(245 days)
ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.
ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).
This 510(k) summary (K031281) for ERGO SRS, a stereotactic radiosurgery treatment planning module, does not contain the detailed acceptance criteria or study results typically found in performance studies for AI/ML-driven medical devices.
The document primarily focuses on establishing substantial equivalence to a predicate device (PLATO SRS V2) based on the fact that ERGO SRS is "identical to PLATO SRS V2. It is the same software integrated with 3D Line USA's ERGO system rather than Nucletron's PLATO system."
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Here's what can be extracted:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document states that the device is "identical" to the predicate, implying that its performance is presumed to be equivalent to the predicate, but no specific performance metrics or acceptance criteria are listed for the ERGO SRS device itself.
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Sample size used for the test set and the data provenance: Not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
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Adjudication method for the test set: Not provided.
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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 provided. This type of study is more common for diagnostic AI tools, whereas ERGO SRS is a treatment planning module.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated, however, as a treatment planning software, it is inherently a "standalone" algorithm in its function of generating plans, which are then reviewed by human clinicians. No performance metrics for this standalone function are provided in this summary.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. For a treatment planning system, ground truth would typically relate to the accuracy of dose calculations, geometric accuracy of planned beams, or clinical outcomes (though outcomes data would be for post-market surveillance rather than 510(k) clearance).
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The sample size for the training set: Not applicable/provided. This device is described as being "identical" to a previously cleared predicate and is software for treatment planning, not a machine learning model that undergoes "training" in the modern sense.
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How the ground truth for the training set was established: Not applicable/provided.
In summary: The provided 510(k) summary primarily relies on substantial equivalence to a predicate device by stating the software is "identical" and merely integrated into a different system. It does not contain the detailed performance study results that would typically include acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment methods for an independent evaluation of the ERGO SRS device's performance.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.