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VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures. VariSeed 7.0 is a software application for planning and evaluating permanent implant brachytherapy procedures for the treatment of prostate cancer with permanent implants that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and intra-operative planning and evaluation.

See the Software Description of the Device, Tab E

This a premarket notification for VariSeed 7.0, a brachytherapy treatment planning system, submitted in 2001. Due to the age of the document and the nature of 510(k) summaries from that period, the detailed information typically expected for acceptance criteria and study designs (especially concerning AI/ML performance) is not present.

Here's a breakdown of what can and cannot be answered based only on the provided text:

What can be extracted:

• Device Name: VariSeed 7.0
• Intended Use: VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures, specifically for prostate cancer, using models conforming to AAPM TG-43. It facilitates pre-operative, intra-operative, and post-operative planning and evaluation.
• Predicate Devices: MMS TherapacPLUS B3DTUI (K982821) and Brachyvision (K992762). This implies that the device demonstrated "substantial equivalence" to these existing legally marketed devices, which was the primary regulatory pathway at the time.

What cannot be extracted from the provided text:

The document does not contain any information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

Explanation for missing information:

In 2001, AI/ML-driven medical devices as we understand them today were nascent, and the regulatory framework for them was not developed. 510(k) submissions for software applications like VariSeed (which is a treatment planning system) focused on demonstrating substantial equivalence to predicate devices, primarily through aspects like:

• Functional equivalence: Does it perform the same tasks?
• Technological equivalence: Does it use similar technology?
• Performance equivalence: Does it produce clinically acceptable results, often compared to the predicate device's expected output or clinical standards of the time (like AAPM TG-43 for brachytherapy)?

The concepts of large-scale validation studies with detailed metrics like sensitivity, specificity, AUC, and multi-reader studies to quantify AI's impact on human performance were not standard requirements for this type of device at that time. The approval was based on its similarity to existing, legally marketed systems, rather than proof of meeting specific, quantitatively defined performance criteria in a clinical study as would be expected for a novel diagnostic or AI-powered device today.

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Pinnacle3TM Radiation Therapy Planning Software is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.

Pinnacle3 Radiation Therapy Planning Software assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues.

The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care.

Plans generated using this software are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Pinnacle Radiation Treatment Planning Software is a system composed of a Sun Unix workstation running the Solaris operating system and software which provides the user with the capability to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan.

The system consists of a number of functional areas: physics, image import, image manipulation, contouring, point definition, photon and electron external beam treatment planning, stereotactic radiosurgery, brachytherapy, plan evaluation, file management and connectivity. Photons, electrons, stereotactic radiosurgery and brachytherapy functions are sold as separate options and may or may not be included in every system.

Pinnacle assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. Plans generated using this software are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

The provided text is a 510(k) summary for the Pinnacle3™ Radiation Therapy Planning Software. It outlines the device description, intended use, and comparison to predicate devices. However, it explicitly states that clinical testing was not performed as part of the development and thus, there isn't detailed information about acceptance criteria, performance data, or specific study methodologies for proving device performance in a clinical context.

Therefore, for aspects related to clinical acceptance criteria and studies (points 1-7, and 9) the information is limited or non-existent in this document.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The document instead refers to "specifications" for non-clinical testing.
• Reported Device Performance: No clinical performance data is reported. The document states: "Verification and Validation testing were completed in compliance with ADAC Laboratories procedures to demonstrate that the Pinnacle Radiation Therapy Planning Software has met all its specifications, demonstrates substantially equivalent performance to its predicate devices, and is safe and effective for its intended use." This indicates regulatory compliance and substantial equivalence to predicates, not specific performance metrics against defined acceptance criteria.

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

• Not applicable. No clinical test set details are provided.

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. No clinical test set details or ground truth establishment are provided.

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

• Not applicable. No clinical test set details are provided.

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. No clinical studies, MRMC studies, or AI assistance details are mentioned. The device is a "Radiation Therapy Planning System," not an AI diagnostic tool.

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

• The document implies standalone testing was done for "Verification and Validation" to ensure it met "specifications." However, this is in the context of a "Radiation Therapy Planning Software" which assists the clinician. The performance referred to is likely the accuracy and reliability of the planning algorithms themselves, not a diagnostic task where standalone performance is measured against human performance for comparison.

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

• Not applicable for clinical ground truth. For the "Verification and Validation testing" of the software, the "ground truth" would likely be based on established physics principles, dose calculation algorithms, and comparisons to known accurate treatment plans (potentially from predicate devices or phantom studies). The document does not specify.

8. The sample size for the training set

• Not applicable. As this is a 510(k) for a radiation therapy planning system (not an AI model in the modern sense), the concept of a "training set" for machine learning algorithms does not apply based on the provided information.

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

• Not applicable for the same reasons as point 8.

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