Search Results

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.

Ask a specific question about this device

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.

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 is an external beam radiotherapy equipment using a linear accelerator with the treatment modalities such as 3D-Coventional radiotherapy, Intensity modulated radiotherapy, Volumetric modulated Arc therapy & Stereotactic body radiotherapy by delivering 6 MV photons with Flattening Filter & Free Flattening Filter.

The Intended Use is achieved under the supervision of the qualified personnel in a shielded room with a patient support system and a control console outside the treatment room. These treatment modalities are delivered with Image Guided Radiation technique using on-board orthogonal kV imaging for generating CBCT and stereotactic images.

SIDDHARTH-II provides an intuitive and simplified workflow for the user to enter, plan, edit and execute patient treatment swiftly. Software functionalities such as patient schedule and patient alignment has been taken care by frontend software & acquiring volumetric imaging is performed by implementing IGRT technology.

Image processing functionalities such as 3D reconstruction and Image registration by calculating couch shift corrections are performed by Online R&V Software (Image Processing) to ensure patient positioning for accurate treatment which is the supporting software for SIDDHARTH-II frontend software.

In order to fulfill the Intended use and to enhance functionality of SIDDHARTH-II, some of the accessories are integrated along with the system as listed below.

• a) Closed Circuit Television System (CCTV)
• b) Mike and Speaker
• c) Virtual Isocenter Laser
• d) Immobilization & Patient Positioning devices (IMPACT)

IMPACT Head base plate is designed to deliver firm support & comfortable positioning for patient's head, neck, and shoulder. Tilting Head Base Plate is designed to provide perfect angulation from 5° to 25° with 5° increments. A standard indexing bar is present which helps in fixing the base plate on couch top.

Head rests made up of Carbon Fibre with six different dimensions (A-F) headrest which provides support to the head & neck region & maintains the maximum reproducibility in every treatment.

Prone head support is intended to deliver the best patient positioning in prone position of head & neck during the treatment. This is indexable on Tilting base plate, head & shoulder base plate which provides an accurate treatment delivery.

Breast board is designed to provide complete, reproducible support for the patients by creating perfect angle required while treatment is in breast region. Breast board can be placed on couch top featured with different tilting angulations to the upper body parts & comfortable armrests with rigid locking mechanism, head support can be placed into the baseplate and ergonomic and rigid body stopper is made available for patient comfort & support.

Wing Board is designed for easy positioning, precise repositioning & high patient comfort during breast & thorax treatments in supine position. Wing board are placed on couch top by using standard indexing bar which comfortably positions and supports the arms when the patient is in supine position. Wing board does not have tilting possibility.

Hip Fix base plate is a comprehensive system which facilitates consistent positioning of hip & pelvic regions by affixing the hip fix base pate on couch top by using standard indexing bar. It has an ergonomic central aperture enabling comfortable supine positioning to patient during the entire screening & treatment.

Belly Board is intended to provide the comfortable positioning for the bowel region when patient is in prone position during the treatment. Lower part of the board supports legs and there are 2 different cushions for resting forehead.

Sigma Pelvic Board is intended to provide a comfortable prone positioning for the patients getting treatment in pelvic and abdomen region. The base plate is light weight, indexable on any couch top and comfortable for the patient.

IMPACT Sigma board System is designed to position the patient for delivering "One for All" treatments to provide support & exact positioning of the patient for all body parts which can fix & detach the sigma board on couch top based on need for base plates.

Thermoplastic immobilization is intended to immobilize patient to increase precision during treatment delivery. These thermoplastic masks are non-sticky, perforated, smooth & durable. The uniform perforation & uniform thickness of these masks are ideal to customise on patient's anatomy to reproduce in the next fraction of treatment.

SBRT System is intended for limiting the patient motion (intrafraction motion) during treatment, to ensure patient is close to the intended treatment site thus avoiding errors, and to hold patient close to the original simulation geometry. It is intended to use for immobilizing the patient for lungs and moving organ treatments. This system consists of couch top made of carbon fibre, bridge rail, Indexing bar, Wing Board, Head Rest, Bridge with Respiratory Plate or Respiratory belt. The patient set-up is similar to all the boards like supine position with the arms mainly positioned above the patient's head. Knees, and feet positioned in indexed positions. The mechanical pressure system consists of a bridge with a respiratory plate. Abdominal compression can also be created with respiratory belt which is inflatable.

IMPACT SRS System immobilizes the patient by confining the head and provide corrective tilting of the head for treatment and simulation.

IMPACT SRS system consists of couch top, Head Base plate, Head Rest and SRS mask.

These SRS thermoplastic masks are non-sticky, perforated, smooth & durable. The uniform perforation & uniform thickness of these masks are ideal to customise on patient's anatomy to reproduce in the next fraction of treatment.

This FDA 510(k) summary describes two devices, SIDDHARTH-II (a medical charged-particle radiation therapy system) and IMPACT (Immobilization & Patient Positioning devices). The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics as acceptance criteria.

The submission claims that clinical testing was not necessary due to the long history of similar devices with proven safety and efficacy and that non-clinical testing supports the safety and effectiveness and demonstrates substantial equivalence. Therefore, there are no explicit acceptance criteria or a study detailed in the provided text that proves the device meets such criteria as would typically be described for AI/ML performance.

However, based on the information provided, we can infer some "acceptance criteria" through the verification and validation (V&V) testing performed and the claim of substantial equivalence.

Here's an analysis based on the provided text, addressing your points where information exists:

1. A table of (Inferred) Acceptance Criteria and the Reported Device Performance

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

The document does not specify a "test set" in the context of an AI/ML clinical study. The performance data section describes "Design Verification testing & biocompatibility requirements" and "Software verification testing" as well as "Electrical safety & electromagnetic (EMC) testing." These are engineering and systems tests, not data-driven performance assessments against a clinical test set. No specific sample sizes for these tests are mentioned. The provenance of any data is not provided, as this is a device clearance for a physical medical device, not a data-driven AI/ML product.

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

This information is not applicable and not provided. The submission focuses on the safety and effectiveness of the physical radiation therapy system and patient positioning devices, demonstrating substantial equivalence through non-clinical testing and conformance to standards, rather than a diagnostic performance study requiring expert adjudication.

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

This information is not applicable and not provided, as there was no diagnostic performance test set requiring adjudication in the context of this submission.
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 MRMC comparative effectiveness study was done or is mentioned. This submission is for a medical charged-particle radiation therapy system and its immobilization accessories, not an AI/ML diagnostic or assistive device that would involve human readers.

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

No standalone algorithm-only performance study was done. This is not an AI/ML device in the sense of a standalone algorithm for diagnosis or treatment planning.

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

This information is not applicable. The "ground truth" for this submission would be defined by the technical specifications, performance standards, material properties, and safety benchmarks outlined by recognized international and FDA standards (e.g., the standards listed in Section VIII). The verification testing confirms adherence to these established standards.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device in the context of diagnostic or predictive modeling.

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

This information is not applicable, as there is no training set for an AI/ML model for this device.

Ask a specific question about this device