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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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