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510(k) Data Aggregation
(370 days)
PINNACLE3 APEX
This software device is intended to assist in formulating radiation treatment plans for modalities including stereotactic radiosurgery, external photon beam, external electron beam, and brachytherapy radiation treatment of benign or malignant disease processes.
The ADAC Pinnacle3 APEX™ device (APEX) is a radiation treatment planning software. It is an extension and enhancement of the currently marketed ADAC Pinnacle3 software (K926008). The APEX offers the identical imaging, display and stereotactic radiosurgery capabilities as the Pinnacle3, but its intended uses have been expanded to also include brachytherapy, external electron beam, and external photon beam treatment planning capabilities.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
Device: ADAC Pinnacle3 APEX™ device (APEX), a radiation treatment planning software.
Overview: The APEX is an extension of the ADAC Pinnacle3 software (K926008), expanding its intended uses beyond stereotactic radiosurgery to include brachytherapy, external electron beam, and external photon beam treatment planning.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical "acceptance criteria" or "reported device performance" in a quantitative manner for most of its claims. Instead, it describes equivalence to predicate devices, use of established methodologies, and verification through specific types of testing.
| Feature/Intended Use | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Stereotactic Radiosurgery | Identical capabilities and visualization functions to the predicate device (Pinnacle3 K926008). No adverse effect on safety and efficacy with the addition of other planning functions. | The APEX has identical stereotactic radiosurgery capabilities and visualization functions as the Pinnacle3. The addition of other planning functions has not affected the safety and efficacy for this use. |
| External Photon Beam | Use of a Superposition Convolution Model method for photon dose computation. Performance verified to conform to Task Group #23 of the American Association of Physicists in Medicine bench testing guidelines for photon beam planning software systems. Equivalent other aspects of photon therapy planning (entry of measured physics data, beam modifiers, energies, treatment machines) to predicates (ADAC XL CAD Plan K894706 and Precision Therapy Inc. Render-Plan 3-D K894722). | The APEX uses a Superposition Convolution Model method for photon dose computation, which iteratively models the computed beam profile by superimposing and convolving a kernel scaled in three dimensions according to patient densities.Bench testing conforming to TG#23 guidelines was conducted, with results verifying the performance of the Convolution method.Other aspects (physics data entry, beam modifiers, energies, machines) are equivalent to predicates. This method replaces 2D algorithms with correction factors used by predicates, providing absolute dose per unit fluence instead of relative dose. |
| External Electron Beam | Use of the same physics data entry to create dose lookup tables as predicates (CAD Plan and Render-Plan 3-D). Use of pencil beam algorithms based on Hogstrom et al. Ability to perform both 2-D and 3-D electron dose calculation. Support for 2-20 MeV electron energy. Use of the same dose analysis tools (dose volume histogram and beam weight optimization). | The APEX uses the same physics data entry and pencil beam algorithms (Hogstrom et al.) as predicates. It can perform both 2-D and 3-D calculations. It supports 2-20 MeV electron energy and uses the same dose analysis tools (dose volume histogram and beam weight optimization). |
| Brachytherapy Planning | Substantially equivalent to the ADAC XL CAD Plan System (K894706) in terms of dose calculation methods (Sievert Integral-equivalent table lookup). Provision of intracavitary and interstitial planning for same radiation sources (seeds, tubes, ribbons). Provision of planar display of isodose distribution. | The APEX uses the same Sievert Integral-equivalent table lookup method for dosage calculation and provides intracavitary and interstitial planning for the same source types as the CAD Plan. It also provides planar display of isodose distribution. Parallel testing demonstrated equivalence with the CAD Plan. |
| Brachytherapy - High Dose Rate (HDR) | Claim of HDR calculation and volumetric dose display, with the same dose algorithm as the predicate device (Render-Plan 3-D K894722). | The APEX includes HDR calculation and volumetric dose display, utilizing the same dose algorithm as the Render-Plan 3-D, capable of calculating at higher dose rates. |
| General Performance | Thorough performance, bench, parallel, and beta site testing conducted and verified prior to release. Software development, validation, and verification according to policies and procedures. Verification and Validation documentation available. | Protocols and results of performance testing (bench, parallel, beta site) are provided in Appendix D of the 510(k). Software development, validation, and verification conducted according to policies and procedures, including engineering diagrams, fault tree analyses, and Verification and Validation documentation (Appendix E). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective). It refers to:
- Bench testing (for photon beam and general performance).
- Parallel testing (for brachytherapy).
- Beta site testing (for general performance).
These types of tests would typically involve a range of test cases, but the specific number of cases or patient data sources is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not specify the number or qualifications of experts used to establish ground truth. It focuses on comparison to established predicate devices and adherence to professional guidelines (e.g., AAPM Task Group #23).
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.
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
No MFRC comparative effectiveness study was done or mentioned. This device is a radiation treatment planning software that computes dose and assists in plan formulation, not a diagnostic AI system designed to assist human readers in image interpretation or diagnosis. Therefore, a study assessing human reader improvement with/without AI assistance in the traditional sense is not applicable to the description provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are essentially standalone performance evaluations of the algorithm's accuracy and equivalence to predicate devices and established methodologies.
- For External Photon Beam, the "bench testing quidelines [sic] for photon beam planning software systems" from Task Group #23 of the AAPM evaluate the algorithm's performance in computing photon dose.
- For Brachytherapy, "parallel testing was conducted to demonstrate the equivalence of brachytherapy planning in these two systems," which implies a direct comparison of the software's output against a known or accepted standard (the predicate).
These tests assess the software's output and calculations directly, without human intervention as part of the performance metric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies the following types of "ground truth" or reference standards:
- Established Methodologies/Physics: For external photon beam, adherence to and verification against Task Group #23 of the American Association of Physicists in Medicine bench testing guidelines serves as a form of ground truth/standard. The Superposition Convolution Model itself is a well-established physics model.
- Predicate Device Equivalence: For stereotactic radiosurgery, external electron beam, and brachytherapy, the ground truth for establishing safety and effectiveness is largely based on equivalence to previously cleared predicate devices (ADAC Pinnacle3, ADAC XL CAD Plan, Precision Therapy Inc. Render-Plan 3-D). This means the predicates' established performance serves as the benchmark.
- Measured Beam Data: For photon dose calculation, the model "uses measured beam data to model iteratively the computed beam profile." This "measured beam data" can be considered a form of ground truth for characterizing the physical properties of the radiation.
8. The sample size for the training set
The document does not specify a sample size for a training set. As a radiation treatment planning software, it's more likely to be developed based on physics principles, mathematical models, and previously validated clinical data/libraries rather than a "training set" in the machine learning sense. The "measured beam data" mentioned for photon dose calculation might be extensive, but it's not described as a "training set" in the context of an algorithm learning from examples.
9. How the ground truth for the training set was established
Since a "training set" in the machine learning context is not explicitly mentioned, the method for establishing its ground truth is also not described. The underlying principles are based on established physics and previously validated clinical practices/device performances.
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