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The PrecisePLAN® Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAN® provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.

PrecisePLAN® 2.00 is an enhancement to the PrecisePLAN® 1.00, which has previously been cleared for commercial distribution (K002240 8/23/2000). This enhancement to PrecisePLAN® does not raise additional types of safety or effectiveness considerations.

The provided text is a Summary of Safety & Effectiveness for PrecisePLAN® 2.00, a treatment planning system for radiation therapy. It claims that PrecisePLAN® 2.00 is an enhancement to a previously cleared device (PrecisePLAN® 1.00) and does not introduce new safety or effectiveness concerns.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details on the performance of the device based on such a study. It primarily focuses on regulatory compliance, quality systems, and risk analysis related to the enhancement.

Therefore, I cannot provide the requested table and information based on the given text.

The document mainly discusses:

• Claim of substantial equivalence: PrecisePLAN® 2.00 is an enhancement to a previously cleared device (K002240) and does not raise additional safety or effectiveness considerations.
• Regulatory compliance: CE mark, ISO 9001, Medical Device Directive 93/42/EEC Annex II, 21 CFR 820.
• Risk analysis: Concluded that it does not introduce new hazards, and the level of concern is "Major" as per FDA guidance.
• Intended Use: Planning the dosimetry of treatments in radiation therapy, including 2D and 3D planning, and optional weight optimization functionality supporting Intensity Modulated Radiation Therapy (IMRT).

There is no data presented regarding specific performance metrics (e.g., accuracy, precision) of the device against predefined acceptance criteria.

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The Render-Plan 3-D® is intended to be used for planning the dosimetry of treatments in radiation therapy. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.

The Render-Plan 3-D® is an enhancement to the Render-Plan 3-D 1) (Formerly known as Renner-Plan) which has previously been cleared for (Formerly Known as Renner-Frish) winest (1999). This enhancement to Render-Plan 3-De does not raise additional types of safety of effectiveness considerations.

The provided document is limited to a summary of safety and effectiveness, and the FDA clearance letter for a device called "Render-Plan 3-D®". It appears to be a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies for effectiveness.

Based on the provided text, the following information can be extracted regarding the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, accuracy, or any clinical outcomes. This submission focuses on demonstrating substantial equivalence and adherence to quality systems and regulations.

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

No information is provided about a specific "test set" with a defined sample size or data provenance. The submission states that the Render-Plan 3-D® is an "enhancement to the Render-Plan 3-D (Formerly known as Renner-Plan) which has previously been cleared for (1999)." This implies that the current device is being compared to its predicate, and effectiveness is asserted largely based on the predicate's prior clearance and the lack of new safety/effectiveness concerns.

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

No information is provided about experts establishing ground truth for a test set. This type of detail is typically found in documentation for clinical trials or performance studies, which are not detailed here.

4. Adjudication method for the test set

No information is provided about an adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study is mentioned. The device is a "Render-Plan 3-D®" intended for "planning the dosimetry of treatments in radiation therapy," which processes inputs for dose setting. It is not described as an AI-assisted diagnostic or interpretative tool that would typically involve human reader performance comparisons.

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

No standalone performance study for the algorithm is described. The device's function is described as processing inputs for dosimetry planning, implying it's a tool used by a healthcare professional rather than a standalone diagnostic.

7. The type of ground truth used

No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as being used for performance evaluation in this summary. The submission relies on affirming compliance with directives and the safety and effectiveness profile of its predicate device.

8. The sample size for the training set

No information is provided about a "training set" or its sample size. This suggests the device's development did not involve a machine learning approach that requires such a set.

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

Since no training set is mentioned, there is no information on how its ground truth might have been established.

Summary of what is provided:

The document focuses on demonstrating that the Render-Plan 3-D® is an enhancement to a previously cleared predicate device, the Render-Plan 3-D (formerly Renner-Plan). The core argument for safety and effectiveness rests on:

• The new device being an enhancement to a predicate and not raising additional types of safety or effectiveness considerations.
• The device bears the CE mark and complies with relevant European Directives (e.g., Medical Device Directive 93/42/EEC Annex II).
• The manufacturer (PTI) operates under a Quality Management System compliant with ISO 9001.
• Risk analysis was conducted, concluding the device does not introduce new hazards and the level of concern is "Major" for software.
• The FDA determined the device is substantially equivalent to legally marketed predicate devices.

The submission is primarily a regulatory filing demonstrating equivalence and compliance with quality standards, rather than a detailed report of a performance study with specific acceptance criteria and outcome data for the device itself.

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