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OnQ rts software is stand-alone software that provides a means of visualizing and comparing medical image data from multiple DICOM compliant imaging modality devices. It is used for the display, evaluation, co-registration and fusion of medical images, contour of anatomical structures and radiation therapy dose distributions to aid in radiation therapy planning, diagnostic radiology, oncology and other medical specialties. Note: The software is not for use with digital mammography

OnQ rts® is a stand-alone medical imaging software program that imports DICOM images from different modalities and provides imaging tools to visualise, compare, contour, co-register medical images, anatomical structures and radiation therapy dose distributions. These procedures are performed by manual, semi-automatic techniques which extract anatomical information for image contouring and analysis from the DICOM data. The system can operate as a single workstation or with multiple workstations, with one of them being the server networked with multiple clients and remotely via Citrix® terminal services. OnQrts is not intended for use with hand-held mobile devices.

OnQ rts software includes the import and export of DICOM data securely via a network connection. The imported images, from different modalities, are processed to provide a clinical picture of the anatomy and corresponding radiation therapy doses. OnQrts co-registers images together, using rigid image registration (RIR) and elastic/deformable image registration (DIR) or a combination of both. These images can display imported or generated contours (anatomical and dose) overlaid onto the fused images.

OnQ rts contouring can be performed manually or .automatically from a library of user defined or prepared pre-contoured CT cases. The library atlas files act as a template that is then mapped to the patients' anatomy. The contours are reviewed and approved before export, e.g. to radiotherapy planning software. OnQrts can import radiation therapy treatment planning data (dose and dose distributions) which can then be displayed for review, radiation therapy dose comparison and analysis. The software provides contour companson tools using a range of comparison metrics that highlight variations between VOIs in terms of size, shape and location. OnQ rts is not a radiation therapy treatment planning system and can only display and evaluate dose plan information generated from radiation therapy equipment.

The provided text describes the 510(k) summary for the OnQ rts® imaging software. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria or a dedicated performance study with specific metrics like sensitivity, specificity, accuracy, or dice scores. Instead, the "acceptance criteria" appear to be met through demonstrating substantial equivalence to predicate devices via non-clinical testing.

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

The document does not specify a sample size for a test set in the context of clinical performance evaluation. The "test plans" mentioned are for internal non-clinical validation. No patient data provenance (country of origin, retrospective/prospective) is provided, as no clinical testing was performed for substantial equivalence.

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

Not applicable. No clinical test set with expert-established ground truth was reported.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with adjudication was reported.

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 reported. This device is described as a standalone imaging software with manual/semi-automatic contouring capabilities, not explicitly an AI-assisted tool in the context of improving human reader performance.

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

The document focuses on the software's functionality as a standalone tool that aids in clinical tasks. It mentions "auto contouring" and "atlas based segmentation" which implies algorithmic components, but no performance metrics for these features in isolation are provided in the summary. The overall evaluation is for the software system, not solely an algorithm's standalone diagnostic performance against a ground truth.

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

For the non-clinical testing, the "ground truth" was implicitly based on the expected behavior and accuracy of the implemented features, likely compared against predefined computational or functional specifications rather than clinical ground truth (e.g., pathology, expert consensus on patient images).

8. The Sample Size for the Training Set

Not applicable. The document does not describe a training set for a machine learning model in the conventional sense. The "library atlas files" mentioned for auto contouring act as a template, but the size or nature of this "training" data isn't specified in terms of machine learning training.

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

Not applicable. No specific training set for a machine learning model is described in the provided text.

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Oncology Systems Model ACU-007S Source Assembly, with an individual activity up to 12Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.

This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, or chemotherapy.

Oncology Systems, Inc. Model ACU-007S is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a single solid radioactive 192 Iridium pellet sealed in a stainless steel capsule that is attached to a cable. Its purpose is to permit manipulation by the Oncology Systems, Inc AccuSource 1000 remote afterloader system for the treatment of cancer and other lesions.

The provided text is a 510(k) summary for the Oncology Systems, Inc. Model ACU-007S 192 Iridium Brachytherapy Source. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or image quality, which are common for diagnostic or AI-powered devices.

As this is a brachytherapy source, the "acceptance criteria" and "study" described in the prompt are not applicable in the way they would be for a diagnostic or AI device. The submission focuses on physical and technical characteristics, intended use, and equivalence to a legally marketed predicate device.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This type of performance data (e.g., sensitivity, specificity, accuracy) is not included in the document for a brachytherapy source. The "performance" here relates to its functional characteristics and safety, which are implicitly accepted by demonstrating substantial equivalence.
2. Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of diagnostic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth determination study is described.
4. Adjudication method for the test set: Not applicable.
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 applicable. This device is not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide:

The document primarily focuses on establishing substantial equivalence to a predicate device (Source Production and Equipment Company Model M-19, K052947). This is the key "acceptance criterion" for a 510(k) submission of this type.

Key information provided related to "acceptance" for this type of device:

• Intended Use: The device is intended for the treatment of cancer and other lesions by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. This is a critical aspect for regulatory acceptance.
• Technological Characteristics: The device is described as a singly-encapsulated 192Iridium Brachytherapy Source consisting of a single solid radioactive 192Iridium pellet sealed in a stainless steel capsule attached to a cable. Its similarity to the predicate device (Source Production and Equipment Company Model M-19) in utilizing photons from 192Iridium is highlighted as the basis for substantial equivalence.
• Predicate Device Comparison: Section 12.1 (mentioned but not included in this extract) would detail the comparison of similarities and differences with the predicate device. This comparison forms the "study" demonstrating that the new device is as safe and effective as the predicate.
• Regulatory Classification: The device is classified under 21 CFR 892.5730 as a Radionuclide brachytherapy source, Regulatory Class II, Product Code KXK. This classification dictates the regulatory pathway for acceptance.

In summary, for K092522, the "acceptance criteria" are met by demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of its design, materials, and intended use, rather than through a clinical performance study with statistical metrics.

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The Accu-Source™ remote control high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.

The Accu-Source™ is a remote afterloading system for High Dose Rate Brachytherapy. The system is designed to deliver a predetermined dose of radiation to organs and tissue via a radioactive source. The ACCU-SOURCE™ system includes an operator console and a remote afterloading device. The ACCU-SOURCE™ system has a tungsten shielded storage safe which houses a radioactive source when the system is not in use. There are encoders and motors used in conjunction with electronic circuitry that drive the source and keep track of its position. A battery is used for back-up power and an uninterruptible power supply is also integrated into the ACCU-SOURCE™ system to charge the battery backup subsystem.

The provided document is a 510(k) summary for a medical device called Accu-Source™, a Remote Control High Dose Rate Afterloading Brachytherapy Device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a formal clinical study with performance metrics as one might see in a de novo or PMA submission.

Therefore, the document does not contain the acceptance criteria and study details as requested in the input prompt (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic device).

Instead, it focuses on demonstrating that the Accu-Source™ device is substantially equivalent to a legally marketed predicate device (Nucletron MicroSelectron HDR Version 2). This is done through a comparison of technical specifications, intended use, and general features.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

• Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the context of a performance study. However, the implicit acceptance criteria for a 510(k) submission are that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is demonstrated by showing similar specifications and performance characteristics to the predicate.
• Reported Device Performance: The document provides a comparison table of technical specifications between the Accu-Source™ and its predicate, the Nucletron MicroSelectron HDR Version 2. This table highlights features, intended use, and various physical and operational parameters. The "performance" here is described by these specifications, rather than quantitative metrics from a clinical study.

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

• Not Applicable: The document does not describe a clinical performance study with a test set of data. It is a comparison of technical specifications against a predicate device.

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

• Not Applicable: No clinical performance study or ground truth establishment is described for a test set.

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

• Not Applicable: No clinical performance study or 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:

• Not Applicable: This device is a remote afterloading brachytherapy system, not an AI-assisted diagnostic tool involving human readers.

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

• Not Applicable: This device is a physical brachytherapy system, not solely an algorithm. Its performance is demonstrated through its physical and operational specifications.

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

• Not Applicable: The concept of "ground truth" for a performance study is not relevant in this 510(k) submission, which focuses on substantial equivalence based on technical specifications and safety features.

8. The sample size for the training set:

• Not Applicable: No machine learning or algorithm development with a training set is described.

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

• Not Applicable: No machine learning or algorithm development with a training set is described.

In summary: The provided 510(k) summary for the Accu-Source™ device establishes substantial equivalence by comparing its technical specifications and intended use to a predicate device, rather than through a detailed clinical or diagnostic performance study that would typically involve acceptance criteria, test/training sets, expert ground truth, or MRMC studies.

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