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SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lessons, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients.

Integrated Radiation Field Analyser (RFA) of Siddharth-II is intended to collect beam data in water under the aspect of machine QA for the following purposes:

• acceptance testing , periodic QA procedures, and/or commissioning of a radiation therapy system.

• beam data analysis according to international therapy dosimetry protocols

• acquisition, formatting and transfer of basic data to treatment planning systems

The indication for use of Immobilization & Patient Positioning devices (IMPACT) is to immobilize the patient during treatment by providing appropriate support and comfort which in turn leads to precise treatment delivery.

SIDDHARTH-II, the subject device remains same as the most recently cleared predicate device SIDDHARTH-II (K210894). In addition, with the features and specifications of existing 510k cleared equipment, the Radiation Field analyzer (RFA) has been permanently integrated with gantry of Siddharth-II to perform beam data analysis as per international therapy dosimetry protocols.

The integrated RFA is retracted and accommodated within the gantry of the radiation therapy equipment after performing data dosimetry operations. This provides an integrated solution for validating the performance of a radiation therapy equipment using an RFA which is in-built with the radiation therapy equipment that is primarily employed for providing radiation treatments to patients.

The following functionalities can be achieved by using this RFA integrated with Siddharth-II.

• . Acceptance testing, Commissioning and Periodic Quality Assurance Measurements for radiation beams emitted by radiation therapy equipment SIDDHARTH-II
• . Beam data analysis according to international therapy dosimetry protocols
• . Collection of beam data for Treatment Planning System

The RFA setup consists of RFA electromechanical arm for 3-dimensional movement of radiation detector. Ion Chamber (Radiation Detector), Built-in Electrometer, RFA water tank and Water Reservoir. The design control procedures applied to the development of the SIDDHARTH-II and its modifications include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met.

All other features and technological characteristics of the SIDDHARTH-II remains as cleared by K210894.

The provided text is a 510(k) summary for the Panacea Medical Technologies Pvt Ltd. SIDDHARTH-II device, specifically addressing the integration of a Radiation Field Analyzer (RFA). It focuses on demonstrating substantial equivalence to a previously cleared predicate device (SIDDHARTH-II, K210894) rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of, for example, a diagnostic performance study.

The document states that "The results of verification and validation activities demonstrate that the acceptance criteria have been met," but it does not explicitly list those criteria in a table format, nor does it provide a detailed study report that would typically include information on sample size, expert adjudication, or MRMC studies for diagnostic performance.

Based on the provided text, here's what can be extracted and what information is not available regarding explicit acceptance criteria and a study proving performance in a diagnostic or clinical efficacy sense:

The acceptance criteria and performance are discussed in the context of engineering and regulatory compliance verification and validation for the addition of the RFA feature, rather than a clinical performance study with human subjects or readers.

Acceptance Criteria and Reported Device Performance (as inferred from the document)

Since there isn't a table of diagnostic performance acceptance criteria, I will infer the performance criteria from the "Performance Data" section (VII) which focuses on non-clinical testing and regulatory compliance.

Study Details (Based on the Provided Text)

Given that this is a 510(k) for an integrated hardware/software component within a radiation therapy system, the "study" described is a non-clinical verification and validation (V&V) of the RFA component's functionality and safety, and regulatory compliance, rather than a clinical trial or performance study of a diagnostic AI.

1. Sample size used for the test set and the data provenance:

   • The document mentions "non-clinical performance testing for RFA feature" involving "radiotherapy dose measurements i.e. with step by step measurements and also measurement accuracy with respect to radiation detector, positioning, reproducibility and mechanical alignment."
   • Sample Size: Not specified in terms of number of cases, but rather as test procedures on the device components (e.g., "step by step measurements"). This likely refers to quantitative measurements conducted during engineering tests, not a patient or image dataset.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing would have been conducted in a lab or manufacturing environment.

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

   • Not applicable / Not specified. This type of information is relevant for studies involving human interpretation or clinical data (e.g., radiologists for ground truth). The testing described is hardware and software functional and safety testing, evaluated against engineering specifications and international standards (like IEC 60731:2016 for dose measurements).

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

   • Not applicable. Adjudication is typically for clinical data consensus or discrepancies among human readers. For non-clinical device testing, the methods involve direct measurement and comparison to predefined engineering specifications and regulatory standards.

4. 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. This type of study is not mentioned or implied because the device is a radiation therapy system with an integrated QA tool (RFA), not a diagnostic AI system intended to assist human readers in image interpretation.

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

   • Yes, in essence, for the RFA component's function. The "non-clinical performance testing for RFA feature" describes evaluating the RFA's ability to perform "radiotherapy dose measurements," "measurement accuracy with respect to radiation detector, positioning, reproducibility and mechanical alignment." This would be the RFA's function operating standalone (i.e., collecting data and measuring) outside of human-in-the-loop interpretation.

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

   • Engineering specifications and international standards. For the RFA's performance, the ground truth is against the expected physical properties of radiation beams and the accuracy requirements defined by standards like IEC 60731:2016. For software, ground truth is conformity to functional requirements and safety standards (e.g., IEC 62304).

7. The sample size for the training set:

   • Not applicable / Not specified. This device is not an AI/ML system that requires a "training set" in the sense of a dataset for machine learning. The "training" for the device development would be the engineering design and programming process.

8. How the ground truth for the training set was established:

   • Not applicable / Not specified. (As above, no ML training set.)

Summary of what the document describes as "proof":

The document primarily relies on non-clinical verification and validation testing of the RFA module and its integration, along with demonstrating conformance to various international consensus standards (e.g., IEC 60601-1, IEC 60731, IEC 62304, ISO 14971) to establish safety, effectiveness, and substantial equivalence to the previously cleared predicate device. It explicitly states that "clinical testing was not necessary to support substantial equivalence data" (Page 11).

Therefore, the "proof" is based on adherence to predefined engineering specifications, the results of hardware and software functional tests, electrical safety, EMC tests, and compliance with the relevant medical device standards.

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