and software functionality to ensure it meets design specifications and safety requirements, often through engineering tests, rather than a diagnostic performance study on a patient sample.

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

Not Applicable (N/A). As above, this device does not utilize a "ground truth" established by experts in the context of diagnostic interpretation. Ground truth for a linear accelerator would relate to its physical performance metrics (e.g., dose accuracy, beam flatness, reproducibility), which are typically verified against established physics and engineering standards, not expert consensus on medical images.

4. Adjudication method for the test set

Not Applicable (N/A). There is no mention of an adjudication method, as it doesn't involve subjective interpretations of medical data requiring such a process.

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 (N/A). This device is a treatment delivery system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not Applicable (N/A). There is no mention of an "algorithm only" performance study because the device itself is a physical linear accelerator, not a standalone algorithm. Its functionality is integral to the hardware.

7. The type of ground truth used

Not Applicable (N/A) in the diagnostic sense. The "ground truth" for this type of device would be established by engineering specifications, physical measurements (e.g., dosimetry data), and regulatory standards for safety and performance of linear accelerators. The submission states, "Varian design control procedures applied to the development of the UNIQUE include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met." This implies the "ground truth" is adherence to these established design and safety requirements.

8. The sample size for the training set

Not Applicable (N/A). As this is a physical medical device and not a machine learning algorithm for diagnostic interpretation, there is no "training set."

9. How the ground truth for the training set was established

Not Applicable (N/A). No training set means no ground truth for it.

In summary: The K101757 submission for the Varian UNIQUE linear accelerator is a 510(k) summary demonstrating substantial equivalence to a predicate device. It focuses on comparing the engineering and functional characteristics of the new device to an existing one, along with stating that internal verification and validation processes confirmed its safety and performance against design requirements. It is fundamentally different from a submission for a diagnostic AI device, which would involve data sets, ground truths, and performance metrics.

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