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510(k) Data Aggregation
(140 days)
XPlan-2 is a stereotactic LINAC-based radiation treatment planning system. XPlan-2 localizes lesions to be treated using CT scans, and digitized angiographic film. XPlan-2 provides a stereotactic planning system for treatment of turnors at sites such as cranial, base of skull, head and neck. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
The XPlan-2 system is a stereotactic radiation treatment planning system. The XPlan-2 system, like the XPlan-1 system, consists of treatment planning software, stereotactic hardware and extensive verification and quality assurance (QA) procedures to ensure the proper system and patient setup and the proper radiation delivery. XPlan-2 radiation treatment plans are designed with stationary or "static" radiation beams. These beams can be shaped with a range of field shaping devices, such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. This premarket notification is intended to describe those additional features or modifications that have been made to the XPlan System and the new Radionics Head and Neck Localizer that is to be used with the XPlan-2.
Here's an analysis of the provided text regarding the acceptance criteria and study for the XPlan-2 and HNL devices:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Accuracy of repeat positioning with the HNL for head and neck region | ±3 mm |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or data provenance (e.g., country of origin, retrospective/prospective). The document focuses on the system's design validation and nonclinical tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention the use of experts to establish ground truth for a test set. The validation described is focused on software and hardware performance against product requirements and equivalency to predicate devices.
4. Adjudication Method
The provided text does not describe any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's technical specifications and substantial equivalence, not on human reader performance with or without the device.
6. Standalone Performance Study (Algorithm Only)
The provided text describes internal validation of the XPlan-2 software and the HNL, stating: "Nonclinical tests were conducted to demonstrate that XPlan-2 software meets all product requirements. This testing also demonstrates that the performance is substantially equivalent to the predicate devices cited above." This indicates that standalone performance testing was done for the algorithm and system, but it's evaluated against internal product requirements and substantial equivalence, not necessarily a separate "standalone" study in the clinical sense with specific metrics like sensitivity/specificity against ground truth (as might be expected for an AI diagnostic device). The primary performance metric mentioned is the HNL's repeat positioning accuracy.
7. Type of Ground Truth Used
For the HNL, the "ground truth" for its accuracy was likely established through physical measurements and engineering verification of its ability to repeatedly position and re-localize an object (e.g., a phantom representing a patient's head and neck) within a specified tolerance using the device's own internal quality assurance equipment and procedures. The text states: "The HNL system has quality assurance equipment and procedures to verify, prior to patient treatment, that the HNL is accurately positioned with respect to the patient's head and neck. Device testing confirms that the accuracy of repeat positioning with the HNL is ±3 mm in the head and neck region."
For the XPlan-2 software, the "ground truth" was likely defined by pre-established product requirements and expected computational outputs from the treatment planning algorithms, verified through nonclinical tests.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. This is a medical device submission focused on new features and substantial equivalence, not an AI model development submission that typically details training data. While the XPlan-2 uses a "Plus (+) Scatter Dose Model" and a "Site-Specific CT Intensity option," the origin or training of these models are not discussed.
9. How Ground Truth for the Training Set Was Established
The provided text does not mention how ground truth for any training set was established, as a training set is not discussed.
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(162 days)
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics XPlan Conformal Treatment Planning Software on any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.
The MMLC is a conformal radiation therapy and radiosurgery device. The MMLC is mounted to a standard radiation therapy LINAC and is capable of shaping the x-ray field (maximum field treatment of 10 cm x 12 cm). A stand-alone computer controls the MMLC unit. The computer communicates with the MMLC to position the leaves according to the treatment plan. An individual motor controls each leaf. Power to the motors and electronics is provided by a switching power supply.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for the Radionics Mini Multi-Leaf Collimator (MMLC). It outlines:
- Proprietary and common names, product code, and classification.
- A general summary of safety and effectiveness.
- Mentions that no applicable performance standards have been issued by the FDA, but lists voluntary standards (EN55011, EN 60601-1-2, EN 60601-1, UL 2601) related to electromagnetic compatibility and electrical safety. These are not performance criteria for the device's therapeutic function.
- Establishment registration details.
- Predicate device (Brainlab Micro Multi-Leaf Collimator K970586).
- Indications for Use, describing the MMLC's purpose in radiation therapy.
- Device characteristics, detailing its mechanism and operation.
- An official FDA letter confirming substantial equivalence to a predicate device.
To answer your request, information regarding specific performance acceptance criteria (e.g., leaf positioning accuracy, dose conformity, mechanical stability tolerances) and studies (e.g., phantom studies, dosimetric measurements, clinical trials) conducted to demonstrate compliance would be required. This type of information is typically found in the full 510(k) submission or internal company documentation, not usually in the publicly available summary for this type of device.
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(158 days)
The Slice Editor Imaging Software Utility is an image manipulation and eontouring software package for use in surgical and treatment planning. The Slice Editor can replace the IMEX contouring utility as the component for contouring anatomes in all applications in which IMEX is currently utilized.
The "Slice Editor" utility. It is an upgraded version of software intended for use in with surgical and treatment planning svstems where a graphical editing facility is used to create and modify anatomical structures. The common name is image editing software and its classification name is Stereotaxic instrument (accessory/utility).
The provided text is a 510(k) summary and related FDA correspondence for the "Slice Editor" imaging software utility. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
Specifically, the document states:
- Device Name: Slice Editor utility
- Intended Use: An upgraded version of software intended for use with surgical and treatment planning systems where a graphical editing facility is used to create and modify anatomical structures. It serves as an image manipulation and contouring package for use with existing and new RSA applications.
- Predicate Devices: IMEX software used in Radionics' XPlan-1 (K972905) and StereoPlan (K946252).
- Technological Characteristics: "The technological characteristics are the same or similar to those found with the predicate devices where contouring sessions generate anatomical data to assist in the treatment planning process."
The 510(k) process for this device relies on substantial equivalence to previously cleared predicate devices. This means the manufacturer demonstrated that the Slice Editor is as safe and effective as the predicate devices, often by showing it has the same or similar technological characteristics and indications for use. This typically does not involve presenting a new study with specific acceptance criteria, as would be expected for a novel device or a device making new claims.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- Acceptance Criteria and Reported Device Performance: The document does not define any specific acceptance criteria for performance metrics, nor does it report any performance data (e.g., accuracy, precision, speed of contouring) for the Slice Editor.
- Study Information (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): As there is no study described that establishes performance against defined acceptance criteria, none of these details are present in the provided text. The submission focuses on demonstrating substantial equivalence based on the device's functional similarity to existing cleared devices.
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