(187 days)
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
| Acceptance Criteria (Inferred from V&V) | Reported Device Performance (Summary from Submission) |
|---|---|
| For SIDDHARTH-II (Linear Accelerator): | |
| Conformance to design requirements and mitigation of identified risks/hazards. | "Testing executed on the system verified conformance to design requirements and ensured all identified risks and hazards were mitigated." |
| Conformance to relevant safety standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-2-1, IEC 60601-2-68, etc.). | "The system conformed to all applicable section of the standards." "Electrical safety & electromagnetic (EMC) testing were conducted on the SIDDHARTH-II which verified complies with the IEC/ES 60601-1 standards for safety & IEC 60601-1-2 EMC standard." "SIDDHARTH-II conforms with the FDA recognized standards and other international standards listed below: ANSI/AAMI ES60601-1, IEC 60601-1-3, IEC 60601-2-1, IEC 60601-2-68, IEC 60601-1-6, IEC 60601-1-2, IEC 62274, IEC 61217, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 60825-1, IEC 60976, ISO 15223-1, and ISO 14971." |
| Software compliance with "Major" level of concern and IEC 62304. | "Software verification testing was conducted as required by FDA's Guidance... it concludes that the software of the subject device was considered as a 'Major' level of concern and also it is in compliance with IEC 62304 Software Life cycle processes." |
| Imaging and radiation therapy capabilities show substantial equivalence to the predicate device. | "The imaging and radiation therapy capabilities of SIDDHARTH-II showed substantial equivalence to the predicate device." "SIDDHARTH-II - Linear Accelerator for radiotherapy is substantially equivalent to the predicate device Varian- Halcyon & True Beam... They tend to deliver the energies in compatible ranges and dose rates are formulated as per International standards with extensive Image Guided Radiotherapy technology using IGRT kV imaging by generating CBCT images which helps in achieving accurate patient positioning for treatment." |
| For IMPACT (Immobilization & Patient Positioning devices): | |
| Dosimetry properties (attenuation factor) demonstrate substantial equivalence to the predicate. | "Bench testing was performed for dosimetry properties that includes attenuation factor and validated to demonstrate SE to the predicate in safety and effectiveness." |
| Patient-contacting materials meet biocompatibility requirements (ISO 10993-1, -5, -10). | "Biocompatibility testing was completed for patient-contacting materials in accordance with ISO 10993-1, ISO 10993-5 and ISO 10993-10." "The biological safety evaluation has supported the claim of safety when used in contact the patient's skin." |
| Conformance to international standards (ISO 10993-1, -5, -10, ISO 14971). | "The IMPACT accessory also conforms to the following international standards as listed: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971." |
| Equivalent design, intended uses, target population, patient positioning, and materials to predicates. | "Panacea claims this equivalence because the proposed devices have equivalent designs, intended uses, target population, patient positioning and used materials." "The design of both the devices are equivalent in shape, construction materials and functionality." (Repeated for various IMPACT components against their respective predicates). |
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.
§ 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.