Search Results

The MicroSelectron HDR Version 2 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.

The microSelectron-HDR is a remote afterloading system for high dose rate brachytherapy treatment using a single iridium-192 radioactive source. The MicroSelectron-HDR delivers a radiation dose distribution conforming to treatment data, r he Miorooolouren . Alle workstation or imported from a treatment planning system. The modifications to the cleared device K953946 are: - Increase of maximum source strength for treatment of patients from 10 Ci (aprox. 40.000 . μGy.m²/h) to 12Ci (aprox. 48.000 μGy.m²/h).

The provided text is a 510(k) summary for the MicroSelectron HDR Version 2, a remote afterloading system for high dose rate brachytherapy. It details the device's technical specifications, intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results (effect size)
6. Standalone (algorithm only) performance
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on regulatory approval based on substantial equivalence to an existing device, rather than detailed performance studies against specific acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device

The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.

Integrated Brachytherap Unit - Digital (IBU-D) is a modification to the Integrated Brachytherapy Unit (IBU) in which the Image Intensifier of the IBU is replaced by a Flat Panel image detector. The Flat Panel image detector used in the IBU-D is the same Flat Panel image detector as used in Nucletron's Simulix Evolution product (K03347).

The Integrated Brachytherpay Unit – Digital (IBU-D) is a localization and simulation device for a Brachy radiation therapy department. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-ray tube housing assembly with collimator on one side and a flat panel image detector. The movements of the IBU-D are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient table has mechanical motions which can be controlled from a hand pendant affixed to the table. Images are displayed and managed by a PC based workstation running specialized software.

The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system.

The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm.

The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality:

• . Image acquisition
• Image display .
• Image annotation .
• Database and DICOM Import / Export functionality
• Position read out and display of the IBU-D gantry. .
• Control of the IBU-D beam limiting device. .

This 510(k) summary (K072445) describes the Integrated Brachytherapy Unit - Digital (IBU-D), a modification of an existing device. It focuses on the substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner as typically found in clinical validation studies for AI/ML devices.

The submission primarily states that the IBU-D is a modification where the Image Intensifier of the original IBU (K973848) is replaced by a Flat Panel image detector. The flat panel detector and the workstation software are the same as used in Nucletron's Simulix Evolution product (K03347). The "study" here is essentially a demonstration of substantial equivalence based on the technological similarity and identical intended use to legally marketed predicate devices, rather than a clinical trial assessing performance against specific metrics.

Therefore, many of the requested elements (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and detailed ground truth establishment for a training set) are not typically found in this type of 510(k) summary for a hardware modification of a conventional medical device. The "reported device performance" is implicitly that it performs equivalently to the predicate devices for its intended use.

However, based on the provided text, I can infer and summarize the acceptance criteria and "study" information as best as possible within the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a hardware modification (swapping an image intensifier for a flat panel detector) and relies on substantial equivalence, explicit quantitative acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are not provided in this document. The "acceptance criteria" are implicitly met if the device functions as intended and is substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not describe a clinical "test set" in the traditional sense of evaluating diagnostic performance on a patient dataset. The "study" for this 510(k) is a technical and functional verification that the modified device functions correctly and is substantially equivalent to existing devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As no clinical test set for diagnostic performance evaluation is described, there is no mention of experts being used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

Not applicable. Without a clinical test set requiring ground truth establishment, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This submission does not include an evaluation of human readers' performance with or without AI assistance, as it concerns a hardware replacement in a radiation therapy simulation system, not an AI/ML diagnostic aid.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a hardware system for visualization and localization in brachytherapy, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant or described.

7. Type of Ground Truth Used

Not applicable. The submission focuses on technological equivalence and functional verification, not on diagnostic accuracy against a specific ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device that requires data for model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, there is no information on how its ground truth would have been established.

In summary: K072445 is a 510(k) submission for a hardware modification to an existing medical device. The "study" conducted for this submission is a demonstration of substantial equivalence based on the technological characteristics and identical intended use compared to legally marketed predicate devices. It does not provide the detailed performance metrics, sample sizes, expert qualifications, or study methodologies typically associated with clinical validation of diagnostic or AI/ML devices.

Ask a specific question about this device

The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.

The Nucletron Intracavitary Mould Applicator Set as described in this submission is designed for Intracavitary Brachytherapy procedures. The device consists of a disposable silicone cylinder, with eight radial placed catheters to the surface of the cylinder, which is inserted Intracavitary into the target volume, i.e. the rectum. The cylinder is fixated, by using an applicator introduction tool and the filling wires are removed, which protected the catheters from kinking during transport. In the center of the cylinder a central catheter can be placed. X-ray catheters or CT markers are inserted into the application. Radiographic images, planal images or transverse images of the target volume are taken to determine the precise position of the applicator. This information is then used for Brachytherapy treatment planning purposes. The Intracavitary Mould Applicator Set is a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the radioactive source. The afterloader is the treatment unit, it strictly provides a treatment path for the treatment source. The physicist and the clinical staff verify that the applicator is properly attached prior to treatment. For the first treatment the Intracavitary Mould Applicator Set is attached to the afterloader (treatment head), doing transfer tube. After the applicator is properly attached, a check cable run is performed to ensure that there are no obstructions, which will interest the transfer of the cable run. In a province of cable run, the radioactive source will be transferred into the applicator and the prescribed dose of radiation will be delivered. After the treatment is completed the Intracavitary Mould Applicator Set is removed from the patient. The device uses similar (implantable) materials as in the legally marketed predicate device cited the Freiburger Flap. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set. The Intracavitary Mould Applicator Set is used as an accessory to the Nucletron microSelectron.

Here's an analysis based on the provided document, addressing your request for acceptance criteria and study information.

Important Note: The provided document is a 510(k) summary for a medical device (Intracavitary Mould Applicator Set) that demonstrates substantial equivalence to a predicate device. This type of submission generally does not include rigorous clinical studies with acceptance criteria, sample sizes, and expert ground truth establishment in the same way a de novo or PMA submission would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, many of your requested points will either be "Not Applicable" (N/A) or indicate that such detailed studies were not required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not applicable. This 510(k) summary does not describe a formal "test set" or a clinical study that would have such a sample size. The substantial equivalence argument is based on comparison of design, materials, and intended use against a predicate device.
• Data Provenance: Not applicable for a traditional test set. The information provided is descriptive of the device and its relation to a predicate device, not data from a specific clinical evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts: Not applicable. No formal ground truth establishment process for a test set is described in this 510(k) summary.
• Qualifications of Experts: N/A.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication is described.

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

• MRMC Study: No. This device is an accessory for brachytherapy and does not involve AI or human "readers" in the diagnostic sense.
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No. This device is a physical applicator, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable for a formal study. The "ground truth" here is the prior FDA clearance of the predicate device (K953946), implying its safety and effectiveness have already been established. The new device is compared against this established benchmark.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable.

Summary of the K041715 Submission:

This 510(k) submission for the Nucletron Intracavitary Mould Applicator Set relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nucletron's Miami Vaginal Applicator Set, K953946). The key argument is that the new device has:

• The same intended use.
• Similar technological characteristics (design, materials, operating principle).
• Raises no new questions of safety or effectiveness.

Therefore, the submission does not contain or require the types of detailed clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, etc.) that would typically be associated with AI/ML devices or novel high-risk devices undergoing a De Novo or PMA pathway. The "acceptance criteria" are effectively satisfied by a successful argument for substantial equivalence, which the FDA concurred with, allowing the device to be marketed.

Ask a specific question about this device

The MicroSelectron PDR is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, intra-operative) or to the surface of the body for radiation therapy.

The microSelectron Afterloading System concerns a microSelectron -HDR (V2) with treatment chambers. The operator console is a PC running dedicated software. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. Connection to a LAN is only for the purpose of Transfer of Treatment Plan Files. It is the same as in the predicate device. The radiotherapy treatment planning software is not part of this 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron PDR. The PC based Afterloader workstation is the current TCS workstation, but ported from a DOS based Afterloader workstation. The PC based Afterloader workstation comes with functionality to support PDR procedures (i.e. Scheduling of treatments). The modifications to the previously cleared device K953946 are: - Addition of RCU and NSD previously cleared device K902533 . - Addition of Radiation Status Indicator . - Changes to TCS to enable the PDR workflow . - Addition of Smoothbase, part of previously cleared device K031158 . The software runs on a PC with a Windows XP platform.

The provided text is a 510(k) summary for the Nucletron MicroSelectron PDR, a remote-controlled radionuclide applicator system. It describes modifications to a previously cleared device (MicroSelectron HDR) and asserts substantial equivalence. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance.

Specifically, the document focuses on regulatory compliance for a modified medical device, outlining its intended use, technological considerations, and comparison to predicate devices, rather than presenting a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a specific study proving the device meets these criteria based solely on the provided text.

Here's an analysis of what information is and is not present in the document, in relation to your questions:

1. A table of acceptance criteria and the reported device performance

• Not present. The document states that the MicroSelectron PDR is "substantially equivalent" to a predicate device (MicroSelectron HDR, K953946). This regulatory assertion implies that its performance is expected to be similar or equal to the predicate, but it does not define specific acceptance criteria or report performance data for the modified device itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present. The document does not describe any specific performance study with a test set, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not present. No ground truth establishment process for a test set is described.

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

• Not present. No adjudication method is described.

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

• Not present. This device is a remote-controlled radionuclide applicator system for radiation therapy, not an AI-powered diagnostic imaging tool that would typically undergo MRMC studies with human readers assisting with interpretation.

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

• Not present. The device is hardware and software designed to "enable an operator to apply...a radionuclide source." It is not an algorithm for standalone performance evaluation in the context you're asking about (e.g., image analysis). The software (TCS) supports the PDR workflow and manages treatment plans.

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

• Not present. No specific ground truth is referenced as no performance study is detailed.

8. The sample size for the training set

• Not present. No training set for an algorithm is mentioned or implied.

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

• Not present. No training set or ground truth establishment for it is mentioned.

Summary of Device and Regulatory Context (based on provided text):

The document is a 510(k) premarket notification for the "MicroSelectron PDR," a modified version of the "MicroSelectron HDR" (K953946).

• Device Type: Remote controlled radionuclide applicator system (Afterloader)
• Intended Use: To enable an operator to apply, by remote control, a radionuclide source into or onto the body for radiation therapy (Interstitial, Intracavitary, Intraluminal, Bronchial, Intra-operative).
• Modifications:
  • Addition of RCU and NSD (previously cleared device K902533).
  • Addition of Radiation Status Indicator.
  • Changes to TCS (Treatment Console Software) to enable PDR workflow.
  • Addition of Smoothbase (part of previously cleared device K031158).
• Substantial Equivalence: Asserted to MicroSelectron HDR (K953946).
• Regulatory Class: Class II, Product Code JAQ (21 CFR 892.5700).

The 510(k) pathway primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if different, does not raise different questions of safety and effectiveness. It often does not require new comprehensive clinical studies detailed with acceptance criteria in the same way a PMA (Premarket Approval) might. The focus here is on regulatory equivalence rather than a detailed, standalone performance study with quantifiable acceptance criteria.

Ask a specific question about this device

Oncentra-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy.

Oncentra-VISIR is a verification system designed to be a tool for supporting the process of preparing, setting up, delivering and recording radiation therapy. It will retrieve data from doseplan systems and simulators automatically or by manual input from the user. It will help administer patient sessions through the booking functionality. At each individual treatment Oncentra-VISIR will present setup data to the operator and also to the linac through a specific interface. Actual setup will be verified. During treatment Oncentra-VISIR can monitor the progress of both Monitor Unit values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded.

The main areas of modification to the previously cleared device K972617 are:

• Image Based Verification (IBV) .
• This module allows the user to schedule image acquisitions on the treatment machine. Once the images are acquired thev are compared to a reference image such as a DRR or digital simulator image. Automated edge detection will mark both the reference and control image and perform a comparison. A resultant displacement is translated into the treatment couch shifts required to reposition the patient correctly for the desired beam placement within the patient.
• Improved user interface improved layout of data making it easier for the user to navigate . and display the data they require. Also improved workflow requiring less clicking and password entry than before.
• Optional double signature for treatment lets 2 therapists sign for treatment delivery .
• Dynamic MLC IMRT support .
• Live MLC display in treatment screens .
• More flexible port filming options such as film only and orthogonal film modes .
• Image acquisition (port film) scheduling .
• Detailed audit trail tracks all changes to patient data with time/date/signature stamps of anv . edit

The software runs on a PC on a Windows NT, 2000, or XP platform.

This submission K041719 for Oncentra-VISIR is a Special 510(k), meaning it's a modification to a previously cleared device (K972617). Special 510(k)s often do not include extensive new performance studies if the modifications are considered minor and do not introduce new risks or significantly alter the fundamental operating principles. The provided text primarily focuses on describing the modifications and affirming substantial equivalence to the predicate device.

Therefore, the document does not explicitly describe acceptance criteria or a dedicated study proving the device meets new performance criteria in the way a traditional 510(k) for a novel device would. The core of this submission is demonstrating that the modifications to the Oncentra-VISIR (previously Helax-VISIR) do not negatively impact its existing safety and effectiveness and that the new features function as intended without introducing new risks.

Based on the provided text, here's an analysis of what can be inferred or is explicitly stated, with a strong caveat that the detailed information requested regarding specific performance testing and statistical analysis is largely absent.

Summary of Device Performance (Based on Affirmation of Substantial Equivalence and Feature Descriptions):

The document focuses on the functionality of the modifications, implying their intended performance is met through internal verification and validation rather than a comparative clinical study against specific acceptance criteria. The key modifications are:

• Image Based Verification (IBV):

  • Functionality: Allows scheduling of image acquisitions on the treatment machine.
  • Performance (Implied): Images acquired are compared to a reference (DRR or digital simulator image). Automated edge detection marks reference and control images. Performs a comparison. A resultant displacement is translated into treatment couch shifts.
  • Acceptance (Implied): The system accurately identifies edges, calculates displacement, and translates it into appropriate couch shifts for correct patient repositioning for desired beam placement. Precision and accuracy of this process would have been verified internally during development, but no specific metrics are provided.

• Improved User Interface/Workflow:

  • Functionality: Easier navigation, reduced clicking, fewer password entries.
  • Performance (Implied): Enhanced usability.
  • Acceptance (Implied): User testing or internal evaluation would have confirmed the improved user experience and workflow efficiency.

• Optional Double Signature for Treatment:

  • Functionality: Allows two therapists to sign for treatment delivery.
  • Performance (Implied): Secure and auditable verification.
  • Acceptance (Implied): Confirmed functionality as a security/verification step.

• Dynamic MLC IMRT support:

  • Functionality: Supports Inverse Modulated Radiation Therapy with dynamic Multi-Leaf Collimators.
  • Performance (Implied): Compatibility and proper functioning with IMRT.
  • Acceptance (Implied): System correctly integrates and controls MLC movements for IMRT.

• Live MLC display in treatment screens:

  • Functionality: Real-time display of MLC positions during treatment.
  • Performance (Implied): Accurate and timely display.
  • Acceptance (Implied): Visual confirmation of MLC operation.

• More flexible port filming options:

  • Functionality: Options like film only and orthogonal film modes.
  • Performance (Implied): Enhanced imaging flexibility.
  • Acceptance (Implied): Confirmed ability to operate in new modes.

• Image acquisition (port film) scheduling:

  • Functionality: Ability to schedule port film acquisitions.
  • Performance (Implied): Reliable scheduling and execution.
  • Acceptance (Implied): Confirmed scheduling capabilities.

• Detailed audit trail:

  • Functionality: Tracks all changes to patient data with time/date/signature stamps.
  • Performance (Implied): Comprehensive and accurate logging.
  • Acceptance (Implied): Confirmed logging of all relevant details.

Detailed Response to Requested Information:

Since this is a Special 510(k) for modifications, the typical structure for a new device's performance study is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (Implied for IBV)	Reported Device Performance (Implied from Description)
   Accurate Image Comparison & Displacement Calculation:	"Automated edge detection will mark both the reference and control image and perform a comparison. A resultant displacement is translated into the treatment couch shifts..."
   - Precision of edge detection	(Not specified)
   - Accuracy of displacement calculation	(Not specified)
   - Correct translation to couch shifts	(Not specified)
   Effective Patient Repositioning:	"...reposition the patient correctly for the desired beam placement within the patient."
   - Reduction in setup errors	(Not specified)
   Improved User Interface/Workflow:	Improved layout, easier navigation, less clicking and password entry.
   - Enhanced usability	(Not specified, but implied by 'improved user interface')
   - Workflow efficiency	(Not specified, but implied by 'improved workflow requiring less clicking')
   Functional Dynamic MLC IMRT Support:	Supports Dynamic MLC IMRT.
   - Compatibility with IMRT	(Not specified, but implied by 'supports')
   Accurate Live MLC Display:	Live MLC display in treatment screens.
   - Real-time accuracy of display	(Not specified)
   Robust Audit Trail:	Detailed audit trail tracks all changes to patient data with time/date/signature stamps.
   - Comprehensive and tamper-proof logging of data changes/signatures	(Not specified, but implied by 'detailed audit trail tracks all changes... with time/date/signature stamps')

   Note: The provided text describes functionalities of the modifications, implying their intended performance is met, but does not provide quantitative acceptance criteria or detailed results from specific performance tests for these new features. It relies on the substantial equivalence argument for the overall device's safety and effectiveness.

2. Sample Size used for the test set and the data provenance:

   • Not explicitly stated. As this is a Special 510(k) for software and feature modifications to an existing device, it's highly likely that testing was performed internally by the manufacturer (Nucletron B.V.) using a combination of simulated data, phantom studies, and potentially internal clinical review, but no specific sample sizes or data provenance (country of origin, retrospective/prospective) for formal test sets against acceptance criteria are provided in the public summary.

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

   • Not applicable / Not explicitly stated. The document does not describe the establishment of ground truth by external experts for a test set in the context of clinical performance evaluation for the modified features. Ground truth for the underlying radiation therapy planning and delivery would be based on established medical physics principles and clinical standards. The "Image Based Verification" feature would rely on algorithms to establish "ground truth" through image registration and edge detection, not human experts for that specific functional test.

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

   • Not applicable / Not explicitly stated. There is no mention of an adjudication process for a test set, as no formal clinical performance study with human readers assessing diagnostic outcomes is described.

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. An MRMC comparative effectiveness study was not performed or referenced in this 510(k) summary. This device is a verification system for radiation therapy, not a diagnostic AI system intended to improve human reader performance in interpreting medical images.

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

   • Implied for specific features, but not explicitly detailed. The "Automated edge detection" within the Image Based Verification (IBV) module would operate in a standalone manner to identify edges and calculate displacement. However, the overall Oncentra-VISIR system is a "human-in-the-loop" device as it provides tools for operators to prepare, set up, deliver, and record radiation therapy, and the operator ultimately makes decisions based on the system's output. The document doesn't provide specific standalone performance metrics for the automated functions.

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

   • Not explicitly stated for a clinical test set. For the Image Based Verification, the "ground truth" for image comparison is a "reference image such as a DRR or digital simulator image." Accuracy would be measured against the known geometry of phantoms or the established reference image, rather than a clinical ground truth like pathology for diagnostic purposes.

8. The sample size for the training set:

   • Not applicable / Not explicitly stated. The modifications described are primarily software feature enhancements and integration rather than a machine learning/AI model that would require a distinct training set in the typical sense for image interpretation. The "automated edge detection" is likely based on established image processing algorithms rather than a deep learning model requiring a large training dataset as understood today for AI.

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

   • Not applicable / Not explicitly stated. (See point 8).

Conclusion:

The K041719 submission for Oncentra-VISIR is a Special 510(k) focusing on software and functional modifications to an already cleared device. As such, it primarily asserts substantial equivalence and describes the added functionalities. It does not contain the detailed, quantitative performance studies against specific acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader studies that would be expected for a novel device or a device introducing entirely new diagnostic capabilities leveraging artificial intelligence. The performance and safety of the modified device are substantiated by verifying the internal functionality of the new features and their integration within the existing, cleared system, rather than through a public summary of a clinical trial.

Ask a specific question about this device

Swift is a software application intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources.

Swift is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

Swift is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician with anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source. The modified device is an accessory to an afterloader. The program consists of two modules: Treatment Planning Software: Swift and Database: Smoothbase. The software runs on a Windows XP platform.

It sounds like you're looking for a detailed breakdown of the acceptance criteria and study data for the Nucletron Swift 2.0 device based on the provided text. However, the provided text does not contain the specific information you're asking for regarding acceptance criteria, device performance, study details, and ground truth establishment.

The document is a 510(k) summary for a medical device (Nucletron Swift 2.0), which primarily focuses on:

• Device Identification: Trade name, common name, classification, manufacturer.
• Predicate Device: Identification of the legally marketed device it's substantially equivalent to.
• Description of Modifications: New functionalities added to the previously cleared device (e.g., Encoder, 3D Ultrasound acquisition, 3D VOI contouring, 3D Catheter recognition, Inverse Plan).
• Intended Use: The same as the predicate device, for brachytherapy treatment planning.
• Substantial Equivalence Statement: A declaration that it's equivalent to the predicate.
• FDA Clearance Letter: Formal approval from the FDA.
• Indications for Use Statement: The approved medical use for the device.

There is no information in the provided text about:

1. Acceptance criteria
2. Reported device performance metrics
3. Sample size for test sets or training sets
4. Data provenance (country, retrospective/prospective)
5. Number or qualifications of experts
6. Adjudication method
7. MRMC comparative effectiveness studies (or effect size)
8. Standalone (algorithm only) performance studies
9. Type of ground truth used (pathology, expert consensus, outcomes data)
10. How ground truth was established for training or test sets

This type of detailed performance data is typically found in the full 510(k) submission, specifically in sections related to performance testing, clinical data, or software validation, which are not included in this summary document.

To answer your request, you would need access to the full 510(k) submission documents for K031158 (Nucletron Swift 2.0) and potentially K022739 (Real Time HDR), as the Swift 2.0 is an updated version of the latter.

Ask a specific question about this device

OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

The Oncentra Treatment Planning (OTP 1.2) system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities". OTP 1.2 contains the following Activities: Anatomy Module: Structure Definition, Target Definition, Image Registration. Beam Module. Connectivity Module. DICOM Import / Export. Dose Module. Evaluation Module: Plan Evaluation, Volume Rendering. In addition, various system utilities are available. The software runs on a Windows XP platform.

This appears to be a 510(k) premarket notification for a radiation therapy planning system (OTP 1.2). The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets such criteria in terms of performance metrics.

The document is a summary of safety and effectiveness information, comparing the device to a predicate device (TheraPlan Plus, K970236) to demonstrate substantial equivalence. It describes the device's intended use and technological considerations but does not present a performance study with detailed acceptance criteria and results in the way a medical device submission often would for novel performance claims.

Therefore, most of the requested information cannot be extracted from this document. I will fill in what can be inferred or explicitly stated, and note where information is missing.

Here's a breakdown based on the provided document:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated or quantified in this document. The submission focuses on substantial equivalence to a predicate device (TheraPlan Plus, K970236) rather than demonstrating specific performance metrics against pre-defined acceptance thresholds for accuracy, sensitivity, or specificity.
• Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, precision, dose calculation discrepancies) are reported in this summary. The assessment of equivalence relies on the device having the same intended use and similar technological characteristics to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not mentioned. No specific test set or study validating performance is described.
• Data Provenance: Not mentioned, as no specific performance study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable, as no ground truth establishment for a specific test set is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable, as no performance study with a test set requiring adjudication is described.

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

• MRMC Study: No, this document does not describe an MRMC study or any study involving human readers or AI assistance in that context. The device is a "Radiation Therapy Planning System," not typically an AI-assisted diagnostic or interpretation tool in the sense of an MRMC study.

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

• Standalone Performance Study: Not described in this document. The submission focuses on substantial equivalence based on intended use and technological features, rather than a standalone performance evaluation against pre-defined metrics.

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

• Type of Ground Truth: Not applicable, as no performance study using ground truth is described.

8. The sample size for the training set

• Sample Size (Training Set): Not mentioned. This device is a "Radiation Therapy Planning System" software, which typically involves algorithms for dose calculation, image processing, and 3D rendering. It's not explicitly stated to be an "AI" or machine learning device that would have a traditional "training set" in the common understanding of those terms. If it uses internal parameters or lookup tables, the data used to derive these is not mentioned.

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

• Ground Truth Establishment (Training Set): Not applicable, as no training set or its ground truth establishment is described.

Ask a specific question about this device

The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited. This device is intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy.

The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer. The radiotherapy treatment planning software is covered by a separate 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System. The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.

The provided text describes a 510(k) premarket notification for a medical device called the "microSelectron®HDR - GENIE Afterloading System". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (microSelectron-HDR V2, K953946), rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a novel AI/software medical device.

Therefore, many of the requested categories related to studies, sample sizes, ground truth, and expert evaluation are not directly applicable or present in this specific 510(k) summary. The information provided is primarily about the device's technical description, intended use, and its relation to a predicate device.

Here's an attempt to address the points based only on the provided text, noting where information is not available:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

This submission is for a medical device (a remote-controlled afterloading system for radiation therapy) that is demonstrating substantial equivalence to a predicate device (microSelectron-HDR V2). It is not presenting a performance study against predefined acceptance criteria for accuracy or efficacy in the same way a software or AI device submission would. The "acceptance" is based on the FDA's determination of substantial equivalence.

Therefore, a table of acceptance criteria and reported device performance, in the context of a new performance study, cannot be generated from this document. The performance is implicitly deemed acceptable because it is substantially equivalent to a device already on the market.

Additional Requested Information (Based on provided text)

1. A table of acceptance criteria and the reported device performance:

   • N/A. As explained above, this document is a 510(k) for substantial equivalence, not a performance study against novel acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided. This type of information is typically associated with performance studies, which are not detailed in this 510(k) summary. The submission focuses on the technical characteristics and intended use being similar to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not provided. This information is relevant for performance studies involving expert review, which is not described here.

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

   • Not provided. This is relevant for performance studies involving expert review, which is not described here.

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. This device is a "Remote Controlled Afterloading System" for radiation therapy, not an AI or imaging diagnostic device that would involve human readers interpreting cases. Therefore, an MRMC study is not applicable in this context.

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

   • Yes, to some extent. The document states: "The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device." While this refers to the hardware system, the core of the submission (and the "study" in a very broad sense) is about the technical specifications of the device itself, functioning independently of real-time human interpretation or decision-making in a diagnostic sense. It's a control system for radionuclide application.

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

   • Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this submission is implicitly the functional and safety performance of the predicate device (microSelectron-HDR V2). The new device is asserted to be substantially equivalent in its design and intended use. The "truth" being established is that the device safely and effectively performs its stated function of applying a radionuclide source, similar to the predicate.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context.

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

   • Not applicable. As above, there is no "training set" for this type of device.

Summary of the "Study" and "Acceptance Criteria" for K021286:

The document K021286 is a Special 510(k) Premarket Notification for the Nucletron microSelectron®HDR - GENIE Afterloading System. The "study" presented here is a demonstration of substantial equivalence to a previously cleared predicate device, the microSelectron-HDR V2 (K953946).

• Acceptance Criteria (Implicit for Substantial Equivalence): The primary acceptance criterion for a 510(k) is that the new device has the same intended use as a legally marketed predicate device and has technological characteristics that are sufficiently similar to the predicate device that it can be determined to be as safe and effective as the predicate device. Minor differences in technological characteristics must not raise different questions of safety and effectiveness.
• Reported Device Performance (Implicit): The functional performance is asserted to be equivalent to the predicate device. The description highlights that the new system is an "entry-level" version with only three treatment channels and uses similar software and applicators as the predicate. The statement "The Nucletron microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels" and "The operators console ... concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device" serves as the core of this claim.
• Proof: The entire 510(k) submission, by outlining the similarities in intended use, technological characteristics, and specifications, serves as the "proof" for substantial equivalence. The FDA's letter (pages 2-4) confirms that they found the device to be substantially equivalent.

Ask a specific question about this device

Nucletron Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

The Nucletron Implant Guidance System as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR, and is intended for interstitial brachytherapy procedures. The Nucletron Implant Guidance System Applicator Set consists of an insertion needle with a plastic sheath, which is inserted through the skin surface into the target volume. The insertion needle is then removed and a closed end plastic catheter is placed into the sheath. A marker on the side of the insertion obturator insures the proper depth of catheter placement. Once the catheter is in place the sheath is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. The catheter is then cut level with the button and attached. A closed end treatment needle is then inserted into the catheter, once in position a metal needle stopper is slid over the needle to the button surface and locked. Radiographic images, planar films or transverse slices, i.e. CT. MR is obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the treatment needle is then attached to the Nucletron remote afterloading equipment (treatment head), mHDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment needles and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions, which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation. When the treatment session is complete, the treatment needles are detached from the transfer tube and remote afterioading equipment. The treatment needles are then removed from the patient. When the course of treatment is completed the catheters and buttons are removed from the patient. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.

The provided text describes a Special 510(k) submission for the Nucletron Implant Guidance System Applicator Set, which is intended for interstitial brachytherapy procedures. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification (510(k)) to the FDA, demonstrating substantial equivalence to previously marketed predicate devices. It focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Technological Considerations: How it compares to predicate devices.
• Regulatory Classification: Its classification under FDA regulations.
• Substantial Equivalence Determination: The FDA's letter confirming substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and a study proving their fulfillment. The information requested, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions, would typically be found in a performance study report, which is not present in this regulatory submission.

Ask a specific question about this device